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Protocol Navigation


Protocol Tracking Management System (PTMS)

https://cims.nichd.nih.gov/ptms
Contact Donna Peterson at petersod@mail.nih.gov or 301-496-8370 to request access.

I.  2014 NICHD IRB Schedule and Deadline for Submissions into PTMS:   Schedule for 2014 NICHD IRB.docx

II.  New Protocol Application (replacing 1195): 

III.  PTMS Training: 

Registration is done through the CIT Training web site.  The course is listed under the Seminars for Scientists category and the direct link to the class is http://training.cit.nih.gov/class_details.aspx?cId=NIHCIT-SS920

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:

  • New Protocols

  1. Required Documentation for an Initial Review: SOP 8 Final v1 6-11-13 508.pdf
  2. Please review the INITIAL_review_submission_checklist.doc for steps required for submission of a new protocol.
  3. 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. 
  4. Sample Protocol template:  CNS Protocol Template 1 27 14.doc
     
  • Continuing Review

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

  • Amendments

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

  • Study Closures

NICHD study closure template memo:  NICHD Study Closure memo template.docx

  • Consents

NICHD Consent template:  NICHD_Consent_Template_3-26-12[1].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.

If you plan to admit children <2 years old, please fill out this checklist and send to Dr. Deborah Merke, Building 10 CRC, Room 1-2740 (phone 496-0718; email: dmerke@mail.nih.gov).

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

IND/IDE Investigator Sponsor Protocols: IND Auditing and DSMC Policies 3-23-11.docx and Sample Regulatory Binder for IND Studies:  Regulatory Binder for IND Studies-3-8.docx

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.