Medical Device Clinical Trial Protocol Template

Nih clinical trial protocol template.

Medical device clinical trial protocol template. Nih electronic protocol writing tool. The agencies are seeking comment on the new protocol template through april 17 2016. The us food and drug administration and the national institutes of health nih have jointly proposed a new template for clinical trial sponsors to use for submitting investigational device exemption ide applications. Division of cardiovascular devices.

Information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. The clinical trial protocol describes the objective rationale design methodology and organization of a clinical study. The irbs unconditional approval statement will be transmitted by the investigator to the sponsor or designee prior to the shipment of study supplies to the site. These can be further customized with different versions of sharepoint.

Careful planning and consideration of device clinical trial study design is an important step in achieving the desired primary and secondary endpoints you desire in the most cost effective and timely manner possible. To download this template you will need access to sharepoint server 30. This clinical trial protocol template is a suggested format for phase 2 or 3 clinical trials supported by the national institutes of health nih that are being conducted under a food and drug administration. Indide protocol word.

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. The irbs written unconditional approval of the study protocol and the informed consent form will be in the possession of the investigator before the study is initiated. Office of device evaluation. Nd preface remove this preface before finalizing and distributing the clinical trial protocol.

Clinical trials for medical devices. Nih clinical trial protocol template. In general the approach to testing devices is fairly similar to testing new drugs there is a need for preclinical research there are strict regulations safety and ethical requirements and. Behavioral and social science studies.

The clinical trial template has site lists of libraries for clinical trial protocols protocol documents announcements calendars issues tasks and document discussions. This protocol template aims to facilitate the development of two types of clinical trials involving human participants. Fda and the ide process owen faris phd.