Manual of Operations and Procedures

Each clinical study should develop a Manual of Operations and Procedures (MOP) that contains information needed for the conduct and operation of a clinical study. The MOP transforms the study protocol into specific guidelines that describe the study organization, operational definitions of the data, participant recruitment, screening, enrollment, randomization, and follow-up procedures, data collection methods, data flow, case report forms, and quality control procedures.

The guidelines below describe each section that is typically included in a multi-center study MOP. The scope of tasks and responsibilities outlined for the conduct of a clinical trial are also useful for investigators of single-site studies.

• Guidelines for Developing a Manual of Operations and Procedures (MOP)
  • Word version [167KB Word file]
  • PDF version [444KB PDF] (not editable)