Resources listed below cover the fundamental elements of initiating a clinical trial at a research site. Resources include site quality assessment measures, education and training resources for site staff, and guides for federal regulation compliance among others. This list is not exhaustive and will be updated periodically. If you have suggestions, please email the Research Community Forum.

I. Protocol Handling
II. Industry Pre-study Site Visit
III. Site Initiation Meetings and Visits
IV. Informed Consent Preparation
V. Study Activation
VI. Compliance and Regulations
VII. Submitting a New Study Application to an Institutional Review Board
VIII. Protocol Review & Monitoring Committee


I. Protocol Handling

(Review for feasibility, and approvals)

II. Industry Pre-study Site Visit

III. Site Initiation Meetings and Visits

IV. Informed Consent Preparation

V. Study Activation

VI. Compliance and Regulations

(Completing an FDA Form 1572; federally required registering of trials on websites)

VII. Submitting a New Study Application to an Institutional Review Board

VIII. Protocol Review & Monitoring Committee