A study Manual of Procedures (MOP), available in PDF or Microsoft Word format, is developed to facilitate consistency in protocol implementation and data collection across participants and clinical sites. Further, the MOP provides reassurance to all participants that scientific integrity and participant safety are closely monitored and increases the likelihood that the results of the study will be scientifically credible.
The MOP is analogous to a toolkit in that it contains information needed for the conduct and operations of a clinical trial. It transforms the study protocol into a guideline that describes 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 (CRFs), and quality control procedures. MOP development requires that the final protocol, CRFs, informed consent documents, adverse and serious adverse events reporting, data management, and administrative forms such as Participant Screening Log, Participant enrollment Log, Delegation of Responsibilities Log, etc., be completed.
The NINDS recognizes the importance of a MOP and has developed a template for the preparation of a study's MOP. While the exact format of the MOP may vary according to specific study needs, this template is meant to provide a useful guideline to investigators formulating their own documents.
Last updated March 20, 2013