Nih Fda Clinical Trial Protocol Template
Refer to nih fda phase 2 and 3 indide clinical trial protocol template when writing protocols for phase 2 and 3 clinical trials that require investigational new drug ind or investigational device exemption ide applications.
Nih fda clinical trial protocol template. Use of this template is optional. This protocol template aims to facilitate the development of two types of clinical trials involving human participants. 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. Try the clinical e protocol writing tool when youre ready to generate a new protocol using the protocol template.
Nih fda phase 2 and 3 indide clinical trial protocol template. This clinical trial protocol template is a suggested format for phase 2 and 3 clinical trials funded by the. Nih fda clinical trial protocol template v10 7 apr 2017 a. Nih fda phase 2 and 3 indide clinical trial protocol template.
The national institutes of health nih and food and drug administration fda developed a clinical trial protocol template with instructional and example text for nih funded investigators to use when writing protocols for phase 2 and 3 clinical trials that require investigational new drug application ind or investigational device exemption. Nih fda clinical trial protocol template v1027 aug 20178 7 since this discovery toyos and colleagues have used ipl off label to treat hundreds of rosacea subjects presenting with dry eye disease.