Procedure for Organization of Protocol Files - IRB PRO115

Abstract:
This procedure lists the responsibilities of the OIRB for organization of protocol files, which allows for tracking of all IRB actions relating to a specific protocol.
Effective Date:
2/19/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO115
Effective Date:   3/30/07
Revision Date:  11/2/09, 2/19/10
Subject:  Procedure for Organization of Protocol Files

PROCEDURE

This procedure describes how protocol files are organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of a protocol.

OIRB Responsibilities

The OIRB staff enters paper documents into protocol records in reverse chronological order or electronically into protocol file folders by document name. This applies to submissions for convened and expedited review. File documents include the following materials:

  • Original and revised IRB Human Subjects Protocol applications and any applicable special approvals (includes applications for initial and continuing review) undergoing convened or expedited review;
  • Applications for exemption or non-human use designation;
  • Sponsor’s protocol, if any;
  • DHHS-approved sample informed consent document, if applicable;
  • Investigator’s Brochure or package inserts, if applicable;
  • Informed consent documents submitted by the investigator and final IRB-approved informed consent document(s);
  • Serious adverse events or unanticipated problems including risks to subjects or others;
  • Proposed amendments/revisions which may include significant new findings and revised informed consent document(s);
  • Recruitment materials, if applicable;
  • Monitoring reports, if any;
  • Investigator's Progress Reports for continuing review;
  • All correspondence generated between the IRB or OIRB staff and the investigator or research staff (including the contact personnel);
  • All correspondence from sponsoring agencies;
  • Copies of IRB-issued approvals.


Approved on March 1, 2010, by:

Sheila Deters Moore, CIP
OIRB Director