Registration and Welcome Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1

Introduction and ground Rules Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Introductions, expectations, and workshop structure

Overview of Randomized Clinical Trials Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Principles of clinical trials, phases, importance, and relevance to SRHR Dr Million M.

ICH-GCP and ethical conduct in clinical trials Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Good Clinical Practice guidelines, participant safety, informed consent Dr Million M.

Protocol development Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Structure and elements of a clinical trial protocol Dr Million M.

Study designs in RCTs Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Parallel, crossover, factorial, cluster, adaptive designs; superiority/non-inferiority trials Dr Dawit A.

Sample size determination Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Basics of power, effect size, and sample size estimation Dr Million M.

Hypothesis testing in RCTs Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Statistical principles and hypothesis formulation Dr Dawit A.

Reflection and wrap-up Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Summary and Q&A

Recap of Day 1 Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1

Randomization and Blinding Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Principles, methods, and practical applications Dr. Dawit A.

Minimizing bias in clinical trials Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Sources of bias, strategies for prevention Dr. Dawit A.

Conduct of a clinical trial Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Investigator responsibilities, regulatory documentation, and site management Dr Million M.

Investigational product management Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Accountability, storage, and record-keeping Dr. Dawit A.

Data management in clinical trials Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Data lifecycle, CRF completion, electronic data capture Dr. Dawit A.

Safety reporting Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Adverse events, serious adverse events, and reporting procedures Dr Million M

Good documentation practice (ALCOA Principles) Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Ensuring data integrity and traceability Dr. Dawit A.

Reflection and Q&A Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Daily summary and participant feedback

Recap of Day 2 Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1

Trial closeout and reporting Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Trial closure, archiving, and post-trial obligations Dr. Dawit A.

CONSORT and manuscript writing Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Reporting results and preparing manuscripts Dr Million M.

Quality assurance and SOPs Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Standard operating procedures, audits, and inspections Dr. Dawit A.

Working with external partners Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Collaboration, confidentiality, and intellectual property Dr Million M.

Monitoring and evaluation of clinical trials Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Clinical and data monitoring approaches Dr Million M.

Metrics and performance indicators Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Evaluating efficiency and outcomes of clinical trials Dr Million M.

Group exercise and closing session Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Case study presentations, discussion, and closing remarks Lead facilitator & SPIRHR

Workshop evaluation Room: Hall 1/3rd floor/SRHR CoE Building - Hall 1 Participant evaluation