Q: Do I have to follow the GCP guidelines even if my study does not involve any experimental drug and what is the scope of the SA GCP guidelines?
A: While SA GCP guidelines focus on the management and regulation of drug trials on human participants, in the absence of alternatives, the basic principles outlined in this document guide any research involving human participants. Most Ethics committees in SA will probably require some proof of GCP training for all research involving human participants regardless of the involvement of experimental or registered drugs in the study. [Reference: SA GCP guidelines, 1.3; p.12]
Q: Which web-based clinical data management systems are supported at UCT?
A: UCT (through eResearch) currently supports OpenClinica, REDCap, OpenMRS and OpenDataKit. Go here for more details.