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.
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators!193 blog subscribers and 580 followers on LinkedIn!
I hope everyone has been doing well! In lieu of the live regulatory reporting I was doing in the past, I have come up with the following newsletter concept:
Research Compliance Chronicle:
At the beginning of each month, I will summarize key regulatory news related to research compliance from the previous month.
It can be easy to miss key information in today’s world – especially with the uncertainty in the research realm.
Consider this your one-stop shop for “ICYMI regulatory update”!
As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
Jennifer McClellan reintroduced the Relieving Economic Strain to Enhance American Resilience and Competitiveness in Higher Education and Research (RESEARCHER) Act.
A direct quote from the McClellan press release states, โThe RESEARCHER Act would support our young researchers, invest in their scientific and economic contributions, and build the STEM workforce of tomorrow. โ
Lisa McClain and Don Davis introduced the Accountability in Foreign Animal Research (AFAR) Act.
According to this press release, this act would prevent U.S. tax dollars from being used to conduct or support research on animals in China, Iran, North Korea, Russia, or other adversarial countries.
I was unable to locate a press release, but the bill was proposed by Timothy Kennedy.
The bill proposes to limit the impoundment, transfer, or reprogramming of Federal funds made available for the National Institutes of Health (NIH), and for other purposes.
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:
Once you’ve reviewed my work, take a look to see how I applied my top tips for scientific writing:
The Do’s
The “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.
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.
Reviewed by Tasha Mohseni
Authored by Neeba Wilson
Good morning, good afternoon, and good evening Compliance Rockstars, Clinical Researchers, Ethics Educators, and Investigators from around the globe!
In this post, Neeba Wilson will help us understand good laboratory practices (GLP). She has a master’s degree in biotechnology and graduate certification in clinical research. She possesses over a decade of experience in research, pharmaceuticals, and life sciences. Her expertise encompasses:
Good Clinical Practice (GCP),
Good Laboratory Practice (GLP),
Good Manufacturing Practice (GMP), as well as
Robust skills in project management, quality control (QC), and quality assurance (QA)
I would like to thank Neeba for her willingness to share her expertise with us and author this post!
As a general reminder, these are her own interpretations. Any legal information discussed within this post should be discussed with your institution.
What are Good Laboratory Practices (GLP)?
GLP provides a structure for overseeing lab operations and guarantee the reliability and quality of data produced during research. Both regulatory compliance and the establishment of trust in scientific findings depend on these activities.
The essential principles of GLP are outlined by the Organization for Economic Co-operation and Development (OECD).
Key Principles of GLP
Organization and Personnel
A well-structured laboratory is crucial for effective operations. This includes having:
Clearly defined roles and responsibilities for all personnel involved in the research process
The training and qualifications of staff must be documented to ensure that everyone is competent in their respective roles
Regular training sessions can help maintain high standards and keep staff updated on the latest practices and technologies.
Quality Assurance (QA)
Implementing a robust quality assurance system is vital for monitoring compliance with GLP standards. This involves:
Regular audits and inspections to ensure that all laboratory activities adhere to established protocols
A dedicated quality assurance unit is responsible for:
Evaluating the effectiveness of GLP implementation,
Identifying areas for improvement, and
Ensuring that corrective actions are taken promptly
QA programs should include a statement listing:
The types of inspections conducted,
Dates when inspections occurred, and
Confirmation that the final report accurately reflects the raw data collected
Standard Operating Procedures (SOPs)
SOPs are essential for maintaining consistency in laboratory operations. These documents outline the specific procedures to be followed for various tasks, ensuring that all personnel perform their duties uniformly.
Regular reviews and updates of SOPs are essential.
These activities incorporate new findings and technologies, thereby enhancing the overall quality of laboratory work.
Documentation and Record Keeping
Accurate and thorough documentation is a cornerstone of GLP.
All laboratory activities, including experimental designs, results, and deviations from protocols, must be recorded meticulously. This not only facilitates transparency but also allows for reproducibility of results, which is critical in scientific research. The final report should include a description of materials and methods, results, and storage locations for study documentation and samples.
Equipment and Facilities
The laboratory environment must be conducive to high-quality research. This includes:
Maintaining equipment in good working order,
Ensuring that facilities are clean and organized, and
That safety protocols are followed
Regular maintenance and calibration of equipment are essential to prevent errors and ensure reliable results. Test facility management plays a crucial role in this aspect which involves:
Documented approval of study plans by the Study Director,
Maintaining a master schedule, and
Ensuring that test and reference items are appropriately characterized
Test and Control Substances
Proper handling and characterization of test and control substances are crucial for the validity of research findings. This includes ensuring that all substances are properly labeled, stored, and disposed of according to regulatory guidelines. Comprehensive records of all substances used in experiments should be maintained to facilitate traceability.
Key Components of GLP
Test Facility Management
For GLP to be implemented successfully, test facilities must be managed effectively. Important duties include:
Study Plan Approval:
The study director is responsible for:
Recording the approval of study plans,
Making sure that every facet of the research is clear, and
Complies with GLP guidelines
Maintenance of the Master Schedule:
Maintaining a master schedule facilitates the planning and coordination of several research and guarantees the effective use of available resources
Test item characterization:
To preserve the study’s integrity, it is essential to make sure that test and reference items are suitably defined
Computer System Validation:
Protocols must be in place to guarantee that the laboratory’s computer systems are appropriate, verified, and maintained in compliance with GLP guidelines
This involves making certain that staff members are competent and aware of their responsibilities.
Quality Assurance (QA)
QA Unit:
A dedicated QA unit is essential for monitoring compliance with GLP standards
This unit conducts regular audits and inspections of laboratory practices, ensuring that all activities are documented and that deviations from protocols are addressed promptly
Documentation of Inspections:
The QA unit should maintain records of all inspections, including the types of inspections conducted and their outcomes
This documentation is crucial for demonstrating compliance during regulatory reviews.
Content of Final Reports
The final report is a critical document that summarizes the study’s findings.
It must include the following:
Identification of Study:
This section includes:
The title, nature, and purpose of the study,
along with a description of the test and reference items
Information Concerning Sponsor and Test Facility:
Details about the sponsor, test facilities, test sites, and key personnel involved in the study must be documented
Dates:
The report should specify the start and completion dates of the study, providing a timeline for the research conducted
Results and Discussion:
A comprehensive analysis of the results obtained during the study, including any statistical evaluations and interpretations, should be included
This section should also discuss the implications of the findings in the context of existing knowledge
Conclusions:
The final report should conclude with a summary of the study’s findings and their relevance to the field,
along with any recommendations for future research or regulatory considerations
Data Management
Raw Data:
All raw data generated during the study must be retained and organized systematically
This includes laboratory notebooks, electronic data, and any other documentation that supports the findings of the study.
Data Integrity:
Ensuring the integrity of data is paramount
This involves implementing measures to prevent data manipulation and ensuring that all changes to data are documented and justified
Training and Competence
Personnel Training:
Continuous training programs should be established to ensure that all personnel are familiar with GLP principles and the specific procedures relevant to their roles
This includes training on equipment use, safety protocols, and data management practices.
Competence Assessment:
Regular assessments of personnel competence should be conducted to ensure that staff members can perform their duties effectively and in compliance with GLP standards
Equipment and Facility Maintenance
Calibration and Maintenance:
All laboratory equipment must be regularly calibrated and maintained to ensure accurate and reliable results
Records of maintenance and calibration activities should be kept as part of the laboratory’s documentation
Facility Conditions:
The laboratory environment must be controlled to prevent contamination and ensure the safety of personnel
This includes maintaining appropriate temperature, humidity, and cleanliness standard
The Importance of Compliance Monitoring
A crucial component of upholding GLP is compliance monitoring.
It requires a careful evaluation of laboratory procedures to guarantee compliance with GLP guidelines. This may consist of:
Frequent Audits:
Performing planned audits to evaluate adherence to GLP guidelines and identify areas in need of development
Education and Training:
Ensuring that laboratory staff receive regular training, so they are knowledgeable about GLP regulations and best practices
Feedback Mechanisms:
Creating opportunities for employees to voice concerns or recommend enhancements to promote a continuous improvement in culture.
Closing Thoughts
The integrity and dependability of non-clinical research depend on GLP.
Labs can improve the caliber of their work, meet regulatory standards, and foster confidence by following the OECD’s guidelines.
A good GLP framework must have strong quality assurance systems, efficient test facility management, and rigorous documentation procedures. Consult the official materials of the OECD for more information on GLP (provided below), including compliance monitoring and comprehensive guidelines. By adhering to these guidelines, labs likely can guarantee top-notch research and promote scientific progress.
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.
Tasha Mohseni
(Author)
Adnan Shaikh
(Author & Reviewer)
Good morning, good afternoon, and good evening Compliance Rockstars, Clinical Researchers, Ethics Educators, and Investigators from around the globe!
It’s hard to believe that January is coming to a close. It feels like just yesterday folks were sending their New Year wishes. It felt as though I was reviewing countless study submissions. I prefer to be on my toes than idle!
ICYMI, TikTok went dark on January 18, 2025 only to return on January 20, 2025. You can read about my insights here:
Now, back to today’s post. On January 6, 2025 the final version of the ICH GCP E6(R3) guidelines. Whether you’re a novice to clinical research (like me) or an expert, this is a HUGE deal. The last revision for ICH GCP E6(R2) was back in November 2016. Without writing this post, I could guess that there are significant differences. But I don’t like to guess…I like to know and understand why.
For background, I primary review IRB studies related to social, behavioral, and education research (SBER). I am extremely interested in learning more about clinical research ethics and clinical trials in general.
Therefore, I would like to thank Adnan Shaikh for his willingness to review and co-author this post!
In this post, we plan to describe in detail the differences between the E6(R2) version and the E6(R3) version. As a general disclaimer, these are our own interpretations of these guidelines. If you have any questions about these guidelines, you should always consult with your institution.
Tasha Mohseni’s POV on General Guideline Differences
Aside from document length, the table below summarizes the general differences between the guidelines:
ICH GCP E6(R2) Summary
ICH GCP E6(R3) Summary
1. Published in November 2016. 2. It emphasized updates needed to integrate modern technology and risk-based approaches into clinical trials. 3. Key updates included: A. Adoption of risk-based monitoring. B. Enhanced guidance on electronic records and data management. C. Emphasis on quality management systems tailored to clinical trial complexities.
1. Published in January 2025. 2. Introduced broader revisions across clinical trial design, oversight, and ethical conduct, emphasizing: A. Greater focus on patient needs and preferences. B. Enhanced data reliability and transparency mechanisms. C. Encouragement of adaptive and innovative trial designs. D. Modernized guidance for handling big data and novel analytical tools.
What Did ChatGPT Have to Say About The Guideline Differences?
I can’t even quantify how long it took me to summarize the general differences for the two documents. Though this was interesting to review, I found it difficult to sift through the information. This might be because I haven’t had exposure in this area. I likely should have completed the GCP CITI training course to provide a foundation. Alas, here we are!
Out of curiosity and efficiency, I decided to upload both guidelines to ChatGPT and asked for itemized differences. Below is a complete response from ChatGPT:
“To provide a detailed, itemized comparison of the ICH E6(R2) and ICH E6(R3) documents, I will identify key differences across major sections and topics in both documents. This will include updates, additions, and revisions. Here’s an itemized list based on their content:
Introduction and Scope
ICH E6(R2):
Introduced updates to integrate risk-based monitoring and electronic systems.
Focused on maintaining ethical principles while improving trial efficiency and data reliability.
ICH E6(R3):
Broader scope, emphasizing patient-centric approaches and advanced technologies like decentralized trials and real-world evidence.
Greater emphasis on stakeholder collaboration and global harmonization.
Quality Management
ICH E6(R2):
Introduced a risk-based quality management system.
Focused on identifying and mitigating risks to critical data and processes.
ICH E6(R3):
Expands the quality management framework to include:
Adaptive approaches.
Continuous quality improvement throughout the trial lifecycle.
Integration of advanced analytics and real-world data for monitoring.
Data Management
ICH E6(R2):
Introduced guidance on electronic systems and electronic data capture.
Added the requirement for an audit trail for all changes in electronic data.
ICH E6(R3):
Extends guidance on managing big data, artificial intelligence (AI), and machine learning (ML) tools.
Updates standards for data security, privacy, and transparency in decentralized trials.
Trial Design
ICH E6(R2):
Focused on traditional trial designs, with some flexibility for centralized monitoring.
ICH E6(R3):
Encourages adaptive, innovative, and patient-centric trial designs.
Includes guidance for decentralized clinical trials (DCTs) and the use of real-world evidence (RWE).
Investigator Responsibilities
ICH E6(R2):
Detailed investigator obligations, focusing on protocol adherence and oversight.
Introduced responsibility for supervising delegated tasks.
ICH E6(R3):
Expands the investigatorโs role to ensure oversight in remote and virtual settings.
Adds accountability for new roles introduced in decentralized models (e.g., telemedicine).
Monitoring
ICH E6(R2):
Introduced risk-based monitoring (RBM) for the first time.
Emphasized centralized monitoring over traditional on-site monitoring.
ICH E6(R3):
Refines RBM principles and promotes greater use of AI-driven monitoring systems.
Integrates remote monitoring for decentralized trials.
Patient-Centric Approaches
ICH E6(R2):
Focused primarily on data integrity and participant safety.
ICH E6(R3):
Strong emphasis on patient engagement, including:
Simplified informed consent processes.
Participant-centered trial design.
Use of digital tools to enhance patient experience and access.
Ethical Considerations
ICH E6(R2):
Rooted in the principles of the Declaration of Helsinki, with updates for vulnerable populations.
ICH E6(R3):
Expands ethical considerations to include:
Diversity and inclusion in clinical trial participation.
Enhanced protection for participants in decentralized and global trials.
Use of Technology
ICH E6(R2):
Introduced electronic systems, requiring validation and audit trails.
ICH E6(R3):
Extends to newer technologies like AI, blockchain, and wearable devices.
Requires validation and traceability for advanced digital systems.
Regulatory Harmonization
ICH E6(R2):
Harmonized standards for the EU, U.S., and Japan.
ICH E6(R3):
Broader harmonization efforts, including additional regions (e.g., Canada, Switzerland).
Greater emphasis on mutual regulatory acceptance of trial data.
Risk-Based Approaches
ICH E6(R2):
Introduced risk-based approaches for trial management and monitoring.
ICH E6(R3):
Refines risk-based approaches with continuous risk assessment throughout the trial lifecycle.
Incorporates new methodologies to address emerging risks in decentralized and digital trials.
Terminology and Glossary Updates
ICH E6(R2):
Updated glossary to include terms like “risk-based monitoring” and “certified copy.”
ICH E6(R3):
Expands glossary to include modern terms like “decentralized trials,” “real-world data,” and “validation of AI systems.”
These itemized differences highlight the evolution of clinical trial guidelines from E6(R2) to E6(R3), reflecting advancements in technology, trial design, and ethical considerations. Let me know if you want a deeper analysis of any specific section!”
At face value, this seems to be an impressive comparative analysis.
You might be wondering why I said the word “seems”.
I say this because I am acknowledging that I am not a subject-matter expert. I can’t even say that I have direct experience with this other than reading the guidelines themselves. I can’t necessarily validate if ChatGPT assessed the information correctly. I could have done more iterative prompting to receive an even more detailed response…but for what? This is why it is so important to have the expertise to verify the information is correct. Whether you become knowledgeable or collaborate with someone who has the expertise. Let’s see what Adnan Shaikh has to say about ChatGPT’s analysis!
Adnan Shaikh’s POV on the ChatGPT Analysis (in his own words)
Hey everyone! I hope you’re enjoying reading Tasha’s content.Here’s my take on the ICH GCP E6(R2) versus ICH GCP E6(R3).
The adoption ICH GCP E6(R3) introduces a transformative update to the principles and practices of clinical research:
The ICH GCP E6(R2) guidelines were more focused
They adhered to the protocol and followed the traditional approach in clinical trial studies, that has an impact of โone size fits all”
While ICH GCP E6(R3) is more modern and advanced approach for clinical trial, it encourages โfit for purposeโ
Which means that proportionality and risk-based approaches focus on the quality of clinical trials
This is critical and fundamental to the safety of participants and the reliability of participants results
I humbly recognize that I am not as expert and that I am still learning
However, to summarize the overall concept of ICH GCP E6(R3), it focuses on the following:
Emphasize proportionality risk-based approach,
Incorporates innovative technologies, and
Promotes adaptability to modern clinical trial design.
In the recent times, AI is claimed to be one of the best tools in helping with clinical research.
Now, I would like to share my POV on ChatGPT.
It is helpful in many ways, for example:
Preparing document with little to no grammatical errors,
Providing information on particular drug molecules, and
Providing information on ICH GCP guidelines
When I prompted ChatGPT about the difference between ICH GCP E6(R2) vs ICH GCP E6(R3), I received the following graphical explanation:
Image of ChatGPT’s graphic representation of the differences between ICH GCP E6(R2) and ICH GCP E6(R3)
As you can see, this further illustrates my point that ICH GCP E6(R3) highly focuses on modern adaptation. By implementing this concept, it can provide more flexibility in clinical research studies. In the era of AI and emerging technologies, itโs important to adapt the modern techniques in clinical trials. It is also criticial to note that this must be done without compromising confidentiality. We must adhere to ethical standards for the responsible use of these emerging technologies.
I am expressing my sincere gratitude to Tasha for involving me in this post. I ‘m looking forward to working with her on future projects!
We hope you find the content useful and thought-provoking! What do you think about current guidelines? Please lead the discussion and leave a comment below!
Again, thank you Adnan Shaikh for your invaluable expertise! For those who would like to learn more about him, you can follow him on LinkedIn and read his brief biography below.
Adnan Shaikha is a Pharm.D (Doctor of Pharmacy) candidate. He is completing his clinical pharmacy internship at New Civil Hospital. His degree will be from the Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, India. He is expecting to graduate with his PharmD degree in June 2025. Additionally, he is doing a certification course on medical writing in clinical research.
We wish you the best of luck on this exciting endeavor and soon-to-be new chapter in your life!
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:
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 โsubstantial evidenceโ to support the claims of effectiveness for new drugs.
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:
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:
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:
FDAโs 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!
