Project Title: _____________________________________________________

Principal Investigator: _____________________________________________

Sponsors: ________________________________________________________

Date of Study Initiation:


Date of Study Completion:


Official with Overall Responsibility for Human Research Participant

Protection Program: _______________________________________________

Risk Assessment:

❏ Minimal

❏ More than Minimal

For each category listed below, please write the name of the individual or body (e.g., Research ERB) responsible for overseeing the task. Please circle either Yes or No (Y or N) where appropriate to indicate if the item is applicable.


Applicable? If yes, please identify responsible party.


Research Design:



If drug, biological agent, or device is administered:


Is the dose/route/indication FDA approved?

Y / N


If not, is there an IND, IDE?

Y / N


Who is the holder of the IND, IDE?



Who is the responsible party for the following:


Manufacturing product following GMP?



Ensuring availability of adequate supply of product to conduct trial?



Packaging, labeling, and distribution?



Storage, usage, disposal, and accountability at clinical sites following GCP?


3. For procedures conducted during the study (e.g., cardiac catheterization, psychological profile), who is responsible for ensuring that:


Procedures are standardized, well established, and clearly defined?



Individuals conducting procedure(s) are properly credentialed and/or trained?


The National Academies of Sciences, Engineering, and Medicine
500 Fifth St. N.W. | Washington, D.C. 20001

Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement