Sponsor Reporting to FDA on DMC Recommendations

Guidance for Industry: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0581 can be found here:

Documents and Forms

Document Name Document Type
FINAL GUIDANCE 0581 9-17-15.Pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Sponsor Reporting to FDA on DMC Recommendations	Agency IC Tracking Number:	CBER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 312.50 21 CFR 312.56 21 CFR 812.40 21 CFR 812.46

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			FINAL GUIDANCE 0581 9-17-15.Pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 37	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 25 %

	Approved	Previously Approved
Annual Number of Responses for this IC	37	37
Annual IC Time Burden (Hours)	19	19
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.