Information Collection

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

IC 6304 under ICR 200903-0910-008 · OMB 0910-0581.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0581 guidance document clintrial dmc.pdf www.fda.gov/cber/gdlns/clintrialdmc.pdf	Other-guidance document

IC Title:

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

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-guidance document			0581 guidance document clintrial dmc.pdf	http://www.fda.gov/cber/gdlns/clintrialdmc.pdf	Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 370

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	1,148	1,148
Annual IC Time Burden (Hours)	1,795	1,795
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.