IRBManager

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What is IRBManager?
IRBManager is the product selected to be used for the entire lifecycle of human subjects research, from the development and submission of protocol applications by researchers to the review of the applications by the NJH HRPP/IRB through approval, amendment, renewal, and eventual closure.

IRBManager, despite its name, allows for the full suite of compliance processes to be handled in one system.  After the rollout for NJH IRB is complete, implementation for the NJH IBC and NJH IACUC processes will begin.

When did the use of IRBManager start?
All NJH IRB Submissions after 01 September 2019 MUST be submitted through the IRBManager system. Please contact NJH HRPP/IRB office for more information on access and training.

I have questions that are not answered here. Whom shall I contact?

Questions about using the IRBManager System or about the IRB Protocol approval process should be directed to the NJH HRPP/IRB staff.

 

Manuals:
Intro Log In Dashboard - July 2019
How To - New Protocol Submission - July 2019
How To - Revise Submission - July 2019
How To - Request for Change or Renewal - July 2019
IRBManager Tips for Use - August 2019
IRB Manager FAQs - October 2019

 

Initial Submissions (Post January 21, 2019)

Archived forms available upon request.

Initial, Expedited and FullBoard Checklist
Initial Exemption Submission Checklist
Radiology Study Protocol Form

 

Consent Documents

Consent Authorization Template Common Rule
Assent Template
ICF Standard Statements

 

Continuing Review for studies approved before January 20, 2019

Archived forms available upon request.

 

Completion for both studies approved before January 20, 2019 and after January 21, 2019

Archived forms available upon request.

 

Amendments & Modifications for both studies approved before January 20, 2019 and after January 21, 2019

Archived forms available upon request.

Conflict of Interest Form

Supplement Form H Request for Waiver or Alteration of HIPAA final

Guidance for Modification Request Form

Download Boilerplate Supplemental Access to NJH Repositories (updated 20 Nov 2018)

Download Boilerplate HIP 020 Partial Waiver of HIPPA Authorization (updated 20 March 2019)

HIP 020 Partial waiver of HIPPA Authorization (updated 25 April 2019)

Supplemental Access to NJH Repositories (updated 25 April 2019)