- Protocol Tracking Management System (PTMS)
- NIH OHSRP Website:
- NICHD Protocol Templates and Forms:
- NICHD SOP/Protocol Related
Protocol Tracking Management System (PTMS)
2014 NICHD IRB Schedule and Deadline for Submissions into PTMS: Schedule for 2014 NICHD IRB.docx
NIH OHSRP Website:
Resource for SOPs, training requirements, IRB information, and other important human subject research protection information: https://federation.nih.gov/ohsr/nih/
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.
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
NIH Problem Report Form: NIH Problem Report Form v1 6-11-13 Fillable.docx
OHSRP approved appendix to protocols for UP language: template language up pd reporting 10-1-2013.rtf
NICHD SOP/Protocol Related
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: NICHD Protocol Monitoring SOP 8.5.13.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 1.15.14.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.