ABSTRACT
Who, what, when, and where The first thing any novice writer of SOPs will be told is that the document should explain who is performing the work, what the work is, and when (in what timeframe) it should take place. There is little argument on those, but then the discussion gets complicated. Authors of articles and instructors on SOP writing will then specify that SOPs should also include some combination of how, why, and where. Each company will have to decide which of these six options are to be addressed in SOPs, but many companies writing good clinical practice (GCP) SOPs stick to who, what, and when and add where as appropriate. This approach is well aligned with the definition for SOP introduced in Chapter 1:
SOPs are written instructions that identify the activities and responsibilities needed to achieve a standard, controlled procedure that ensures compliance to GCP and applicable regulatory requirements and reflects business needs in support of clinical research.
