SCOPE
This training program defines the complete knowledge and performance requirements for personnel involved in clinical research to become certified global auditors for Good Clinical Practice (GCP). The program integrates GCP requirements from ICH E6(R3), Health Canada Part C, Division 5 of the Food and Drug Regulations, and FDA regulations (21 CFR Parts 50, 56, 312, 314.50, and 314.80) with auditing practices based on ISO 19011:2026 for internal, second-party (vendor/CRO/site audits), and global regulatory compliance auditing.
The participant learns what GCP requires under multiple regulatory frameworks, how to audit those requirements, and how to conduct audits across multiple jurisdictions and organizational boundaries.
Regulatory Frameworks Covered
ICH E6(R3) – International ethical, scientific, and quality standard for designing, conducting, recording, and reporting clinical trials. Provides the foundation for GCP principles and practices adopted globally. Covers the 11 fundamental principles, roles and responsibilities of investigators, sponsors, and IRBs/IECs, informed consent, protocol development, essential records, and quality management.
Health Canada Part C, Division 5 – Canadian regulations for clinical trials involving human subjects, including C.05.010(a) through (j) covering scientific soundness, protocol compliance, quality systems, REB approval, qualified investigator (no more than one per site), medical supervision by QI, qualified personnel (education/training/experience), written informed consent, records and information (C.05.012), and GMP compliance for investigational drugs. Also includes C.05.011 (labelling) and C.05.012 (records with 15-year retention).
21 CFR Part 50 – FDA protection of human subjects regulations, including general requirements for informed consent, elements of informed consent (basic and additional), exception from informed consent requirements for emergency research, documentation of informed consent, and additional safeguards for children in clinical investigations.
21 CFR Part 56 – FDA Institutional Review Board regulations, including IRB registration, membership requirements (at least five members with scientific, non-scientific, and unaffiliated representation), IRB functions and operations, expedited review procedures, criteria for IRB approval, and IRB records retention (3 years).
21 CFR Part 312 – FDA Investigational New Drug Application regulations, including IND content and format, protocol amendments, information amendments, IND safety reporting (15-day and 7-day reports), annual reports, clinical holds, sponsor responsibilities, investigator responsibilities, recordkeeping (2 years), and investigator disqualification.
21 CFR Part 314.50 – FDA content and format of New Drug Applications, including application form, summary, technical sections (chemistry/manufacturing/controls, nonclinical pharmacology/toxicology, human pharmacokinetics/bioavailability, clinical data, statistical, pediatric use), case report forms and tabulations, patent information, and exclusivity.
21 CFR Part 314.80 – FDA postmarketing reporting of adverse drug experiences, including definitions of adverse drug experience, serious adverse drug experience, unexpected adverse drug experience, individual case safety report (ICSR), 15-day alert reports, periodic adverse drug experience reports (quarterly for 3 years, then annually), and recordkeeping requirements (10 years).
Auditing Practices Covered (ISO 19011:2026)
- Principles of auditing (integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, risk-based approach)
- Audit programme management (objectives, risks, resources, procedures, implementation, monitoring, review, improvement)
- Conducting an audit (initiation, preparation, execution, reporting, follow-up)
- Remote auditing methods (virtual audits, technology considerations, security, contingency planning)
- Competence and evaluation of auditors (personal behaviour, knowledge and skills, evaluation methods, maintaining competence)
- Second-party auditing (supplier qualification, vendor audits, sponsor-CRO relationships, site qualification audits, service provider oversight)
Operational Areas Covered
- Informed consent processes
- Institutional Review Board operations
- Investigational New Drug applications
- New Drug Applications
- Postmarketing safety reporting
- Investigator responsibilities
- Sponsor responsibilities
- Essential records and Trial Master File
- Risk-based approaches
- Audit planning, execution, reporting, CAPA, and closure
The program is designed for global auditing across internal, second-party, and regulatory readiness contexts and does not qualify individuals to conduct regulatory inspections on behalf of authorities.
OBJECTIVES
Upon completion of this program, the participant will be able to perform the following tasks:
- Interpret and apply ICH E6(R3) GCP requirements, Health Canada Division 5 requirements, and FDA 21 CFR Parts 50, 56, 312, 314.50, and 314.80 requirements to clinical trial conduct.
- Understand and apply the seven auditing principles (integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, risk-based approach).
- Plan, manage, and execute internal, second-party, and global audits in full accordance with ISO 19011:2026.
- Conduct vendor and CRO audits to assess service provider compliance with GCP and contractual requirements.
- Conduct site qualification audits to assess investigator and site readiness for clinical trial participation.
- Develop audit checklists, sampling plans, and audit protocols tailored to GCP risks and multiple regulatory frameworks.
- Collect objective evidence through on-site and remote interviews, observation, and document review.
- Identify and classify non-conformities (major, minor, observation) with clear justification referencing specific regulatory requirements.
- Write non-conformity reports that are factual, complete, and actionable.
- Prepare and distribute audit reports to appropriate management levels and stakeholders.
- Notify management of critical findings using escalation procedures.
- Track CAPA using a formal CAPA tracking log with status codes.
- Verify effectiveness of corrective and preventive actions.
- Close an audit properly with closure memo and management acknowledgment.
- Contribute audit results to management review and continual improvement.
- Prepare organizations for regulatory inspections and respond to inspection findings.
- Conduct remote audits using validated technology platforms and secure communication methods.
- Assess compliance with Health Canada Division 5 requirements including REB approval, QI supervision, informed consent, and record retention.
- Audit IND submissions for content, safety reporting, and protocol compliance.
- Audit NDA submissions for content, format, and technical sections.
- Audit postmarketing safety reporting for compliance with 314.80 requirements.
- Audit IRB operations for composition, functions, and recordkeeping.
- Audit informed consent processes for compliance with 21 CFR Part 50 and ICH E6 requirements.
- Audit investigator qualifications, delegation, and oversight for compliance with 21 CFR 312.60 and Health Canada C.05.010(e), (f), (g).
- Audit sponsor quality systems, monitoring, and auditing for compliance with Health Canada C.05.010(c) and ICH E6.
- Conduct remote audits using ISO 19011:2026 remote auditing guidelines.
TARGET AUDIENCE
This program is specifically designed for personnel involved in the conduct, oversight, or auditing of clinical trials in accordance with ICH E6(R3), Health Canada Division 5, and FDA regulations. Typical roles include:
- Quality Assurance Personnel – Responsible for independent monitoring of clinical trials, conducting internal and vendor audits, and assuring GCP compliance across multiple regulatory frameworks.
- Clinical Research Associates (Monitors) – Responsible for site oversight and monitoring activities who need to understand auditing principles.
- Study Directors and Clinical Trial Managers – Have overall responsibility for trial conduct and need to understand how their studies will be audited.
- Clinical Investigators and Site Staff – Responsible for trial conduct at sites and need to understand audit requirements.
- Sponsor Personnel – Medical, regulatory, clinical operations staff who oversee trial conduct.
- CRO Personnel – Service providers conducting trial activities on behalf of sponsors.
- IRB/IEC Members and Coordinators – Responsible for ethical oversight and review of clinical trials.
- Data Management and Biostatistics Professionals – Responsible for data integrity and analysis.
- Pharmacovigilance and Safety Specialists – Responsible for safety reporting and signal detection.
- Regulatory Affairs Professionals – Responsible for regulatory submissions and compliance.
- Vendors and Service Providers – Laboratories, central imaging, electronic data capture providers, contract research organizations.
- Global Clinical Trial Managers – Responsible for multi-regional trials with varying regulatory requirements.
- Regulatory Compliance Officers – Responsible for ensuring organizational compliance with global GCP regulations.
- Audit Program Managers – Responsible for planning, managing, and overseeing audit programmes across multiple regions and vendors.
- Clinical Research Coordinators – Responsible for day-to-day trial activities at sites who need to understand audit expectations.
- Pharmacovigilance Safety Specialists – Responsible for safety data collection, assessment, and reporting.
- Data Managers – Responsible for clinical database design, validation, and data quality.
- Biostatisticians – Responsible for statistical analysis plans and data analysis.
The prerequisites for enrolment include completion of basic GCP awareness training of at least four hours or equivalent on-the-job experience. Participants should have at least six months of experience in clinical research. Basic computer skills using Excel and Word are also required.
Certification Details
Upon successful completion of this training program, participants will receive a certificate of completion that documents their understanding of GCP Global Auditor Certification requirements.
Certification Requirements:
- Complete all 10 training modules
- Achieve a passing score of 80% or higher in each training module
Training Records:
- Training records must be documented, monitored, and retained
- This program provides downloadable certificates and maintains records of completion for organizational audit and inspection purposes
