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!270+ blog subscribers and counting!
It makes me ecstatic to see more and more folks subscribing to the blog! I’m happy that this blog is a useful resource to you all. I aim to continue to provide meaningful, unique content. As I mentioned before, I love to explain complex topics in a simpler format. Speaking of learning and reinforcing concepts:
To solidify a concept, I like to see the content in various mediums (e.g., text, audio, visual).
Podcasts can be an excellent learning tool! Whether you are reinforcing concepts or would like to learn something new, podcasts can aid in this. If you love learning on the go, then this post is for you!
In this post, I will list the best podcasts for staying up to date on research, compliance, and administration.
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As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
Let’s learn about these top-notch podcasts! Please note that these aren’t listed in any particular order.
Is there a podcast that you feel fits into this category that I didn’t mention? Please leave a comment below for myself and the community!
Dan Sfera aka “The Clinical Trials Guru” shares his thoughts on the clinical research industry, business, entrepreneurship, sports and really just about anything he feels like at the moment.
I absolutely love to follow Dan on LinkedIn. He offers extraordinary insights to the clinical research community. You can also check out the following resources related to Dan’s work:
This podcast discusses issues that impact scientific research monthly, from clinical research to ethical considerations. Hosted by Alexa McClellan.
There is a new episode each month. CITI Program’s blog also provides insights to their podcast episodes by breaking down the episode by podcast chapters and providing transcripts (example below):
Engaging with Online Communities: Ethical Considerations for Researchers (episode)
Engaging with Online Communities: Ethical Considerations for Researchers (blog)
This podcast discusses a broad range of technology ethics topics. Hosted by Daniel Smith.
There is a new episode each month. CITI Program’s blog also provides insights to their podcast episodes by breaking down the episode by podcast chapters and providing transcripts (example below):
This podcast discusses issues that impact higher education institutions. Hosted by Ed Butch.
There is a new episode each month. CITI Program’s blog also provides insights to their podcast episodes by breaking down the episode by podcast chapters and providing transcripts (example below):
Professional Development: A Conversation about Career Transitions (episode)
Professional Development: A Conversation about Career Transitions (blog)
This podcast dives into the intricacies of pre-award, post-award, compliance, communications, and all the essential elements in between. You can tune in on the last Thursday of every month for insightful discussions and expert insights for research administrators across the globe. The SRAI blog is also an excellent resource to deep dive into the complexities of research administration.
Though I haven’t personally checked out this podcast yet, these are my TOP THREE episodes I would check out first:
This podcast covers ethics and compliance-related topics and addresses issues ranging from FCPA to HIPAA to helplines.
Though I haven’t had the pleasure of listening to this podcast yet, I like how the episodes are succinct. If you’ve heard of the phrase, “Big things come in small packages”, this certainly applies! If you have a short attention span (which I tend to have at times), then this podcast is for you! Here are my TOP THREE episodes I plan to check out first:
This podcast is dedicated to helping scientists thrive. Brought to you by STEMCELL Technologies.
On their website, you can find excellent educational resources. With respect to podcasts, you can find summaries and video recordings of each episode here: Podcasts
JP Flores sets out to capture stories of resilience, scientific journeys, and inspiration that have built and shaped many diverse scientists.
I appreciate that this podcast strives to celebrate scientists. I haven’t had the opportunity to listen to this podcast yet, but these are the TOP THREE I am striving to check out first:
Advarra speaks with leading experts to dig into pressing issues and explore solutionswithin research and clinical trials.
Advarra has a plethora of resources ranging from their blog to on-demand webinars. This was my go-to podcast when I first started in compliance trying to learn the ropes. Though they haven’t had any recent episodes, I still find the information useful!
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!260+ blog subscribers and counting!
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Welcome to the RAC Digest!
RAC stands for “Research Administration and Compliance”.
The RAC Digest will feature select publications from the previous month.
These 12 articles will come from journals related to research administration and research compliance.
As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
If your institution does not have access to the publications listed below and you would like access, please fill out the form below:
The study surveyed 642 IRB professionals and found substantial support for incorporating gender-neutral language in IRB guidance and consent documents.
Though this concept is highly supported, there are a few obstacles that hinder application. A couple of examples include:
Lack of resources and awareness
Perception that changes are not required by federal regulations
Most respondents agreed that gender-neutral language is appropriate in IRB guidance, templates, and consent forms regardless of AAHRPP accreditation status.
However, respondents whose IRBs were not accredited showed stronger agreement than respondents whose IRBs were accredited.
Most respondents indicated that the FDA and OHRP should provide guidance for IRBs and investigators regarding the use of gender-neutral language in IRB materials.
Bobier challenges the conception of undue inducement.
An offer is considered “undue” if it impairs the individualโs ability to make rational or voluntary decisions.
He proposes a collectivist alternative, arguing that inducements are undue when they result in the disproportionate enrollment of protected classes.
This theory draws on the legal concept of disparate impact. I.e., shifting the ethical concern from individual autonomy to collective justice and equity.
Finally, he states that this method of thought can be easily operationalized by IRBs.
Inducements are undue when they result in an unjustified disparate enrollment pattern:
A protected class of individuals is overly enrolled,
that protected class is not integrally tied to the study objectives, and
There are alternative recruitment methods available that would not result in this enrollment pattern.
The article emphasizes that the inclusion of adolescents is essential for developing effective, age-appropriate interventions and policies.
An interesting point to mention is that if state laws permit minors to consent to specific medical services (e.g., contraception), they can also independently consent to participate in research related to the service.
Researchers and IRBs are encouraged to design studies that minimize risks and respect adolescents’ autonomy.
Relatedly, the authors offer guidance on how IRBs can interpret regulations to support ethical inclusion, e.g., when waivers of parental consent are appropriate.
The study found no significant difference in informed consent comprehension between detained individuals with ADHD and those without ADHD.
Individuals with ADHD and without ADHD demonstrated similar willingness to sign the informed consent forms and participate in research.
Unfortunately, the overall understanding of the informed consent content was low in both participant groups.
This highlights a broader issue in conveying complex consent form content effectively to detained individuals.
Further research could investigate the effectiveness of alternative informed consent formats in improving the understanding of informed consent such as:
The study aimed to examine how the quality of interactions between clinical research staff and participants from racial and ethnic minority groups affects their trust in the research process and their willingness to engage in future clinical trials.
The study found that negative experiences were associated with a decreased willingness among participants to enroll in future studies.
This suggests that improving the quality of interactions between research staff and participants from minority groups can enhance trust and potentially increase participation rates in clinical trials.
It is recommended to implement training programs for research staff to guide culturally sensitive interactions and foster trust.
Emory University’s Office of Research Administration (ORA), in collaboration with the Goizueta Business School, developed a proof-of-concept generative AI chatbot named ORAgpt.
This tool aims to provide research administrators with instant, accurate information on ORA processes and policies.
Further, the tool would streamline administrative tasks and supporting research operations.
The study challenges the conventional view of participant recruitment as a transactional, outcome-driven process.
The author advocates for a relationship-building approach, emphasizing sustainable, respectful participantโresearcher interactions.
Here, the invitational rhetoric framework is explored in how it can build sustainable participantโresearcher relationships.
Using this framework as an analytical lens, the study evaluated how study advertisements on university Study Discovery Sites (SDSs) foster conditions of:
Value,
Safety, and
Freedom.
Several recommendations were provided to researchers including designing recruitment materials that avoid oppressive language (e.g., stating “participant” in lieu of “subject”).
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 by:
Mila Babaev
Reviewed by:
Tasha Mohseni
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators!260+ blog subscribers and counting!
I hope everyone is doing well! I can’t believe we are already halfway through 2025. If you’ve been subscribed to the blog from the beginning, you know that I have always promoted collaboration. I love to feature guest authors in my blog.
Check out the collaborative posts that have been published thus far listed below!
To highlight these contributors moving forward, I have developed a new type of post called “Subscriber Spotlight”.
For these posts, you can expect to see:
An introduction of the valued subscriber,
How long the individual has been a subscriber,
Relevant social media and/or publications, and
A brief description of what they would like to share with you all!
As a general reminder, these are solely the author’s interpretations (and none of their employer or associated affiliations). Any legal information discussed within this post should be discussed with your institution.
Let’s get started:
Who is Mila Babaev?
Mila Babaev, CIP has been a loyal subscriber since December 2024. Per her LinkedIn profile:
She is an IRB and Compliance professional with over a decade of experience supporting Principal Investigators and study teams.
Further, she is versed in federal, state, and institutional level regulations and policy pertaining to the protection of humanโsubjects research.
She is currently pursuing a Masterโs degree in Research Administration and Compliance
Her goal is to gain new knowledge from this degree and move into a management role.
Lastly, she was recently given the opportunity to conduct internal audits/quality reviews on research trials at Atlantic Health System.
Let’s dive into her piece on “Preparing a readable consent form”.
Preparing a readable consent form
Relevant regulatory requirement
In reference to research consent forms, 45 CFR 46.116, requires that:
โThe information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.โ
However, many consent forms submitted to the IRBs I have worked for in my 10 years as an IRB administrator contain language which far exceeds the 6th-8th grade recommended language.
The literature is in line with my experience; a review of written consent forms in 2018 revealed that most are written at a 10th grade reading level or higher across all medical specialties.
Key suggestions to achieve a readable consent form
In my conversations with researchers, it became clear that some do not even realize the terms aren’t in Layman’s terms.
They are composing and reading the consent through the lens of a scientist/researcher.
The guidance offers two useful ways to detect whether there is an issue with lay language and readability, in general…
Read the form out loud to others and gather feedback
Check grade level via a word processing tool, such as Microsoft Word
To check the readability via Microsoft Word:
On the โFileโ tab, click the โOptionsโ button
Then, on the โProofingโ tab, under โWhen correcting spelling and grammar in Wordโ, make sure โCheck grammar with spellingโ is selected
Next, under โWhen correcting spelling and grammar in Wordโ, select the โShow readability statisticsโ check box
After the grammar check is complete, Word displays a message box showing you the readability grade-level
This tool can be valuable to researchers as well as IRB members when completing their reviews.
Of course, it would be wonderful to have a tool that pinpoints exactly which words need to be defined in lay terms, so that none are missed. With the current AI wave, I think a tool designed for this purpose can be developed. At present, ChatGPT seems to do a decent job. I copy/pasted all the language in this text up to this point into ChatGPT and posed the question Is any of this language not in lay terms, appropriate for 6th-8th grade reading level? Quite a few responses came up, amongst them โlegally authorized representative.โ
You can see other key readability tips outlined in the Johns Hopkins article below:
Use active verbs
Write concise sentences; You can divide one sentence into two
Limit each paragraph to one idea
Keep words to three syllables or less, if possible
Describe study design procedures such as โdouble blind,โ and โplacebo/controlledโ at first use
Hadden, K. B., Prince, L. Y., Moore, T. D., James, L. P., Holland, J. R., & Trudeau, C. R. (2017). Improving readability of informed consents for research at an academic medical institution. Journal of Clinical and Translational Science, 1(6), 361โ365. doi:10.1017/cts.2017.312
We hope you found this content useful!
Thank you again, Mila, for your continued support of this blog! Sharing your knowledge with the research and compliance community is truly appreciated. Looking forward to more collaboration with you on human research.
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!250+ subscribers and counting!
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I hope everyone has been doing well! It’s time for another monthly recap of research and compliance news. For those who have not read this type of blog post before:
Research Compliance Chronicle:
At the beginning of each month, I will summarize key regulatory news related to research compliance from the previous month.
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. Please note that only links will be provided from the Federal Register for the numerous rules published by the FDA.
A resolution was called on the Trump administration to reverse course on a decision to stop seeking public input on many major changes to programs and policies overseen by the Department of Health and Human Services (HHS).
A key quote should be noted from this press release: โPublic comment periods are a key component of our First Amendment rights and demonstrate a commitment to an engaged public to wise, representative government.โ
Related (though not in this press release), HHS has created a form on Regulations.gov to submit ideas to rescind regulations that are not making the US health system better: Deregulation Suggestions Form
A letter was written to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. for firing HHS employees responsible for managing and responding to public records requests, despite publicly promising โradical transparency.โ
HHS sub-agencies are often responsible for managing public access to government records under the Freedom of Information Act (FOIA).
The sub-agencies which are impacted (and listed below), are responsible for handling exceptionally sensitive information, including health records, legal documents, and proprietary company information:
National Institutes of Health (NIH),
The Centers for Disease Control and Prevention (CDC),
The Administration for Children and Families (ACF), and
If you work within export controls and/or conflicts of interest, this press release is for you!
The University of Pennsylvania was found to have inaccurate and incomplete foreign disclosures.
Under Section 117 of the Higher Education Act (HEA) of 1965 (20 U.S.C. ยง1011f), U.S. colleges and universities receiving federal financial aid must disclose gifts, contracts, or restricted agreements from foreign sources valued at $250,000 or more annually.
Per the press release, Section 117 is intended to protect national security and academic integrity by monitoring foreign influence in higher education.
This draft guidance provides recommendations for screening donors for evidence of, and risk factors for, infection with Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis.
Comments must be submitted for review by Monday, July 7, 2025.
This draft guidance updates information regarding sepsis included in the guidance entitled โEligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,โ dated August 2007 (August 2007 HCT/P DE Guidance).
Once finalized, this guidance will update recommendations for making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider.
Comments must be submitted for review by Monday, July 7, 2025.
The purpose of this guidance document is to provide an overview of the mechanisms available to submitters through which they can request interactions with the FDA related to medical device submissions.
Comments may be submitted at any time related to this final guidance document.
The FDA issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or invalid.
They couldn’t ensure the reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted at their respective testing facilities.
The General Correspondence Letters are the latest step taken to address concerns around testing data and the integrity of data coming from foreign countries.
The following documents listed below have been rescinded:
Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications, 86 FR 35810 (July 7, 2021).
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Repeal of Current Regulations and Issuance of New Regulations: Delay of Effective Date and Resultant Amendments to the Final Rule, 66 FR 15347 (Mar. 19, 2001).
Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, 86 FR 22439 (Apr. 28, 2021).
Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972, 86 FR 27984 (May 25, 2021).
Secretary Robert F. Kennedy, Jr. articulated the Trump Administrationโs decision that it fully intends to withdraw from the World Health Organization (WHO).
He also shared his vision for the future of global health.
Policies, actions, and definitions defined in this Executive Order supersede NIHโs implementation of the White House Office of Science and Technology Policy (OSTP) May 2024 U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP Policy).
NIH will not accept competitive applications for grants and cooperative agreements submitted for due dates after today and/or R&D contract proposals submitted to solicitations issued after today for dangerous gain-of-function research, as defined in Section 8 of the Executive Order.
NIH intends to suspend ongoing funding in accordance with guidance developed under Section 3(b) of the Executive Order.
All NIH awardees should review ongoing research activities to proactively identify potential dangerous gain-of-function research and identify safe actions to halt such research and to effectively comply with guidance once established.
The purpose of this Request for Information (RFI) is to solicit broad community input on priority artificial intelligence (AI) benchmarks and associated benchmark datasets to advance the development, evaluation, and validation of AI applications in cancer research and care.
A benchmark typically includes a dataset, a problem specification, and a defined score.
NIH is requesting input on effective strategies for mitigating controlled-access human genomic data leakage when developing and sharing generative AI tools and applications.
To uphold the principles espoused in the NIH Genomic Data Sharing Policy, NIH has temporarily paused the sharing of generative AI models and their parameters based on NIH human genomic controlled-access data, as well as the retention of these tools beyond the projectโs closeout (see NOT-OD-25-081).
Effective May 5, 2025, NSF will apply a standard indirect cost rate not to exceed 15% to all grants and cooperative agreements awarded to IHEs for which indirect costs are allowable.
Introduced by Rep. Nancy Mace, Violet’s Law, would allow dogs, cats, primates, rabbits, and other animals to be retired and re-homed when they are no longer needed for research in federal labs.
Congressman Raul Ruiz, M.D. and Congressman Larry Bucshon, M.D. announced the introduction of bipartisan legislation to improve participation in clinical trials by underrepresented populations.
This Act builds on the successes of clinical trials legislation passed into law last Congress by addressing economic barriers that can prevent participation in clinical trials.
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.
Published on 5/26/2025; Revised on 5/28/2025
Thank you, Kim Serpico, Ed.D., CIP, for your thoughtful suggest of including cost within the summary certification table!
Feedback is always welcomed by my readers to ensure I am disseminating information in the most helpful way.
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators!250+ blog subscribers and counting!
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Imagine this…
You have more than two years of experience in your research compliance and regulatory role.
You’ve had exposure to various research areas (e.g., SBER, biomedical, clinical trials).
You’re wondering what to do next to boost your professional development.
Maybe, you think about taking a course or an intensive training specializing in a specific topic.
Or maybe, you’re thinking bigger. You’re thinking about obtaining a certification to showcase your expertise. A certification may even secure a promotion for you. Then, the questions pour in:
Which certification best aligns with my career goals?
What are the requirements to obtain the certification I’m interested in?
Are there any application fees?
Or maybe, you already have a certification, and you ask yourself:
Which certification would complement my current certification to help further advance my career?
I would like to discuss 10 certifications related to research and regulatory compliance. For this post, you can expect:
Summary tables comparing key features of each certification.
A breakdown of the organizations offering these certifications.
A breakdown of each individual certification.
As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
Let’s explore these certifications:
PRIM&R, SOCRA, ACRP, and HCCA Certification Quick Comparison
Created as an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community.
Current members: $395.00
Non-members: $450.00
Computer based testing (testing center or home proctoring): 1. Additional $115 (North America – USA, Canada, Mexico) 2. Additional $175 countries outside North America
1. Research study start-up 2. Research study implementation 3. Research study closure
Formally recognizes clinical research professionals of all types, regardless of their roles or functional activities on the clinical study team.
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
1. Domains 2. Knowledge statements 3. Tasks
Exam content (Detailed links will be provided below)
ACRP: Certified Clinical Research Associate (CCRA)
Formally recognizes clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor.
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
1. Domains 2. Knowledge statements 3. Tasks
Exam content (Detailed links will be provided below)
ACRP: Certified Clinical Research Coordinator (CCRC)
Formally recognizes clinical research professionals with experience coordinating and facilitating clinical trial activities in adherence to GCP, under the direction of a principal investigator.
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
1. Domains 2. Knowledge statements 3. Tasks
Exam content (Detailed links will be provided below)
ACRP: ACRP Medical Device Professional (ACRP-MDP)
Formally recognizes clinical research professionals with specialized knowledge in medical device clinical trials.
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
1. Domains 2. Knowledge statements 3. Tasks
Exam content (Detailed links will be provided below)
ACRP: ACRP Project Manager (ACRP-PM)
Formally recognizes clinical research professionals with specialized knowledge in project management.
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
1. Domains 2. Knowledge statements 3. Tasks
Exam content (Detailed links will be provided below)
HCCA: Certified in Healthcare Research Compliance (CHRC)
Showcase knowledge of relevant regulations and expertise in research compliance processes sufficient to assist the healthcare industry organizations in understanding and addressing legal obligations, and promote organizational integrity through the operation of effective research compliance programs.
Showcase knowledge of relevant regulations and expertise in compliance processes sufficient to assist the healthcare industry organizations in understanding and addressing legal obligations, and promote organizational integrity through the operation of effective compliance programs.
HCCA: Certified in Healthcare Privacy Compliance (CHPC)
Showcase knowledge of relevant regulations and expertise in privacy compliance processes sufficient to assist the healthcare industry organizations in understanding and addressing legal obligations, and promote organizational integrity through the operation of effective privacy compliance programs.
Table 1: Research and regulatory certifications broken down by certification purpose, cost, exam content, and regulatory/ethical frameworks to review.
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The Organizations Behind These Certifications
Public Responsibility in Medicine and Research (PRIM&R)
PRIM&R is a nonprofit,โฏfounded in 1974 that works to ensure the highest ethical standards in research by:
Providing education,
Membership, and
Other professional resources to the research and research oversight community, including those who work with:
Human research protections programs (HRPPs),
Institutional review boards (IRBs),
Animal care and use programs,โฏand
Institutional animal care and use committeesโฏ(IACUCs).โฏ
You can read more PRIM&R’s mission, values, and membership here: PRIM&R homepage.
The Society of Clinical Research Associates (SOCRA)
SOCRA is a non-profit, charitable and educational membership organization incorporated in 1991 committed to providing:
Education,
Certification, and
Networking opportunities to all persons involved in clinical research activities.
You can read more SOCRA’s mission, values, and membership here: SOCRA homepage.
The Association of Clinical Research Professionals (ACRP)
ACRP is a registered charitable organization whose mission is to promote excellence in clinical research. Their vision ensures that clinical research is performed ethically, responsibly, and professionally everywhere in the world. ACRP is moving the people and practice of clinical research forward by:
Being the Most Passionate Advocate for the Clinical Research Profession.
Providing the Tools Clinical Research Professionals Need to Build Their Own Career Journeys.
Creating Connections through Community.
Empowering Organizations to Trust that Their Studies Are in the Hands of Qualified Professionals.
Leading the Way for Workforce Development in Clinical Research.
You can read more ACRP’s mission, values, and membership here: ACRP homepage.
Health Care Compliance Association (HCCA)
Established in 1996, HCCA supports healthcare compliance professionals as part of the overarching mission of SCCE & HCCA, a member-based professional association with more than 19,000 members in over 100 countries.
SCCE & HCCA is dedicated to enabling the lasting success and integrity of organizations worldwide by:
Promoting high standards in compliance and ethics programs,
Nurturing a community of compliance and ethics practitioners, and
Consists of 130 objective, multiple-choice questions, and covers human subjects protection regulations, IRB responsibilities, and institutional responsibilities.
Exam length is three hours long and is a computer-based exam.
No notes or reference materials are allowed while taking the exam.
Certification fee
Testing in the US: $425.00 exam fee
Testing outside the US (internationally): $535.00 exam fee
$110.00 exam fee cost will be waived if international test takers opt for online-remote proctoring
Eligibility requirements (education and employment)
Education:
None specified.
Employment:
Two years of full-time, relevant Human Research Protection Program (HRPP) experience, completed within two weeks of the conclusion of the chosen testing period.
Relevant HRPP experience must include:
Managing HRPP policies and procedures
Managing pre-review of IRB materials
Managing review of IRB materials
Managing exempt study review determinations
Managing research protocol approval or reliance process
Below is a table of FDA guidance documents with the following keywords: Institutional Review Board, IRB, and Clinical Investigator (as stated within CIP Exam Reference sheet)
Further, both draft and final guidance documents have been provided for convenience (as the resource list doesn’t clarify this aspect).
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
Eligibility requirements (education and employment)
There are two pathways based on work experience and if a waiver is applicable. You can read about these in detail here: ACRP-CP Certification Eligibility.
Exam domain breakdown
Ethical and Participant Safety Considerations
Standard of care vs. clinical research protocol requirements
Clinical equipoise vs. therapeutic misconception
Content of the key documents ensuring subject protection (e.g., IB, protocol, informed consent documents)
Considerations for vulnerable populations
Past and current ethical issues in clinical research (e.g., diversity)
Risks vs. benefits in the selection of research subjects
Unblinding procedures
Confidentiality and privacy
Elements and process of informed consent/assent
Protocol deviation/violation identification, documentation, and reporting processes
Recruitment and retention plan/strategies
Safety monitoring and reporting
Subject discontinuation criteria/procedures
Conflict of interest in clinical research
Fraud and misconduct
Clinical Research Standards and Guidelines
Stakeholders and regulatory institutions and frameworks in clinical research
Phases of clinical research
Regulatory reporting requirements (e.g., pre- and post-approval, safety)
Standards for handling hazardous goods, materials, and biological samples
Audit and inspection processes (preparation, participation, documentation, and follow-up)
IRB/IEC role, composition, purpose, and reporting requirements
Protocol submission, approval, and amendment processes
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
Eligibility requirements (education and employment)
There are two pathways based on work experience and if a waiver is applicable. You can read about these in detail here: ACRP-CP Certification Eligibility.
Exam domain breakdown
Scientific Concepts and Research Design
Elements of a protocol
Elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use)
Rationale for participant eligibility requirements
Rationale for trial design
Study design characteristics (e.g., double-blind, crossover, randomized))
Study objective(s) and end points/outcomes
Use of comparator or control product in study design
Treatment assignments (e.g., randomization, open label, registries)
Stages of product development
Ethical and Participant Safety Considerations
Adverse events definitions/classification, documentation, and reporting (e.g., SAE, AESI, SUSAR)
Blinding/unblinding procedures
Elements of eligibility required by IRB/IEC
Confidentiality and privacy requirements
Risks and benefits of the safety profile
Elements of the informed consent
Informed consent process requirements
Protection of human subjects (e.g., IRB/IEC requirements, Declaration of Helsinki, participant compensation)
Protocol deviation/violation identification, documentation, and reporting processes
Recruitment and retention plan/strategies
Safety monitoring
Participant discontinuation criteria/procedures
Vulnerable participant populations
Conflicts of interest in clinical research (e.g., financial for PI or staff, family and site participation in trial)
Elements of potential fraud and misconduct
Regulatory Requirements
IRB/IEC reporting requirements and communication
IRB/IEC purpose, role, and composition
Protocol and protocol amendment submission and approval processes
Regulatory authority reporting requirements and communication (e.g., safety, CSR)
Clinical Trial Operations (GCP)
Elements of an effective root cause analysis and corrective and preventive action (CAPA) plan
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
Eligibility requirements (education and employment)
There are two pathways based on work experience and if a waiver is applicable. You can read about these in detail here: ACRP-CP Certification Eligibility.
Exam domain breakdown
Scientific Concepts and Research Design
Elements of a protocol
Elements of an Investigational Brochure (IB) and/or investigational device use
Elements of and rationale for subject eligibility requirements
Rationale for complying with a protocol
Statistical principles related to study design (e.g., sample size, screen fail rate)
Study design characteristics (e.g., double-blind, crossover, randomized)
Study objective(s)
Study endpoints/outcomes
Rationale for using supplemental/rescue/comparator product in study design
Treatment assignments (e.g., randomization, open label, registries)
Ethical and Participant Safety Considerations
Adverse events classification, documentation and reporting
Blinding/unblinding procedures
Components of subject eligibility requirements
Confidentiality and privacy requirements
Elements of the IB related to identifying risks and benefits
Elements of the informed consent form
Informed consent process requirements (e.g., paper, eConsent, assent)
Protection of human subjects including vulnerable subject populations
Protocol deviation/violation identification, documentation, and reporting processes
Subject recruitment and retention plan/strategies (e.g., social media, digital, print)
Safety monitoring and elements of pharmacovigilance and/or product/device vigilance (e.g., CIOMS, IDMC/DSMB, safety databases)
Subject discontinuation criteria/procedures
Subject safety
Conflicts of interest in clinical research
Ethical responsibilities including fraud and misconduct
Product Development and Regulation
Audit and inspection processes (preparation, participation, documentation, and follow-up)
Clinical development process (e.g., preclinical, clinical trial phases, device class)
Clinical trial registries and requirements
Elements of fraud and misconduct
IRB/IEC and other regulatory body reporting requirements
IRB/IEC role, composition, and purpose
Protocol and protocol amendment submission and approval processes
Safety reporting requirements
Significant milestones in the evaluation of efficacy and safety (e.g., interim analysis result, DSMB review)
Clinical Trial Operations (GCPs)
Site staff qualifications for delegation of responsibilities, duties, and training requirements
Elements of effective corrective and preventive action (CAPA) process(es) and plan(s)
Monitoring activities (frequency of visits, data review, and follow-up)
Pre-study/site selection criteria and visit activities
Principal investigator oversight responsibilities
Project feasibility considerations
Roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority)
Site initiation and close-out activities
Site staff qualifications
Study close-out activities
Study and Site Management
Communication documentation requirements between all study entities
Content of contract and study budget
Equipment and supplies use and maintenance
Investigational product accountability and documentation requirements
Study staff training procedures and documentation requirements
Investigational product characteristics, labeling requirements, and packaging
Investigational product shipment
Investigational product storage
Non-compliance management
Project timelines (e.g., data lock, enrollment period, recruitment/retention)
Purpose of and process(es) for protocol compliance
Sample collection, processing, shipment, and storage requirements
Subject compliance assessment
Subject responsibilities for study participation and visit activities
Vendor management
Data Management and Informatics
Data management activities including data privacy
Elements and purposes of data collection tools (e.g., eCRF, EDC, IWRS blinding)
Essential Documents for the conduct of a clinical trial (e.g., paper/electronic, trial master file)
Record retention, certified copy, and destruction practices and requirements
Source data review (SDR) and source data verification (SDV) purpose and process
Study documentation practices and requirements (Accurate, Legible, Complete, Original, Attributable, Contemporaneous, Consistent, Enduring, Available (ALCOA+))
Consists of 60 multiple choice questions that must be answered within 90 minutes.
The ACRP-MDP exam is referenced to the International Conference on Harmonization (ICH) Guidelines and International Organization for Standardization Guideline (ISO) 14155:2011.
The exam assesses your proficiency in medical devices related to clinical research.
Certification fees
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
Eligibility requirements (education and employment)
To be eligible for this exam, you must have one of the following ACRP certifications:
Consists of 60 multiple choice questions that must be answered within 90 minutes.
The exam is referenced only to the International Conference on Harmonization (ICH) Guidelines.
No other regulatory framework is tested, including country-specific regulations (i.e, FDA or EMA).
Certification fees
Exam and application fees differ based on time of year (spring versus fall) and the year itself. It is recommended that you review the ACRP Certification Handbook for the most recent fee schedule.
Eligibility requirements (education and employment)
To be eligible for this exam, you must have one of the following ACRP certifications:
HCCA: Certified in Healthcare Research Compliance (CHRC)
Brief overview
The examination will be scored on participantsโ responses to 100 of the 120 multiple-choice questions spread across all subject areas.
Certification fees
Current members (SCCE or HCCA): $350.00
Non-members: $450.00
Eligibility requirements (education and employment)
Requirements vary based on job experience and continuing education units (CEUs). These can be reviewed in greater detail within the specific certification’s handbook: CHRC Candidate Handbook.
Exam domain breakdown
You can review the table of the exam content here (which was also highlighted in the summary table at the beginning of this post): Detailed content outline (PDF)
The examination will be scored on participantsโ responses to 100 of the 120 multiple-choice questions spread across all subject areas.
Certification fees
Current members (SCCE or HCCA): $350.00
Non-members: $450.00
Eligibility requirements (education and employment)
Requirements vary based on job experience and continuing education units (CEUs). These can be reviewed in greater detail within the specific certification’s handbook: CHC Candidate Handbook.
Exam domain breakdown
You can review the table of the exam content here (which was also highlighted in the summary table at the beginning of this post): Detailed content outline (PDF)
HCCA: Certified in Healthcare Privacy Compliance (CHPC)
Brief overview
The examination will be scored on participantsโ responses to 100 of the 120 multiple-choice questions spread across all subject areas.
Certification fees
Current members (SCCE or HCCA): $350.00
Non-members: $450.00
Eligibility requirements (education and employment)
Requirements vary based on job experience and continuing education units (CEUs). These can be reviewed in greater detail within the specific certification’s handbook: CHPC Candidate Handbook.
Exam domain breakdown
You can review the table of the exam content here (which was also highlighted in the summary table at the beginning of this post): Detailed content outline (PDF)
