The objective of the training was to train internal Clinical Research Associates (CRA) who will monitor the progress of the project to ensure that it is conducted in accordance with the approved protocol, study relevant SOPs, GCP and all regulatory requirements. They are responsible for verification of adequacy of study personnel qualification as well as facilities, the accuracy and completeness of the CRF entries, source documents and other study related records, appropriate study materials and equipment storage, usage and accountability, informed consent procedures and patient’s eligibility, maintenance of the essential documents.
Helen Mahiga: “I learnt that a CRA should be independent, and follow all GCP, protocol and local legislation. The CRA is not an enemy but is there to help and support staff for the progress of the trial.”
Walia Caldeira: “The CRA must be precise, objective, organized, and plan their activities. Ensure the quality of all documents related to the trial and report the facts found. GCP is the foundation.”
(Momodou Jallow, Helen Mahiga, Walia Caldeira, Mosidi Masoba)