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How to Present PhD Progress Report to Doctoral Committee Members in 03 Simple Stages

As I reflect on my journey through the challenges and triumphs of presenting my PhD progress to the doctoral committee, I’m reminded of the invaluable lessons learned and the transformative experiences gained along the way.

1. Diverse Committee Composition: From the outset, the composition of the doctoral committee struck me with its diversity—comprising experts from within and outside my university, each member brought a unique perspective and wealth of knowledge to the table. Their ability to seamlessly map my research problem to their respective domains underscored the richness of their insights and the importance of their feedback in shaping the trajectory of my study.

2. Thorough Preparation: Meticulously crafting my presentation was only the first step. I realized the necessity of thorough preparation, ensuring that each slide effectively communicated my research objectives, methodology, preliminary findings, and future directions. Despite the initial nerves, I remained composed and focused, drawing upon months of dedication and hard work invested in my research.

3. Anticipating Diverse Requests: During one particularly memorable meeting, the committee members had varied requests—one member asked for a demonstration of my work, while another member wanted to delve into the intricacies of my data collection, cleaning, and wrangling process. These diverse requests underscored the importance of being prepared for any eventuality during the presentation, including the need for live demonstrations and detailed explanations of data-related processes.

4. Embracing Constructive Criticism: I welcomed the committee’s feedback with an open mind. Their constructive criticism and encouragement not only bolstered my confidence but also reignited my passion for my work. I learned to recognize the invaluable role of feedback in guiding the next steps of my research journey.

5. Displaying Previous Meeting Observations: One valuable lesson I learned along the way was the importance of displaying and addressing previous committee meeting observations in subsequent presentations. It was during my second presentation that one committee member suggested this approach, highlighting the need to showcase how suggestions were addressed and incorporated into the research progress. From that point onward, I made it a regular practice to include this information in my presentations, ensuring transparency and accountability in my research journey.

In retrospect, each PhD progress presentation was a transformative experience, shaping me into a more resilient, prepared, and adaptable researcher.

As I reflect on the journey of presenting my PhD progress, I invite you to join me in exploring the intricacies of navigating these pivotal meetings. From preparation to presentation, and from feedback to refinement, each step of the journey offers valuable insights into the art and science of doctoral progress presentations.

Introduction

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The PhD Doctoral committee is constituted by the university in which the candidate has registered for PhD. The committe is there   to support and guide the research scholar  till his final thesis is submitted. The committe involves the experts in the domain of the candidate from various universities and research labs. The Committee will evaluate your progress and help to make sure that you are on track to get your dissertation within a reasonable time.

At the beginning of your research, their focus will be on making sure you have defined reasonable and achievable objectives. Later, they will help you decide when it is time to write your thesis. Finally, they will be there at your thesis seminar and defence presentations. Their support as mentors will likely continue as you move on in your career.

Doctoral committee meeting happens usually once in 06 months. Here it is expected that the research scholar has to present his  PhD progress work of the past six months. The meeting should not be felt like an exam. The outcome should be productive advice to you for your future research.

The  Presentation of  PhD Progress Report to Doctoral Committee Members happens in three stages namely: i) Before the meeting:   i.e. Once you start preparing the report for the meeting to till the meeting begins. ii) During the meeting:  i.e. From entering into the meeting hall to  till the meeting gets over and iii) After the meeting:   i.e. From the time meeting concludes to till the next six months before you really start preparing for your next meeting report.

Before the PhD Progress Presentation Meeting

Along with your supervisor go through all the comments given in the previous PhD progress doctoral committee meeting. Discuss in detail with your supervisor the work carried out for the past six months. If any issues are still pending have justification for not addressing or partially addressing those issues.

Do not hide details regarding the implementation and pending issues with your supervisor.  This actually helps the supervisor to defend you and take inputs from the committee members regarding the future course of directions.

A summary of  PhD progress and plans should be prepared and submitted to the  Doctoral committee at least one week prior to the meeting. Make sure that you have gone through the report with all grammatical corrections and plagiarism checks.

Send out the agenda to your committee members beforehand, but also remind them of the topics you want to cover before you begin the presentation. If you have any manuscripts published or accepted send your committee a copy of the same.

You should prepare a  PhD progress presentation (no more than 20 minutes without interruption) that includes a brief background of your research, objectives and the work carried out from the last presentation to till date. Without fail discuss in detail the presentation slides with your supervisor. In your presentation slides list all the previous comments and your response for each committee in the form of a table.

If you are planning to change the title of your work getting consent from the committee members is essential. Have at least    04-05 titles which you and your supervisor feel appropriate beforehand. This will ease the process of changing the title immediately in the meeting and the committee can recommend the same to the university along with regular suggestions.

The best way to ensure that your  PhD progress meeting goes smoothly is to meet individually with each committee member to discuss your results well in advance. If you cannot meet with them in person, share your results ( refer my blog on how to write result section ) over email and ask for their feedback. If there are any disagreements, resolve them before the meeting by speaking with your supervisor to ensure that the meeting goes smoothly.

During the PhD Progress Presentation Meeting

Before the start of the PhD progress presentation give copies of the one-page summary to other faculty members who are attending the session. Submit copies of the complete report to the committee members including your supervisor. No need to present details of any published work. Provide a reprint or preprint, preferably ahead of the meeting. If your work is software based then keep the demo ready. If you do not have a working module then show the video demonstration of the model. This will help the committee members to suggest future directions for your work.

During your PhD progress committee meeting, you should focus on the last six months’ work rather than the background. Only spend as much time on the background as is relevant to what you will be talking about.

There should not be any surprise slides/facts to your supervisor during your committee meeting.

At your first PhD progress Doctoral committee meeting, you will present an outline of your plan for your research. You can build a detailed description of what you plan to do ( literature survey to carry out,  algorithms or theorems to study,  experiments to carry out, software and hardware components to add, systems integration to perform, tests to accomplish ).  The plans can be represented with specific milestones and timelines with a  Gantt Chart .

Example: The sample Gantt chart below shows a set of activities planned for the next few months for the Research work. This can be extended to any length. This chart helps the committee members to know how well the researcher has planned the research activities.

At subsequent PhD progress meetings you should present a brief introduction (one or two slides) to remind the committee of your research area – don’t expect them to recall everything from the last meeting, but no need to go into great detail. Aim to put your work in context.

Show your current working objective in the form of a block diagram. This will set the boundary for the presentation and discussion. This will help the committee members to focus on the specified objective. For example in the figure below the candidate is focusing on the “Wheeled mobile Robot” objective in Robot Path Planning.

Make sure you are comfortable moving back and forth among your slides.  Do not cross the time limit. Add photographs of any field visits for data collection , or conference presentations in your presentation slides. If you had any interactions with domain experts in your area then add interaction details with a date. If you have visited any organization as a resource person relating to your Ph.D. work with your supervisor then add that details.

Seek advice from your committee members during the meeting. Note down all the suggestions by yourself or ask one of your research colleagues to note the same.  This is highly desirable, almost to the point that you should make it mandatory. Give a timeline of your plans. What will you be doing over the next month, and what do you hope to accomplish before your next meeting in the next six months’ time.

Keep additional slides along with your regular slides. Get into additional slides detail if any clarifications are sought on any equations or algorithms etc.

Additional slides can be presented as follows:

i) The equipment details you are planning to purchase or currently using for implementation.

ii) The Algorithms which you have implemented or planning to implement.

iii) The mathematical model you have developed,  or

iv) Any slides that you think are important but do not have time to cover at the end of your presentation.

Here are some tips regarding the presentation, including time management, devices, backup, laptop usage, uploading PowerPoint, video, and audio:

• Practice your presentation beforehand to ensure it fits within the allocated time.
• Use a timer or stopwatch during practice sessions to gauge your pace.
• Be mindful of the time during the actual presentation and make necessary adjustments to stay on track.
• Ensure your laptop or presentation device is in good working condition.
• Carry a backup copy of your presentation on a USB drive or cloud storage.
• Test the compatibility of your presentation files with the equipment at the presentation venue in advance.
• Close any unnecessary applications or notifications on your laptop to avoid distractions.
• Disable sleep mode or screensavers to prevent interruptions during the presentation.
• Familiarize yourself with the laptop’s function keys or shortcuts for adjusting display settings, volume, etc.
• Save your PowerPoint presentation in a compatible format (e.g., PPT or PPTX).
• Verify that all embedded media (images, videos, audio) are properly linked and functional.
• If possible, upload your presentation to the venue’s computer system before the session to avoid last-minute technical issues.
• Check the audio and video components of your presentation beforehand to ensure they work properly.
• If you plan to play a video, ensure it is in a compatible format and smoothly integrated into your presentation.
• Test the sound levels to ensure audibility for everyone in the room.

Additional tips (from personal experience):

• Rehearse your presentation multiple times to build confidence and familiarity with the material.
• Prepare cue cards or key points to refer to if needed, but avoid excessive reliance on them.
• Maintain eye contact with the audience to engage them and convey confidence.
• Speak clearly and project your voice to ensure everyone can hear you.
• Use visual aids and diagrams to enhance understanding and clarify complex concepts.
• Incorporate storytelling or real-life examples to make your presentation more engaging.
• Practice smooth transitions between slides and maintain a logical flow throughout.
• Be prepared to answer questions and engage in discussions following your presentation.

Remember, the more prepared and confident you are, the better you can deliver your presentation effectively.

After the PhD Progress Presentation Meeting

End your  PhD progress committee meeting with a summary of what you have discussed, common points that you have reached and an action plan for the next six months. Your action plan needs to have “actionable” items, specifically what milestones you will work towards after the meeting and approximate timelines.

A written summary of the  PhD progress committee meeting will be prepared by the supervisor and the committee, and that will be sent to the University. You will receive a copy of this and a copy will be placed in your research file.

Send an email note to each of your committee members through your supervisor to thank them for their time, and summarize the action items or milestones you agreed to. This will give your committee members another chance to give you feedback or suggestions.

During the meeting, you might have accepted to complete some implementation before the next meeting, but you may run out of time or you may not get any ideas regarding implementation. In such situations, have a discussion with your supervisor and the committee members and discuss the challenges faced by you. They may either extend the implementation time or ask you to change the methodology of implementation.

Simply do not wait for suggestions from committee members till the next PhD progress presentation meeting. In order to build trust between you and your committee members, you need to take committee members and your supervisor into confidence before taking any major decisions.

In the meeting, the committee might have suggested publishing your work in a quality conference or journal for better citations. Selecting a reputable journal and avoiding predatory conferences and journals is crucial for maximizing the visibility and impact of your research article.

By publishing in a respected journal, you increase the likelihood of attracting a broader and more qualified readership, thus increasing the chances of your article being cited by other researchers. Choosing the right journal involves considering factors such as the journal’s scope, target audience, impact factor, indexing in reputable databases, peer-review process, and overall reputation in the field.

Additionally, it is important to stay vigilant and avoid predatory conferences and journals that may engage in unethical practices or lack rigorous peer-review processes. These predatory outlets may hinder the credibility and recognition of your work. By carefully selecting a reputable journal, you position your research for greater exposure, credibility, and citation potential.

Visit my articles on ” How to identify and avoid predatory conferences and journals ” and “ Identifying Reputable journals for your research paper “. These articles will help you in getting your articles cited by many authors.

Here is an email template which you can communicate to your doctoral committee members in case you fail to keep the deadline or are unable to work on the ideas you proposed. Please take consent from your supervisor before sending any communication to Doctoral Committee members.

Improving both oral presentation and visual presentation skills is crucial for effective communication. To enhance your oral presentation skills, focus on aspects such as clarity, organization, and delivery. Practice speaking clearly, using appropriate tone and volume, and engaging with your audience. Additionally, consider refining your body language, utilizing effective gestures, and maintaining eye contact. For further guidance and resources on honing your oral presentation skills, you may explore reputable platforms and online courses available in this domain.

When it comes to visual presentation skills, it is essential to create visually appealing and impactful slides or visuals. Pay attention to design elements, such as color schemes, fonts, and layout, to ensure coherence and readability. Utilize visuals, such as graphs, charts, and images, to convey information effectively. Incorporate appropriate animations or transitions to enhance the flow and engagement of your presentation. To access valuable tips, techniques, and tools for enhancing your visual presentation skills, you can explore recommended platforms and tutorials available online.

If you are interested in further developing your oral presentation skills, I recommend checking out this comprehensive course on oral presentation skills . It covers essential techniques, strategies, and practical exercises to help you deliver impactful presentations confidently. Likewise, if you want to enhance your visual presentation skills, you may find this resource on v isual presentation design highly beneficial. It provides valuable insights, best practices, and examples to create visually stunning and effective presentations. Feel free to explore these resources to elevate your presentation skills and captivate your audience.

Presenting your PhD progress report to the doctoral committee can be a daunting task, but it is an essential part of your PhD journey. The committee is there to provide guidance and support, ensuring that you are on track to complete your dissertation within a reasonable time. It is crucial to approach the committee meeting with a positive attitude and view it as an opportunity to receive productive advice for your future research.

Remember that the presentation of the progress report to the committee happens in three stages: before, during, and after the meeting. The preparation of the report should be meticulous and thoughtful, and during the meeting, you should be open to constructive feedback and suggestions. After the meeting, you should take note of the committee’s recommendations and use them to shape your future research endeavours.

As you move forward in your career, the support and guidance of the doctoral committee will likely continue to be a valuable resource. By effectively presenting your progress report to the committee, you can make the most of this opportunity and receive the guidance you need to succeed in your PhD program.

Frequently Asked Questions

Research Objective: Clearly state the objective of your research and the problem you are addressing. Methodology: Provide a brief description of the methodology or approach you are using to conduct your research. Key Findings: Highlight the major findings or results you have obtained so far in your research. Progress Update: Summarize the progress you have made during the past six months, highlighting significant achievements or milestones reached. Challenges: Briefly mention any challenges or obstacles you have encountered in your research and how you are addressing them. Future Plans: Outline your planned next steps and future goals for your research, including anticipated timelines or milestones. Relevance and Impact: Discuss the relevance and potential impact of your research in your field or discipline. Support Needed: Specify any specific support, resources, or expertise you require to further advance your research.

To effectively demonstrate a software-based project during the presentation: Have the demo prepared and functional Show a video demonstration if the software is not available or requires specific conditions Focus on showcasing key features and functionalities Provide context and explain the purpose of the software

Include only the necessary level of detail in the background section of your presentation, focusing on what is directly relevant to your research and the specific objectives you will be discussing. Keep it concise and provide enough context to help the doctoral committee members to understand the significance and motivation of your work without delving into unnecessary details.

Maintain open and regular communication with your supervisor throughout the research process. Share progress updates, challenges, and findings with your supervisor in a timely manner. Discuss any potential issues or deviations from the original plan as soon as they arise. Seek feedback and guidance from your supervisor at various stages of your research. Keep your supervisor informed about any changes in methodology, data, or results. Address any concerns or questions from your supervisor before the committee meeting to align expectations.

The types of questions you can expect from committee members regarding your research plan may include: Clarification questions seeking a deeper understanding of your research objectives, methodology, or proposed experiments. Questions about the theoretical framework or literature review supporting your research. Inquiries about the feasibility and potential limitations of your proposed research. Questions related to the significance and impact of your research in the field. Suggestions for alternative approaches or methodologies to consider. Questions about the expected timeline and milestones for your research. Inquiries about potential ethical considerations or data management strategies. Questions exploring the potential implications and practical applications of your research. Requests for additional details or explanations on specific aspects of your research plan. Questions about the expected contributions of your research to the existing body of knowledge in your field.

When responding to suggestions and feedback given by the committee members during the meeting: Listen actively and attentively to understand the suggestions and feedback. Thank the committee members for their input and valuable insights. Remain open-minded and receptive to different perspectives and ideas. Clarify any points of confusion or seek further clarification, if needed. Acknowledge the validity of the suggestions and show a willingness to consider them. Provide thoughtful responses that demonstrate your understanding of the suggestions. Clearly articulate your rationale if you choose not to implement a specific suggestion. Engage in constructive discussions and ask follow-up questions, if appropriate. Demonstrate your ability to integrate feedback into your research plan or adjust your approach. Express gratitude for the committee members’ support and guidance throughout the process.

Lack of Clear Objectives: If your progress presentation fails to clearly define and articulate the objectives of your research, it may be rejected. The committee expects a clear understanding of what you aim to achieve and the significance of your research goals. Inadequate Progress: Insufficient progress made during the specified period can lead to rejection. The committee expects tangible advancements in your research within the given timeframe. If there is a lack of substantial work or limited progress, they may question the feasibility or dedication to your research. Methodological Issues: If there are flaws in your research methodology or data collection techniques, the committee may reject your progress presentation. It is essential to demonstrate a robust and well-designed research approach that aligns with the requirements of your field. Poor Presentation Skills: Your presentation skills play a crucial role in conveying your research effectively. If your presentation lacks clarity, coherence, or fails to engage the audience, it may lead to rejection. Effective communication and the ability to present complex ideas in a concise and understandable manner are vital. Inadequate Literature Review: A comprehensive literature review is expected in a progress presentation. If your review of existing literature is incomplete, lacks depth, or fails to address relevant studies, your presentation may be rejected. It is essential to showcase a thorough understanding of the existing research and its relationship to your work. Failure to Address Committee Feedback: If you neglect to incorporate previous feedback and suggestions from the committee, it may result in rejection. The committee expects you to demonstrate the ability to reflect on and address their recommendations, showing your commitment to improving your research. Remember, the specific parameters for rejection may vary depending on your academic institution and the expectations set by your doctoral committee. It is crucial to consult your supervisor and committee members for clear guidelines and expectations for your progress presentation.

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6.1 There shall be a Research Advisory Committee (RAC), or its equivalent body for similar purpose as defined in the Statutes of the University for each Ph.D. scholar. The RAC shall have the following responsibilities:

(1) To review the research proposal and finalize the topic of the research.

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(3) To periodically review and assist in the progress of the research work of the research scholar in every six month duration.

6.2 A research scholar shall appear before the Research Advisory Committee (RAC) once in six months to make a presentation of the progress of his/her work for evaluation and further guidance.

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• To periodically review and assist in the progress of the research work of the research scholar.
• A research scholar shall appear before the RAC once in six months to make a presentation of the progress of his/her work for evaluation and further guidance. The progress reports shall be submitted by the RAC to the DRC with a copy to the research scholar every six months; and
• In case, the progress of the research scholar is unsatisfactory, the RAC shall record the reasons for the same and suggest corrective measures. If the research scholar fails to implement these corrective measures, the RAC may recommend to the BoR through the DRC with specific reasons for cancellation of the registration of the research scholar.
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How to Make a Successful Research Presentation

Turning a research paper into a visual presentation is difficult; there are pitfalls, and navigating the path to a brief, informative presentation takes time and practice. As a TA for  GEO/WRI 201: Methods in Data Analysis & Scientific Writing this past fall, I saw how this process works from an instructor’s standpoint. I’ve presented my own research before, but helping others present theirs taught me a bit more about the process. Here are some tips I learned that may help you with your next research presentation:

More is more

In general, your presentation will always benefit from more practice, more feedback, and more revision. By practicing in front of friends, you can get comfortable with presenting your work while receiving feedback. It is hard to know how to revise your presentation if you never practice. If you are presenting to a general audience, getting feedback from someone outside of your discipline is crucial. Terms and ideas that seem intuitive to you may be completely foreign to someone else, and your well-crafted presentation could fall flat.

Less is more

Limit the scope of your presentation, the number of slides, and the text on each slide. In my experience, text works well for organizing slides, orienting the audience to key terms, and annotating important figures–not for explaining complex ideas. Having fewer slides is usually better as well. In general, about one slide per minute of presentation is an appropriate budget. Too many slides is usually a sign that your topic is too broad.

Limit the scope of your presentation

Don’t present your paper. Presentations are usually around 10 min long. You will not have time to explain all of the research you did in a semester (or a year!) in such a short span of time. Instead, focus on the highlight(s). Identify a single compelling research question which your work addressed, and craft a succinct but complete narrative around it.

You will not have time to explain all of the research you did. Instead, focus on the highlights. Identify a single compelling research question which your work addressed, and craft a succinct but complete narrative around it.

Craft a compelling research narrative

After identifying the focused research question, walk your audience through your research as if it were a story. Presentations with strong narrative arcs are clear, captivating, and compelling.

• Introduction (exposition — rising action)

Orient the audience and draw them in by demonstrating the relevance and importance of your research story with strong global motive. Provide them with the necessary vocabulary and background knowledge to understand the plot of your story. Introduce the key studies (characters) relevant in your story and build tension and conflict with scholarly and data motive. By the end of your introduction, your audience should clearly understand your research question and be dying to know how you resolve the tension built through motive.

• Methods (rising action)

The methods section should transition smoothly and logically from the introduction. Beware of presenting your methods in a boring, arc-killing, ‘this is what I did.’ Focus on the details that set your story apart from the stories other people have already told. Keep the audience interested by clearly motivating your decisions based on your original research question or the tension built in your introduction.

• Results (climax)

Less is usually more here. Only present results which are clearly related to the focused research question you are presenting. Make sure you explain the results clearly so that your audience understands what your research found. This is the peak of tension in your narrative arc, so don’t undercut it by quickly clicking through to your discussion.

• Discussion (falling action)

By now your audience should be dying for a satisfying resolution. Here is where you contextualize your results and begin resolving the tension between past research. Be thorough. If you have too many conflicts left unresolved, or you don’t have enough time to present all of the resolutions, you probably need to further narrow the scope of your presentation.

• Conclusion (denouement)

Return back to your initial research question and motive, resolving any final conflicts and tying up loose ends. Leave the audience with a clear resolution of your focus research question, and use unresolved tension to set up potential sequels (i.e. further research).

Use your medium to enhance the narrative

Visual presentations should be dominated by clear, intentional graphics. Subtle animation in key moments (usually during the results or discussion) can add drama to the narrative arc and make conflict resolutions more satisfying. You are narrating a story written in images, videos, cartoons, and graphs. While your paper is mostly text, with graphics to highlight crucial points, your slides should be the opposite. Adapting to the new medium may require you to create or acquire far more graphics than you included in your paper, but it is necessary to create an engaging presentation.

The most important thing you can do for your presentation is to practice and revise. Bother your friends, your roommates, TAs–anybody who will sit down and listen to your work. Beyond that, think about presentations you have found compelling and try to incorporate some of those elements into your own. Remember you want your work to be comprehensible; you aren’t creating experts in 10 minutes. Above all, try to stay passionate about what you did and why. You put the time in, so show your audience that it’s worth it.

For more insight into research presentations, check out these past PCUR posts written by Emma and Ellie .

— Alec Getraer, Natural Sciences Correspondent

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Amanda B. Parrish, PhD, RAC Director, Regulatory Affairs and Quality Erika Segear, PhD, RAC

Oct 30, 2019

190 likes | 203 Views

Office of Regulatory Affairs and Quality. Updates from the Office of Regulatory Affairs and Quality (ORAQ): Regulatory Review Requirements Changes in ORAQ Costs Submission Processes. Amanda B. Parrish, PhD, RAC Director, Regulatory Affairs and Quality Erika Segear, PhD, RAC

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Office of Regulatory Affairs and Quality Updates from the Office of Regulatory Affairs and Quality (ORAQ):Regulatory Review RequirementsChanges in ORAQ CostsSubmission Processes Amanda B. Parrish, PhD, RAC Director, Regulatory Affairs and Quality Erika Segear, PhD, RAC Associate Director, Regulatory Affairs

Office of Regulatory Affairs and Quality ORAQ Background • Regulatory Affairs Group Founded in 2007 • Initiated and supported through Duke CTSA funding • Free and optional resource for the Duke community • Duke faculty not required to utilize services in order to conduct research requiring FDA oversight • First few years included 4 FTEs • Office Growth and Expansion • Study teams worked to support staff by adding effort into grants—developed a model for dedicated support of FTE • Expansion to centralize GMP QA support under ORAQ in 2016 with migration into the School of Medicine • Merged with DCRI Regulatory Services in 2019 • Currently, 28 RA and GMP QA professional staff members

ORAQ Organizational Structure

Office of Regulatory Affairs and Quality ORAQ Mission • ORAQ offers regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. • Our goal is to provide the Duke community with the tools, training, and support needed to navigate the complex regulatory pathways that accompany translational research. We aim to do this by providing support in the following areas: • Early Regulatory Strategy Development • Preclinical Testing and GMP Manufacturing • Regulatory Submissions and Maintenance • FDA Meetings and Inspections • Education and Training • Outreach and Collaboration

Office of Regulatory Affairs and Quality Regulatory Affairs Landscape • Current Numbers: • Over 140 active INDs and 6 active IDEs • Over 155 approved applications (ITPs, ODDs, DMFs) • Approved BLA (marketing application) • SOM Concerns: • About 1/3-2/3 of regulatory submissions do not have any review • Post-hoc errors have been found putting IND/IDE holders at risk or causing delays • Challenge for teams to keep up with changing regulatory landscape • SOM Goals: Improve quality of submissions, decrease regulatory risk, and thwart delays

Office of Regulatory Affairs and Quality New Institutional Review Requirements • Previous Model: • Use of ORAQ for regulatory support is optional. • Proposed Change: • All FDA regulatory submissions associated with a clinical trial (IND/IDE/ITP) will be required to go through ORAQ for review.

Office of Regulatory Affairs and Quality New Institutional Review Requirements • The initial application and/or amendment can still be drafted by the study team, but the submission needs to be reviewed by ORAQ before being sent to FDA. • The submission can be prepared and shipped by the study team, but ORAQ will offer support for this work to aid the study teams with this workload. • ORAQ must obtain a final copy of all submissions and will store in a central repository. • The study team can still serve as the secondary FDA contact, but any formal FDA correspondence (requests for information, etc.) should be shared with ORAQ.

Office of Regulatory Affairs and Quality New Institutional Review Requirements • Timeline: Requirements will be phased in with review of initial/original applications starting November 1, 2019. • Start collecting copies of all submissions at this time. • Obtain information on submission burden and evaluate ORAQ resources. • Review of additional submissions, such as supplements, reports, amendments, etc., will be phased in over a period of one year. We will notify sponsors and research support staff directly when new review requirements go into effect. Up to date information will also be available on our website.

Office of Regulatory Affairs and Quality New Institutional Review Requirements • What is the process for requesting reviews? • Workflows and review processes are in development. • In the next couple of weeks, we anticipate having a service request form available on our website. • Request review of initial/original submissions • Submit copies of all submissions • Website will also outline expectations on ORAQ review times and submission processes.

Office of Regulatory Affairs and Quality Changes in ORAQ Costs • Previous Model: • ORAQ services were no cost to the clinical research community at Duke University. • Proposed Change: • ORAQ will move to a cost recovery model, whereby effort that is not already paid for will be charged back to academic departments or fund codes monthly. • This change was communicated by SOM leadership to Department Chairs in an August 2019 meeting.

Office of Regulatory Affairs and Quality ORAQ Costs • ORAQ’s Service Request Form will contain fields for faculty and/or support staff to self-report department or fund code for charge back. • Collaborative projects will be required to select a primary department or fund code for billing. • This determination will be made by the study team or faculty involved in the project. • Study teams should work with ORAQ to estimate project costs and plan for these costs in grant applications.

Office of Regulatory Affairs and Quality New Submission Processes • Previous Model: • All drug/biologic submissions sent to CDER or CBER for research INDs (i.e., non-commercial INDs) submitted in triplicate on paper and shipped FedEx overnight. • Proposed Change: • All drug/biologic submissions sent to CDER or CBER for research INDs will be submitted electronically through FDA’s Electronic Submissions Gateway in non-eCTD format .

Office of Regulatory Affairs and Quality New Submission Processes • Advantages: • Faster receipt times—submission arrives same day • Less burdensome preparation • More cost effective • Non-eCTD submissions can be converted back to paper if faculty ever leave Duke • Important changes: ORAQ will provide study teams with an electronic copy (merged PDF) of the final submission for record keeping. Hard copies will no longer be provided.

Office of Regulatory Affairs and Quality Additional information

Office of Regulatory Affairs and Quality Additional information • Information on Website • Newsletter Messaging • Emails to Current Regulatory Sponsors • Emails to Research Support Offices • Research Wednesday Presentation (2/26/2020)

Office of Regulatory Affairs and Quality ORAQ Resources • Location: Office of Regulatory Affairs and Quality Duke University – Hock Plaza 2424 Erwin Road, 4th Floor Durham, NC 27705 • Website: http://medschool.duke.edu/ORAQ • Includes new and updated regulatory template documents • Contact information for our staff • Event subscription/Request a Speaker • Additional QA resources • Training Program: [email protected] • Contact for Questions: [email protected]

Office of Regulatory Affairs and Quality Questions/Discussion

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PhD Synopsis Writing: 4 questions your committee (RDC/DRC) will definitely ask you

• PhD Synopsis Writing: 4 questions

By Aaron Category : PhD Synopsis

It is important for a PhD candidate to be able to anticipate in advance the kind of questions that will be asked by your committee when you present your  proposal.

Before we go forward to figure out which are the most probable questions, you must know what the main reasons behind conducting a RDC are:

• Whether you understand your thesis topic well or not
• what are the reasons behind your thesis topic selection
• Do you have sufficient knowledge of research methodology to apply in your proposed study?
• Are you passionate enough about doing PhD, that you will sustain all the pressure that will come with it?
• Is there novelty in your research topic to generate substantive contribution in research in the coming times to come?
• Does your topic have the longevity to remain useful and interesting to the research community for a long time to come?

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Before we discuss the most probable questions, remember that if the RDC asks you a lot of questions, it does not mean that they doubt your topic or potential or they may reject your synopsis. Their purpose is to brainstorm and take out the best version of your research topic. So you must relax and let your ideas flow out in a spontaneous manner. Make sure you give a patient hearing to each of the questions and answer them succinctly but at the same time analytical and sufficiently inclusive.

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Sometimes if you don’t understand a specific question, it is okay to seek clarification either directly or by paraphrasing the question in your own words and placing it in front of them as, “Is this what you mean?”

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