Programme Scope

What this test series covers

Good Clinical Practice fundamentals, Investigator responsibilities, Sponsor obligations, Ethical conduct of clinical trials, Declaration of Helsinki, IRB/IEC requirements.

Study design, Protocol elements, Randomisation, Blinding, Sample size, Endpoints, Efficacy and safety outcomes — clinical research methodology.

FDA 21 CFR Parts 11/50/56/312, ICH E8/E9/E10, IND/NDA/BLA submissions, EMA Guidelines, Informed consent regulations.

CRF design, Data collection, EDC systems, CDISC standards, Statistical analysis plans, Protocol deviation reporting.

SAE reporting timelines, CIOMS forms, SUSAR/SUSUR classification, MedWatch, EudraVigilance, signal detection.

Site selection, Initiation, Monitoring visits, Audit readiness, TMF management, Protocol compliance verification.

Learning Objectives

What this test series achieves

To assess clinical research certification readiness across all major competency domains through timed MCQ mock examinations

To master ICH-GCP E6(R2) principles — sponsor/investigator responsibilities, informed consent, IRB/IEC oversight, and GCP compliance requirements

To develop regulatory affairs competency — FDA 21 CFR Parts 50/56/312, IND/NDA/BLA requirements, ICH guidelines, and EMA regulatory frameworks

To build clinical trial design and methodology MCQ competency — study design, randomisation, blinding, endpoints, and statistical analysis plans

To master pharmacovigilance and safety reporting — SAE timelines, SUSAR reporting, MedWatch, and EudraVigilance requirements

To identify competency-level gaps using AURA analytics calibrated to ACRP and SOCRA certification blueprints

To track readiness with a real-time clinical research certification Pass Probability Score updated after every session

To reinforce site operations and monitoring competencies — TMF management, audit readiness, and protocol compliance verification

Target Audience

Who can enrol

Programme Certification

Your certificate