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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 patients and clinical sites. Further, the MOP provides reassurance to all participants that scientific integrity and patient 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, patient 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 Patient Screening Log, Patient enrollment Log, Delegation of Responsibilities Log, etc., be completed.

The NINDS recognizes the importance of a MOP and has developed a guidelines template for the preparation of a study's MOP.

MOP Template: [MS Word Version] [PDF Version]

For additional information, please call (301) 496-9135.

 

Last updated April 20, 2007