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The document is an application form for the Research Ethics Review Committee (ERC) at Sohail University, designed for faculty members conducting research involving human participants. It outlines the necessary steps for submission, including required information, documentation, and ethical considerations. The form includes sections on participant information, data confidentiality, research details, project finance, and a declaration by the principal investigator to ensure compliance with ethical standards.
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ing to the ICH Good Clinical Practice guidelines, a protocol should include the following topics: Title Page (General Information) Background Information. Objectives/Purpose. Study Design. Selection and Exclusion of Subjects. Treatment of Subjects. Assessment of Efficacy. Assessment of Safety.
List all the treatments to be administered including products name, dose, route of administration, and the treatment period for subjects. Include all medication permitted before and during the clinical trial. Include the procedures for monitoring subject compliance.
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.
Clinical Trial Protocol Development Title Page (General Information) Background Information. Objectives/Purpose. Study Design. Selection and Exclusion of Subjects. Treatment of Subjects. Assessment of Efficacy. Assessment of Safety.
The study protocol should contain in details the background, the objective, the rationale and the importance, as well as the design, the methodology, the Institutional Review Board approval, the informed consent and the statistical considerations of the RCT.

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A clinical study protocol is a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data. The protocol also outlines steps for protecting subjects and obtaining quality data.
Key Elements of a Protocol Document Title and Abstract: Clearly state the research projects title and provide a concise summary of the study. Introduction: Describe the background, rationale, and objectives of the research. Methods: Detail the procedures, materials, and instrumentation to be used in the study.

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Jan 20, 2015 A fully developed clinical protocol is the basis for both the IRB Application and the initial IND submission. Review the IND Protocol Template

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