I'm looking for information about

Can't find what you're looking for? You may need to login to see more documents.

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Multi-Site and Performance Site applications: Reporting to IRBMED

IRBMED

| Approval Date:

July 23, 2021 2:00 pm

This document provides the reporting requirements to IRBMED for both Multi-Site HUM application and Performance Site HUM application when U-M

  • is a coordinating center
  • is not the single IRB (sIRB)/IRB of record/reviewing IRB for sites other than U-M.

When U-M IRBMED is the sIRB/IRB of record/reviewing IRB, follow the sIRB Research reporting plan available in the IRBMED Multi-site Research Documents folders.

Reporting Table

PDF version of Reporting Table
Report Type Within Multi-Site Application HUM Reporting

(Events at non-UM Participating Sites, and reports addressing the whole study – U-M and other sites)

 Within Performance Site HUM Application Reporting

(Events at U-M Site)
SAEs N/A (unless UaP – see below) Report per Adverse Event Reporting or approved Study-Specific Reporting Plan.
UaPs, including both AEs and ORIOs Report UaPs per Statement of Practice: External Adverse Event Reports Unanticipated Problems.

Identify in the submission title whether the UaP is or will be accompanying an Amendment updating study documents (ICD, protocol, IB, etc.)

 Report potential UaPs per Unanticipated Problems Involving Risks to Subjects or Others.
Deviations, including time-sensitive modifications Report within 7 days of becoming aware of the event or information:

  • Protocol deviations that may represent a systematic problem requiring local evaluation by IRBMED to determine that sufficient local resources are available for safe conduct of the study
  • Major protocol deviations that may impact the safety of subjects (including breaches of confidentiality) and/or put the institution at risk
  • Deviations from eligibility criteria for one or two subjects. (Not available for investigator-initiated studies managed through O-CTSU.)
 Report per Other Reportable Information or Occurrence (ORIO) Guidance

If seeking IRB approval beforehand: See guidance Time-Sensitive Modifications
Data and Safety Monitoring (DSMB, DSMC, DMC) Correspondence (Reports, Letters)
  • Submit determination / outcome reports received individually during the year per Other Reportable Information or Occurrence (ORIO) Guidance.
  • Annual summary report (e.g. CERVANT report for oncology) must be submitted as part of SCR (upload into 4.1).
    • On the summary, identify any reports previously submitted individually by writing the Adv# next to the item(s).
  • If determination / outcome requires a response from UM (i.e., UM site action item), report as an ORIO per IRB reporting guidance.
    • When a single report addresses U-M and external events, Performance Site ORIO should respond only to the U-M event(s).
Annual Report to the FDA If the IND/IDE holder is from UM, upload into the SCR submission

N/A if the IND/IDE holder is not from UM

 N/A
Other Correspondence to the FDA (i.e. amendment) Upload into eResearch in an amendment N/A
Other ORIOs Anything else that affects the entire study, e.g.:

  • Safety information that could affect risk to participants, or otherwise require changes to study materials
  • Termination of study with all remaining patients in FU taken off study;
  • Closure to accrual;
  • Response to Protocol Review Committee (PRC) due to low accrual for the entire study
 Report per Other Reportable Information or Occurrence (ORIO) Guidance

In many cases, a report from the Coordinating Center to Performance Sites can be submitted by Performance Site as part of SCR.

UNIT: Institutional Review Boards (IRBMED)

TOPICS: Adverse Events & Other Reportable Information and Occurrences / eResearch Regulatory Management (eRRM) / Investigator & Study Team Responsibilities

TAGS: CTSO Work Guide / Study Coordinator

Questions?

Contact us at [email protected] or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available at our webpage.

Edited By: [email protected]
Last Updated: December 9, 11:30 AM