ELEMENT I.8.C.

ELEMENT I.8.C.: When the sponsor has the responsibility to conduct data and safety monitoring, the organization has a written agreement with the sponsor that addresses provisions for monitoring the data to ensure the safety of participants and for providing data and safety monitoring reports to the organization.

IRB or ECs have the responsibility to ensure that provisions for data and safety monitoring are adequate and that results from data and safety monitoring justify the continuation of IRB or EC approval of the research study.

When the organization works directly with the sponsor, or its agent, and the sponsor, or its agents, has the responsibility for data and safety monitoring, the contract or funding agreement should include arrangements so that data and safety monitoring plans are provided to the organization, or provided to the researcher who provides them to the IRB or EC. Contracts and funding agreements should stipulate that reports from data and safety monitoring are provided to the researcher who provides them to the IRB or EC.

If an independent IRB does not work directly with the sponsor, it should have a mechanism to ensure it receives the data and safety monitoring plan in order to review the research study and results of the data and safety monitoring to ensure that continuation of IRB or EC approval of the research study is justified.

Regulatory and guidance references

VA: VHA Directive 1209
AAHRPP Tip Sheet: Provisions in Contracts and Funding Agreements

Required written materials

Essential requirements:
1. Policies and procedures have contracts or other funding agreements require the sponsor to send data and safety monitoring reports to the organization.
  1. Contracts or other funding agreements specify the time frame for providing routine and urgent data and safety monitoring reports to the organization.
2. For independent IRBs:
  1. If the organization contracts with sponsors or clinical research organizations, contracts or other funding agreements state that sponsors are required to send routine and urgent data and safety monitoring reports to the IRB.
  2. Policies and procedures include the process used to ensure that contracts obligate the sponsor to send routine and urgent data and safety monitoring reports to the researcher or organization conducting the research, such as an attestation or other written statement from the researcher or clinical research organization, for example a master service agreement or work order.
    1. Policies and procedures require researchers or the organization conducting the research to forward this information to the IRB.
3. When following VA requirements:
  1. For VA facilities:
    1. The appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:
      1. The industry Sponsor holds the FDA investigational device exemption (IDE).
      2. The industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.
      3. The VA PI has substantially designed the protocol for clinical studies.

Outcomes

Contracts or other funding agreements require the sponsor to provide reports of data and safety monitoring to the organization.
The independent IRB or EC has a mechanism to ensure it receives data and safety monitoring plans prior to IRB or EC approval of the research.
The independent IRB or EC has a mechanism to ensure it receives routine and urgent reports of data and safety monitoring.

Proceed To: ELEMENT I.8.D.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.8.C.