Site Performance Tools
Guidance for Sponsors, Investigators, and Institutional Review Boards. Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c) February 2012
This new guidance is intended to help sponsors, investigators and Institutional Review Boards better understand the new informed consent requirement set forth in 21 CFR 50.25(c). The guidance will assist those involved in applicable FDA-regulated clinical trials to better understand the new informed consent requirement, including small businesses.
Long-Term Document Storage Calculator
The long-term document storage calculator is a very flexible Excel document created by Michael Jay for determining the cost of storing trial documents. Users can enter number of boxes, years in storage, facility costs, and more in order to arrive at the proper pricing.
Study Budget Activity Checklist
The Study Startup and Activities Checklist is a useful tool when beginning to price out a new clinical trial at your site.
