Table 1.
Good Clinical Practices (GCPs) course theoretical modules administered to participants
| Number | Topic/event | Practicals/case studies |
|---|---|---|
| Session 1: opening session | ||
| 01 | Pre-course test | |
| 02 | GCP: a historical perspective | |
| 03 | From the test tube to the person: current requirements in a clinical development plan | Sample clinical development plan |
| 04 | Implications of GCP in developing countries: experiences from African countries | Cases from participants, discussion |
| 05 | Who is an investigator and what does (s)he do? Including issues on delegation of tasks | |
| 06 | Who/what is a sponsor? | |
| 07 | Ethics committees and their role | |
| 08 | Source documents and essential documents (ED) (before, during, and after the trial) | Exercise on identifying the ED for pre-trial, initiation, during trial, and post-trial periods |
| 09 | Maintaining the investigator's file | |
| Session 2: trial preparations | ||
| 10 | Standard operating procedures (SOPs) | Presentation and group exercise: developing list of SOPs and develop one |
| 11 | Informed consent process; informed consent form | Presentation and discussions, informed consent movie, case studies |
| 12 | Quality assurance/quality control | |
| 13 | Laboratory organization and safety | |
| 14 | Organization and personnel | |
| 15 | Setting up of cohorts for clinical research: experiences from Nanoro | Presentation and discussion |
| 16 | The Trovan Trial in Nigeria | Case study and group presentations |
| Session 3: conduct of the trial 1 | ||
| 17 | Selection of the source of the investigational product; handling of the study product and accountability | |
| 18 | Adverse events/serious adverse events; suspected unexpected serious adverse reactions | AE/SAE, SUSARs exercises |
| 19 | Role of regulatory authorities | Presentation and discussion |
| 20 | Role of the clinical monitor | Presentation and discussion |
| 21 | Clinical trial insurance | Presentation and discussion |
| 22 | Trials audits and inspections | Presentation and discussion |
| Session 4: conduct of the trial 2 | ||
| 23 | Randomization and keeping the blind | |
| 24 | Data Safety Monitoring Boards (DSMBs) | |
| 25 | Clinical data management and dealing with data queries | |
| 26 | Pre-mature termination of the trial and study closeout issues | |
| 27 | Reports: investigator obligations | |
| 29 | Making it happen presentations (from theory to practices: challenges for a clinical investigator) | |
| Session 5: trial end | ||
| 30 | The participants and research community | |
| 31 | An overview of clinical trial methodology: the example of malaria | |
| 32 | Capacity building in clinical trials: the example of the Institute of Tropical Medicine (Belgium) and the IRSS/Center Muraz (Burkina Faso) | |
| 33 | Post-course test | |