NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research: Phase 2 or 3 clinical trials that require …

2024年7月1日 · This page includes seven different protocol templates for developing a variety of different new research protocols. None of the templates are likely to be perfect for a given …

Protocol A written account of all the procedures to be followed in a trial, which describes all the administrative, documentation, analytical and clinical processes used in the trial.

2020年5月4日 · Listed below are several templates to assist you in composing your protocol document. Instructions specific to items on the templates appear in red text in brackets. …

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 …

2022年6月15日 · The IRB provides several protocol templates on this page. They follow the format of typical NIH and industry multicenter protocols. The Intervention template is ICH GCP …

Clinical Trial Protocol CQAW039A2317 / NCT03226392 A 12-week, multicenter, randomized, double-blind, placebo- controlled study to assess the efficacy and safety of

This protocol template is a tool to facilitate the development of a research study protocol specifically intended for the investigator initiated studies. It contains sample text to assist …

Clinical Trial Protocol CQGE031C2303 / NCT03580356 A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and

2024年6月20日 · NIH-FDA Protocol Template for Phase 2 and 3 Clinical Trials This template aims to facilitate the development of Phase 2 and 3 clinical trial protocols that require a Food and …