1.16 ORA Record Keeping Requirements

Last Revised: 01/17/2024

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for maintenance of documentation of IRB and ORA activities. Retention of records by the investigator is described in HRPP policy 1.17 (Retention of Research Records).


2.0 Policy

It is the policy of the Organization that the ORA will maintain documentation of all IRB activities in accordance with 45 CFR 46.115 and 21 CFR 56.115 as applicable. Records for each protocol will be organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of the protocol.


3.0 Procedures


4.0. Availability of IRB and ORA records

All IRB records are accessible for inspection and copying at reasonable times and in a reasonable manner in accordance with 45 CFR 46.115 and 21 CFR 56.115.


DOCUMENT HISTORY:

 Written: 4/7/2016 (Approved: 4/7/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised: 10/11/2022 - typo corrected in 3.2.27.2/3.2.27.3 - rational to rationale {by Robert Lewis, IRB Assoc}

 Revised: 7/22/2022 - Extensive revisions; removed list of items to be retained, and substituted appropriate regulatory language; specified location of retained records; clarified duration of retention of paper records (per HRPP 1.17).

 Revised: 01/17/2024 – Modified 3.1.1 to specify that records of protocol modifications will be retained along with other documents.


Revision #15
Created 21 October 2019 21:49:14 by Autumn M Eberly
Updated 17 April 2025 15:30:12 by Robert A Lewis