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I agree to conduct the described trial in compliance with all stipulations of the protocol, regulations and ICH E6 Guideline for Good Clinical Practice (GCP). Principal Investigator Name: Principal Investigator Signature: Date:.
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FAQ
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A protocol is a written document that serves many purposes: It instructs the physician (primary investigator) and staff (study coordinators) how to execute the trial. It describes how a trial is conducted, ensures the safety of study participants and ensures the integrity of the data collected throughout the trial.
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The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. It also describes the eligibility of the participants, the length of the study, the medications and the related tests.
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Protocol writing allows the researcher to review and critically evaluate the published literature on the interested topic, plan and review the project steps and serves as a guide throughout the investigation. The proposal is an inevitable document that enables the researcher to monitor the progress of the project [5].
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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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This protocol template is a tool to facilitate the development of a research study protocol specifically designed for the investigator initiated studies. It contains sample text to assist investigators in answering the questions reviewer may have. Protocol template instructions and samples are in italics.
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The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analysed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.
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The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analysed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.
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In multi-site trials, it is good practice to ensure the Principal Investigator signs a protocol signature page to confirm receipt and also their agreement to work to the current version of the protocol.
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