OHRS News - Thursday 12-07-17

December 07, 2017

Policy Revision:  IND and IDE Safety Reports

The DF/HCC policy for receipt and review of IND/IDE Safety Reports by the DF/HCC Overall Principal Investigator has been revised.  For externally sponsored Phase II, II/III, III and IV studies it is the responsibility of the sponsor to actively notify DF/HCC Investigators of events that meet the definition of an unanticipated problem and/or safety information that has implications for the conduct of the research or the informed consent document.  Sponsors are also expected to bring this information to the attention of DF/HCC investigators. 

Please note the DFCI IRB Reporting policy has not changed.   

The following OHRS Information Sheet has been revised with the updated DF/HCC policy:

Forms Revisions:  OnCore Management Groups

Several OHRS forms have been revised to allow for study staff to indicate the appropriate management groups to be added to OnCore.  Management groups listed in OnCore enables study staff under that management group to have access to that study.  Please see below for a list of the affected forms and the location of this change in each form.

    • New Protocol Application for Clinical Trials - Part A #7a-d
    • New Protocol Application for Non-Clinical Trials - Part Aa-d
    • Request to Add/Remove Site Amendment Form - Part B  

Institutional Engagement

OHRS has created a new guidance document regarding Institutional engagement to accompany HRP-311.

Requesting OnCore Access (per CTRIO)

As a reminder, please refer to the process outlined in the DFHCC New Researcher Checklist when requesting an OnCore staff profile or OnCore system access.