PI Responsibilities post-CRRI approval

SBU's ORC retains on-site monitoring responsibility for all studies, reviewed locally or by CRRI.

  • Reports of Unanticipated Problems (see Note #2 below) and sponsor monitor visit reports should be submitted as soon as possible to both ORC and CRRI.

ORC and CRRI will work collaboratively if either party uncovers protocol deviation/potential noncompliance.

Note #1: As referenced above, redacted consent documents, and inclusion/exclusion criteria checklists will be audited at time of continuing review.

Note #2: Report Unanticipated Problems to Both, SBU Office of Research Compliance and CRRI Investigators approved through CRRI's IRB must still report Unanticipated Problems to the SBU Office of Research Compliance, in addition to CRRI reporting requirements

The policy is available here

The form is available in the IRBNet project designer of your study.

Continuing Review Submissions

When the PI submits continuing review materials to CRRI, the following must also be submitted to SBU via IRBNet:

  • A redacted (subject name/initials/ID# blacked out) copy of the consent form of the latest subject enrolled in the study. If it is a study involving children, upload the parent permission and the minor assent forms, as applicable.
  • A redacted, completed checklist for the latest subject enrolled during the prior approval period. Random audits of the I/E backup (‘source’) documentation will be conducted by ORC to assess compliance with subject eligibility.
  • A completed up-to-date registration form, so that current training and signature of all study personnel can be confirmed by ORC.
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