Deviations from controlled procedures

Deviations from controlled procedures Deviations from, or changes to, procedures found in controlled documents will happen almost as soon as the document is released. In some of these cases, the study team may not even realize that they have not followed a particular procedure correctly-especially if the outcome of the procedure was not adversely affected. At some point, often at the time that the study is closing down and review of the trial master file (TMF) is taking place, someone will notice. We will call those situations retrospective deviations. In other cases, a study team plans to follow a different procedure-whether to look for new efficiencies, adjust to changes in regulation, or pilot a new system. We will call these situations prospective deviations. In this chapter, we will look at the two kinds of deviations, how they are recorded, and what should be done with them once they are identified.