Study guide
11.1 Stakeholders, Regulatory Institutions & Global Frameworks in Clinical Research
ACRP Certified Professional ACRP-CP
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1 Chapter 1: GCP Principles, Roles & Delegation
1.1 The Eleven ICH E6(R3) Principles of GCP & Guideline Structure 1.2 Sponsor & Investigator Responsibilities and Delegation of Authority 1.3 Staff Training, Qualifications & Delegation of Authority Log (DOAL) 1.4 CRO Oversight, Vendor Management & Transfer of Regulatory Obligations (TORO)
2 Chapter 2: Essential Records, Source Documentation & Data Confidentiality
2.1 Essential Records Before, During and After the Trial (ICH E6(R3) Appendix C) 2.2 Trial Master File (TMF) and Investigator Site File (ISF) Structure & Inspection Readiness 2.3 Source Documentation, ALCOAC Principles & Medical Record Standards 2.4 Confidentiality, Privacy & Protection of Participant Personal Information
3 Chapter 3: Monitoring, Quality Management & Audits
3.1 Risk-Based Quality Management (RBQM) & Quality Management Systems (QMS) 3.2 Monitoring Visit Types: Site Selection, SIV, IMV, and Close-Out 3.3 Risk-Based Monitoring (RBM), Centralized Monitoring & Source Data Verification (SDV vs SDR) 3.4 Quality Audits, Regulatory Inspections, Non-Compliance & Root Cause Analysis / CAPA
4 Chapter 4: Site Feasibility, Start-Up, Facilities & Laboratory Operations
4.1 Site Feasibility Assessment, Capability Analysis & Investigator Selection 4.2 Contractual Agreements: Clinical Trial Agreements, Budgets, Indemnification & Financial Arrangements 4.3 Site Initiation Preparation, System Access & Regulatory Greenlight 4.4 Protocol Review, Operational Feasibility & Institutional Approvals 4.5 Site Facilities, Equipment Maintenance, Calibration & Trial Supplies 4.6 Biological Samples & Hazardous Goods: Collection, Storage, Disposal & Shipment
5 Chapter 5: Subject Recruitment, Retention & Study Visits
5.1 Subject Recruitment Strategies, Advertising Guidelines & Ethical Constraints 5.2 Screening, Eligibility Verification & Inclusion/Exclusion Adherence 5.3 Subject Retention, Compliance, Visit Scheduling & Protocol Window Management 5.4 Managing Lost to Follow-Up, Subject Withdrawal & Early Termination Procedures
6 Chapter 6: Protocol Compliance, Deviations & Site Close-Out
6.1 Protocol Compliance, Waivers vs. Violations & Deviation Management 6.2 Investigational Site Close-Out Activities & Final Reconciliations 6.3 Record Retention, Archiving Requirements & Post-Trial Responsibilities
7 Chapter 7: Research Ethics, Vulnerable Populations & Research Integrity
7.1 Historical Milestones: Nuremberg Code, Belmont Report & Declaration of Helsinki 7.2 Ethical Principles: Beneficence, Non-Maleficence, Autonomy, Justice & Equipoise 7.3 Vulnerable Populations (Pediatrics, Pregnant Women, Prisoners, Cognitively Impaired, Economically Disadvantaged) 7.4 Conflict of Interest, Research Misconduct & Fraud in Clinical Research
8 Chapter 8: Informed Consent & Institutional Review Boards (IRB/IEC)
8.1 Informed Consent Elements, Process & Ongoing Consent / Re-Consent Requirements 8.2 Assent in Minors & Legally Acceptable Representative (LAR) Requirements 8.3 IRB/IEC Composition, Functions, Review Types (Full, Expedited, Exempt) & Continuing Review
9 Chapter 9: Safety Reporting & Adverse Event Management (ICH E2A)
9.1 Adverse Events (AE) vs. Adverse Drug Reactions (ADR) & Serious Adverse Events (SAE) Definitions 9.2 Causality Assessment, Expectedness, Reference Safety Information (RSI) & SUSARs 9.3 Expedited Reporting Timelines (7-day fatal/life-threatening, 15-day other serious) & Periodic Safety Updates (DSUR)
10 Chapter 10: Investigational Product (IP) Management & Accountability
10.1 Investigational Product Lifecycle, Labeling, Packaging & Blinding Procedures 10.2 IP Shipping, Receipt, Temperature Monitoring, Excursion Handling & Chain of Custody 10.3 IP Storage, Dispensing, Accountability Logs & Destruction/Return Procedures 10.4 Emergency Unblinding (Code Breaking) Protocols & Subject Safety Procedures
11 Chapter 11: Regulatory Frameworks, Submissions & Product Reference Information
11.1 Stakeholders, Regulatory Institutions & Global Frameworks in Clinical Research 11.2 Protocol Submission, Approval & Amendment Processes 11.3 Investigator's Brochure, Instructions for Use & Reference Product Information 11.4 Regulatory Reporting Requirements Before and After Marketing Authorisation
12 Chapter 12: Clinical Data Management, EDC & Electronic Records
12.1 Electronic Data Capture (EDC), eCRF Design & Clinical Data Management Systems (CDMS) 12.2 Computerised Systems, Data Governance & Audit Trails (ICH E6(R3) Annex 1 §4) 12.3 Data Validation, Edit Checks, Discrepancy / Query Management & Resolution 12.4 Medical Coding (MedDRA, WHO Drug), SAE Reconciliation, Data Transfer & Database Lock
13 Chapter 13: Trial Design, Biostatistics, Data Monitoring & Transparency
13.1 Phases of Clinical Research (Phase 0, I, II, III, IV) & Translational Medicine 13.2 Study Designs: Parallel, Crossover, Factorial, Adaptive & Non-Inferiority / Equivalence 13.3 Randomization Schemes, Stratification, Blinding Methods & Minimizing Bias 13.4 Endpoints (Primary, Secondary, Surrogate, Composite), Sample Size & Biostatistical Concepts (p-values, CI, ITT vs PP) 13.5 Interim Analyses, DSMB/IDMC Oversight & Efficacy and Safety Evaluation Milestones 13.6 Trial Registration, Results Transparency & Communicating Results to Participants
11.1 Stakeholders, Regulatory Institutions & Global Frameworks in Clinical Research
Key Takeaways Explain This Topic AI
ACRP states that the ACRP-CP exam is referenced only to ICH Guidelines and that no other regulatory framework is tested, including country-specific regulations such as those of the FDA or EMA.
ICH was launched in 1990 and reformed in 2015 into the International Council for Harmonisation, a non-profit legal association under Swiss law governed by the ICH Assembly.
ICH guidelines fall into four categories — Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M) — and clinical trial conduct sits in the Efficacy series.
The formal ICH procedure runs through five steps, and Step 4 is the point at which a harmonised guideline is adopted and recommended to the regulatory bodies for implementation.
Under ICH E6(R3) Principle 10, a sponsor may transfer and an investigator may delegate activities to service providers, but each retains overall responsibility and oversight.
Last updated: August 2026
Stakeholders, Regulatory Institutions & Global Frameworks
Quick Reference — read this before anything else in the chapter: ACRP states on the ACRP-CP certification page that 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)." The permitted reference set is ICH E6(R3), E2A, E8(R1), E9, E9(R1), E11(R1) and the Declaration of Helsinki . Learn national statutes for your job; answer exam items from ICH.
Why this is tested
The ACRP-CP Exam Content Outline opens Domain 2 with 2A, "Stakeholders and regulatory institutions and frameworks in clinical research." It is a map question: can you say who does what, who answers to whom, and which document governs which relationship.
- Part 1 — The standards bodies
- The International Council for Harmonisation (ICH)
Fact Detail
Launched 1990, by the regulatory authorities and research-based pharmaceutical industry of the United States, the European Union and Japan
Reformed 2015 — renamed from International Conference to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use , and constituted as a non-profit legal association under Swiss law
Governing body The ICH Assembly , which first met in October 2015 and admits regulatory authorities and industry associations from well beyond the original three regions
Purpose Harmonise technical requirements so that clinical data can be mutually accepted across regions, reducing duplicated studies and unnecessary human exposure
Observers Include the World Health Organization (WHO)
Exam Watchout: ACRP's own website still writes "International Conference on Harmonization" — the pre-2015 name. Do not let that mislead you: the body is the Council , and the acronym was deliberately retained through the rename.
The four guideline categories
- Prefix Category What it covers Relevant to you
- Q Quality Chemistry, manufacturing, stability, GMP Indirectly, via Principle 11 on investigational product
S Safety Nonclinical/preclinical toxicology, carcinogenicity, genotoxicity Background to the Investigator's Brochure
E Efficacy Design, conduct, safety and reporting of clinical trials This is your series
M Multidisciplinary Cross-cutting standards — MedDRA, the Common Technical Document, electronic standards MedDRA coding
The Efficacy guidelines ACRP names
- Guideline Title Why it is on the list
- E6(R3) Guideline for Good Clinical Practice The core standard — Principles, Annex 1, Annex 2, Appendices
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting AE/ADR/SAE definitions and expedited reporting timelines
- E8(R1) General Considerations for Clinical Studies Quality by design, critical to quality factors, study types
- E9 Statistical Principles for Clinical Trials Design, randomisation, analysis populations, interim analysis
- E9(R1) Addendum on Estimands and Sensitivity Analysis What treatment effect is actually being estimated
E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population Paediatric development, assent, age classifications
- The formal ICH procedure Step 1 Consensus building — the Expert Working Group drafts a technical document
- Step 2 Confirmation of consensus (2a) and adoption of the draft guideline by the
- regulatory members (2b), then release for public consultation
- Step 3 Regulatory consultation and discussion — comments received and addressed
- Step 4 ADOPTION of the harmonised guideline, recommended to the regulatory
- bodies of the ICH regions for implementation
- Step 5 Implementation — each authority incorporates it into its own framework
Step 4 is the milestone to remember. ICH E6(R3) Principles and Annex 1 reached Step 4 on 6 January 2025 ; Annex 2 reached Step 4 on 3 June 2026 . Step 5 dates then vary by region, which is why a guideline can be "adopted" globally but come into force on different dates in different countries.
The World Medical Association
The WMA is a physicians' organisation, not a regulator. It issues the Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants , first adopted in 1964 and most recently revised at the 75th WMA General Assembly, Helsinki, October 2024 . ICH E6(R3) Principle 1 anchors GCP directly in it.
Part 2 — Regulatory authorities as a category
You are not tested on any single authority's statutes, but you are expected to know what an authority does : it reviews applications to begin trials, inspects for compliance, receives safety reports, and grants or refuses marketing authorisation.
- Region Authority
- United States Food and Drug Administration (FDA)
- European Union European Medicines Agency (EMA) and national competent authorities
- Japan Pharmaceuticals and Medical Devices Agency (PMDA)
- Canada Health Canada
- United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA)
- Switzerland Swissmedic
- Australia Therapeutic Goods Administration (TGA)
- China National Medical Products Administration (NMPA)
- Brazil ANVISA
- Global normative body World Health Organization (WHO) — not a regulator; sets norms and guidance
ICH E6(R3) Annex 1 3.8.1 puts the obligation generically: before initiating a trial, the sponsor (or sponsor and investigator) "should submit any required application(s) to the appropriate regulatory authority(ies) for review, acceptance and/or permission to begin."
Part 3 — The operational parties
Party Core obligation E6(R3) home
Sponsor Initiates, manages and finances the trial; designs it; selects investigators; manages quality and risk; maintains oversight of everything transferred Annex 1 section 3
Investigator Responsible for the conduct of the trial at the site; medical care of participants; protocol compliance; supervision of delegated activities Annex 1 section 2
Institution The medical or dental facility where the trial is conducted; provides the resources and often holds the contract Annex 1 section 2
IRB/IEC Independent ethical review; protects rights, safety and well-being; approves before enrolment; periodic review Annex 1 section 1; Principle 3
Contract research organisation (CRO) / service provider Performs transferred sponsor activities under a documented agreement Principle 10; Annex 1 3.3, 3.6
- Regulatory authority Reviews, permits, inspects, receives safety reports, authorises marketing Annex 1 3.8
- Participant Consents voluntarily; may withdraw at any time without penalty Principle 2
Data monitoring committee Independent review of unblinded comparative data; recommends continuation, modification or termination Annex 1 3.9.9; ICH E9 4.6
Central laboratory, imaging vendor, IRT provider Specialist service providers under the same oversight rules as a CRO Principle 10
Funder Provides financial support; must be disclosed in the protocol and to participants Declaration of Helsinki (2024) ¶22, ¶26
The rule that ties the map together
ICH E6(R3) Principle 10.1: "The sponsor may transfer or the investigator may delegate their tasks, duties or functions (hereafter referred to as activities), but they retain overall responsibility for their respective activities."
Principle 10.2 adds that where activities have been transferred or delegated to service providers, "the responsibility for the conduct of the trial, including quality and integrity of the trial data, resides with the sponsor or investigator, respectively."
Exam Watchout: This is the single most reliable answer stem in the domain. Whenever an item asks who is accountable after work has been outsourced or delegated — CRO, central laboratory, sub-investigator, study nurse — the accountable party is the one who transferred or delegated it. A contract can move the work ; it cannot move the responsibility .
Realistic exam scenario
Scenario: A sponsor contracts a CRO for monitoring and a separate vendor for interactive response technology handling randomisation and drug supply. Twelve weeks into enrolment, an inspection finds that the CRO has not visited two sites since initiation, that randomisation at one site assigned three participants to a stratum for which they were not eligible, and that neither issue was picked up by the sponsor. The sponsor's position is that both failures belong to its vendors and that its own systems were sound.
Evaluation:
Principle 10.1 and 10.2 defeat the sponsor's position. Transfer of monitoring and randomisation activities does not transfer responsibility for the conduct of the trial or for the quality and integrity of the data.
Principle 10.3 requires the sponsor to maintain appropriate oversight of transferred activities. Not detecting a missed monitoring schedule for twelve weeks is itself the finding — the absence of oversight, not merely the vendors' errors.
Annex 1 3.12 governs what happens next: noncompliance affecting the reliability of results triggers root cause analysis and CAPA, and if it is serious, notification of the regulatory authority and/or IRB/IEC.
The stratification errors also raise a participant-level question under Principle 1: were those three participants placed at risk or treated outside the protocol's safety framework?
Correct actions: the sponsor performs a root cause analysis covering its own oversight process as well as the vendors' performance; assesses the impact on the three misallocated participants and on the analysis; documents deviations; implements CAPA that includes defined oversight metrics, escalation triggers and a review cadence for vendor performance; and reports as required. Terminating a vendor is available under 3.12.3 where significant noncompliance persists after remediation, but it does not retrospectively relieve the sponsor of accountability.