Good Practices in the Conduct of Clinical Trials: Good Community, Pharmacy and Laboratory Practices

In addition to essential Good Clinical Practice (GCP) and Human Subject Protection (HSP) training that all study staff implementing clinical trials receive, CAPRISA has several science support cores to further enhance the quality of clinical trial conduct. This chapter shares experiences and insights from the Pharmacy, Laboratory and Community Cores that have been garnered over several decades of conducting clinical trials and provides insights on the systems for ensuring scientific integrity and meeting ethical obligations. Experiences on establishing respectful partnerships with communities where the research is being undertaken and preparing volunteers for informed and voluntary study participation are highlighted as well as good pharmacy and laboratory practices. The Pharmacy core has to ensure blinding, integrity of the investigational new drug, correct and accurate dispensing of study product to participants and accountability for products dispensed. The Laboratory core needs to ensure that systems are in place for correct specimen collection; the best and most appropriate laboratory assays are utilised, the specimens are transported appropriately and processing for storage or further shipping is accurate. Given that not all assays are performed in real time, the Laboratory Core has to maintain an effective and efficient specimen repository/BioBank to locate and ship specimens to local and international collaborating laboratories. These three science support cores have been set up to function across multiple clinical trials in different geographical locations ensuring cost-effectiveness and efficiency.