Form 2 Results Information Submission Data Entry Forms

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

Attachment 5 - Results Information Submission Data Entry Forms

Initial Results Information of Non-regulated Submissions

OMB: 0925-0586

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Attachment 5 DRAFT

4 Nov 2019

Attachment 5 - ClinicalTrials.gov Results Reporting Data Entry Screen Shots (DRAFT)

OMB NO: 0925-0586
EXPIRATION DATE: 02/29/2020
Burden Statement
Public reporting burden for this collection of information is estimated to vary from 2.0 to 8.0
hours per response for registration, 10.0 to 45.0 hours per response results information
submissions, and 15 minutes to 2 hours for other submissions including certifications for delay,
extension requests, and expanded access. These estimates include the time for reviewing
instructions, searching existing data sources, gathering the data needed, and completing and
reviewing the collection of information. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it displays a currently valid OMB
control number. Send comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-0586). Do not return the completed form to this address.

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