Device - Voluntary

Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0925-0586 can be found here:

Documents and Forms

Document Name Document Type
Form 2 Device - Voluntary Form and Instruction
1 survey ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf Form and Instruction
2 survey ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf Form and Instruction
ClinicalTrials.gov _Basic Results_ Data Element Definitions.pdf ClinicalTrials IC Document
ClinicalTrials.gov_Protocol Registry_ Data Element Definitions.pdf ClinicalTrials IC Document

Information Collection (IC) Details

IC Title:	Device - Voluntary	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	2	survey	ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf		Yes	Yes	Paper Only
Form and Instruction	1	survey	ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 545	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	4,360	4,360
Annual IC Time Burden (Hours)	8,720	8,720
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
ClinicalTrials	ClinicalTrials.gov _Basic Results_ Data Element Definitions.pdf	12/19/2008
ClinicalTrials	ClinicalTrials.gov_Protocol Registry_ Data Element Definitions.pdf	12/19/2008

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