- Protocol Tracking Management System (PTMS)
- NIH OHSRP Website:
- NHGRI Website:
- NICHD Protocol Templates and Forms:
- New Protocols
- Continuing Review
- Study Closures
- Unanticipated Problems, Deviations and Non-Compliance
- Short form consent for non-English speaking subjects
- Research Use, Storage and Disposition of Human Subjects’ Samples and Data
- Approved Protocol language for human Material Transfer Agreements (hMTA)
- I. New Protocols Involving Children <2 years old for Admission to NIH
- II. IND/IDE Investigator Sponsor Protocols
- III. Protocol Monitoring
- IV. Clinical Protocols that have Not accrued subjects after approval
Protocol Tracking Management System (PTMS)
I. 2015 NICHD IRB Schedule and Deadline for Submissions into PTMS: Schedule for 2015 NICHD IRB dates and submission deadlines.docx
II. New Protocol Application (replacing 1195):
- Glossary of Terms: Intramural_Clinical_Protocol_Applications_Glossary_3-12-14.pdf
- Initial review application (replaces 1195) output document: IR Application Output Doc_Updated03052014.docx
- Continuing Review application (replaces 1195-1) output document: CR-03-12-2014.pdf
- Amendment application output document: AM-03-12-2014.pdf
- Supplements to protocol application: Supplements- Word Version 3.6.14 copy.zip
III. PTMS Training:
NIH OHSRP Website:
Resource for SOPs, training requirements, IRB information, and other important human subject research protection information: https://federation.nih.gov/ohsr/nih/
Resource for online informed consent. Contains sample consent language related to genomic data sharing, return of results, confidentiality, etc. http://www.genome.gov/informedconsent
NICHD Protocol Templates and Forms:
- Required Documentation for an Initial Review: SOP 8 Final v1 6-11-13 508.pdf
- Please review the INITIAL_review_submission_checklist.doc for steps required for submission of a new protocol.
- IND Protocols: FDA "Tool Chest" developed as an educational and practical tool for NIH investigators who are planning to submit an IND application to the FDA.
- Sample Protocol template: CNS Protocol Template 1 27 14.doc
1. Checklist for Continuing Review: CR_Checklist 11.29.13.rtf
2. Template for NICHD Continuing Review annual progress memorandum:NICHD CR Progress Memo Template_12_2013 dp.docx
3. The protocol should include a section entitled “Research Use, Storage and Disposition of Human Subjects’ Samples and Data” (or a comparable phrase) if applicable: Stipulations_regarding_Research_Use.Revised.doc
4. Protocol must have monitoring plan. See section III. below for sample plans.
5. OSHRP approved UP language to be added as protocol appendix until incorporated into body of protocol: template language up pd reporting 10-1-2013.rtf
1. Template for Amendment to request addition of Associate Investigator:NICHD_add_AI__Memo-Template_final2012.docx
Sample E-mail to be sent to Associate Investigator:NICHD_add_AI__Memo-Template_final 1.3.14.docx
2. Template for Amendment to delete an Associate Investigator: NICHD_remove_AI__Memo-Template.docx
3. Template for Amendment to change protocol: NICHD Amendment memo_2013-May_DP.docx
NICHD study closure template memo: NICHD Study Closure memo template.docx
NICHD Consent template: NICHD_Consent_Template_3-26-12.doc
Unanticipated Problems, Deviations and Non-Compliance
OHSRP approved appendix to protocols for UP language: template language up pd reporting 10-1-2013.rtf
Short form consent for non-English speaking subjects
NICHD template for request for expedited review for use of "short form" consent NICHD Short form consent memo- expedited.docx
Research Use, Storage and Disposition of Human Subjects’ Samples and Data
Sample language to be included in protocols when applicable: Sample Research Use Specimens_data language_Nieman.docx
Approved Protocol language for human Material Transfer Agreements (hMTA)
Sample language to be included in protocols when applicable: NICHD CD memo to investigators hMTA 10 24 14 FDP.pdf
I. New Protocols Involving Children <2 years old for Admission to NIH
All protocols that include plans to evaluate patients below the traditional threshold (<2 yrs) should be submitted to the CC Pediatrician, Dr. Deborah Merke, prior to IRB submission. The protocol review is to assess patient-care requirements and identify CC and IC services likely to be affected by the admission of such children.
It is recommended by the Pediatric Care Committee, for patients < 2 years old and/or < 10kg that you contact Debbie Merke and/or David Lang before admission to discuss the care of the patient while they are admitted. (Caroline Hudson, BSN, RN, CPON Clinical Manager/ 1NW Pediatrics,301-480-6742)
II. IND/IDE Investigator Sponsor Protocols
III. Protocol Monitoring
1.NICHD Standard Operating Procedure (SOP) for Intramural Clinical Protocol Monitoring: revised NICHD Protocol Monitoring SOP march 2014.doc
2.Guide for writing an IND/IDE Protocol Monitoring Plan: NICHD Protocol Monitoring Guide 9.24.12v2.pdf
3.Sample of a Completed IND/IDE Protocol Monitoring Plan: revised IND monitoring plan Jan 15 2014.doc
4. Sample of a Completed non-IND and non-DSMC Protocol Monitoring Plan: sample non IND monitoring plan 4 1 14.doc
IV. Clinical Protocols that have Not accrued subjects after approval
There are significant costs in both time and effort expended in maintaining protocols that have not accrued subjects. In order to address this issue the following policies will be implemented.
1. Protocols approved by the NICHD IRB that have not enrolled any subjects at the time of the first continuing review will be terminated by the NICHD Office of the Clinical Director.
2. The Accountable Investigator of a protocol may request, prior to the submission date for the first continuing review that an additional year be provided. This request should include substantial evidence that recruitment consistent with meeting the goals of the protocol will commence in a timely manner. If recruitment has not commenced by the second continuing review, the protocol will be terminated.
3. Terminated protocols will not be reactivated. A new protocol submission will be required.