Responsible Research: A Systems Approach to Protecting Research Participants

HRPPP ACCOUNTABILITY TEMPLATE
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.

PROTOCOL DEVELOPMENT
Applicable? If yes, please identify responsible party.
1.	Research Design:	___________________
2.	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?	___________________