Question:

Question edited from the original:  What regulatory documents do I need to submit for an observation study other than protocol and ICF?
-Clinical project manager, CRO

Answer:

To supplement the protocol and consent form, the submission should include the respective IRB’s required submission document(s) that provide information about the study, investigator (if one is included with the initial submission), the investigator’s site location and qualifications.

Also submit any recruitment materials such as advertisements, flyers, and letters, and telephone or web-based screening scripts. WCG’s white paper, “Subject Recruitment Materials: Understanding the Requirements for IRB Review” provides additional details regarding these types of materials and what type should be submitted.