Clinical Study Protocol Template

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Clinical study protocol template. The following templates are primarily designed for studies focused on. Risk assessment for trial sop. Preparing to apply for a u01 clinical trial registering with clinicaltrialsgov patient research registries clinical trial policies guidelines and templates. For example information related to the manufacture of the investigational drug should not appear in the clinical protocol.

Save as a word file to begin drafting your protocol. Protocol feasibility assessment sop. The first type of trials are phase 2 and 3 clinical trial protocols that require a food and drug administration fda investigational new drug ind or investigational device exemption ide application. 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.

I am new to this website and also to the clinical research industry for that matter i only am able to see the pdf of these courses just wanted to know are these audio lectures and also. Suggested templates for phase 1 and 2 clinical trials. For more information on protocol resources at ucsf and for a video with information about protocol development please. I ndependent monitoring of the study for compliance with the clinical protocol and with ide regulations will be conducted periodically at a minimum annually by qualified staff of institution.

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. Original study protocol and the final protocol with a summary of changes. Original reporting and analysis plan statistical analysis plan which is the final statistical. This protocol template aims to facilitate the development of two types of clinical trials involving human participants.

Protocol template download version. Investigator initiated clinical research data and safety monitoring guidelines and policies clinical study templates and forms nih and other federal guidelinespolicies for clinical research. The template documents open as word files. Indide protocol word.

Contact april firstencel at 2163681819 or aprilfirstencel at caseedu with any questions. The nih provides many resources for protocol development to assist investigators in writing and developing clinical research protocols that are in compliance with regulatorygcp requirements. Hence the clinical research protocol should be designed in such a way so as to minimize the potential for protocol deviations. Nor should the clinical protocol include a detailed description of the procedures associated.

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