Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

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A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics:

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• Title Page (General Information)
• Background Information
• Objectives/Purpose
• Study Design
• Selection and Exclusion of Subjects
• Treatment of Subjects
• Assessment of Efficacy
• Assessment of Safety
• Adverse Events
• Discontinuation of the Study
• Statistics
• Quality Control and Assurance
• Ethics
• Data handling and Recordkeeping
• Publication Policy
• Project Timetable/Flowchart
• References
• Supplements/Appendices

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Clintract can help your company with the difficult task of designing, registering, and implementing clinical trial protocols.  Our medical writers have the proven experience and background to construct clinical protocols with sound scientific rationale and study outcomes.