ELEMENT I.8.B.

In studies where sponsors conduct research site monitoring visits or conduct monitoring activities remotely, the organization has a written agreement with the sponsor that the sponsor promptly reports to the organization findings that could affect the safety of participants or influence the conduct of the study.

This Element does not apply when the sponsor is not responsible for monitoring the research. Monitoring of the research refers to overseeing the progress of a research study. An organization that works directly with a sponsor should require the sponsor or its agents to report to the organization findings of serious or continuing non-compliance detected during the monitoring process that could affect the safety of participants or influence the conduct of the study.

If an independent IRB or EC or an organization does not work directly with the sponsor, the independent IRB or EC or organization should have a mechanism to ensure it receives copies of the monitoring reports that contain

findings that could affect the safety of participants or influence the conduct of the study. An organization in this case should make the findings available to the IRB or EC.

Regulatory and guidance references

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

Required written materials

Essential requirements:
1. Policy and procedures have contracts or other funding agreements require the sponsor to promptly, or in a timely manner, appropriate to the level of risk involved, report to the organization any findings that could:
  1. Affect the safety of participants.
  2. Influence the conduct of the study.
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 promptly report to the IRB findings that could affect the safety of participants or influence the conduct of the study.
  2. Policies and procedures include the process used to ensure that contracts with the researcher obligate the sponsor to promptly report any findings of study monitors that could affect the safety of participants or influence the conduct of the study 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.
  3. Policies and procedures require researchers or the organization conducting the research to promptly 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.

Common types of materials that may be used to meet the element

Contract template
Reviewer checklist for contract language

Outcomes

Contracts and other funding agreements require the sponsor to promptly report to the organization any findings that could:
- Affect the safety of participants.
- Influence the conduct of the study.
An independent IRB or EC or an organization that does not work directly with the sponsor has a mechanism to receive findings that could affect the safety of participants or influence the conduct of the study. An organization in this case makes the findings available to the IRB or EC.

Proceed To: ELEMENT I.8.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.8.B.