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.
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators!190 blog subscribers!
I hope everyone has been doing well! I know it has been a while since I’ve published a post. I’ve been attempting to follow all the compliance news occurring. It seems as though something new happens every week, if not every day. There is certainly a lot of stress and uncertainty within the research and compliance world.
Which is why I feelthis post couldn’t be shared at a more appropriate time.
I would like to share top career hacks for compliance professionals. Not only can you apply these hacks to your career, but also in your life.
In these times of uncertainty, it is crucial to take a step back and reconnect with yourself.
As much as we talk about emotional intelligence and empathy towards others, self awareness is just as important. We should always take active steps to center ourselves.
As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
Let’s take a moment to reflect on these career and personal wellness hacks:
It’s okay to say “I don’t know”
Have you ever been asked a question during a presentation or meeting you weren’t sure how to answer?
Did the question seem out of left field? Was it about a topic that you didn’t account for? Maybe it was related to something that you deemed irrelevant?
As you imagine this scenario, I want you to try to remember how you felt. Did it make you feel incompetent? Were you caught off guard? How about your physical state? Were your palms sweaty? Did your jaw clench? Did you feel shortness of breath?
As someone with anxiety, I have certainly had these moments. Just sheer panic and fear of what someone would think of me. But you know what I’ve learned? It’s worse to pretend like you know the answer.
The best thing to say is, “I don’t have the answer right now. I can certainly look into this and get back to you.”
or
Another option I like is to say, “This is an excellent question and something I didn’t consider. Let me get back to you once I learn more information.”
By admitting you don’t know something, it shows integrity to your audience. It’s important to be candid. You should try not to focus on feeling incompetent. If anything, this is an opportunity for growth. You get to learn something new!
You can apply this in your personal life as well. You could be having a conversation with someone, and you have no clue what they’re saying. Again, in lieu of being embarrassed, take a leap and learn more about it! I always like to say that I am a “forever student”. I truly enjoy learning on my own, but even more so from others. Especially if they are passionate about the topic.
Build your network
Ever heard of the proverb, “it takes a village”?
Well, that’s because it does! You can read all the policies and procedure pertinent to your compliance area. You can watch all the videos you want from experts discussing a topic in depth. What you have to learn to accept is that you possibly couldn’t learn all of this on your own. And that’s okay. There’s a reason why we have different folks for various compliance areas. Sometimes, IRB professional needs to connect with a COI team for potential conflicts of interest related to an investigator’s research. Perhaps that same IRB professional needs to check in with Export Security for an investigator’s travel plans.
Recognizing that it takes a village is another positive step forward towards career growth. I urge you to build your network. Get to know folks from various fields in research administration/operations at your institution. Have lunch with them and ask them what it is they do. Ask them how does your area of expertise intersect with their daily tasks.
What about folks who were multiple compliance hats at their institution?
These folks should look at building their network outside of their institution. Of course, institutions have their own sets of policies and procedures. The key is to connect with folks who may have encountered the same or similar issue that you have. How did these folks handle the situation at their institution? Can you directly apply the resolution at your institution? If not, can you adapt certain aspects of the resolution?
When you have a group of folks you can ask questions and bounce ideas off of, this is called your network. Applying this concept to your personal life, we call this a support system. To compare, your support system is comprised of individuals that you can count on. These are the people you go to when you’re in a pickle and you don’t know what to do. These are the people you can also bounce ideas off of. This is why human connection is so important both at work and outside of the workplace.
Give yourself mental resets
Have you ever worked on a project where you just stared at your screen for hours? You wanted to make progress but felt stuck.
Perhaps you’re setting up decorations for your child’s birthday party. You have a vision of how the decorations should look, but you’re overwhelmed with frustration. Things aren’t turning out as you pictured in your mind.
If this has ever happened to you, you’re not alone. At moments like these when all seems lost, you need to step back. This is what we call a mental reset. By taking a break from the situation, you are allowing yourself that space to be gentle with yourself. Sometimes closing the laptop or stepping into another room away from the decorations can provide the clarity you need.
You can take mental resets by:
Simply stepping away from what is causing you frustration.
Going for a walk and getting fresh air.
Taking deep breaths to steady your mind.
Practicing meditation or prayer.
Doing something that brings you joy. Maybe a book you’ve been reading.
For anxiety, trying the grounding technique and stimulating your senses.
Washing your face with cold water to refresh yourself.
Whichever method you choose, I guarantee that you will feel much better at tackling your issue. These mental resets will help you figure out how to solve your problem. The beautiful thing is that there aren’t limits to the number of mental resets one can take. Take as many mental resets (i.e., breaks) as needed to center yourself and start again.
Celebrate your triumphs
Did you just receive an award at work for outstanding performance? Maybe you finally organized that storage closet that you never let your house guests see.
Whatever the achievement may be, no matter how big or small, should be celebrated! It doesn’t have to be an elaborate celebration with a lot of people and balloons. It can be something simple as buying that shirt you’ve had in your cart for months. Or maybe you take a day trip to enjoy nature. Celebrating your triumphs can promote your self-worth. As much as you remember the bad times, take the space to embrace the good times. Fill your heart and life with as much joy as you can. Life is too short not to be celebrated.
Group similar tasks together
In today’s world, it is so easy to be overwhelmed.
You can find yourself drowning in reviewing submissions, emails, meetings, and spontaneous tasks that fall in your lap. Days such as these are often unpredictable. It’s essential to take a step back and pause before you react.
At the start of your day, look at your calendar and compare this to any anticipated daily tasks.
Are there any daily tasks that coincide with a particular meeting you have scheduled that day?
If so, group those tasks together and prioritize completion based on when the meeting will start. If you’re unsure which tasks to complete first with respect to the meeting, review the meeting agenda (if available). Then, complete the tasks in the order of the meeting agenda.
If an agenda is unavailable, complete the tasks in a logical order that aligns with your compliance area’s process flow. When you present your task deliverables in this format, meeting attendees will be able to follow along with ease.
What if your free of meetings for the day and you have this daunting to-do list?
Again, review this list and see which tasks are similar to one another. Once you have grouped similar tasks together, consider how these tasks should be completed:
Are any of these task groups dependent on one another?
Can any of these task groups be completed quicker than other task groups?
Do any of these task groups depend on an action from a collaborator?
Can any of these task groups be streamlined via automation (e.g., creating a mail merge file)?
You can also apply this methodology in your personal life.
Again, let’s consider the following:
Are any of these task groups dependent on one another?
Can any of these task groups be completed quicker than other task groups?
Do any of these task groups depend on an action from another household member?
Can any of these task groups be streamlined (e.g., setting up automatic withdrawals on bill payments)?
By pausing to plan and group tasks together, you’ll find that your daunting, busy day won’t seem so grim. If something seems impossible:
Take a mental reset to acknowledge you are unsure how to proceed. Remember, it’s okay if you don’t know the answer.
Reach out to your network (i.e., support system) for guidance.
Work through your tasks at your own pace. I promise you there isn’t a time limit.
Give yourself a pat on the back for taking care of business. You made it! Celebrate it!
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.
