NCCAM Clinical Research Toolbox
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.