ABSTRACT
At nearly every training course, workshop, or seminar on standard operating procedures (SOPs) the question œoating around in many peoples’ minds is: “Do I really have to have SOPs?” The answer is unequivocally, “Yes.” International Conference on Harmonisation (ICH) guidelines and Food and Drug Administration (FDA) regulations explicitly require SOPs. ICH E6 GCP states:
The explicit reference to data in Section 5.1.1 means that clinical data management groups are not exempt and should not be overlooked. The FDA rule 21 CFR (Code of Federal Regulations) Part 11, which is one of the main regulations that apply to clinical data management, also refers in several places to having procedures and written policies, and the related FDA guidance document “Computerized Systems Used in Clinical Investigations” lists recommended SOPs. Given that there is no way around having SOPs, this chapter will look at what SOPs are, what data management procedures should be standardized (that is, what is the list of essential SOPs), how to develop those SOPs, and how to assure and document compliance with SOPs.
