Clinical Protocol Template

Generic protocol documents and instructions for ctep studies instructions for submitting protocol documents to ctep pdf step by step guide for submitting esubmission ready documents to ctep pdf generic protocol template ms word updated september 17 2019.

Clinical protocol template. Sections where the text is italicized. The use of a standard protocol format this sample template was developed to assist protocol teams and principal investigators who are developing niaid daids supported andor sponsored clinical trial protocols. Suggested templates for phase 1 and 2 clinical trials. This protocol template aims to facilitate the development of two types of clinical trials involving human participants.

This template should only be used for for studies limited to 1 the use of existing data or specimens 2 where the only study procedure is a retrospective chart review or use of existing biological samples and 3 where the analysis plan is limited to purely descriptive summary statistics. The following templates are primarily designed for studies focused on. Protocol template download version. Severity or frequency of which is not consistent with the risk information in the clinical study protocol or elsewhere in the current ide application.

This template provides a general format applicable to all clinical trials that are evaluating study productsinterventions. Indide protocol word. Download the templates of your choice. 322 eliciting adverse effect information.

Save as a word file to begin drafting your protocol.