Clinical trial manual of operations

This Manual of Operations (MOP) describes the HIV Prevention Trials Network (HPTN) structure; operating policies; roles and responsibilities of entities and individuals within the HPTN; protocol development and approval processes; standardized study operations procedures; data and specimen collection and processing procedures; and quality management, monitoring and . The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. DGHI is pleased to share these documents with others who are working in resource-limited locations. Although most of these SOPs were developed for AIDS clinical trials, many of these documents can be .  · Introduction. The purpose of this document is to provide a Manual of Operating Procedures (MOP) template for principal investigators (PIs) of multisite clinical trials. The role of the MOP is to facilitate consistency in protocol implementation and data collection across participants and study www.doorway.rud Date: 05/18/

Manual of Operations 84 Financial Documents 84 Data Management 85 Data Dictionary 86 Creating the Study Database 88 Testing 89 Statistical Analysis 90 Location of Database 90 Transfer of Information 91 Investigational Product Inventory 91 Background and Purpose 91 Contacting. continuing review of trials, protocols and amendments, and of the methods and material to be used to obtaining and documenting informed consent of the trial participant. Manual of Procedures (MOP) A "cook book" that translates the protocol into a set of operational procedures to guide study conduct. Institute's linical Trials Operations Manual (hereafter referred to as the Gold ook) were adapted from the Mary Babb Randolph Cancer Center Clinical Trials Operations Manual (referred to as the Blue Book). The West Virginia Clinical and Translational Science Institute wishes to both acknowledge and thank the.

Introduction. The purpose of this document is to provide a Manual of Operating Procedures (MOP) template for principal investigators (PIs) of multisite clinical trials. The role of the MOP is to facilitate consistency in protocol implementation and data collection across participants and study sites. The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. DGHI is pleased to share these documents with others who are working in resource-limited locations. Although most of these SOPs were developed for AIDS clinical trials, many of these documents can be modified and extrapolated to meet your specific project needs. Overview of the Manual of Operations (MOP) A MOP is a handbook that details a study’s conduct and operations. It transforms the study protocol into a guideline that describes a study’s organization, operational data definitions, recruitment, screening, enrollment, randomization, follow-up procedures, data collection methods, data flow, and.