Question: What are the IRB submission requirement for observational studies?

June 14, 2019 Lindsay Abraham, JD, CIP

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.

About the Author

Lindsay Abraham, JD, CIP

Ms. Abraham joined Western IRB (WIRB) in 2010 and is currently the Regulatory Lead for the IRB Chairs at WIRB. Ms. Abraham has co-authored several White Papers on topics related to IRB work, and both chairs Board meetings and provides guidance to the Board and clients regarding the interpretation of federal and state laws pertaining to IRB operations and functions. Ms. Abraham also presents education and training courses for Board members and staff. Prior to joining WIRB, Ms. Abraham practiced in the field of family law, and holds a Juris Doctorate from Seattle University School of Law.

Follow on Linkedin Visit Website More Content by Lindsay Abraham, JD, CIP
Previous Post
Question: What are the signature requirements for translated informed consent documents?
Question: What are the signature requirements for translated informed consent documents?

Next Post
Question: Does the Common Rule apply to Medicare-covered investigational device studies?
Question: Does the Common Rule apply to Medicare-covered investigational device studies?

Ask The IRB Experts

Submit Question