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
| Purpose | Cost | Exam Content (Domains) | Regulatory and Ethical Frameworks to Review | |
| PRIM&R: Certified IRB Professional (CIP) | Constitutes formal recognition of an IRB professionalโs broad knowledge of IRB functions and expertise about HRPPs. | 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 | 1. Human subjects protections 2. IRB responsibilities 3. Institutional responsibilities | CIP exam references and resources (Detailed links will be provided below) |
| SOCRA: Certified Clinical Research Professional (CCRP) | 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 | Preparation resources (Detailed links will be provided below) |
| ACRP: ACRP Certified Professional (ACRP-CP) | 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. | Current members (SCCE or HCCA): $350.00 Non-members: $450.00 | Detailed content outline (PDF) | Exam resources (Detailed links will be provided below) |
| HCCA: Certified in Healthcare Compliance (CHC) | 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. | Current members (SCCE or HCCA): $350.00 Non-members: $450.00 | Detailed content outline (PDF) | Exam resources (Detailed links will be provided below) |
| 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. | Current members (SCCE or HCCA): $350.00 Non-members: $450.00 | Detailed content outline (PDF) | Exam resources (Detailed links will be provided below) |
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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
- Offering knowledge-rich educational opportunities.
You can learn more about each of these organizations below (though only HCCA will be discussed in this post):
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PRIM&R: Certified IRB Professional (CIP)
Brief overview
- 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 - Managing regulatory documentation
- Managing IRB records and databases
- Facilitating IRB meeting (e.g., ensure quorum, distribute
meeting materials) - Developing and provide education on IRB regulations
and processes - Providing consultation on IRB submission
- Monitoring for changes in federal regulations and
guidance - Managing review of noncompliance and unanticipated
problems - Managing IRB meeting minutes
Exam domain breakdown
- Human subjects protection (29%)
- Historical background
- Research ethics
- Belmont principles
- International codes and standards
- Nuremburg Code
- Declaration of Helsinki
- ICH GCP-E6
- Regulatory applicability
- Common Rule
- FDA (e.g., human subjects, drugs/biologics,
devices) - Other FDA (e.g., HUD, expanded access,
emergency use) - Agency differences (e.g., DOD, DOJ, NIH)
- IRB responsibilities (54%)
- IRB membership and authority
- Levels of review
- Types of review
- Regulatory criteria for approval
- Informed consent
- Privacy and confidentiality considerations (e.g., HIPAA, CoC)
- Vulnerable populations
- Monitoring and review of reportable events (e.g., unanticipated problems, noncompliance, research misconduct)
- Meeting minutes
- Institutional responsibilities (17%)
- Cooperative research (e.g., reliance, local context, sIRB)
- Policies, procedures, and IRB Records
- Conflict of interest (e.g., IRB, researchers, institutional)
- Regulatory reporting obligations
- Document management and retention
- Educational programs
Resources to review
FDA Regulations
- 21 CFR 50 (Protection of Human Subjects)
- 21 CFR 56 (Institutional Review Boards)
- 21 CFR 312 (Investigational New Drug Application)
- 21 CFR 361 (Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research)
- 21 CFR 600 (Biological Products: General)
- 21 CFR 812 (Investigational Device Exemptions)
- 21 CFR 814 Subpart H (Humanitarian Use Devices)
OHRP Regulations
- 45 CFR 46 (Protection of Human Subjects – The Common Rule) – also consists of:
- Exemptions
- Subpart BโAdditional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- Subpart CโAdditional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
- Subpart DโAdditional Protections for Children Involved as Subjects in Research
- Subpart EโRegistration of Institutional Review Boards
- Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)
Other Regulations
Other Agencies
- DOD
- DOJ
- NIH
Privacy and Confidentiality
- 34 CFR 98 (PPRA โ Protection of Pupil Rights Amendment)
- 34 CFR 99 (FERPA โ Family Educational Rights and Privacy)
- HIPAA (Health Insurance Portability and Accountability Act)
- Certificates of Confidentiality (CoC)
Ethical Codes
- The Belmont Report
- WMA Declaration of Helsinki โ Ethical Principles for Medical Research Involving Human Participants
- Nuremburg Code
- ICH E6 Good Clinical Practice (GCP)
- CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
Training Modules
- OHRP Human Research Protection Training
- CITI Program’s Comprehensive CIP Course for Advanced Learners
FDA Guidance
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).
OHRP Guidance
- Complete alphabetical list of all guidance published by OHRP
Certification handbook
To learn more about this certification, review the link here: CIP Exam Handbook
SOCRA: Certified Clinical Research Professional (CCRP)
Brief overview
- Consists of 130 multiple choice questions.
- The test questions are designed to be straightforward and easily understood.
- The questions are reviewed by experts in test question development and SOCRA language representatives for fairness and readability.
- The exam is updated at least annually to assure it is up-to-date and reflective of the current regulatory environment.
Certification fees
- Current members: $395.00
- Non-members: $450.00
- Computer based testing (testing center or home proctoring)
- Additional $115 (North America – USA, Canada, Mexico)
- Additional $175 countries outside North America
Eligibility requirements (education and employment)
- There are three categories based on the level of experience and/or education you have. See: Candidate eligibility.
Exam domain breakdown
- Research study start-up (approximately 40 questions)
- Coordinate the development of initial research study protocol
- Create or obtain research study documents (e.g., informed consent, essential documents, case report forms, financial disclosure statements)
- Obtain research study approval from necessary stakeholders (i.e., IRB, research study sponsor, and relevant regulatory authorities)
- Obtain research study product, related materials, equipment, tools and aids
- Select research study sites
- Train research study staff members
- Evaluate research studyโs compliance with relevant local, state and provincial laws
- Research study implementation (approximately 50 questions)
- Execute research study in accordance with the protocol
- Assure regulatory compliance
- Manage research study product (e.g., treatment, procedure, medication, medical device, questionnaire)
- Identify, document & report research study anomalies
- Manage subjects
- Maintain the research study
- Communicate with research study stakeholders
- Perform/participate a research study audit
- Research study closure (approximately 10 questions)
- Perform/participate a research study closeout visit
- Develop & submit research study closure reports
- Archive/retrieve research study records
Resources to review
- There is some overlap with PRIM&R’s CIP certification:
- FDA regulations
- OHRP regulations
- Ethical codes (CIOMS is not referenced)
- In addition, the following resources should be reviewed:
Certification handbook
To learn more about this certification, review the link here: CCRP Certification Exam Handbook.
ACRP: ACRP Certified Professional (ACRP-CP)
Brief overview
- The exam consists of 125 multiple choice questions that must be answered within 180 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).
- You can read more about how the exam is developed here: How Are Certification Exams Developed.
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)
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
- Efficacy and safety evaluation milestones (e.g., interim analysis result, DSMB review)
- Clinical Trial Operations (GCPs)
- Conduct, documentation, and management of clinical trials
- Study staff roles, training, qualifications, and delegation of responsibilities
- Control, storage, and dispensation of investigational products/devices
- Adverse event classification, reporting, and management
- Study reporting requirements (e.g., SAEs, deviations, INDs, IRB)
- Study monitoring
- Audits and inspections
- Protocol/GCP deviation identification and management
- IRB/IEC requirements such as submission, review, and approval of documents
- Corrective and preventive action (CAPA) processes
- Source data review and verification
- Site selection activities
- Principal investigator responsibilities
- Roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority)
- Site initiation, maintenance, and closeout activities
- Study and Site Management
- Quality management activities in the conduct of clinical research
- Responsibilities and obligations involved in the conduct of a clinical trial
- Oversight requirements of PIs, sponsors, contract research organizations (CROs), and regulatory authorities
- Contractual agreements (e.g., budgets, clinical trial agreement)
- Maintenance and use of equipment and supplies
- Investigational product/device accountability and documentation requirements
- Investigational product/device reference materials (e.g., Investigator brochure, instructions for use, user manual)
- Non-compliance management
- Sample collection, storage, disposal, and shipment requirements
- Assessment of subject compliance
- Study evaluation for feasibility
- Record retention and destruction practices and requirements
- Essential documents for the conduct of a clinical trial (e.g., trial master file)
- Research Design and Data Management
- Clinical trial design (e.g., double-blind, cross-over, randomization)
- Elements of a protocol
- Elements and purpose of an Investigational Brochure (IB) and Instructions for Use
- Rationale for subject eligibility requirements
- Study objectives, hypotheses, and end points/outcomes
- Basic concepts of biostatistics and informatics in research
- Flow of data throughout clinical research
- Data collection, correction, and queries (e.g., electronic data capture, audit trails)
- Data quality systems and privacy principles
- Study documentation practices (ALCOA-C)
Resources to review
- Guideline for Good Clinical Practice E6 (R2)
- Definitions and Standards for Expedited Reporting (E2A)
- General Considerations for Clinical Trials E8 (R1)
- Statistical Principles for Clinical Trials E9
- Statistical Principles for Clinical Trials E9 (R1)
- Clinical Trials in Pediatric Population E11 (R1)
- The Declaration of Helsinki (DoH)
Certification handbook
To learn more about this certification, review the link here: ACRP Certification Handbook.
ACRP: Certified Clinical Research Associate (CCRA)
Brief overview
- The exam consists of 125 multiple choice questions that must be answered within 180 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).
- You can read more about how the exam is developed here: How Are Certification Exams Developed.
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)
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
- Elements of and rationale for monitoring plan(s)
- Monitoring responsibilities (e.g., purpose, extent, procedures)
- Principal investigator responsibilities
- Principles of risk-based monitoring/data governance
- Project feasibility considerations
- Responsibilities of various clinical trial entities/personnel (e.g., CROs, sponsors, regulatory authority, data manager)
- Audits and inspection processes (preparation, participation, documentation, and follow-up)
- Pre-study and site selection activities
- Study and Site Management Activities
- Communication documentation requirements (e.g., phone, email)
- Equipment and supplies use and maintenance
- Investigational product/device management (e.g., accountability, dispensing shipment, storage, labeling, and documentation requirements)
- Processes and management of non-compliance (e.g., IRB, GCP, CFR, protocol)
- Roles of various clinical trial entities/plan (e.g., medical monitor, vendors, IRB/IEC, sponsor, CRO)
- Sample/diagnostic collection, shipment, verification, reporting, and storage requirements (e.g., lab, imaging, raters)
- Participant compliance and responsibilities for study participation
- Contracts and budgets (e.g., participant compensation, site payments)
- Management of study site documentation (e.g., ISF/TMF reconciliation)
- Delegation, qualification, and training of appropriate responsibilities at site
- Site initiation activities
- Interim visit activities
- Site close-out activities
- Essential document requirements (e.g., Trial Master File, Investigator Site File)
- Data Quality
- Data privacy principles and access to site/participant records (e.g., paper vs. EMR)
- Elements and purposes of data collection tools (e.g., CRF/eCRF, patient reported outcome devices)
- Elements of and process for data query (e.g., query writing)
- Purpose of pharmacovigilance (e.g., CIOMS, IDMC/DSMB, safety databases)
- Record retention and destruction practices and requirements
- Source data review (SDR) and source data verification (SDV) purpose and process
- Source documentation requirements and GDP (e.g., ALCOA+)
- Critical variables and critical processes
- Impact of efficacy and safety (e.g., interim analysis result, DSMB review)
Resources to review
- Guideline for Good Clinical Practice E6 (R2)
- Definitions and Standards for Expedited Reporting (E2A)
- General Considerations for Clinical Trials E8 (R1)
- Statistical Principles for Clinical Trials E9
- Statistical Principles for Clinical Trials E9 (R1)
- Clinical Trials in Pediatric Population E11 (R1)
- The Declaration of Helsinki (DoH)
Certification handbook
To learn more about this certification, review the link here: ACRP Certification Handbook.
ACRP: Certified Clinical Research Coordinator (CCRC)
Brief overview
- The exam consists of 125 multiple choice questions that must be answered within 180 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).
- You can read more about how the exam is developed here: How Are Certification Exams Developed.
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)
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)
- Elements of and process for data query
- Reporting requirements for pharmacovigilance and/or product/device vigilance (e.g., CIOMS, IDMC/DSMB, safety databases)
- 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+))
Resources to review
- Guideline for Good Clinical Practice E6 (R2)
- Definitions and Standards for Expedited Reporting (E2A)
- General Considerations for Clinical Trials E8 (R1)
- Statistical Principles for Clinical Trials E9
- Statistical Principles for Clinical Trials E9 (R1)
- Clinical Trials in Pediatric Population E11 (R1)
- The Declaration of Helsinki (DoH)
Certification handbook
To learn more about this certification, review the link here: ACRP Certification Handbook.
ACRP: ACRP Medical Device Professional (ACRP-MDP)
Brief overview
- 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:
- Certified Clinical Research Coordinator (CCRC)
- Certified Principal Investigator (CPI) (this certification will not be discussed as it doesn’t fit the scope of this post)
- ACRP Certified Professional (ACRP-CP)
- ACRP Certified Clinical Research Associate (CCRA)
Exam domain breakdown
The domains, knowledge statements, and tasks can be reviewed in the table provided here: ACRP-MDP Exam Content Outline.
Resources to review
- Guideline for Good Clinical Practice E6 (R2)
- Definitions and Standards for Expedited Reporting (E2A)
- General Considerations for Clinical Trials E8 (R1)
- Statistical Principles for Clinical Trials E9
- Statistical Principles for Clinical Trials E9 (R1)
- Clinical Trials in Pediatric Population E11 (R1)
- The Declaration of Helsinki (DoH)
- ISO 14155:2011 (International Organization for Standardization)
Certification handbook
To learn more about this certification, review the link here: ACRP Certification Handbook.
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ACRP: ACRP Project Manager (ACRP-PM)
Brief overview
- 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:
- Certified Clinical Research Coordinator (CCRC)
- Certified Principal Investigator (CPI) (this certification will not be discussed as it doesn’t fit the scope of this post)
- ACRP Certified Professional (ACRP-CP)
- ACRP Certified Clinical Research Associate (CCRA)
Exam domain breakdown
The domains, knowledge statements, and tasks can be reviewed in the table provided here: ACRP-PM Exam Content Outline.
Resources to review
- Guideline for Good Clinical Practice E6 (R2)
- Definitions and Standards for Expedited Reporting (E2A)
- General Considerations for Clinical Trials E8 (R1)
- Statistical Principles for Clinical Trials E9
- Statistical Principles for Clinical Trials E9 (R1)
- Clinical Trials in Pediatric Population E11 (R1)
- The Declaration of Helsinki (DoH)
Certification handbook
To learn more about this certification, review the link here: ACRP Certification Handbook.
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)
Resources to review
- Office for Human Research Protections
- Public Responsibility in Medicine and Research
- National Institutes of Health
- Centers for Medicare and Medicaid Services-Medicare Clinical Trial Policies
- Office of Research Integrity
- Office of Civil Rights
- U.S. Department of Health and Human Services, Office of Inspector General
- OIG searchable database of excluded individuals and entities
Certification handbook
To learn more about this certification, review the link here: CHRC Candidate Handbook.
HCCA: Certified in Healthcare Compliance (CHC)
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: 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)
Resources to review
- Federal Sentencing Guidelines, Chapter 8
- Center for Medicare and Medicaid Services
- OIG searchable database of excluded individuals and entities
- Office for Civil Rights
- U.S. Department of Health and Human Services, Office of Inspector General
- Office of Federal Contract Compliance Programs
- PhRMA Code
- U.S. House of Representatives
- Government Printing Office
Certification handbook
To learn more about this certification, review the link here: CHC Candidate Handbook.
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)
Resources to review
- HIPAA Privacy Rule
- Federal HIPAA reporting
- ARRA provisions
- US. Department of Education on FERPA provisions
- U.S. Department of Health and Human Services joint guidance on FERPA and HIPAA
Certification handbook
To learn more about this certification, review the link here: CHPC Candidate Handbook.
I hope you found this post useful!
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