Research Navigator PRMC Submission Instructions
1)
Log onto Research Navigator via Navigator Submissions
2)
Create a new study in My Studies if one has not already been created.
OR
If the study has already been created, use the “filter by” option to locate.
Using this option will require the “Edit Study” function in My Studies.
3)
Complete as much information as possible in the study record, especially section 6, PRMC information*.
*Even though all of the fields do not have asterisks [required entry], complete all applicable information to your study
(i.e. protocol version date, pilot study status, sponsor type, NCI program affiliation, author status, placebo/bio-specimen
research information, site projections, study priority, DSMC type, external monitor information, etc). This information
generates the PRMC application; missing responses will result in an incomplete application.
Disease Group Management (DMG) Approval
Please note regarding question 14.0 , that a Disease Group Management (DMG) approval is required FOR ALL STUDIES
to complete the PRMC application. The Principal Investigator or designee is responsible for completing the DMG
approval form, obtaining DMG leader signature, and uploading the document in My Studies. To obtain the DMG
approval form, you must print the PRMC application generated in Research Navigator located at the bottom-left of the
taskbar.
The last 2 pages consists of the DMG form and the list of Disease Management Group leaders that you should email in
reference to your study’s disease area. Please include this form and the protocol in the email to the DMG leader. Use
the “Edit Study” function when ready to upload the completed signed approval. If you are unsure which DMG leader to
contact, please email prmc.coordinator@nyumc.org.
Sample DMG Checklist form:
Sample PRMC application:
4)
Upload all relevant PRMC documents in Section 7 Uploads. This includes the protocol and any other study related
documents such as the pharmacy and lab manual, Disease Management Group (DMG) approval form, disease
group schema* (if applicable), etc.
*Disease Group Schema
Please be advised that for all Interventional studies that require PRMC full board review, a protocol schema is
required. The purpose of the schema is to provide justification for opening the protocol. It should be an
explanation of how it fits into the overall NYU research program for the specific disease site (therapeutic studies)
and how competing studies will be prioritized. You may contact the PRMC Coordinator at
prmc.coordinator@nyumc.org for examples.
5)
Once the protocol and all study-related documents have been uploaded*, click “Finish.” You will return to the
main study page in My Studies where you can now view the PRMC application located at the bottom-left of the
taskbar.
* Documents not ready for upload, i.e. DMG approval form, can be uploaded at a later time, but must be uploaded
before the Principal Investigator signs off on the PRMC application in Research Navigator.
6)
Once all documents have been uploaded (including the DMG approval form), you must click the “Submit” button
via the main study page in My Studies.
This will generate the “Sign PRMC Application” button located at the bottom-left of the taskbar*.
The Principal Investigator must sign off on the PRMC application via
Research Navigator. The PRMC application is not submitted until the
PRMC coordinator receives notification that the PRMC application was
signed. Please allow 48 hours for PRMC coordinator to confirm
application was received. If you are submitting on a deadline date,
please email the PRMC coordinator after the Principal Investigator signs
off.
What happens next…
For Non-Therapeutic/Non-Interventional studies such as:
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Cooperative groups Clinical Trials
 Database Extraction
NIH Grant- SPA
 Data Base Development
Chart Review
 Registry
Questionnaire / Survey
 Tissue Sample Acquisition
Image review
And other non-interventional studies that do not require patient consent
Non-Therapeutic/Non-Interventional studies will undergo PRMC Administrative review. This
is an expedited review mechanism and do not need to adhere to submission deadlines for full
board PRMC meetings. PRMC administrative reviews take about 10 business days to
complete.
For Therapeutic/ Interventional studies such as:
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Industry Sponsored Clinical Trials
Institutional /Investigator Initiated Clinical trials
Therapeutic/ Interventional studies will undergo PRMC Full Board review. As part of the PRMC
full board review process, primary and secondary protocol reviewers will be designated by the
PRMC Chairman to review the study protocol. In addition, a biostatistician will review the
protocol for biostatistical methodology. At the upcoming PRMC meeting, the PI or Co-PI will
present and describe the study overall. The reviewers will critique the protocol and make the
recommendation for approval, approval with stipulations, deferment, or disapproval. The
committee will further discuss the protocol and then they will vote on the motion. If the study
is approved, you will receive written notification of the PRMC approval within 24 hours via
email as well as updated in Research Navigator.
Throughout the review process, the PRMC coordinator will send any feedback from the
reviewers so that you will have the opportunity to reply in writing as well as to be prepared to
address them at the meeting.
As the meeting date approaches, reminder emails along with the meeting agenda will be
distributed. The meeting typically starts at 8 am and ends promptly by 9 am at the Laura And
Isaac Perlmutter Cancer Center located at 160 E 34th Street in room 1121.
After receiving PRMC approval, you may proceed with IRB submission. Please contact the IRB
at 212.263.4110 for any submission-related questions.