Section revised: 3/13/13

In studies where Sponsors conduct research site monitoring visits or conduct monitoring activities remotely, STANFORD has a written agreement with the Sponsor that the Sponsor promptly reports to STANFORD findings that could affect the safety of participants or influence the conduct of the study. (AAHRPP Element I.8.B)

Stanford University and Palo Alto Institute for Research and Education (PAIRE) have included in their standard sponsored research contract templates*, provisions that the sponsor will notify the Protocol Director or the IRB of:

i. Non-compliance with the protocol or applicable laws, particularly those laws related to participants, that could impact the safety or welfare of the participants

ii. Serious adverse events that have been reported to the FDA or other governmental agency in relation to the protocol at STANFORD or any other site

iii. Unanticipated problems in the protocol at STANFORD or any other site that could relate to risks to participating participants, and

iv. Circumstances that could affect participants’ willingness to continue to participate in the protocol or the IRB’s continuing approval of the protocol.

When non-standard contract templates are used, the sponsor is asked to include equivalent statements.

*See Stanford University Clinical Trials/Study Agreement template (Human Research Protection Program section), Stanford University Sponsored Research Agreement template (Appendix 2, Section 17), and VA Cooperative Research And Development Agreement (CRADA) templates (section 3.4 Human Subjects Protection).

Data and Safety Monitoring (DSM) in sponsor agreements

When the Sponsor has the responsibility to conduct data and safety monitoring, STANFORD 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 STANFORD. (AAHRPP Element I.8.C)

For sponsored research, Stanford agreements specify that, as appropriate:

· Provisions are made for monitoring study data which could affect participants’ safety;

· The results of this monitoring are reported to the researcher (PD) so that:

- Routine monitoring reports will be submitted as part of Continuing Review applications to the IRB, and

- Urgent reports (those meeting the criteria in guidance GUI-P13 Events and Information which Require Prompt Reporting to the IRB) are submitted according to the guidelines specified in this same guidance.

See Stanford University Clinical Trials/Study Agreement template (Human Research Protection Program section), Stanford University Sponsored Research Agreement template (Appendix 2, Section 17), and VA Cooperative Research And Development Agreement (CRADA) template (section 3.4 Human Subjects Protection).