ICH-GCP & Regulatory Affairs Course

Module 1: Introduction to Clinical Research

Overview of Clinical Trials (Phases I–IV)
Roles of stakeholders (Sponsor, CRO, Investigator, CRC)
Good Clinical Practice (GCP): history and purpose
Key terms: SOPs, Protocol, IB, CRF, ICF, AE/SAE

Module 2: ICH-GCP Guidelines (E6 R2 & R3 Updates)

Principles of ICH-GCP
Responsibilities of:
- Investigator
- Sponsor
- Ethics Committee (IRB/IEC)
Informed Consent Process (with case scenarios)
Essential documents before, during, and after the trial
Risk-based Monitoring & Quality Management Systems
New E6(R3) focus: Risk-based and digital trial approach

Module 3: Clinical Trial Regulations – Global & National

Regulatory frameworks:
- FDA (21 CFR Parts 50, 54, 56, 312)
- EMA (EudraLex Volume 10, CTR EU No. 536/2014)
- India (CDSCO, NDCT Rules, 2019)
Roles of regulatory authorities: FDA, EMA, CDSCO, MHRA, TGA
Clinical trial application process
Import/export of IPs and biological samples

Module 4: Ethics Committee & Regulatory Submissions

Composition and SOPs of EC/IRB
Site Regulatory File (Investigator Site File)
Clinical trial registration (e.g., CTRI, EudraCT, ClinicalTrials.gov)
Submission checklist: Protocol, ICF, IB, EC approval, insurance

Module 5: Safety Reporting & Pharmacovigilance

AE/SAE definitions, documentation, and reporting timelines
SUSAR and DSUR reporting
Role of Data Safety Monitoring Board (DSMB)
Case study on SAE reconciliation

Module 6: Clinical Trial Documentation & Audit Preparedness

Source Documentation & CRF Completion
Monitoring visit types and documentation
Audit & Inspection Readiness (FDA, EMA, CDSCO)
Common findings during inspections and how to avoid them

Module 7: Digital Tools & E-Systems in Clinical Trials

Electronic Data Capture (EDC) and eCRF systems
eTMF, eSource, and Remote Monitoring
Regulatory compliance for digital tools (Part 11, Annex 11)

Module 8: Practical Training (For CRCs)

Mock EC submissions
Site initiation and monitoring simulation
Source-CRF verification exercises
SAE reporting forms and narratives
Trial Master File (TMF) preparation

Certification & Assessment

Final test based on ICH-GCP and regulatory guidelines
Scenario-based evaluation
Issuance of certificate recognized by industry partners or CROs