GOOD CLINICAL PRACTICE TRAINING
On 25 and 26 November we had a Good Clinical Practice (GCP) training. It actually was a refresher training because the staff of KCRI has had many trainings before. With the upcoming studies, it was important to refresh our knowledge on GCP and to have updated GCP certificates. Members of the TB research team and HIV research team of KCRI were thaught about several topics in GCP. Facilitators were seniors from KCRI and from KCMUCollege and the National Institute of Medical Research.
Topics covered were:
GCP principles
History of ethics in research
Obtaining ethical clearance
CRERC/NIMR/TFDA issues
SOPs
Research in vulnerable subjectes like children
Agreements
Quality assurance, control and management
Reporting of adverse events
Data management, data handling and case report forms
Informed Consent
Investigator Site File and Trial Master File
Research methodology in relation to GCP
Auditing and accreditation
At the end, all participants received their GCP certificates and a full copy of the ICH guidelines for Good Clinical Practice