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Chapter 6:  Strategies for Successful Clinical Negotiation

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Introduction, section 6.1: introduction.

• SECTION 6.2: MENTALLY PREPARING
• SECTION 6.3: SETTING THE AGENDA
• SECTION 6.4: CONSTRUCTING THE STORY
• SECTION 6.5: TOUCH (EXAMINE) THE PATIENT
• SECTION 6.6: SEEKING DYADIC UNDERSTANDING—TOWARDS A SHARED REPRESENTATION OF ILLNESS
• SECTION 6.7: STEP 6: OUTLINING A PLAN
• SECTION 6.8: STEP 7: CONFIRMING SHARED UNDERSTANDING
• SECTION 6.9: SPECIAL CASES
• SUMMARY POINTS:
• QUESTIONS FOR DISCUSSION:
• Full Chapter
• Supplementary Content

Effective clinical negotiation rests on understanding the patient’s concerns, developing realistic goals, and working collaboratively to achieve them. In this way, clinical negotiation overlaps with shared decision-making.

The consumerist model of shared decision-making grants pre-eminence to patient preferences, while the clinical negotiation paradigm gives equal weight to professional expertise and experience.

Clinicians should:

Take a few moments to mentally prepare for each encounter.

Allow the patient time to present their complete agenda.

Develop a chronological understanding of the current illness.

Conduct a focused physical examination, as the exam yields essential information, creates connection with the patient, and signals the clinician’s unique expertise.

To better understand how the patient thinks about their illness, ask direct questions, show empathy, and pursue information uncovered in the history of present illness or suggested by the patient’s own statements.

Generate a collaborative plan by summarizing what has been learned, suggesting a tentative course of action, asking for the patient’s input, integrating the patient’s feedback, and proposing a modified plan.

Confirm shared understanding.

When thinking of negotiation in ordinary life, most people probably imagine two parties with divergent interests facing off across a boardroom table. In clinical practice, however, negotiation mostly takes place between allies, is constrained by the guardrails of professionalism, and is often implicit. The clinician recommends something that is painful (like an injection or blood draw), inconvenient (like taking a medication daily for many years), expensive (like submitting to a treatment not covered by insurance), or risky (like surgery). In collaboration with the clinician, the patient decides whether the potential benefits are worth the costs—measured not just in dollars but also time, sequelae, and risks. Through a combination of words, gestures, and actions, the patient telegraphs their degree of enthusiasm for the recommended treatment. The patient who is not comfortable with a prescribed medication, for example, may not say so explicitly; rather he might simply miss pills, “forget” to obtain refills, or switch physicians. If the physician is attuned to subtle signs of the patient’s unease, she might be able to produce an effective counter-offer: consolidating multiple blood draws, prescribing medicines that are easier to take and cheaper to purchase, suggesting a less-invasive surgical option. If not, the patient will find his own way.

However implicit or explicit the negotiation, it helps to have a strategy.

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Job Negotiations in Academic Medicine: Building a Competency-Based Roadmap for Residents and Fellows

• Perspective
• Published: 01 October 2018
• Volume 34 , pages 146–149, ( 2019 )

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• Rebecca A. Berman MD, FACP 1 &
• Amy S. Gottlieb MD, FACP 2  

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Negotiation skills are critical to career success, yet many physicians feel ill-equipped to negotiate for professional opportunities. Enhancing competencies in this arena may be especially critical for women and underrepresented minorities to reduce disparities in compensation and resources that begin upon entry into the workforce as junior faculty. This perspective offers a comprehensive overview of negotiation strategies and the job search process for individuals finishing medical training and seeking first-time employment. First, we extrapolate lessons from clinical medicine to provide a negotiation roadmap for residents and fellows. We use both a clinical and an employment scenario to illustrate the concept of principled negotiation in which negotiating partners elicit each other’s values and interests and identify options for mutual gain. We then describe approaches to seeking and negotiating job opportunities and discuss typical timelines for these activities. We supply a list of professional needs to consider before a negotiation begins and introduce the concept of a best alternative to negotiated agreement to help ensure essential requirements are met in a final employment offer. Finally, we explore the utility of third-party assistance and published benchmarks and offer best practices for negotiating.

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Negotiation skills are critical to career success. 1 Research, as well as our own observations leading negotiation workshops, reveals that many physicians feel uncomfortable or are ill-equipped to negotiate for jobs or professional opportunities. 2 , 3 , 4 , 5 It is time to move the cultural needle, at the very least to help trainees launch themselves into fulfilling, productive careers. Enhancing negotiation competencies may be especially critical for women and underrepresented minorities. 6 , 7 , 8 Evidence suggests that these individuals experience disparities in compensation and access to resources important for professional success and that inequities begin upon entry into the academic medical workforce as junior faculty. 9 , 10 , 11 , 12 , 13 , 14 , 15

We in the medical profession model and practice negotiation strategies routinely while providing care for our patients. 16 Thus, we must recognize our collective experience and begin talking about negotiation with our trainees in the context of job seeking. Acknowledging that senior physician-faculty may not feel confident initiating these types of discussions or have an arsenal of job-seeking experience to draw upon, we offer below a competency-based negotiation roadmap as well as some nuanced guidance. We anchor our approach within the context of a clinical scenario (see Text Box 1) to illustrate aspects of successful negotiation that exist within a typical professional endeavor.

Text Box 1: A clinical scenario illustrating key negotiation principles

The clinical scenario provides an excellent example of what Fischer and Ury termed principled negotiation in their classic negotiation text, Getting to Yes , and is distinct from positional negotiation . 17 Positional negotiation focuses on a specific viewpoint rather than on the ideas that engender a particular stance. Relying on positional negotiation , the physician in the case would insist that her patient needs a colonoscopy without initiating a dialogue with him about the recommendation. Conversely, principled negotiation rests on give and take as well as on appreciative inquiry, reflective listening, and identification and discussion of mutual goals.

Similar to thoughtful clinical care, successful negotiation often takes time and may require multiple conversations that build upon one another. The goal of a first negotiation encounter is to understand the other person’s rationale, challenges, and interests and to gain agreement to discuss again. The doctor’s understanding of the benefits of colon cancer screening and her successful efforts to elicit information from the patient about his perceived obstacles allow her to identify solutions that reflect evidence-based practice and address the patient’s concerns. Text Box 2 illustrates how these same clinical skills could be applied to a job negotiation.

Text Box 2: Applying clinical skills to a job negotiation

In addition to applying familiar clinical strategies to career negotiation, trainees (and those mentoring trainees) may benefit from the competency-based roadmap below. This roadmap provides a guide to seeking and negotiating a first position after residency or fellowship.

COMPETENCY #1: NETWORKING

It is critical to start the job search early. In academic medicine, new hires usually begin in July. Although networking in general is part of one’s ongoing professional development, it should accelerate a year before graduation. This is an opportune time to introduce oneself, gain general job advice, and get on the radar of individuals who may ultimately be helpful in a job search.

Residents and fellows often find themselves seeking positions for which there are no formal job-postings, application processes, or deadlines. In order to identify potential opportunities, trainees should meet with program directors, mentors, senior colleagues, and peers the summer before graduation in order to share big-picture career interests (for example, research or medical education). Most people love to give advice, and in the process, individuals develop an understanding of a trainee’s professional intentions, often become personally invested in his or her job search, and are able to provide introductions or recommendations. Additionally, if relocating to another city, reaching out to training program alumni in that geographic area to get an overview of the local marketplace is useful.

Professional societies are fertile ground to initiate job-related conversations and cultivate connections. Many have formal mentorship programs that allow access to senior faculty nationally. Attending regional and national conferences of these organizations should be a priority, if finances allow, in the year prior to a concerted job search. Going to sessions given by individuals at target institutions provides an opportunity to learn more about work being done at those organizations and creates a forum for personal introductions afterward.

At most academic medical institutions, the fiscal year begins October 1. Prior to that, few organizations can identify with certainty their capacity for new hires. For graduating trainees, job interviews will typically extend from the fall into the winter, and contracts may not be signed until early spring.

COMPETENCY #2: IDENTIFYING THE “ASK”

Job negotiations are not just about salary. They should reflect all facets of one’s professional life that impact career success. 18 Everything is up for negotiation at the point of entry into an organization. Once a position has begun, it may be harder to request and obtain resources. Taking a flexible approach, rather than focusing on salary alone, offers more options to achieve a satisfactory negotiation outcome while allowing the future employer to safeguard equity with existing employees. In preparing for negotiation conversations, candidates should make an exhaustive list of professional needs (see Text Box 3) and rank order them.

Text Box 3: Alphabetical list of professional needs to consider in job negotiation

COMPETENCY #3: IDENTIFYING A BATNA AND PRIORITIZING PREFERENCES

A Best Alternative to a Negotiated Agreement, i.e., a BATNA, is a term from the business literature to describe an identified backup plan for a failing negotiation. 17 Each side has a BATNA. The more BATNA(s), the stronger one’s negotiating leverage. In the context of job negotiations, BATNAs often refer to a candidate’s other employment prospects that set the minimum standard for a position being negotiated. An alternative offer can be an effective BATNA only if it is a viable option that one is willing to pursue.

Additionally, within a particular job, there may be opportunities to leverage one’s professional and personal priorities to gain a stronger negotiating position. Is salary more important than title? Is having no in-house call more important than the amount of telephone call? Is having a part-time research assistant more important than having an administrative assistant? Before any job negotiation takes place, candidates should identify and rank order these important preferences. Recognizing what is and is not a deal-breaker will make compromising on lesser-valued aspects of the negotiation easier. For example, if having guaranteed protected time is one’s top priority, then compromising on other elements (e.g., base salary) will come more easily.

To establish BATNAs as well as a list of personal and professional priorities, one must first understand the marketplace. Obtaining objective data, similar to the clinical case above, soliciting input from experienced colleagues, and developing impressions from interviews for similar positions inform this process. Identifying concrete negotiating options based on self-reflection, evidence, third-party guidance, and, if possible, alternative job opportunities is critical. Having options engenders leverage at the negotiating table.

COMPETENCY #4: OBTAINING THIRD-PARTY ASSISTANCE

Job negotiations can feel like an onslaught of details, rules, and regulations that often vary by state. It is useful to engage third-party assistance for support in the process.

Mentors can be helpful both to prepare for negotiations and, potentially, to advocate on one’s behalf if things go awry. Although relying on a trusted mentor to read through job offers may be an option, we believe it is prudent to hire an attorney to do this work. A good attorney will help identify and keep track of critical details. For example, if negotiating for a part-time position, is call pro-rated in the contract? Although a lawyer will not typically negotiate the contract directly, she can offer useful advice and serve as a confidential resource. For example, one of our trainees hired an attorney who identified that a “non-compete” clause in her contract was standard in the trainee’s target city. This knowledge allowed the trainee to redeploy her energies toward other aspects of the contract that were negotiable and thereby saved some of her negotiating leverage. The small monetary investment, approximately $500, is worthwhile to ensure that terms of the employment agreement are clear and fair. There is no need to advertise the fact that an attorney has been consulted. Additionally, both mentors and attorneys can serve as reality checks as one revisits priorities and BATNAs that arise during the negotiation process.

COMPETENCY #5: NEGOTIATING

Giving oneself permission and encouragement to negotiate is essential. Clinical training has provided the skills necessary for success. Similar to a challenging patient encounter, during a negotiation one must understand the negotiating partner’s rationale, challenges, and interests. It is important not to get entrenched in a particular position. By getting a sense of each other’s values and principles, parties can consider and identify areas of mutual benefit.

Separating the person from the problem is also critical. Again, as physicians, we are skilled at this approach. In a job negotiation, the personality of one’s negotiating partner is not the problem that needs to be solved.

We recommend relying on market and institutional data to the greatest extent possible to support the negotiation. Additionally, asking alumni connections in a given city for local salary conventions may be useful. For those who feel uncomfortable asking about salaries, a mentor can help investigate local market practices as well. We strongly encourage obtaining salary information from national benchmarking sources. The Association of American Medical Colleges (AAMC) publishes a list of faculty salaries at US medical schools by geographic region and private versus public status. 19 It is readily available for purchase but expensive. Medical Group Management Association (MGMA) is another salary resource but may be more difficult to obtain as an individual. 20 Institutions often use a combination of these two benchmarks (AAMC and MGMA) to devise salary scales. Trainees should ask their program directors to borrow institutional copies of these resources, if they exist.

Most negotiations involve challenging moments. We recommend negotiating in person or, second best, by phone. Email and text tone can be misinterpreted and it is best to limit electronic communication during a negotiation when possible. If at a loss for words, using open-ended questions and reflecting back what was said can provide both parties time to gather thoughts and gain insights. If a negotiation comes to a standstill, asking for a break to think things over and then return to the discussion later is prudent. Negotiations take place over time. It is better to arrive at a positive outcome than to rush to an undesirable end.

FINAL THOUGHTS

Negotiating a job is a process with multiple points of contact. The first meetings should be introductory with the goal of presenting oneself, discussing career goals, and identifying how one might fit into an institution’s broader vision. The main purpose of the first interview is to articulate one’s career interests and skillset, to be enthusiastic about the job opportunity, and to learn more about the position and the needs of the institution. At this point, negotiations should be broad and focused on general desires. For example, “I’m hoping to have a largely clinical job with some precepting and ideally some protected time for a medical education role.” This is not the time to be negotiating salary or benefits. Once a position has been offered, then it is time to prioritize one’s list of needs to determine the ask and begin discussing aspects of the position that are most personally important (e.g., more protected time). Negotiations often involve many meetings over several months, and some of the nitty-gritty details (like time allotted for continuing medical education) may be negotiated in the final stages once the contract has been drafted. Additionally, licensing, DEA application, and credentialing with insurance companies can take 4 to 6 months to finalize after committing to a job, and it is important to be aware that patient care cannot occur until these processes have been completed.

By harnessing negotiating skills honed in clinical training and using this competency-based roadmap, residents and fellows can begin their first position with the best chances for professional success. Faculty should encourage trainees to be intentional in their job negotiations and reinforce the message that what they want is out there. They only need to ask.

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Rebecca A. Berman MD, FACP

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Correspondence to Rebecca A. Berman MD, FACP .

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A workshop by the two co-authors entitled “Build Your Own Negotiation Toolkit” was presented at the Society of General Internal Medicine’s Annual Meeting in Denver, CO, USA, on April 13, 2018.

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Berman, R.A., Gottlieb, A.S. Job Negotiations in Academic Medicine: Building a Competency-Based Roadmap for Residents and Fellows. J GEN INTERN MED 34 , 146–149 (2019). https://doi.org/10.1007/s11606-018-4632-2

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Received : 20 February 2018

Revised : 01 June 2018

Accepted : 03 August 2018

Published : 01 October 2018

Issue Date : January 2019

DOI : https://doi.org/10.1007/s11606-018-4632-2

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Negotiation skills for clinical research professionals.

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Perspectives in Clinical Research , 01 Jul 2011 , 2(3): 105-108 https://doi.org/10.4103/2229-3485.83224   PMID: 21897886  PMCID: PMC3159209

Abstract 

Free full text , negotiation skills for clinical research professionals, sanjay hake.

Department of Clinical Operations, Boehringer Ingelheim India Pvt. Ltd., Bandra (East), Mumbai - 400 051, India

Tapankumar Shah

Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors.

• INTRODUCTION

Negotiation may be defined as a process of producing a desirable outcome with the agreement of the other party using knowledge, time or power.[ 1 ]

The level of an individual's negotiation skills is based on two competencies:

One's ability to use the right mix of knowledge, time, and power to conceptualize the negotiation process determines the level of strategic competency.

One's ability to efficiently implement the negotiation strategy determines the level of execution competency. One needs to have effective communication skills to be a competent executive.

While negotiating the focus should be on the interest then the position. The reason being position is a proposal or Negotiated Solution identifies only one pathway forward and is likely to be rejected whereas, interest is the why of the proposal, which usually identifies several pathways forward and pathway in common is often the solution sought to be achieved.[ 2 ] The motive while negotiating should be to ascertain interests of the opposite party and communicating our interest.

• OBJECTIVES OF NEGOTIATION

Negotiation is a part of day-to-day life with various objectives like:

Saving money, time, or effort,

Getting a job or a contract or a project or an order,

Getting better services, etc.

Influencing behavior or changing relationship

Sometimes people also negotiate for:

Beating the opposition to prove superiority, or

Winning an argument to satisfy ego

Over and above the above-mentioned objectives, in clinical research, one also negotiates for compliance and deliverables.

Steps for successful negotiation

Negotiation needs advance planning and patience because the objective is to establish the terms on which parties with differing and often conflicting aims will co-operate. Following are the steps for successful negotiation [ Figure 1 ]:

Categories of steps for successful negotiation

Prepare well for the Engagement

Creating Value: develop effective and creative solutions that meet the needs of everyone involved in the negotiation.

Allow Creative Flexibility: drive innovative thinking, rather than aggression, confrontation, arguments or disagreements.

Understand Negotiation Styles: know your own style, as well as that of the counterpart. Also know your limitations, and how they can work for and against you.

Managing the Process: understand your movement through various stages of the process.

Handling Relationships: build strong relationships and develop trust.

Learning Mindset: keep abreast of changes in the industries in which we work. Continue learning and developing communication skills, as well as the techniques for relationship building, and persuasion.

• TYPES OF NEGOTIATION

Co-operative/competitive

Co-operative negotiators look for a win-win situation where both parties know that they were able to get the best possible result; whereas, Competitive negotiators aim to “win” in the negotiation. Their goal is to get as much value as possible for their objectives, whether their counterpart gets any satisfaction or not.

Inductive/deductive/mixed

Inductive refers to starting on small details and working upward until a settlement is reached. Deductive negotiations start with an agreed upon strategy.

Mixed negotiations are the most common; they are a blend of inductive and deductive methods.

Soft/hard/principled

Soft and hard bargaining involves negotiating a position rather than interests. Soft bargainers seek agreement despite great cost, and offer concessions as a way to create or preserve a positive relationship with the other side. Hard bargainers are competitive, hide their bottom line, and offer few concessions, if any.

Principled negotiation which is the recommended type of negotiation relies on interests rather than positions.

Phases of negotiation: Four main phases

Preparation: one needs to do their research well, update their facts, knowledge, and review previous examples or past precedents that might have bearing on the current situation prior to entering into a negotiation. When doing research and preparing for negotiations, there are some important considerations:

Collecting facts

Knowing priorities

Knowing principles

Identifying common grounds:

Agreeing on common ground in a negotiation means that there are some areas that can be excluded from bargaining, and that you are fostering a relationship with your counterparts.

Identifying your walk away position:

What is the least that you will accept (or the highest price that you are willing to pay)?

Identifying your next best alternative:

See if the issue can be settled before the bargaining phase begins if it meets your criteria as the next best alternative.

Exchanging Information: identifying the limitations and impacts to all parties and outlining options for consensus.

Bargaining: while bargaining never jump to a conclusion and also know when the bargaining is over.

Closing: secure the commitment to carry out the agreement and ask the other party to summarize their understanding of the agreement [ Figure 2 ].

How to retain your composure

Clinical Research (CR) professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. A course on negotiation skills must be included in the training and development programme for CR professionals.

The CR departments of pharmaceutical companies deal with the following internal and external parties:

Global clinical development team for the placement of clinical trials. Generally, these negotiations require all three elements - knowledge (experience, and talent of the people to execute a particular clinical trial in the best possible manner), time (timelines, speed), and power (potential of the market once the product is launched, recruitment potential)

Investigators for budget, compliance, and patient numbers. These negotiations mainly require effective communication skills and knowledge to negotiate the site budgets, achieve timelines, and target patient enrollment. Sometimes, power also has a role to play especially while dealing with non-compliant sites.

Contract Research Organizations (CROs) to negotiate budget, achieve timelines, and also for the best services.

Regulators for timely approvals using knowledge and effective communication skills.

In this article, we will discuss the negotiation skills required for the two most important roles involved in CR industry - Monitors, and Project Manager

Monitors/ clinical research associates

The monitor is a key person for the conduct of a clinical trial at site level. [ Figure 3 ] The quality of data, recruitment, and timelines are directly dependent on the monitor's negotiations with the site staff. Monitors also need good negotiation skills to negotiate the budget with the investigators. Considering the fact that the monitors are not the ultimate decision makers on most of the aspects, they need more of execution-oriented negotiation skills than the strategic negotiation skills; however, they must have proper blend of both execution oriented, and strategic negotiation skills.

Communication channel for monitors in a clinical trial

Graphical representation of the blend of negotiation skill required for the monitors [ Figure 4 ].

Graphical representation of the blend of negotiation skill required for the monitors

Project managers

Project Manager (PM) is a key person for the overall conduct of a clinical trial at the global or local level. [ Figure 5 ] Completion of a clinical trial within the timelines, and planned budget entirely depends on the PM. PM's role involves making projections, providing directions to other team members, and decision making. For the role that the PMs have to play, they need greater strategic negotiation skill than the execution oriented negotiation skills.

Communication channel for Project Manager in a clinical trial

Graphical representation of the blend of negotiation skill required for the PMs [ Figure 6 ].

Graphical representation of the blend of negotiation skill required for the PMs

• CONCLUSIONS

A CR professional is as successful as his/her negotiations skill are; hence, a training module on negotiations skills must be included in the training curriculum for CR professionals.

Negotiation is a set of skills that can be learned and practiced so that your ability to negotiate improves with each negotiation.

In a successful negotiation all parties win. Therefore, negotiation is not necessarily adversarial. Knowledge, power, time and personality are at play in every negotiation.

Not every negotiation is about reaching a win-win solution.

While negotiating, the length of the relationship is very important. Some (e.g., Labor) negotiations are about long-term relationships. The terms that you bring up in this kind of negotiation will have a long lasting effect on the company and its employees.

A sustainable agreement is one which reflects the reality of business and real issues that people face.

In negotiation, Time Really Is Money, because you can gain a lot of money for your organization by taking time to prepare in advance.

Every negotiation involves money is a misconception. According to Roger Dawson, an authority on negotiation: Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules (principles) and tactics (gambits). Also, advance preparation is a must.

Good negotiators strive for Win–Win outcomes.

• Acknowledgments

“Negotiation – A Key Competency for Clinical Research Professionals” A Learning and Development Program Presented by Dr. Aamir Shaikh, Founder, Assansa at ISCR workshop on 10 th April 2010

Source of Support: Nil.

Conflict of Interest: None declared.

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Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.

Negotiation Skills for Clinical Research Professionals

Upcoming Courses

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This interactive workshop is tailored to the key negotiation skills required for clinical research professionals. During this two-day workshop you will discover and put into practice the fundamentals of negotiation. Topics will include: communication mastery, preparing for a negotiation, persuading and influencing without authority, how to identify your negotiating parties needs, how to build rapport to create mutually beneficial negotiating outcomes, addressing difficult behavior and negotiating tactics, and transform conflict into collaboration. Case studies, scenarios, group discussion, negotiating planning and practice and review of best practices in negotiation will be used throughout the workshop to enhance your learning experience.

• Develop key communication (verbal and non-verbal) strategies
• Describe and apply the critical steps for a successful negotiation
• How to influence without authority
• Create and analyze a negotiating matrix (template)
• Design and conduct a successful negotiation (face-to-face or virtually)
• Confidently negotiate in difficult situations
• Develop strategies so that all parties benefit from the negotiation process and outcome

• Site Managers
• Clinical Research Associates
• Clinical Research, Managers
• Project Managers
• Team Leaders
• Clinical Research Professionals involved in procurement, resource management and negotiations

The course will be led by one of the following instructors:

Natalie Currie, B.Sc.

Click here for complete trainer biographies

Day 1: 8:30 a.m. – 5:00 p.m.

• Core Communication Skills: Develop effective, verbal communication skills (including asking powerful questions that match your communication goals, engaging in active listening to build rapport and learn to effectively say no while supporting your professional relationships); Discover the role that non-verbal communication plays in negotiating (ensure that your non-verbal and verbal communication are fully aligned and learn to decode facial expressions, gestures and body language in others); Apply simple strategies to enhance cross-cultural negotiation; Match your communication medium to your objective (when should you make a telephone call verses sending an e-mail?)
• Team Dynamics: Recognize the role that team dynamics play in all negotiations; Cultivate high performance team behavior; Apply techniques to foster credibility and trust; Enhance your emotional intelligence; Develop skills to become more persuasive and influence without authority
• Negotiation Preparation: Determine your negotiation goals; Develop an effective negotiation strategy; Create and analyze a negotiating party map (strategies for building rapport and defining your negotiating parties goals (needs and wants); Create options for mutual gain through brainstorming; Determine mutually agreeable negotiating standards to create successful commitments; Conduct effective virtual negotiation sessions; Discover how the environment contributes to the negotiating outcomes; Teams develop their negotiation plan and enhance their negotiating strategy through coaching and group discussion

Day 2: 8:30 a.m. – 5:00 p.m.

• Negotiate in Challenging Situations: Identify difficult behavior and tactics used in negotiation; Transform tactics and conflict into highly cooperative collaboration; Proactively address impasses that may occur in negotiations; Project confidence and communicate persuasively under pressure
• Multi-party Negotiation Simulation: Participate in a multi-party negotiation simulation developed by leading negotiation experts; Obtain coaching feedback based on your participation in the negotiation simulation; Create a 30, 60 and 90 day personal action negotiation plan so that you can immediately apply the concepts and skills learned over the 2-day workshop

• Interactive verbal and non-verbal communication exercises
• Clinical research learning scenarios
• Video clip case study analysis
• Small group negotiation strategy planning
• Team brain-storming exercise
• Strategies for proactively addressing negotiating tactics and conflict
• A multi-party negotiation simulation
• Coaching feedback
• Customizable negotiation strategy planning and personal action planning templates

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.

Click here for our seminar cancellation policy

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.

Improving Communication in Clinical Research

By: Anatoly Gorkun, MD, PhD, Chartered MCIPD             Senior Manager, Global Clinical Development, PPD UK

Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

Introduction

Communication is a key tool for clinical researchers, yet problems due to inactive communication are common. It is important to monitor possible ineffective communication in order to develop effective solutions to proactively prevent the negative consequences of ineffective communication.

Some time ago, the author received feedback from two clinical trial managers (CTM) on the same clinical research associate (CRA) at the same time. One clinical trial manager said:

(CTM’s Name) “is perfectly performing as expected from an experienced CRA. Her time has been allocated to manage a few difficult sites. Due to her learning agility and deep experience, the situation is improving now. She is a very good team player.”

The other clinical trial manager told the author:

“I know this CRA is new to the company and is still learning; however, with the upcoming data cleaning, I need your help.

I would suggest she has a co-monitoring visit with someone who is experienced. She needs to understand that this reconciliation is not just making a match between source data vs. case report form but also questioning what is being reported and identifying gaps, and being able to address issues with the site staff.

I would appreciate your feedback and actions.”

Both studies were relatively similar, and in this specific example, the problem appeared to be the communication between the CRA and CTM.

The Importance of Communication in Clinical Research

There are various definitions of communication, including:.

“The imparting or exchanging of information by speaking, writing, or using some other medium.” ( oxforddictionaries.com )

“Two-way process of reaching mutual understanding, in which participants not only exchange (encode-decode) information, news, ideas, and feelings but also create and share meaning.” (businessdictionary.com).

The second definition is broader and reflects the nature of communication more accurately.

Poor communication in clinical research has many negative effects (Table 1) including stress, possible conflicts between clinical research professionals, and a breakdown in relationships. Other negative effects of poor communication are unmet expectations (ineffectiveness), wasted time because work is inefficient and must be re-done, non-compliance, possible harm to subjects, and possible invalidation of data.

As an example: an in-house CRA approached the line manager and said, “I’ve done what the project team wanted, but when I finished the task they said it was not what they expected.” The line manager asked if the CRA had checked with the project team before starting the task to clarify what they wanted. She said, “No, because the task seemed very clear.”

Communication that is free of assumptions is one of the characteristics of ideal communication (Table 2). It is important to listen, ask questions to ensure understanding of the task, agree to what needs to be done, and confirm the agreement. Communication is a two-way process that requires mutual understanding.

Successful Communication Methods

The most suitable method of communication depends upon the situation and to some extent, the receiver’s preferences. For urgent situations, a telephone call is best, followed by an email to summarize the call. The communicator should not bombard the person with emails, because he/she does not know whether the person is receiving and reading the emails. In some situations, more than one communication method is appropriate, such as emailing instructions and then following up with a telephone call.

Sometimes it happens that the site monitor and the in-house CRA as well as the project assistant may ask the research nurse at the site the same question. This may not be the most efficient approach. Communication should be streamlined in order to prevent it from being chaotic.

The following email communication is between a clinical trial manager (CTM) and a CRA on an urgent issue that required immediate attention. A delay in resolving the issue might affect deliverables and the company’s image.

• CTM → CRA, February 21: Check if all Adverse Events were entered into eCRF. Urgent, due in 2 days. Table attached.
• CTM → CRA, February 24: “A kind reminder, please.”
• CTM → CRA, February 24: “Please send me your answers today.”
• CTM → CRA, February 28: “I need your answers, please.”
• CTM → CRA, March 01: “Client requested us to provide the answer. Please complete this task.”
• CTM → CRA, March 06: “I need your answers URGENTLY please.”
• CTM → CRA, March 06: “Please do it tomorrow and let me know.”
• CRA → CTM, March 06: “I would do, but I don’t know what to check.”
• CTM → CRA, March 06: “The table is attached.”
• CTM → CRA, March 08: “Any news from the sites?”
• CRA → CTM, March 08: “Hopefully tomorrow.”

The clinical trial manager sent the first email to the CRA on February 21st and did not receive a reply from the CRA until March 6 th , nearly two weeks later. When the CRA responded that she did not know what to check, the CTM simply forwarded the same attachment. The CTM should have picked up the telephone and talked to the CRA.

Ideal communication is transparent. Transparency is:

“the perceived quality of intentionally shared information from a sender”

(Schnackenberg AK, Tomlinson EC. (March 2014). “Organizational transparency: a new perspective on managing trust in organization-stakeholder relationships,” Journal of Management . 10.1177/0149206314525202).

Transparency makes it easy for others to understand what actions have been completed and which actions need to be taken. It implies openness and accountability.

In another case, a project manager sent the following message to a line manager:

“As you know [name of CRA2] replaced [name of CRA1] at the end of March.

Unfortunately, by that date, the site performance decreased with late queries and SDV (Source  Data Verification) backlog due to pending monitoring visits.

Until today both sites still have not been visited and the plan is not available. I appreciate if you guarantee to have both sites visited by the end of April.”

The line manager spoke to the CRA, who said that the visits had been scheduled a long time ago. The project manager had been on holiday. When the project manager came back, he did not speak with the CRA about the status of the visits but instead escalated the issue.

Considerations in using appropriate communication include:

• The purpose of the specific communication
• How communicating will benefit the situation
• Whether something different can be done
• Whether alternative communication is necessary, and if so, the best method to use.

In the example, considering these four questions would have enabled the project manager to realize that talking directly to the CRA was the appropriate communication method for this situation.

In this case, the CRA needed advice from the CTM:

CRA: “I need to complete a number of overdue study-specific learning items on my LMS (Learning Management System) but I don’t have time. I am so busy.”

 CTM: “Then, do it wisely.”

The advice was not clear. Communication must also be concise. It is necessary to be clear about the purpose/goal of the message, to stick to the point, and to be brief.

Ideal communication is timely. In determining the best time for the message, the communicator must consider whether to communicate now or later. In some cases, it is better to wait and to communicate one message with another. It may also be helpful to pre-prepare the receiver of the communication with a brief heads-up.

A CRA was having communication issues with two clinical research sites. At the same time, this CRA had to deliver a presentation at a departmental meeting and wanted feedback from the line manager. The line manager knew that the sites were struggling to work with this CRA because of his insufficient communication skills. The line manager decided to wait a couple of days to speak with the CRA about his presentation/communication skills and the issue with the sites at the same time, as that was a good chance to demonstrate the importance of expressing thoughts clearly and explicitly.

It is also important to acknowledge receipt of an email or other communication when we are not going to provide our answer immediately. For example:

“I’ve received your message. It will take me a week to collect the requested information. I’ll get back to you by …”

Ideal communication is diplomatic and constructive. It is okay to disagree with someone; however, communication should focus on a person’s opinion or approach and not insult the person. For example, instead of saying,

“I don’t agree with you …,” say something like, “May I suggest that we discuss more options …”

An in-house CRA sent the following email message to a research nurse:

“I sent you my request 2 weeks ago, and it’s complete silence from your side. I find it so frustrating because we need to close all queries by the end of this week.”

The research nurse said that she would not respond to requests like this. After coaching the in-house CRA on communication methods, there was a visible improvement noticed, and the relationship with the site improved.

It is always better to be constructive. Avoid being very direct or pushy, and suggest options instead of criticizing or expressing frustration.

Ideal communication must be culturally respectful since clinical research is conducted internationally. Culturally respectful communication helps to avoid misunderstanding, to establish rapport, to build better relationships, and to facilitate more efficient work. Even among English-speaking countries, words or phrases can have slightly different meanings. For example, in the United States, “I hear what you say” means that the communicator accepts the other person’s point of view. In the United Kingdom, it may rather mean “I am not keen on discussing it further as I am not in agreement with this.” Also, accepting country or region-specific accents should be a part of cultural respect.

Ideal communication is also fair.

The following communication happened between a site monitor and a line manager.

Site monitor to line manager:

“I’m very busy and working very hard, however, I do not get enough support from the in-house CRA.”

The monitor’s line manager to in-house CRA’s line manager:

“I think that the in-house CRA might provide better support to the site monitor. Could you please check on the issue with the CRA’s performance and fix it?”

It turned out that the in-house CRA was doing a good job; however, the problem was that the site monitor needed to provide an explanation regarding the backlog of work that was created and decided to blame the in-house CRA for lack of support. Communication should be fair and should not blame other people unfairly.

Ideal communication is open, honest, and logical.

The following examples highlight communication between a line manager and a direct report during two performance reviews and a 1:1 meeting.

Mid-year performance review meeting, Line Manager to a direct report:

“You are leading a very important project really well. It’s going to be a great year for you!”

Monthly one-to-one meetings throughout the year:

The project delivery was on time and good quality. Every month, the line manager confirmed that she was happy with all of the work and there was nothing to improve.

End-of-year performance review meeting, Line Manager to a direct report:

“You’ve been struggling to deliver the project and managing it below expectations.”

The end-of-year performance review feedback was not logical because the previous messages were all positive. Ideal communication should avoid misunderstanding, conflicts, and disappointment.

Ideal communication is well-structured and compelling. Communicators should try not to tell a long story that makes it difficult for the receiver to determine what the communicator needs. This is important in everyday life with everyone, including communication with senior leaders and clinical investigators, both of whom are usually very busy.

The “rhetorical kipper” from Gareth Bunn can be used to plan communication. Using this model, communication is designed from the “tail of the kipper” and delivered from the “head.” After presenting the topic, three ideas or points are presented, and then finally, the request is made or the main message is delivered. The author’s direct reports found it useful to apply the rhetorical kipper method. Proper communication should be positive, assertive, and inspirational.

Case Study on Different Feedback

The case study presented at the beginning of this article illustrated different feedback from two clinical trial managers on the same CRA. One clinical trials managers stated that:

[CRA’s Name] “is perfectly performing as expected from an experienced CRA.

She has been allocated to manage a few difficult sites. Due to her learning agility and deep experience, the situation is improving now. She is a very good team player.”

I would suggest that she has a co-monitoring visit with someone experienced. She needs to understand that this reconciliation is not just making a match between source data vs. case report form but also questioning what is being reported and identifying gaps, being able to address issues with the site staff. 

I would appreciate reviewing your feedback and actions.”

The reason for the different feedback was not different complexity of the studies but that the clinical trial manager was micro-managing the CRA. She had a different management style than the CRA was used to. The first clinical trial manager delegated the tasks and trusted the CRA to complete them. The second clinical trial manager required daily reports from the CRA, assuming that if there was no daily report, it meant that the job was not done. She also had negative experiences working with a previous CRA and assumed that the new CRA would act in the same way.

Thus, the second clinical trial manager’s style was based more on assumptions. After a root cause analysis of the situation, the CRA learned how to recognize different working styles and started working with the second CTM more efficiently.

Many skills are required for appropriate and effective communication (Table 3), including listening and observing, planning, and dealing with difficult situations dearly and empathetically. Methods of ensuring that communication is appropriate and effective include awareness of communication issues (Table 4). If we face a communication issue, we should not assume that it will disappear by itself. A root cause analysis should be done to determine the cause of the issue, and then a plan should be developed to manage the problem. The plan should include feedback to ensure that the other person understands and accepts the plan. Line managers can arrange for soft skills coaching and training for people who need to improve their communication skills. If nothing else works, such issues can be escalated.

In clinical research, it is important to monitor possible ineffective communication approaches and to proactively develop effective solutions to prevent negative consequences.

The Effects of Poor Communication in Clinical Research

• Possible conflicts and breakdowns in relationships
• Unmet expectations (ineffectiveness)
• Waste of time (inefficiency)
• Non-compliance
• Possible harm to subjects
• Possible invalidation of data

Ideal Communication

• Assumption-free
• Proper methods utilized
• Transparent
• Appropriate
• Clear and concise
• Diplomatic and constructive
• Culturally respectful
• Open, honest, and logical
• Well-structured and compelling
• Proper communication style

Communication Skills

• Listening and observing
• Nonverbal communication (body language, facial countenance)
• Negotiations
• Dealing with difficult situations
• Friendliness
• Flexibility (open-mind)
• Giving and receiving feedback

Communication Strategies to Prevent or Fix Issues

• Be aware of communication issues
• Observe and discover issues
• Do not assume that the issues disappear by themselves
• Perform root-cause analysis 
• Feedback, and how to ensure that it is understood and accepted
• Soft skills coaching
• Soft skills training
• Escalating (if nothing else works)

6 thoughts on “Improving Communication in Clinical Research”

Nice article.thanks

Be sure to communicate in the mindset of a team member, or stakeholder with the same goals and not as an outsider looking in with judgement.

This is a great inspiring article.

Nice article! Thanks for sharing this informative post. Keep posting!

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Negotiation Skills Workshop

This workshop is designed for Predoc IRTAs, Postdoc IRTAs, Visiting Fellows, Research Fellows, Clinical Fellows, and Staff Scientists/Clinicians to learn effective strategies for handling negotiations.

This workshop is led by Scott Morgan, a Communications Specialist with The Morgan Group.

Participants will:

• Discover a wider range of options when dealing with negotiations and complicated interpersonal conversations.
• Explore what’s at stake, tips for managing emotions and reactivity, using mindfulness and neutrality as communication tools, as well as how we contribute to the complexity of the discussion.
• Discuss the basics of negotiations (job negotiations in particular) and creative strategies to find common ground for starting a meaningful dialogue.
• Learn how to say no, plan exit strategies, and learn strategies to build trust and long-term commitment.

This workshop is held annually in October.

Check your email and the OFT group on Microsoft Teams for event details.

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• The art of negotiating...

The art of negotiating as a doctor

• Related content
• Peer review
• Beryl De Souza , honorary secretary, Medical Women’s Federation ,
• Andrew Barton , London regional coordinator, British Medical Association
• 1 London, UK
• bds{at}dr.com

Beryl De Souza and Andrew Barton look at the importance to doctors’ work and careers of negotiation skills

We all need negotiation skills in our day to day lives. We negotiate with our family about how to spend holidays, we negotiate with contractors about when to come to the house for a delivery or repairs, and we negotiate in shops when making big purchases.

As doctors, we negotiate with patients when discussing treatment options and when agreeing our job plans and responsibilities. Each of these situations has a different level of risk and impact. Nonetheless, many of the skills of negotiation covered in industrial relations courses are transferable to other circumstances.

The importance of negotiation as a career skill for doctors is often not taught in medical school or in postgraduate training. But negotiation can be necessary in training—for example, to ensure a particular skill is learnt and practised. Negotiation is also important for academics and others when developing a job plan around dual commitments and deciding a workable and appropriately remunerated timetable.

The BMA provides extensive training on negotiation for its local negotiating committee representatives, and negotiation training is also available through BMJ Learning. Such training covers the concepts, knowledge, and skills needed to work in a team and negotiate terms and conditions in the workplace. Much of what is covered would be useful as part of a doctor’s role.

The classic example of where negotiation skills are needed is in job planning. This is where you might have to bargain hard to ensure you keep in your job plan what you believe will develop you as a doctor, such as an educational, college, or committee role that you find useful in your job. From the point of view of the staff of a trust or clinical commissioning group, they would want you to provide a service and there is a vital need for you to negotiate. There are two models that can be used in the job planning scenario: positional bargaining and principled negotiations.

Positional bargaining

Positional bargaining is the traditional model of negotiation, where each side takes a position, argues for it, and makes concessions to reach a compromise. When negotiators bargain over positions, they tend to lock themselves into those positions. Bargaining over positions creates incentives that stall settlement. The result is often an agreement that is less satisfactory to each side than it could have been.

Principled negotiations

Roger Fisher and William Ury 1 have developed an alternative to positional bargaining, a method of negotiation explicitly designed to produce wise outcomes efficiently and amicably. This method, known as principled negotiation or negotiation on the merits, will often result in a much more acceptable result as a “win-win” for both sides to the negotiations.

Anticipating the other side’s case

Negotiation deals with conflict and with uncertainty, and being informed helps you to manage both. Good organisation increases your bargaining strength. A major step in preparing for negotiations entails assessing the bargaining situation and making a realistic judgment about your relative bargaining strength. Negotiation also involves dealing with detail and analysing precisely what you are going to negotiate about. There are two main considerations: one is the issue you are negotiating about, and the other is the person you are negotiating with.

Negotiation is about trying to reach agreement, and this means that you have to deal with the other side’s case. Anticipating the other side’s case is an important part of your preparation. When the actual negotiation is in progress you will be trying to get information from them about how they see the situation, what their interests are, what they want out of the negotiation, what concessions they may offer, and what other options they have.

Planning a strategy

Never negotiate without a clear idea about what your objectives are. To clarify your objectives ask two basic questions:

What is the most I can realistically hope to get?

What is the least I absolutely need to have?

In deciding the most you can achieve, you must set demanding but realistic objectives. In deciding the least you can have you must think about what options you would have if no agreement were reached. What will you do if there were no agreement? What is your best alternative to a negotiated agreement (BATNA)? The negotiating range is the distance between the most that you can achieve and the least that you will accept. The concept of a BATNA is psychologically and strategically important. A good negotiator will always have anticipated in advance what to do if no agreement is reached.

All negotiators work towards agreement. It is essential that both parties agree what they have agreed with each other before they leave the table, and that the agreement is recorded in an acceptable manner. This is the way to pre-empt subsequent confusion, disagreement, and hostility. If the summary of what it is that you believe has been agreed does cause conflict, then it is necessary to re-open negotiations until you can find an agreement. Failure to reach full agreement before you implement a deal is as disastrous as trying to implement a deal that has not been agreed at all.

Many skills of negotiation are transferable to other areas of our lives, and the box looks at some examples of using negotiation skills training in other aspects of doctors’ daily lives. If this article has whetted your appetite for discovering more about developing negotiation skills perhaps you should consider being a BMA representative on a local negotiating committee to learn more.

Using negotiation skills

Quality improvement.

A lead clinician in a hospital who was implementing a new care pathway for patients would use a wide range of negotiation skills, including influencing skills, identifying areas of resistance, and planning a strategy to overcome any difficulties.

Team working

Negotiation skills can help individuals become more diplomatic and persuasive and improve team working relationships. Encouraging a more collaborative approach can also improve patient care.

Family life

Trying to arrange anything in some families can be exasperating, with everyone pulling in different directions, but negotiation skills can help with this. Planning skills can be used to create “win-win” situations and compromises can be reached by trading off different perspectives.

Job planning

Doctors sometimes find themselves having to cope with an unfair job plan or extra work being expected without any recognition. Sometimes a number of doctors in an area feel the same, and this can have a demoralising effect on work-life balance. Learning negotiation skills can give such doctors the confidence to create an action plan for their next job plan review, with the aim of incorporating all work into a new job plan and negotiating extra supporting professional activities (SPA) time for education.

Competing interests: We have read and understood the BMJ’s policy on declaration of interests and have no relevant interests to declare.

• ↵ Fisher R, Ury W. Getting to yes: negotiating agreement without giving in. Random House, 1991.

Collaboration in a competitive healthcare system: negotiation 101 for clinicians

Affiliations.

• 1 Australian Institute of Health Innovation, Macquarie University , Sydney, Australia.
• 2 Townsville Executive Team, Townsville Hospital and Health Service, Douglas, Australia.
• 3 Health and Wellbeing Service Group, Townsville Hospital and Health Service, Douglas, Australia.
• 4 Townsville Skills Centre, Townsville Hospital and Health Service, Douglas, Australia.
• 5 Clayton Utz, Brisbane, Australia.
• PMID: 29624132
• PMCID: PMC5925852
• DOI: 10.1108/JHOM-12-2017-0333

Purpose The purpose of this paper is to evaluate the effectiveness of negotiation training delivered to senior clinicians, managers and executives, by exploring whether staff members implemented negotiation skills in their workplace following the training, and if so, how and when. Design/methodology/approach This is a qualitative study involving face-to-face interviews with 18 senior clinicians, managers and executives who completed a two-day intensive negotiation skills training course. Interviews were transcribed verbatim, and inductive interpretive analysis techniques were used to identify common themes. Research setting was a large tertiary care hospital and health service in regional Australia. Findings Participants generally reported positive affective and utility reactions to the training, and attempted to implement at least some of the skills in the workplace. The main enabler was provision of a Negotiation Toolkit to assist in preparing and conducting negotiations. The main barrier was lack of time to reflect on the principles and prepare for upcoming negotiations. Participants reported that ongoing skill development and retention were not adequately addressed; suggestions for improving sustainability included provision of refresher training and mentoring. Research limitations/implications Limitations include self-reported data, and interview questions positively elicited examples of training translation. Practical implications The training was well matched to participant needs, with negotiation a common and daily activity for most healthcare professionals. Implementation of the skills showed potential for improving collaboration and problem solving in the workplace. Practical examples of how the skills were used in the workplace are provided. Originality/value To the authors' knowledge, this is the first international study aimed at evaluating the effectiveness of an integrative bargaining negotiation training program targeting executives, senior clinicians and management staff in a large healthcare organization.

Keywords: Negotiation; Non-technical skills; Resilient health care; Training.

Publication types

• Evaluation Study
• Competitive Behavior*
• Cooperative Behavior*
• Health Facility Administrators / education*
• Health Personnel / education*
• Interviews as Topic
• Middle Aged
• Negotiating*
• Program Evaluation
• Qualitative Research
• Young Adult

Contract Negotiation

Why does it take so long to negotiate contract terms and language in CTA?

After required study documents are submitted to RMG CT Intake Team , your study will be assigned a Clinical Trail Contract Officer (CTCO) to negotiate the CTA terms and language.

Your CTRMG team takes a collaborative approach to negotiating CTAs. With this approach, a successful negotiation upholds Stanford policies, as a nonprofit educational institution, while also partnering with for-profit sponsors. This partnership is grounded on mutually acceptable terms within the CTA.  

It is important to take time necessary to ensure that Stanford’s specific needs are addressed and when necessary to communicate with any third party parties involved in conducting the study. Sometimes an agreement on contractual terms between parties with such different fundamental organizational purposes requires escalation for final approval.

Stanford’s contract requirements differ between company-sponsored trials and investigator-initiated trials.

We take time to ensure we agree on the best possible agreement and strengthen our relationship with sponsor. 

Whenever possible, we encourage sponsors to use the Accelerated Clinical Trials Agreement (ACTA), a Master Agreement with reasonable compromise language that was collaboratively developed by a working group of different stakeholders, including pharmaceutical companies, not-for-profit organizations, and academic research institutions. Use of this standardized agreement greatly expedites the contracting process.

Many industry sponsors prefer to use their own CTA template and when it does not comply with Stanford’s institutional requirements, negotiation on the contract’s terms and conditions is required.

Stanford currently has over 100 Master Agreements in place with pharmaceutical, device and biotechnology companies and use of these existing agreements also greatly expedites the negotiation process.

There are 6 key areas of concern that often require negotiation and may delay contract execution: intellectual property, study data, indemnification, subject injury, confidentiality, and publication rights. Reimbursement procedures are also often addressed within the contract terms.

Some investigational device studies require Stanford Hospital to negotiate a Purchase Agreement with the sponsor. Please refer to hospital website link in Resources section for the online form to initiate this agreement.

How to work with your CTCO to support contract negotiation process

Reach out at any time to the CTCO assigned to your study.  Your scheduled KO meeting is an ideal time to bring up any questions you may have regarding the CTA. If not yet determined, at this meeting the CTCO will confirm the following details:

• Was PI involved in writing the protocol?
• Will any intellectual property arise from conducting the study?
• Does the PI have any financial disclosures to be considered?

Who signs the CTA?

Principal Investigator as Signatory . As a PI, you are not party to the CTA since you will be performing the agreement solely in your capacity as a Stanford employee.  However, PIs sign the CTA to attest that they have read and understood its terms and their obligations and responsibilities. A PI does not have authority to sign a CTA on behalf of Stanford.

Key CTA Negotiation Hot Points:

1. Intellectual Property (IP) Rights

IP Rights refer to patents and other intellectual property rights in inventions. Stanford does not include copyrights in the category of IP rights that may be assigned to sponsors by CTA. While Stanford employees are required to assign rights to patentable inventions to the university all rights in copyright remain with the creator and thus, Stanford cannot assign to sponsor rights that it does not have.

2. Study Data

CTA should include terms to allow PI

• access to final study data and analysis for data from all sites
• retain a copy of Stanford generated data to document the research & provide patient care
• to publish Stanford data

3. Indemnification

When a sponsor- initiated study involves a drug or device, the sponsor must indemnify, defend and hold harmless all Stanford affiliated parties from and against all claims, liability, damage, loss or expense arising from conducting the study that are not due to Stanford’s negligence or willful failure to follow the protocol.

For example, sponsor must cover claims arising from subject injury or illness caused by the investigational product according to the protocol. Also, claims from the sponsor’s use of study data and any IP rights granted to the sponsor must be covered.  For investigator-initiated studies, the sponsor’s liability for these claims is restricted to areas the sponsor is responsible for (e.g. manufacture of the product or use of study data).

4. Subject Injury

When a sponsor- initiated study involves a drug or device, the sponsor must agree to provide funding to cover medical care costs for any study related injury or illness. As a general policy, the sponsor’s subject injury obligation should cover a subject’s medical care costs regardless of whether these costs are covered by the subject’s insurance. Stanford does not agree to bill a subject’s insurance for injuries sustained in connection with an industry-sponsored clinical trial.

For investigator-initiated studies (IIS), Stanford will cover subject injury medical costs and the CTAs are reviewed by Stanford’s Risk Assessment Committee (RAC) so that the financial risk to Stanford may be assessed. If the risk is determined to be too high, RAC may not allow study to proceed.  

5. Sponsor’s Confidential Information

Sponsors may require confidentiality of sponsor-provided information and study terms and may request that the data generated by the study be treated as confidential information for purposes other than academic publication. Due to Stanford’s openness in research policies, neither the existence of the CTA nor the identity of the study may be confidential. Stanford should have the right to disclose the confidential information as needed, to review, conduct and oversee the study, to adhere to applicable regulations and to assure appropriate medical care of study subjects.

6. Publication Rights

As an educational and research institution, Stanford’s basic mission is the discovery and publication of new ideas and technologies.  CTA must provide for the right to publish and present research results. As part of Stanford’s commitment to openness in research, Stanford does not agree to let sponsors keep study results confidential, prevent their publication, or “hide” bad results.

Other Contractual Requirements that may be Problematic

Insurance Coverage:

Sponsors are expected to maintain, through study period and for a reasonable period after study has ended, a level of insurance (defined by Stanford IRB’s determined risk level of the study) to cover their financial obligations under the CTA.

Use of Stanford Name:

Sponsor must agree not to use Stanford name or logo in press releases, marketing or any other promotional documents without Stanford’s prior review and written approval.

Restrictions to conducting research:

CTA may not restrict Stanford from engaging in other research. For example, with the assumption that this is clearly discussed in the informed consent, investigators should be able to collect, retain and use tissue specimens from study subjects for research unrelated to the study and the investigational drug or device being tested.

• PI as Signatory
• Initiate a contract with Stanford Hospital (Device studies)
• Negotiating for Success (ASCO published article)

Negotiation Skills for Clinical Research Professionals

12 - 13 April 2011

Interactive workshop

Philadelphia, Pennsylvania, US

This interactive workshop is tailored to the key negotiation skills required for clinical research professionals. Topics will include: communication mastery, preparing for a negotiation, persuading and influencing without authority, how to identify your negotiating parties needs, how to build rapport to create mutually beneficial negotiating outcomes, addressing difficult behavior and negotiating tactics, and transform conflict into collaboration.

Organiser: Barnett Educational Services

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Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense

An essential course for all clinical research professionals involved in the clinical trial agreement and/or budget process for industry-initiated trials..

Although designed from a site perspective, the course outlines key elements for consideration by both sponsors and sites. The course highlights important aspects of creating a budget for a clinical trial such as protocol analysis and per-subject budgeting including start up, variable and hidden costs of a clinical trial.

This interactive course incorporates knowledge checks and real-world scenarios you are likely to encounter during the creation and negotiation of a clinical trial agreement and budget.

Participants will get the following tools:

• Common Budget Categories
• Examples of Start Up Costs
• Examples of Variable Costs
• Examples of Budget Footnotes

Upon completion of this training program, participants should be able to:

• Describe an industry-initiated clinical trial budget.
• Detail the phases of budget development.
• Describe the budget negotiation process.

This course helps clinical research personnel involved with agreements and/or budget process for industry-initiated trials and all other clinical research personnel build competency in Clinical Trials Operations (GCPs), Communication and Teamwork, Leadership and Professionalism, and Study and Site Management. Explore Competencies >

Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date

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Training needs of clinical research associates

Samyuktha ajay.

Clinical Operations, Feasibility and Site ID, Quintiles India, 5th Floor, Leela Business Park, M. V. Road, Andheri (E), Mumbai - 400 059, India

1 Clininvent Research Pvt Ltd, A-103, Everest Chambers, Marol Naka, Andheri - Kurla Road, Andheri (E), Mumbai - 400 059, India

Clinical research is a relatively new field in our country that has seen very rapid growth in the last few years. Availability of personnel appropriately trained to the specific requirements of the role they will perform in clinical research is critical for capacity expansion. Our study attempts to understand the specific areas of knowledge and skills that are important for the role of a clinical research associate. The survey was conducted among clinical research professionals from industry and academia who had more than five years of clinical research experience and held important decision making positions in clinical research (stakeholders). The survey questionnaire was designed as a matrix of various clinical research roles on the y-axis and six knowledge modules and eight skills on the x-axis. Respondents were asked to rate the importance of the knowledge /skills to the role of clinical research associates on a three point scale. In discussing results, a significant response was considered to be 50% or greater positive response from the total group. The significant findings were that general, ethics and clinical trial execution modules were rated as critical for the role of clinical research associate. Regulatory module was rated as important for the role. The other significant responses were that three of the sub-topics in the methodology module - framing a research proposal/protocol and experimental design, designing case report forms and EDCs and conducting PK studies - were rated as important and one sub topic in the data management and statistics module was rated as not important. All the skills except leadership skills were rated as critical for the role. The findings of our survey were in general on the lines of expectations of performance of the role. The general, ethics and clinical trial execution modules are critical knowledge areas for the role of a clinical research associate. No clear trends emerged for some of the other modules. Leadership skills were not rated as critical to the role. This kind of a survey gives a good direction when training curriculum has to be designed for specific roles in clinical research. However, there is a need to expand the sample size to fine-tune the knowledge and skills areas.

INTRODUCTION

GATT compliance in 2005 and the positive regulatory changes that ensued have made India an increasingly attractive location for clinical research. We have witnessed a rapid growth in this sector in the last few years[ 1 ] with projections for increased requirements for personnel in the various roles like clinical research associate (CRA), investigators, site coordinators, data management personnel, statisticians etc.[ 2 ] These roles are very well differentiated in terms of their performance expectations and availability of training tailored to the specific role requirements will be critical to capacity expansion.[ 3 ]

The CRA has the very critical role of ‘monitoring’ a clinical trial, which includes that the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). About the training of monitors, the GCP guideline mentions only that monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately and that a monitor’s qualifications should be documented.

Since clinical research itself is a relatively new field in India, we considered it is important to understand the requirements of knowledge and skills for the diverse roles. This paper describes the survey findings of the knowledge and skills needed for the role of a clinical research associate. We conducted a survey among key stakeholders in clinical research professionals in the industry, who by virtue of their positions had directly or indirectly employed or worked with CRAs.

MATERIALS AND METHODS

We chose to have the opinion of important stakeholders in clinical research on what they think are important knowledge and skill areas for a person performing the role of a clinical research associate. We looked for people who had more than five years of clinical research experience and held important decision making positions in clinical research (stakeholders). Forty eight such people were identified and they formed the population for this survey. The survey questionnaire was designed as a matrix of various clinical research roles on the y-axis and the areas of knowledge and skills on the x-axis.

Knowledge areas were further classified into six broad categories with sub-topics in each module as follows-

• Regulations
• Methodology
• Data management and statistics
• Clinical trial execution

Skills were classified as-

• Negotiation
• Conflict management
• Interpersonal skills
• Presentation skills
• Communication skills

Each respondent graded the importance of the area of knowledge/skill for the role by grading it as:

3 - Critical - Performance of the role is not possible without knowledge of this area

2 - Important - Knowledge is important, but not critical to performance

1 - Not important - Knowledge is not important for performance in the current role

In discussing results, descriptive statistics will be used. A significant response was considered to be 50% or greater positive response from the total group as described by Stonier and Gabby in a similar study conducted by them.[ 4 ]

Of the 48 questionnaires sent, we obtained 31 responses. Fifteen were from Indian CROs, six from multinational pharma companies, five from multinational CROs, three from Indian pharma companies and two from academic medical institutions [ Table 1 ].

Role profile of respondents

The work experience distribution was as follows:

Knowledge modules

A frequency distribution of grades for knowledge areas and skills are given in Tables ​ Tables2 2 and ​ and3 3 [ Figure 1 ].

Clinical research knowledge areas for clinical research associates

Clinical research skill areas for clinical research associates

Responses for the role of clinical research associate (n=31)

The key findings for knowledge and skills were as follows:

Knowledge areas

There were 31 responses for knowledge areas and 26 responses were considered as evaluable for skills areas.

The general, ethics and execution modules were rated as ‘critical’ by 50% and more respondents. All the sub-topics in the clinical trial execution module were rated as critical.

The regulatory module and all the sub topics within were rated as “important” by 50% or more respondents.

The other significant responses were –

• Sub topics - Framing a research proposal/protocol and experimental design, designing case report forms and EDCs and conducting PK studies were rated as ‘important’
• Data coding and cleaning were rated as “not important’ by 50% or more respondents.

Ratings for the other modules and sub topics did not reach significance level.

Data of 26 responders were considered as evaluable for the skills. All the skills except leadership skills were rated as ‘critical’ by more than 50% of respondents. Team work and conflict management received the highest number of “critical’ responses closely followed by negotiation, interpersonal, presentation and communication skills.

Our survey suggests that for the CRA role, knowledge of the subtopics within the general, ethics and clinical trial execution modules is critical. These modules included most of the sub-topics that directly impact his critical role of ‘monitoring’ a clinical trial- including the ethical aspects of the rights and well-being of human subjects and the execution aspects that the reported trial data are accurate, complete, and verifiable.

There was no clear trend otherwise, with the regulatory module and all the sub topics within it being rated as ‘important’. This is rather surprising to find as compliance with GCP, and with the applicable regulatory requirement(s) is also an important aspect of the monitoring role. It was also interesting to note that while significant number of stakeholders rated the execution aspects of pharmacovigilance and safety management as ‘critical’, the regulations pertaining to the same were rated as ‘important’.

The only other survey done in India to understand training needs was done in 2003, to give direction to the curriculum development for courses proposed by the Academy for Clinical Excellence (ACE).[ 5 ] We were involved in this survey as executive curriculum committee members and active contributors for the set-up of curriculum for ACE. The population surveyed included investigators, CRO and pharmaceutical industry professionals and academia. The questionnaire captured the response as a rating of the importance of training in four modules of clinical research: clinical research regulations and environment, clinical research administration, clinical research methodology and applied clinical research. The methodology module received the highest rating, with 38% respondents rating it as important. However, this survey did not cover specific knowledge subtopics or skills for different roles.

The CRA is the central point of communication between sites and the sponsor and it was as expected to find communication skills, presentation skills, computing, interpersonal, conflict management, negotiation and team work rated as critical. It was surprising to find no significant trends in leadership skills for this role, which was probably because of the understanding and perception of the term leadership.

Although our survey had a small sample size, the trends that emerged match the performance expectations of the role, validating the study data. The three point grading we used to grade the importance of the areas of knowledge and skills requirements was probably not discriminatory enough. Hence there was equal weight given to critical and important grades for some subtopics for the CRA role. It was probable that the grading of ‘critical’ and ‘important’ were directionally similar and not characterized enough to avoid interchangeable use. Besides, we had a larger number of industry respondents and under-representation of academia, probably skewing the data to industry expectations. Our respondents belonged to organizations of various sizes and types and their own experiences would have colored their perception of training requirements of this role. Also, there were few areas that were grouped as knowledge areas, which could probably be better classified as competencies, eg, writing investigators’ brochure or designing case report forms and EDCs. Another limitation of our study was that we had not added behavioral indicators to describe each of the skills terms.

Survey was launched in 2006 and since then the clinical research industry has grown exponentially, with much technological advancement –e.g. most studies are now using e-CRFs. The role of the CRA has also evolved from the traditional role of compliance monitor to a new one of site relationship builder is being discussed with different competencies.[ 6 ] Zimmerman includes skills in using and troubleshooting hardware- computers, peripherals and other office apparatus and knowledge of multiple software programs- standard word processing database, project management, productivity programs and custom designed intranet software program as important competencies in preparing CRAs for the 21st century.[ 7 ]

The challenge to define the training requirements of this role can be understood from the predicament that even the association of clinical research professionals (ACRP), the leading certifier of CRAs for the last several years, is still trying to define what the minimum education and training requirements for CRAs ought to be.[ 8 ]

This kind of a survey gives a good direction when training curriculum has to be designed for specific roles in clinical research. However, there is a need to expand the sample size to fine-tune the knowledge and skills areas.

Disclaimer: All opinions expressed herewith are those of the authors and do not reflect the views of their organizations.

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Negotiating Effective Clinical Trial Agreements and Study Budgets with Research Sites

Applied Clinical Trials

Negotiating skills can be applied to clinical trial agreements, budgets, and more for effective and fair contracts.

For each clinical trial, a clinical trial agreement (CTA) and budget are negotiated between the investigator and the sponsoring company so that the costs of carrying out the trial are reimbursed. Negotiation is a part of everyday life, especially in clinical trials. Many professionals and lawyers spend hours daily negotiating. However, few people have ever formally learned the strategies and techniques of effective negotiations, and even fewer still have mastered them. This article is aimed to share some lessons learned throughout my career as a clinical trial contract negotiator and team lead. The lessons learned have come from my own contract negotiation experiences in a variety of situations, as well as research on the most up-to-date negotiation theories and techniques.

It is important to understand the guiding principles that permeate the entire negotiation process. Some of these principles include:

• Negotiating strategically and not instinctively
• Importance of being prepared
• Protecting your reputation
• Expertise comes from knowledge and practice

Negotiate strategically, not instinctively

Let us say you are at your desk on a Monday morning following a long holiday weekend and you are overwhelmed by your to do list and your inbox, and wondering if this year's merit raise will in any way reflect your true value to the company. So, as you sit at your computer and start to dig out of the unrelenting number of messages, Jane, a contracts manager from a large academic university, calls and asks if you have a few minutes to chat about some outstanding budget items that need to be ironed out before the contract can be executed and the site initiation visit (SIV) can be scheduled. Knowing the value of this site and of the principal investigator (PI), who is a key opinion leader (KOL), you ultimately agree to take her call and walk through the budget issues. Since you're mostly up to speed with the current issues and intended to call Jane later in the day anyhow, you tell Jane that you are fine to chat now. You just ask Jane to hang on for a minute or two while you pull up the last revisions of the budget. While you dig up the necessary information Jane asks some innocuous questions to keep the conversation flowing. Once you find what you need, you jump right into the negotiations.

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Research: Negotiating Is Unlikely to Jeopardize Your Job Offer

• Einav Hart,
• Julia Bear,
• Zhiying (Bella) Ren

A series of seven studies found that candidates have more power than they assume.

Job seekers worry about negotiating an offer for many reasons, including the worst-case scenario that the offer will be rescinded. Across a series of seven studies, researchers found that these fears are consistently exaggerated: Candidates think they are much more likely to jeopardize a deal than managers report they are. This fear can lead candidates to avoid negotiating altogether. The authors explore two reasons driving this fear and offer research-backed advice on how anxious candidates can approach job negotiations.

Imagine that you just received a job offer for a position you are excited about. Now what? You might consider negotiating for a higher salary, job flexibility, or other benefits , but you’re apprehensive. You can’t help thinking: What if I don’t get what I ask for? Or, in the worst-case scenario, what if the hiring manager decides to withdraw the offer?

• Einav Hart is an assistant professor of management at George Mason University’s Costello College of Business, and a visiting scholar at the Wharton School. Her research interests include conflict management, negotiations, and organizational behavior.
• Julia Bear is a professor of organizational behavior at the College of Business at Stony Brook University (SUNY). Her research interests include the influence of gender on negotiation, as well as understanding gender gaps in organizations more broadly.
• Zhiying (Bella) Ren is a doctoral student at the Wharton School of the University of Pennsylvania. Her research focuses on conversational dynamics in organizations and negotiations.

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