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

ICR 202302-0925-001

OMB: 0925-0586

Federal Form Document

Forms and Documents

Document Name	Status
Form 1 Initial Data Entry Personnel Form Form and Instruction	Modified
Form 5 Expanded Access records - Updates Form and Instruction	Modified
Form 5 Expanded Access Records - Initial Form and Instruction	Modified
Form 4 Extension Requests and Appeals Form and Instruction	Modified
Form 3 Certification to Delay Results Form and Instruction	Modified
Form 2 Update Results Information of Voluntary and Non-regulated Submissions Form and Instruction	Modified
Form 2 Initial Results Information of Voluntary and Non-regulated Submissions Form and Instruction	Modified
Form 2 Update Results Information on Non-regulated Submissions related to the NIH Policy Form and Instruction	Modified
Form 2 Initial Results Information of Non-regulated Submissions related to the NIH policy Form and Instruction	Modified
Form 2 Results Triggered by Voluntary Submission Form and Instruction	Modified
Form 2 Updates Form and Instruction	Modified
Form 2 Initial Results Information Submission Form and Instruction	Modified
Form 1 Updated Registration of Voluntary and Non-regulated Submissions Form and Instruction	Modified
Form 1 Initial Registration of Voluntary and Non-regulated Submissions Form and Instruction	Modified
Form 1 Updated Registration of Non-regulated Submissions related to the NIH Policy Form and Instruction	Modified
Form 1 Initial Registration of Non-regulated Submissions related to NIH Policy Form and Instruction	Modified
Form 1 Registration Triggered by Voluntary Submission Form and Instruction	Modified
Form 1 Updates Data Entry Personnel Form and Instruction	Modified
Supporting Statement A - FINAL 01302023 (1).docx Supporting Statement A	2023-02-08
pub 30-day FRN2023-02381.pdf Supplementary Document	2023-02-06
Attachment 9 - Privacy Impact Assessment.docx Supplementary Document	2023-02-06
Attachment 8 - Privacy Act Review (1).pdf Supplementary Document	2023-02-06
Attachment 4 - Results Information Data Element Definitions (2021).pdf Supplementary Document	2023-02-06
Attachment 1 - Registration Data Element Definitions (2020).pdf Supplementary Document	2023-02-06

IC Document Collections

IC ID	Document Title	Status
6153	Initial Data Entry Personnel Form Form and Instruction	Modified
239370	Expanded Access records - Updates Form and Instruction	Modified
239368	Expanded Access Records - Initial Form and Instruction	Modified
239366	Extension Requests and Appeals Form and Instruction	Modified
239365	Certification to Delay Results Form and Instruction	Modified
239364	Update Results Information of Voluntary and Non-regulated Submissions Form and Instruction	Modified
239363	Initial Results Information of Voluntary and Non-regulated Submissions Form and Instruction	Modified
239362	Update Results Information on Non-regulated Submissions related to the NIH Policy Form and Instruction	Modified
239361	Initial Results Information of Non-regulated Submissions related to the NIH policy Form and Instruction	Modified
239360	Results Triggered by Voluntary Submission Form and Instruction	Modified
239359	Updates Form and Instruction	Modified
239358	Initial Results Information Submission Form and Instruction	Modified
239357	Updated Registration of Voluntary and Non-regulated Submissions Form and Instruction	Modified
239356	Initial Registration of Voluntary and Non-regulated Submissions Form and Instruction	Modified
239355	Updated Registration of Non-regulated Submissions related to the NIH Policy Form and Instruction	Modified
239347	Initial Registration of Non-regulated Submissions related to NIH Policy Form and Instruction	Modified
239344	Registration Triggered by Voluntary Submission Form and Instruction	Modified
239338	Updates Data Entry Personnel Form and Instruction	Modified