Good Clinical Practice Training

26 Nov 2014, KCRI

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



Research in vulnerable subjectes like children


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