Introduction to Randomized Clinical Trial (RCT)

Introductions, expectations, and workshop structure

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

Dr Million M.

Good Clinical Practice guidelines, participant safety, informed consent

Dr Million M.

Structure and elements of a clinical trial protocol

Dr Million M.

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

Dr Dawit A.

Basics of power, effect size, and sample size estimation

Dr Million M.

Statistical principles and hypothesis formulation

Dr Dawit A.

Summary and Q&A

Principles, methods, and practical applications

Dr. Dawit A.

Sources of bias, strategies for prevention

Dr. Dawit A.

Investigator responsibilities, regulatory documentation, and site management

Dr Million M.

Accountability, storage, and record-keeping

Dr. Dawit A.

Data lifecycle, CRF completion, electronic data capture

Dr. Dawit A.

Adverse events, serious adverse events, and reporting procedures

Dr Million M

Ensuring data integrity and traceability

Dr. Dawit A.

Daily summary and participant feedback

Trial closure, archiving, and post-trial obligations

Dr. Dawit A.

Reporting results and preparing manuscripts

Dr Million M.

Standard operating procedures, audits, and inspections

Dr. Dawit A.

Collaboration, confidentiality, and intellectual property

Dr Million M.

Clinical and data monitoring approaches

Dr Million M.

Evaluating efficiency and outcomes of clinical trials

Dr Million M.

Case study presentations, discussion, and closing remarks

Lead facilitator & SPIRHR

Participant evaluation