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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 1 Registration Data Entry Forms 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 Request for the Extension of the Results Information Submission Deadline (document unavailable) Form and Instruction
Form 1 Request for the Extension of the Results Information Submission Deadline (document unavailable) 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 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 (document unavailable) Form and Instruction
Form 1 Results Information Submission Data Entry Forms (document unavailable) 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 (document unavailable) Form and Instruction
Form 1 Registration Data Entry Forms (document unavailable) Form and Instruction
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
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 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

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

OMB Details

Initial Data Entry Personnel Form

Federal Enterprise Architecture: Health - Consumer Health and Safety

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.