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Introduction to Randomized Clinical Trial (RCT)

→ 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

50
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

Free to access ClinOps training
  • Wed, December 3
    • 8:30 AM → 9:00 AM
      Registration and Welcome 30m
    • 9:00 AM → 9:30 AM
      Introduction and ground Rules 30m

      Introductions, expectations, and workshop structure

    • 9:30 AM → 10:30 AM
      Overview of Randomized Clinical Trials 1h

      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 → 10:45 AM
      Coffee Break 15m
    • 10:45 AM → 11:45 AM
      ICH-GCP and ethical conduct in clinical trials 1h

      Good Clinical Practice guidelines, participant safety, informed consent

      Dr Million M.

      2.ICH GCP and Clinical trial site responsibilities May 2025_final.pptx
    • 11:45 AM → 12:30 PM
      Protocol development 45m

      Structure and elements of a clinical trial protocol

      Dr Million M.

      3.Clinical Trial Protocol June 2025Final.pptx
    • 12:30 PM → 1:30 PM
      Lunch break 1h
    • 1:30 PM → 2:30 PM
      Study designs in RCTs 1h

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

      Dr Dawit A.

      1. Study Designs in RCTs_final.pptx
    • 2:30 PM → 3:00 PM
      Sample size determination 30m

      Basics of power, effect size, and sample size estimation

      Dr Million M.

      4. Sample size in CT.pptx
    • 3:00 PM → 3:15 PM
      Coffee break 15m
    • 3:15 PM → 4:30 PM
      Hypothesis testing in RCTs 1h 15m

      Statistical principles and hypothesis formulation

      Dr Dawit A.

      2. Hypothesis Testing in RCTs.pptx
    • 4:30 PM → 5:00 PM
      Reflection and wrap-up 30m

      Summary and Q&A

  • Thu, December 4
    • 9:00 AM → 9:10 AM
      Recap of Day 1 10m
    • 9:10 AM → 9:30 AM
      Randomization and Blinding 20m

      Principles, methods, and practical applications

      Dr. Dawit A.

      3. Randomization and Blinding.pptx
    • 9:30 AM → 10:30 AM
      Minimizing bias in clinical trials 1h

      Sources of bias, strategies for prevention

      Dr. Dawit A.

      4. Minimizing Bias in RCTs.pptx
    • 10:30 AM → 10:45 AM
      Coffee break 15m
    • 10:45 AM → 11:30 AM
      Conduct of a clinical trial 45m

      Investigator responsibilities, regulatory documentation, and site management

      Dr Million M.

      1.1 Conducting a Trial I.pptx
    • 11:30 AM → 12:30 PM
      Investigational product management 1h

      Accountability, storage, and record-keeping

      Dr. Dawit A.

      1.2 Conducting a Trial II.pptx
      5. Investigational product management.pptx
    • 12:30 PM → 1:30 PM
      Lunch Break 1h
    • 1:30 PM → 2:30 PM
      Data management in clinical trials 1h

      Data lifecycle, CRF completion, electronic data capture

      Dr. Dawit A.

      6. Data Management in Clinical Trials.pptx
    • 2:30 PM → 3:00 PM
      Safety reporting 30m

      Adverse events, serious adverse events, and reporting procedures

      Dr Million M

      2. Safety Reporting.pptx
    • 3:00 PM → 3:15 PM
      Coffee Break 15m
    • 3:15 PM → 4:30 PM
      Good documentation practice (ALCOA Principles) 1h 15m

      Ensuring data integrity and traceability

      Dr. Dawit A.

      7. Good Documentation Practice.pptx
    • 4:30 PM → 4:45 PM
      Reflection and Q&A 15m

      Daily summary and participant feedback

  • Fri, December 5
    • 9:00 AM → 9:10 AM
      Recap of Day 2 10m
    • 9:10 AM → 9:45 AM
      Trial closeout and reporting 35m

      Trial closure, archiving, and post-trial obligations

      Dr. Dawit A.

      8. Trial closeout and reporting.pptx
    • 9:45 AM → 10:30 AM
      CONSORT and manuscript writing 45m

      Reporting results and preparing manuscripts

      Dr Million M.

      CONSORT_2025_expanded_checklist.pdf
    • 10:30 AM → 10:45 AM
      Coffee break 15m
    • 10:45 AM → 11:30 AM
      Quality assurance and SOPs 45m

      Standard operating procedures, audits, and inspections

      Dr. Dawit A.

      9. Quality in RCTs.pptx
    • 11:30 AM → 12:30 PM
      Working with external partners 1h

      Collaboration, confidentiality, and intellectual property

      Dr Million M.

    • 12:30 PM → 1:30 PM
      Lunch break 1h
    • 1:30 PM → 2:30 PM
      Monitoring and evaluation of clinical trials 1h

      Clinical and data monitoring approaches

      Dr Million M.

    • 2:30 PM → 3:00 PM
      Metrics and performance indicators 30m

      Evaluating efficiency and outcomes of clinical trials

      Dr Million M.

    • 3:00 PM → 3:15 PM
      Coffee break 15m
    • 3:15 PM → 4:30 PM
      Group exercise and closing session 1h 15m

      Case study presentations, discussion, and closing remarks

      Lead facilitator & SPIRHR

    • 4:30 PM → 4:45 PM
      Workshop evaluation 15m

      Participant evaluation

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