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

OMB 0925-0586

This information collection request seeks approval of an extension of the existing Paperwork Reduction Act clearance for the collection of Clinical Trial Registration and Results Information via the ClinicalTrials.gov web site operated by the National Library of Medicine (NLM) under the authority of the Director of the National Institutes of Health (NIH). The purpose of the clinical trials registry data bank is to enhance patient enrollment and provide a mechanism to track the progress of clinical trials. The information is intended to provide current and reliable information on the broadest possible scale to members of the public, including to physicians and researchers, about the existence, nature, enrollment status, location, eligibility criteria, sponsorship and progress of clinical trials.

The latest form for Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM) expires 2023-02-28 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 1 Initial Data Entry Personnel Form Form and Instruction
Form 5 Expanded Access records - Updates Form and Instruction
Form 5 Expanded Access Records - Initial Form and Instruction
Form 4 Extension Requests and Appeals Form and Instruction
Form 3 Certification to Delay Results Form and Instruction
Form 2 Update Results Information of Voluntary and Non-regulated Submissions Form and Instruction
Form 2 Initial Results Information of Voluntary and Non-regulated Submissions Form and Instruction
Form 2 Update Results Information on Non-regulated Submissions related to the NIH Policy Form and Instruction
Form 2 Initial Results Information of Non-regulated Submissions related to the NIH policy Form and Instruction
Form 2 Results Triggered by Voluntary Submission Form and Instruction
Form 2 Updates Form and Instruction
Form 2 Initial Results Information Submission Form and Instruction
Form 1 Updated Registration of Voluntary and Non-regulated Submissions Form and Instruction
Form 1 Initial Registration of Voluntary and Non-regulated Submissions Form and Instruction
Form 1 Updated Registration of Non-regulated Submissions related to the NIH Policy Form and Instruction
Form 1 Initial Registration of Non-regulated Submissions related to NIH Policy Form and Instruction
Form 1 Registration Triggered by Voluntary Submission Form and Instruction
Form 1 Updates Data Entry Personnel Form and Instruction
Supporting Statement A - FINAL 01302023 (1).docx Supporting Statement A
pub 30-day FRN2023-02381.pdf Supplementary Document
Attachment 9 - Privacy Impact Assessment.docx Supplementary Document
Attachment 8 - Privacy Act Review (1).pdf Supplementary Document
Attachment 4 - Results Information Data Element Definitions (2021).pdf Supplementary Document
Attachment 1 - Registration Data Element Definitions (2020).pdf Supplementary Document
Initial Data Entry Personnel Form Form and Instruction
Expanded Access records - Updates Form and Instruction
Expanded Access Records - Initial Form and Instruction
Extension Requests and Appeals Form and Instruction
Certification to Delay Results 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
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
Results Triggered by Voluntary Submission Form and Instruction
Updates Form and Instruction
Initial Results Information Submission Form and Instruction
Updated Registration of Voluntary and Non-regulated Submissions Form and Instruction
Initial Registration of Voluntary and Non-regulated Submissions 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
Registration Triggered by Voluntary Submission Form and Instruction
Updates Data Entry Personnel Form and Instruction

All Historical Document Collections

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 Form

Fillable Fileable

Form and instruction

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