Introduction to Randomized Clinical Trial (RCT)

Name: Introduction to Randomized Clinical Trial (RCT)
Start: 2025-12-03T07:25:00+03:00
End: 2025-12-05T17:30:00+03:00
Location: SRHR CoE Building

Dec 3, 2025, 7:25 AM → Dec 5, 2025, 5:30 PM Africa/Nairobi

Hall 1/3rd floor/SRHR CoE Building - Hall 1 (SRHR CoE Building)

Hall 1/3rd floor/SRHR CoE Building - Hall 1

SRHR CoE Building

Description

Organized by: St. Paul Institute for Reproductive Health and Rights (SPIRHR)
Venue: SPIRHR CPD center, third floor of CERH building
Date: Dec 3-5, 2025

Wed, December 3
- 1
  
  Registration and Welcome
- 2
  
  Introduction and ground Rules
  
  Introductions, expectations, and workshop structure
- 3
  
  Overview of Randomized Clinical Trials
  
  Principles of clinical trials, phases, importance, and relevance to SRHR
  
  Dr Million M.
  
  1.Phases of clinical trials and trial authorization May 2025_final.pptx
- 10:30 AM
  
  Coffee Break
- 4
  
  ICH-GCP and ethical conduct in clinical trials
  
  Good Clinical Practice guidelines, participant safety, informed consent
  
  Dr Million M.
  
  2.ICH GCP and Clinical trial site responsibilities May 2025_final.pptx
- 5
  
  Protocol development
  
  Structure and elements of a clinical trial protocol
  
  Dr Million M.
  
  3.Clinical Trial Protocol June 2025Final.pptx
- 12:30 PM
  
  Lunch break
- 6
  
  Study designs in RCTs
  
  Parallel, crossover, factorial, cluster, adaptive designs; superiority/non-inferiority trials
  
  Dr Dawit A.
  
  1. Study Designs in RCTs_final.pptx
- 7
  
  Sample size determination
  
  Basics of power, effect size, and sample size estimation
  
  Dr Million M.
  
  4. Sample size in CT.pptx
- 3:00 PM
  
  Coffee break
- 8
  
  Hypothesis testing in RCTs
  
  Statistical principles and hypothesis formulation
  
  Dr Dawit A.
  
  2. Hypothesis Testing in RCTs.pptx
- 9
  
  Reflection and wrap-up
  
  Summary and Q&A
Thu, December 4
- 10
  
  Recap of Day 1
- 11
  
  Randomization and Blinding
  
  Principles, methods, and practical applications
  
  Dr. Dawit A.
  
  3. Randomization and Blinding.pptx
- 12
  
  Minimizing bias in clinical trials
  
  Sources of bias, strategies for prevention
  
  Dr. Dawit A.
  
  4. Minimizing Bias in RCTs.pptx
- 10:30 AM
  
  Coffee break
- 13
  
  Conduct of a clinical trial
  
  Investigator responsibilities, regulatory documentation, and site management
  
  Dr Million M.
  
  1.1 Conducting a Trial I.pptx
- 14
  
  Investigational product management
  
  Accountability, storage, and record-keeping
  
  Dr. Dawit A.
  
  1.2 Conducting a Trial II.pptx
  
  5. Investigational product management.pptx
- 12:30 PM
  
  Lunch Break
- 15
  
  Data management in clinical trials
  
  Data lifecycle, CRF completion, electronic data capture
  
  Dr. Dawit A.
  
  6. Data Management in Clinical Trials.pptx
- 16
  
  Safety reporting
  
  Adverse events, serious adverse events, and reporting procedures
  
  Dr Million M
  
  2. Safety Reporting.pptx
- 3:00 PM
  
  Coffee Break
- 17
  
  Good documentation practice (ALCOA Principles)
  
  Ensuring data integrity and traceability
  
  Dr. Dawit A.
  
  7. Good Documentation Practice.pptx
- 18
  
  Reflection and Q&A
  
  Daily summary and participant feedback
Fri, December 5
- 19
  
  Recap of Day 2
- 20
  
  Trial closeout and reporting
  
  Trial closure, archiving, and post-trial obligations
  
  Dr. Dawit A.
  
  8. Trial closeout and reporting.pptx
- 21
  
  CONSORT and manuscript writing
  
  Reporting results and preparing manuscripts
  
  Dr Million M.
  
  CONSORT_2025_expanded_checklist.pdf
- 10:30 AM
  
  Coffee break
- 22
  
  Quality assurance and SOPs
  
  Standard operating procedures, audits, and inspections
  
  Dr. Dawit A.
  
  9. Quality in RCTs.pptx
- 23
  
  Working with external partners
  
  Collaboration, confidentiality, and intellectual property
  
  Dr Million M.
- 12:30 PM
  
  Lunch break
- 24
  
  Monitoring and evaluation of clinical trials
  
  Clinical and data monitoring approaches
  
  Dr Million M.
- 25
  
  Metrics and performance indicators
  
  Evaluating efficiency and outcomes of clinical trials
  
  Dr Million M.
- 3:00 PM
  
  Coffee break
- 26
  
  Group exercise and closing session
  
  Case study presentations, discussion, and closing remarks
  
  Lead facilitator & SPIRHR
- 27
  
  Workshop evaluation
  
  Participant evaluation