Basics of Randomized Clinical Trial (RCT)

Introductions, expectations, and workshop structure

Principles of clinical trials, phases, importance, and relevance to SRHR

Good Clinical Practice guidelines, participant safety, informed consent

Structure and elements of a clinical trial protocol

Parallel, crossover, factorial, cluster, adaptive designs; superiority/non-inferiority trials

Basics of power, effect size, and sample size estimation

Statistical principles and hypothesis formulation

Summary and Q&A

Principles, methods, and practical applications

Sources of bias, strategies for prevention

Investigator responsibilities, regulatory documentation, and site management

Accountability, storage, and record-keeping

Data lifecycle, CRF completion, electronic data capture

Adverse events, serious adverse events, and reporting procedures

Ensuring data integrity and traceability

Daily summary and participant feedback

Trial closure, archiving, and post-trial obligations

Reporting results and preparing manuscripts

Standard operating procedures, audits, and inspections

Collaboration, confidentiality, and intellectual property

Clinical and data monitoring approaches

Evaluating efficiency and outcomes of clinical trials

Case study presentations, discussion, and closing remarks

Participant evaluation