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Category: Lessons Learned

  • Top Tips for Medical Writing vs. Scientific Writing

    Top Tips for Medical Writing vs. Scientific Writing

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Authored/ Reviewed by Tasha Mohseni

    Contribution by Adnan Shaikh

    Good morning, good afternoon, and good evening Compliance Rockstars, Clinical Researchers, Ethics Educators, and Investigators from around the globe!

    I hope you are doing well! I can’t believe we are already in February 2025. It feels like just yesterday I was celebrating New Years Eve with my loved ones.

    In this post, I plan to define medical writing versus scientific writing. Then, Adnan will end the post with helpful tips for both medical and scientific writing.

    I would like to thank Adnan Shaikh for his willingness to contribute to this post!

    Let’s get ready to learn! As a general reminder, these are our own interpretations. Any legal information discussed within this post should be discussed with your institution.

    What is medical writing?

    Medical writing can be defined as the process of creating scientific and clinical documents related to:

    • Healthcare,
    • Medicine, and
    • Life sciences

    This type of writing typically yields the following types of content:

    • Regulatory documentation,
    • Research publications,
    • Educational materials related to healthcare, medicine, and life sciences, and
    • Promotional content for healthcare professionals and patients

    To be a successful medical writer, it is recommended to acquire skills in:

    • Understanding of medical and scientific concepts
    • Strong writing and communication skills
    • Ability to interpret and summarize complex data
    • Knowledge of regulatory guidelines (e.g., FDA)
    • Proficiency in literature searching and referencing

    What is scientific writing?

    Scientific writing is the structured dissemination of research findings, theories, and technical information in a clear and objective manner. This type of writing is commonly used in the following fields:

    • Academia,
    • Medical field, and
    • Technical fields (e.g., engineering)

    When I think about scientific writing, not only do I think about research publications I also think about research documentation.

    What do I mean by “research documentation”?

    Well, I mean your research protocol! To be a strong scientific writer, it is essential to:

    • Explain complex ideas in a concise format
    • Avoid technical jargon (i.e., write in a way that anyone who is not in your field would understand)
    • Use credible references to support your hypothesis
    • Let graphics and tables enhance the “research story” you’re trying to tell

    Is there truly a difference between these writing styles?

    To be honest here, I would say that I am well versed in scientific writing. I had to do some research and learn about what is considered medical writing. Even though I explained the differences here, if you’re scratching your head right now you maybe wondering…

    Tasha, there’s so much overlap. Aren’t these pretty much the same thing?

    I was feeling the same way! Even when I was doing my research on what constitutes medical writing, scientific writing would often appear! Therefore, I decided to go to my old friend, ChatGPT. First, I prompted ChatGPT to create a Venn diagram of medical writing versus scientific writing.

    For those who may not know, a Venn diagram is an illustration of two overlapping circles comparing two topics. In the area where the circles intersect, these are similarities between the two topics. Outside of the circle overlap, are the differences between the two topics.

    Below is the result from ChatGPT:

    Venn diagram comparing medical writing to scientific writing created by ChatGPT

    Though I technically haven’t done medical writing, I can see the significant overlap with scientific writing! It makes sense to me now why when I was researching medical writing, scientific writing often popped up.

    Next, I prompted ChatGPT to put this into a table for comparison:

    Tabular comparison of medical writing versus scientific writing created by ChatGPT

    What I love about this table even more than the Venn diagram is how ChatGPT defined these writing styles based on:

    • Content
    • Sentence structure
    • Audience

    I feel these components are so important! I almost wished I started out knowing this comparison.

    I wouldn’t have driven myself bonkers trying to figure it out for myself!

    Now that we have a better understanding of this, let’s see what top tips Adnan has to offer us!

    Top tips for medical writing

    Hello researchers, I am glad to be here once again. I’m excited to share my top tips for successful medical writing!

    Remember to rely on the following organizations below : 

    These associations provide many informational resources for professionals or novice learners, such as books and webinars. These materials will guide you on your journey to improve your medical writing skills. They will also help in understanding novel approaches in this field. 

    Other essential key skills for medical writing are:

    • Proficiency in the English language,
    • Ability to simplify medical and scientific terminologies,
    • Knowledge of clinical research, regulatory bodies, and ICH GCP Guidelines,
    • Proofreading of the content,
    • Ability to interpret complex research content, and
    • Knowledge of statistics

    I recommend writing in a daily gratitude journal and to connect with other seasoned medical writers. With knowledge sharing and daily practice, you will be on your way to mastering this skill!

    One bonus tip I’d like to offer is to complete an internship or get training by the organizations mentioned above. Whether you’re experienced or new to the field, these top tips will mold you to become a better medical writer.

    Top tips for scientific writing

    Scientific writing is completed by researchers from various backgrounds. Completing an academic project within my PharmD program provided the exposure I needed to grow in this area. You can review my publications here as a sample of scientific writing:

    1. Pemphigus Vulgaris: An Overview
    2. An Observational Prospective Study on Drugs Utilization Pattern in Cardiovascular Diseases at a Tertiary Care Hospital

    Once you’ve reviewed my work, take a look to see how I applied my top tips for scientific writing:

    The Do’sThe “Don’t”s
    1. Find gaps in published literature that could lead to your research question.
    2. Prepare content simultaneously. While conducting your literature search, use this time to also list your references.
    3. Use active and passive appropriately.
    4. Define abbreviations and acronyms when first introducing them in your paper.
    5. Always read the journal authors’ instructions in depth. This is to ensure your work is suitable for the journal of interest.    		1. Avoid filler words such as “like” or “you know”.
    2. Avoid using the same word repetitively; this often happens with transition words.
    3. Avoid directly copying and pasting as this leads to plagiarism. Further, if Artificial Intelligence (AI) tools were used to generate your content, you must credit this tool in your paper.
    4. Avoid errors by ALWAYS proofreading your content before submitting to the journal for review.

    Always remember that practice makes perfect! I’d like to express gratitude to Tasha for providing me this space to showcase my ideas and thought with you.

    We hope you found this post insightful!

  • FDA Clinical Investigator Training Course: Day 3 Insights

    FDA Clinical Investigator Training Course: Day 3 Insights

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Hello, clinical researchers and clinical research educators!

    We concluded the last day of the FDA Clinical Investigator Training Course (CITC)! I’m happy to share my certificate of attendance for the training.

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    I feel highly informed of FDA regulations and guidance documents with respect to clinical investigation. If you’re dying to know how this training ended, I URGE you to read this post. I encourage you to also read my other two posts regarding the first two days of the FDA CITC session:

    Before you begin…

    Please remember to be kind to yourself.

    This is a complicated subject matter. Don’t expect to become an expert right away. Take your time and focus on one topic area at a time. Reach out and ask questions to subject-matter experts who can make this information easier to understand.

    In this post, I will cover what was discussed for Day 3 of the course:

    Clinical Trial Quality as Fitness for Purpose

    We started off with a previously mentioned FDA regulation, 21 CFR Part 314. 126 (Adequate and well-controlled studies).

    Reports of adequate and well-controlled investigations provide the primary basis for determining whether there is โ€œsubstantial evidenceโ€ to support the claims of effectiveness for new drugs.

    eCFR :: 21 CFR 314.126 — Adequate and well-controlled studies.

    Under this regulation, there are seven characteristics of adequate and well-controlled studies. The presentation carried on that there are several stakeholders involved to optimize clinical trial quality:

    • Sponsors
    • Contract Research Organizations (CROs)
    • Institutional Review Boards (IRBs)
    • Clinical Investigators

    It was also noted that the quality of a clinical trial starts right at the design phase. The following resource related to design was shared: CTTI Quality by Design. Clinical investigators should focus on critical-to-quality (CTQ) factors. CTQ factors are factors whose integrity impacts:

    • Protecting participants
    • Reliability and interpretation of study results
    • Decision making based on study results

    The rest of the presentation primarily focused on the International Council for Harmonization (ICH) Good Clinical Practice (GCP) E6(R3). With respect to quality, the primary principles that solidify this concept are listed below:

    • Principle #6: Quality should be built into the scientific and operational design and conduct of clinical trials.
    • Principle #7: Clinical trial processes, measures and approaches should be implemented in a way that is proportionate to the risks to participants and to the importance of the data collected.
    • Principle #8: Clinical trials should be described in a clear, concise and operationally feasible protocol.

    Investigator Responsibilities – Regulation and FDA Expectations for the Conduct of Clinical Trials

    I want to warn you that there are MANY references in this section. PLEASE take your time as you process this information. I was overwhelmed gathering all the links that were mentioned!

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    We started off by defining the difference between an “investigator” and a “sponsor” per 21 CFR Part 312.3 (Definitions and interpretations). Then, we were introduced to the following regulations that ensure the
    integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects:

    Next, we reviewed FDA regulations related to a clinical investigator’s responsibilities. It was noted that this is NOT an all-inclusive list:

    It was noted per 21 CFR 312.53(c) that investigators must submit a completed and signed Form FDA-1572 to the sponsor prior to conducting their clinical investigation. Several investigator oversight responsibilities were discussed and the following guidance was shared: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects. With respect to informed consent, the following regulation and resources were mentioned:

    The presentation concluded by discussing Clinicaltrials.gov reporting requirements. It was noted that registration is required within 21 days of first human subject enrolled.

    International Clinical Trials

    Clinical trials conducted internationally has the ability to:

    • Provide access to diverse populations
    • Promote enhanced generalizability of results
    • Accelerate patient recruitment
    • Address health issues that affect various regions around the world
    • Enables sponsors to enter multiple markets simultaneously

    It was noted that inclusion of U.S. participants is crucial for FDA evaluation. This is especially important if the trial results are intended to support regulatory approval in the United States. Clinical investigators conducting an FDA-regulated study outside the US can
    request a waiver from FDA 1572 Signature. This is because IND applications are NOT required for clinical trials conducted outside of the United States. Next, FDA inspections for international clinical trials was discussed. The common pitfalls found during an FDA inspection are listed below:

    • Failure to follow investigational plan/protocol
    • Inadequate/inaccurate records
    • Inadequate drug accountability
    • Failure to obtain and/or adequately document informed
      consent
    • Failure to report adverse drug reactions and issues
      related to IRB communication

    The presentation concluded by discussing the key updates in ICH E6 (R3) and shared the following resources:

    FDA’s Good Clinical Practice (GCP) Compliance Review for NDAs and BLAs

    First, the FDA Bioresearch Monitoring Program was discussed. This is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. These inspections are in accordance with:

    • Good Laboratory Practice (GLP)
    • Clinical investigators in accordance with Good Clinical Practice (GCP)
    • Sponsors/Contract Research Organizations (CROs)
    • Clinical trial monitors
    • In vivo bioequivalence facilities
    • Institutional review boards (IRBs)
    • Radioactive drug research committees
    • Postmarketing adverse drug experience reporting (PADE), and
    • Risk evaluation and mitigation strategies reporting (REMS)

    The presentation shifted its focus to specifically Good Clinical Practice (GCP) inspections. The goal of GCP inspections is to provide assurance that the data are reliable and that the rights of participants are protected. We also learned about the various stakeholders involved in GCP inspections such as:

    • Clinical Investigators
    • Sponsors
    • Sponsor-Investigators
    • Contract Research Organizations (CROs)

    I was surprised to learn that GCP inspections are not required as
    part of the marketing application review process. Lastly, we learned more about FDA’s organizational structure. Specifically:

    Clinical Investigator Inspection Readiness

    The purpose of conducting clinical investigator inspections is to ensure that:

    • The clinical investigator conducts their investigation according to the investigational plan
    • The clinical investigator obtains institutional review board (IRB) review and approval
    • The clinical investigator obtains informed consent
    • The clinical investigator controls the investigational product(s) under investigation

    There are routine/surveillance and for-cause inspections. Inspections typically follow this format:

    • Pre-announcement (typically five days before the start of the inspection and provides the scope of the investigation)
    • Form FDA 482 (Notice of Inspection) and Opening Meeting
    • Inspection
    • Closeout Meeting and Form FDA 483 (Inspectional Observations, if issued)
    • Post-inspection Activities

    Finally, the following resources were shared throughout the presentation (and a bonus one I found):

    FDAโ€™s Use of Alternative Approaches to Evaluate GCP Compliance

    First, the presentation defined Remote Regulatory Assessments (RRA). As cited in the guidance, an RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs assist in protecting human and animal health, informing regulatory decisions, and verifying certain information submitted to the Agency. RRAs are NOT inspections. You can read this guidance if you want to learn more about RRAs: Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry. International collaboration for clinical trials was also discussed. Foreign collaborations can enable efficiency use of resources and improved inspection coverage. Lastly, the evaluation of GCP with respect to innovative technologies was discussed. The following resources were shared for this last topic:

    Thank you for bearing with me during this highly intensive training! I hope you learned as much as I did. Again, I encourage you to bookmark this post (and the two previous posts). These posts provide a great overview of FDA resources and clinical trials.

    Don’t forget to leave a comment about your favorite session covered during the training!

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  • FDA Clinical Investigator Training Course: Day 2 Insights

    FDA Clinical Investigator Training Course: Day 2 Insights

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Hello, clinical researchers and clinical research educators!

    We just concluded Day 2 of the FDA Clinical Investigator Training Course (CITC)! I would say after yesterday’s training, I have exposure to FDA regulations now. At the very least, I know where to locate FDA resources. If you’re in the same boat as me, I URGE you to read this post. I encourage you to also read FDA Clinical Investigator Training Course: Day 1 Insights if you didn’t attend yesterday’s session.

    Before you begin…

    Please remember to be kind to yourself.

    This is a complicated subject matter. Don’t expect to become an expert right away.

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    In this post, I will cover what was discussed for Day 2 of the course:

    DISCLAIMER: There was a seventh presentation, but I was unable to attend.

    Did you attend Day 1 or Day 2 of the course?

    Please leave a comment BELOW!

    Leave a Reply

    Before you take a deep dive into these sections...

    It would be helpful to have a strong chemistry background. I have very minimal experience in chemistry and could understand some terms. Again, like yesterday, I will highlight key takeaways.

    I would love to further explore these topics with the appropriate subject-matter expert!

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    Chemistry, Manufacturing and Controls: Regulatory Considerations Through Clinical Development

    First, we learned about pharmaceutical quality. Pharmaceutical quality assures safety, efficacy, and availability of every dose. With Chemistry, Manufacturing and Controls (CMC), we can assess pharmaceutical quality. CMC is involved throughout the whole product life cycle from the pre-clinical stage to marketing. 21 CFR Part 314.30 defines the difference between the following terms:

    Drug SubstanceDrug Product
    An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.A finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.

    The presentation continued with IND requirements of both drug substances and drug products. There were also aspects of the Common Technical Document (CD) which must include the following for:

    Drug substances:

    • Source
    • Complexity
    • Characterization
    • Impurities

    Drug products:

    • Specification
    • Stability

    It's important to note that prior to submitting an IND, the FDA provides one pre-IND meeting. In this meeting, the FDA will assess the substance or product in your application. Here are some resources from the training (and a bonus link) related to this topic:

    Pharmacology/Toxicology in the Investigator's Brochure

    The Investigator's Brochure (IB) has four key elements of nonclinical information:

    • Pharmacology
    • Safety Pharmacology
    • Pharmacokinetics
    • Toxicology

    Pharmacology provides proof of concept, data on the intended/primary and unintended/secondary targets, support toxicology species selection. Safety pharmacology assesses the potential effects on physiological functions on vital organ systems such as the cardiovascular system, central nervous system, and respiratory system. Pharmacokinetics refers to the drug's movement through the body as it passes through absorption, distribution, metabolism, and excretion (ADME). Lastly, toxicology determines if the proposed clinical study is safe and also identifies a starting dose for the drug. There were MANY guidance documents referenced in this presentation. If you search through the FDA guidance document database, you can search for the umbrella topics listed below:

    • S1 Carciogenicity Studies
    • S2 Genotoxicity Studies
    • S3 Toxicokinetics and Pharmacokinetics
    • S4 Toxicity Testing
    • S5 Reproductive Toxicology
    • S6 Biotechnology-derived Products
    • S7 Safety Pharmacology Studies
    • S8 Immunotoxicology Studies
    • S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
    • M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials
    • Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations

    Why Clinical Pharmacology is Essential in Drug Development

    Clinical pharmacology is the study of pharmacokinetics (PK) and pharmacodynamics (PD). From my understanding, both PK and PD measure what the drug does to the body. However, PK studies the concentration of the drug over time. While PD studies the effect of the drug over time. When we put these tools together (PK + PD), we can see the exposure/response relationship of the drug.

    With this relationship, we can ensure the right patient receives the right drug at the right dosage and timing.

    Clinical pharmacology studies occur from the point of initial submitting an IND (first-in-human) up until the post-approval phase. Clinical pharmacology studies can include:

    • First-in-human studies
    • ADME studies
    • Bioavailability studies
    • Food effect studies
    • Hepatic impairment studies
    • Renal impairment studies

    Though specific references weren't shared for this presentation, I would like to share a bonus link: Model-Informed Drug Development Paired Meeting Program. Through this program, sponsors can meet with FDA reviewers to assess:

    • Dose selection or estimation
    • Clinical trial simulation
    • Select appropriate response measures, predict outcomes, etc.
    • Predictive or mechanistic safety evaluations

    Decentralized clinical trials (DCTs) are trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. In other words, these decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. This can promote:

    • Accessibility to patients (especially those with rare diseases or mobility issues)
    • Promotes patient convenience and trial efficiency

    The presentation also shared investigational products suitable for DCTs, investigator oversight, safety assessments, sponsor's responsibilities, and other DCT considerations. It was also discussed that in context of clinical trials, the FDA is interested in digital health technologies (DHT) such as:

    • Wearables,
    • Interactive applications, and
    • Instruments placed in the patient's environment that measure clinical features of interest in a clinical trial

    When using DHTs in DCTs, study teams should consider confounders of measurement. An example of a confounder would be if the DHT provided different measurements depending on how the patient is wearing the device. The four references below were shared during the presentation. I also found a bonus reference that complements the topic discussed.

    You might be familiar with the presentation if you attended FDA's webinar, Informed Consent โ€“ More than Just Another Document to Sign. on November 8, 2024. For today's event, I'm going to share with you resources from this presentation. I will also share two bonus links related to the FDA webinar that was held in November:

    mRNA Vaccines

    The presentation started with a timeline of vaccination milestones. Next, different types of vaccine platforms were discussed. Some advantages of an mRNA vaccines relate to:

    • Speed of manufacturing
    • Speed of delivery
    • More sophisticated immune response

    There was also discussion revolving around the biosafety and biodistribution of mRNA vaccines. There are no resources to share in relation to this presentation.

    I'm so excited to see how the FDA wraps up our training course! There is so much great information in here. I am certainly glad I had an overview of this topic. I was sweating studying the FDA regulations for the CIP. I'm still sweating it a bit, but at least I'm better off than when I started! I at least know where to go to find these resources in preparation of the exam. I hope you find this content useful!

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  • FDA Clinical Investigator Training Course: Day 1 Insights

    FDA Clinical Investigator Training Course: Day 1 Insights

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Hello, clinical researchers and clinical research educators!

    I’ve been so excited to attend the FDA Clinical Investigator Training Course (CITC) this week. I have no experience with clinical research or FDA regulations. If you’re in the same boat as me, I URGE you to read this post.

    Before you begin…

    Please remember to be kind to yourself.

    This is a complicated subject matter. Don’t expect to become an expert right away. I plan to bookmark this post myself as reference as I prepare for the CIP certification.

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    In this post, I will cover what was discussed for Day 1 of the course:

    FDA Legal Framework and Guidance Documents

    Showcasing the FDA regulations within Title 21 CFR.

    Title 21 CFR is the FDA regulation. At first glance, this is quite intimidating! I personally had no idea of all the FDA regulations out there. I was only aware of 21 CFR Part 50 and 21 CFR Part 56 (as these relate to human subjects research). I am extremely thankful that the FDA has guidance documents for these! The FDA has a repository of guidance documents to assist with interpreting the regulations. You can browse by topic or by product. If you are interested in seeing FDA guidance documents related to clinical trials, you can review them here: Clinical Trial Guidance Documents

    FDA Applications

    An Investigation New Drug (IND) application allows for interstate shipping of products statewide. INDs also allow for the initiation of clinical studies in humans. There are three types:

    Before submitting an IND application, investigators should see if they meet the IND exemption criteria. The FDA can place a clinical hold on IND application to delay or suspend the investigation. Clinical holds are placed based on specific criteria. These criteria also vary depending on the phase of your clinical investigation.

    The next two types of applications are marketing applications that tell the product’s story. The application can be related to marketing for a new product. These applications are also required for adding more information to a product currently on the market.

    • The New Drug Application (NDA), as the name implies, is the application required for introducing a new drug the market.
    • The Biologics License Application (BLA) contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product.

    Clinical Trial Design Basics and Statistics

    The remaining sections should have their own posts dedicated to them. There is nothing basic about this. Clinical trial design is an intricate process. I plan to only highlight key takeaways (so you are not as overwhelmed as I was with this information). If you are interested in having me explore any of these topics in depth, please leave a comment!

    The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation.

    eCFR :: 21 CFR 314.126 — Adequate and well-controlled studies.

    I want to highlight this regulation as this serves as the foundation in designing adequate and well-controlled studies. To meet this, study teams must have:

    • Defined objectives and a summary of methods within the protocol
    • Permits a valid comparison with a control to provide a quantitative assessment of drug effect; there are five types of controls:
      • Placebo
      • Dose comparison (i.e., comparing the product at different dosages)
      • No treatment
      • A different active treatment
      • Historical
    • Adequate selection of participants and assignment to treatment/control groups to minimize bias
    • Adequate measures to minimize biases on subjects, observers,
      and analysts
    • Well-defined and reliable assessment of subjectsโ€™ responses
    • Adequate analysis of results to assess the effects of the drug

    The presentation also discussed aspects of enrichment, study arm assignment, endpoints, and other design considerations. The next presentation also emphasized the importance of clinical study design. Focusing on a solid study design and conduct will make statistical analyses straightforward. Study design, conduct, and analyses all have common goals (that may conflict with one another):

    • To address a specific clinical question
    • To minimize bias and minimize variability
    • To ethically, safely, and feasibly conduct the trial

    Statistical principles discussed were related to bias, bias types, variability, z-statistic, sample size, and multiplicity.

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    Drug Safety Considerations

    This is a humbling moment for me. I’ve been struggling trying to summarize what was discussed here. Again, all of these sections could have their own posts. However, I rather speak to a subject-matter expert (SME) related to this topic. I want to ensure I am providing you all accurate information. If I come across a SME, I will be sure to share key considerations for this aspect! I do have some resources below related to the topic from the course. This can serve as background for this highly complex subject area:

    Special Populations

    The “TL;DR” version:

    • Though pregnant women aren’t considered a “vulnerable population” under the Common Rule, they still require additional protections.
    • Education in regulatory definitions is essential to appropriately applying federal regulations.

    For those who still wish read about my journey:

    The main, and dare I say, most controversial highlight was related to pregnant women in clinical trials – or so I thought. You may be aware that 2018 Common Rule, Subpart B provide additional protections for this special population. At first, I thought I misheard what I’m about to tell you. I took a look at the slides just to be sure. Within the presentation, it was noted that the Common Rule has removed the reference of pregnant women being “vulnerable”. This raised all kinds of red flags for me:

    • What do you mean pregnant women aren’t vulnerable?
    • What about the HHS update from October 2024?
    • Doesn’t a vulnerable population by default have additional protections under the Common Rule?

    I know the “TL;DR” version may have spoiled this for you. However, I want to take the time here to stress an important concept here. Having a fundamental understanding of regulatory definitions is essential. This might be attributed to me only being in research compliance since January 2022. When I heard that pregnant women weren’t considered a vulnerable population, I thought this meant that there are no longer additional protections for this special group. My head was spinning. I thought to myself, I need to connect with my team right away; THIS IS HUGE.

    Before I rushed to send an email, I decided to do take a moment and breathe. I wanted to pause to collect my thoughts. Federal regulations can be tricky to interpret. I wasn’t sure who to ask to confirm this information (or how to search on Google). Then, I remembered the sacred texts of human subjects research: Institutional Review Board: Management and Function: Management and Function 3rd Edition. I originally purchased this textbook to help me prepare for the CIP. However, I find myself referring to this textbook on a daily basis.

    I went to chapter 9-4 of the textbook where additional protections for pregnant women are discussed. The text indicates that in the pre-2018 Common Rule, pregnant women (along with other special groups) were considered vulnerable. For a special group to be considered vulnerable:

    • The individuals within this group will have a compromised ability in providing consent., or
    • The individuals within this group are at special risk of exploitation.

    Another way of saying this: special groups of this nature are vulnerable to coercion and unduly influence. I decided to review the Annotated Comparison of the Pre-2018 Common Rule with the Revised Common Rule. Whether you are new to the field or a seasoned professional, I strongly encourage you all to review the annotated comparison. It’s really nice because you can see additions and deletions to the Revised Common Rule. Within the annotated comparison, I read an excerpt where vulnerability was discussed. The excerpt confirmed my understanding of the annotated comparison and of the text. I’m really glad I decided to pause and educate myself before taking action with my team. It’s true what they say, think before you speak (or act).

    Thank you for bearing with me on this long and informative post! I can’t believe all this information was covered in four hours. And to think there’s two more days of training to go! Stay tuned for more updates on the FDA clinical investigators course.

    Don’t forget to leave a comment about your favorite session covered during the training!

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