Common use of Review of Research Activities Clause in Contracts

Review of Research Activities. GSK shall provide the IRO with a list of all Research activities (as defined in Section III.B.3.u of the CIA) that were “active” (as classified in GSK’s tracking system) during the IRO Reporting Period, and the IRO shall select a sample of 40 such activities, which sample shall include a review of each type of Research (i.e., GSK-Sponsored post-marketing clinical trials, other GSK-Sponsored post- marketing studies, and post-marketing investigator-sponsored studies (ISSs).) The IRO shall review samples of each type of Research in proportion to the relative number of each type of Research that occurred during the reporting period. GSK shall provide the IRO with documents relating to the Research activities sufficient for the IRO to conduct the reviews outlined below. For each sampled Research activity, the IRO will review whether: (i) the activity was approved consistent with GSK’s standards, policies, procedures and processes regarding sponsorship or support of Research, including obtaining required approval for the Research by GSK’s medical and/or research organizations and ensuring that the Research was conducted for the purpose of fostering increased understanding of scientific, clinical or medical issues; (ii) there is an executed written agreement with the Researcher that meets the requirements of GSK’s standards, policies and procedures and, among other things, requires the Researcher to disclose in any publication of Research, GSK’s support and any financial interest the researcher may have in GSK; and (iii) GSK’s sales, marketing, or other commercial personnel did not participate in the design, conduct, or publication of the Research activity except as permitted under the limited exceptions in GSK’s policies and procedures.