ABSTRACT
Where to put the output In Chapter 4, we saw that the general philosophy of writing SOPs includes addressing the question of what action to take and identifying any output generated. In good clinical practice (GCP) SOPs, the what that is the output of a procedure very often includes or even focuses on a document or form. Many writers of SOPs are not aware that they need to say not only what is created but what to do with that document or form that is generated as part of the process (where to put the output). Some more experienced writers may know to say something like “retain in the study files,” but that is not clear enough. Does it mean storing it in the shared folders for the study until the study is over? Does it mean printing it out and putting it in a folder? Should it be submitted for offsite storage? Should it go into the study’s trial master file (TMF) to be available for inspection? Because many people who work with SOPs are not necessarily familiar with practices and trends regarding documents and the TMF, this chapter will start by providing some background, then make the connection back to SOPs.
