OMB control number

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

OMB 0925-0586 · HHS/NIH.

OMB 0925-0586

This is a revision of a previously approved submission. The National Library of Medicine (NLM) operates the ClinicalTrials.gov website under the authority of the Director of the National Institutes of Health (NIH). ClinicalTrials.gov supports the collection of Clinical Trial Registration and Results Information necessary to implement statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and regulatory requirements at 42 Code of Federal Regulations (CFR) Part 11. Information collection at ClinicalTrials.gov also serves as a means of enhancing enrollment or complying with policies of federal agencies and other organizations. Information is collected via electronic submission to the ClinicalTrials.gov Protocol Registration and Results System (PRS). The information in the databank is publicly available. It is intended to provide current and reliable information on the broadest possible scale to members of the public, including patients, physicians, and researchers, about the existence, nature, enrollment status, location, eligibility criteria, sponsorship, progress, and outcomes of clinical trials.

The latest form for Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM) expires 2029-05-31 and is listed under ICR 202512-0925-004.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Information Required for Waiver Requests and Appeals	Form and Instruction
Form 1 Information Required for Waiver Requests and Appeals	Form and Instruction
Form 1 Expanded Access Record Data Element Definitions and Data Entry Forms	Form and Instruction
Form 1 Expanded Access Record Data Element Definitions and Data Entry Forms	Form and Instruction
Form 1 Expanded Access Record Data Element Definitions and Data Entry Forms	Form and Instruction
Form 1 Expanded Access Record Data Element Definitions and Data Entry Forms	Form and Instruction
Form 1 Request for the Extension of the Results Information Submission Deadline	Form and Instruction
Form 1 Request for the Extension of the Results Information Submission Deadline	Form and Instruction
Form 1 Certification to Delay Submission of Results Information	Form and Instruction
Form 1 Certification to Delay Submission of Results Information	Form and Instruction
Form 2 Results Information Submission Data Entry Form	Form and Instruction
Form 2 Results Information Submission Data Entry Form	Form and Instruction
Form 2 Results Information Submission Data Entry Forms	Form and Instruction
Form 2 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Results Information Submission Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form
Form 1 Registration Data Entry Forms	Form
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
Form 1 Registration Data Entry Forms	Form and Instruction
ClinicalTrials.gov Supporting Statement A_Final 2_4_2026.docx	Supporting Statement A
ClinicalTrials.gov Supporting Statement A_Final 2_4_2026.docx	Supporting Statement A
Attachment 8 - Privacy Act Memo Signed 2025_8_18.pdf	Supplementary Document
Attachment 8 - Privacy Act Memo Signed 2025_8_18.pdf	Supplementary Document
Attachment 9 - Privacy Impact Assessment - 2025Mar11.pdf	Supplementary Document
Attachment 9 - Privacy Impact Assessment - 2025Mar11.pdf	Supplementary Document
30day 0586.pdf	Supplementary Document
30day 0586.pdf	Supplementary Document
Initial Data Entry Personnel Form	Form and Instruction
Initial Data Entry Personnel Form	Form and Instruction
Initial Data Entry Personnel Form	Form and Instruction
Waiver Requests and Appeals	Form and Instruction
Waiver Requests and Appeals	Form and Instruction
Waiver Requests and Appeals	Form and Instruction
Expanded Access records - Updates	Form and Instruction
Expanded Access records - Updates	Form and Instruction
Expanded Access records - Updates	Form and Instruction
Expanded Access Records - Initial	Form and Instruction
Expanded Access Records - Initial	Form and Instruction
Expanded Access Records - Initial	Form and Instruction
Extension Requests and Appeals	Form and Instruction
Extension Requests and Appeals	Form and Instruction
Extension Requests and Appeals	Form and Instruction
Certification to Delay Results	Form and Instruction
Certification to Delay Results	Form and Instruction
Certification to Delay Results	Form and Instruction
Update Results Information of Voluntary and Non-regulated Submissions	Form and Instruction
Update Results Information of Voluntary and Non-regulated Submissions	Form and Instruction
Update Results Information of Voluntary and Non-regulated Submissions	Form and Instruction
Initial Results Information of Voluntary and Non-regulated Submissions	Form and Instruction
Initial Results Information of Voluntary and Non-regulated Submissions	Form and Instruction
Initial Results Information of Voluntary and Non-regulated Submissions	Form and Instruction
Update Results Information on Non-regulated Submissions related to the NIH Policy	Form and Instruction
Update Results Information on Non-regulated Submissions related to the NIH Policy	Form and Instruction
Update Results Information on Non-regulated Submissions related to the NIH Policy	Form and Instruction
Initial Results Information of Non-regulated Submissions related to the NIH policy	Form and Instruction
Initial Results Information of Non-regulated Submissions related to the NIH policy	Form and Instruction
Initial Results Information of Non-regulated Submissions related to the NIH policy	Form and Instruction
Results Triggered by Voluntary Submission	Form and Instruction
Results Triggered by Voluntary Submission	Form and Instruction
Results Triggered by Voluntary Submission	Form and Instruction
Updates	Form and Instruction
Updates	Form and Instruction
Updates	Form and Instruction
Initial Results Information Submission	Form and Instruction
Initial Results Information Submission	Form and Instruction
Initial Results Information Submission	Form and Instruction
Updated Registration of Voluntary and Non-regulated Submissions	Form and Instruction
Updated Registration of Voluntary and Non-regulated Submissions	Form and Instruction
Updated Registration of Voluntary and Non-regulated Submissions	Form and Instruction
Initial Registration of Voluntary and Non-regulated Submissions	Form
Initial Registration of Voluntary and Non-regulated Submissions	Form
Initial Registration of Voluntary and Non-regulated Submissions	Form
Updated Registration of Non-regulated Submissions related to the NIH Policy	Form and Instruction
Updated Registration of Non-regulated Submissions related to the NIH Policy	Form and Instruction
Updated Registration of Non-regulated Submissions related to the NIH Policy	Form and Instruction
Initial Registration of Non-regulated Submissions related to NIH Policy	Form and Instruction
Initial Registration of Non-regulated Submissions related to NIH Policy	Form and Instruction
Initial Registration of Non-regulated Submissions related to NIH Policy	Form and Instruction
Registration Triggered by Voluntary Submission	Form and Instruction
Registration Triggered by Voluntary Submission	Form and Instruction
Registration Triggered by Voluntary Submission	Form and Instruction
Updates Data Entry Personnel	Form and Instruction
Updates Data Entry Personnel	Form and Instruction
Updates Data Entry Personnel	Form and Instruction

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202512-0925-004	Revision of a currently approved collection	2026-02-20
202302-0925-001	Extension without change of a currently approved collection	2023-02-08	Approved without change
202001-0925-001	Extension without change of a currently approved collection	2020-01-28	Approved without change
201701-0925-002	Revision of a currently approved collection	2017-01-10	Approved without change
201508-0925-001	Extension without change of a currently approved collection	2015-08-28	Approved without change
201204-0925-002	Revision of a currently approved collection	2012-04-30	Approved with change
200901-0925-002	Revision of a currently approved collection	2009-01-07	Approved without change
200805-0925-001	Revision of a currently approved collection	2008-05-29	Approved without change
200803-0925-002	Revision of a currently approved collection	2008-03-10	Approved with change

OMB Details

Initial Data Entry Personnel Form

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
Form	Name	Electronic access	Type
Form 1	Registration Data Entry Forms	Fillable Fileable	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.