IRO Review of Control Documents for Selected Physicians and/or Related Entities Clause Samples

This clause establishes the requirement for an Independent Review Organization (IRO) to examine control documents associated with certain physicians or related entities. In practice, the IRO will review records such as contracts, policies, or compliance documents to ensure they meet regulatory or contractual standards. The core function of this clause is to provide an objective assessment of compliance and internal controls, thereby helping to identify and address potential risks or deficiencies within the organization.
IRO Review of Control Documents for Selected Physicians and/or Related Entities. For each physician and/or Related Entity selected as part of the sample, the IRO shall review the Control Documents identified by the IRO as necessary and sufficient to validate each Payment reflected in the Listing to evaluate the following: a) Whether Control Documents are available relating to each Payment reflected in the Listing for the sampled physician and/or Related Entity; b) Whether the Control Documents were completed and archived in accordance with the requirements set forth in GSK’s policies; c) Whether the aggregate value of the Payment(s) as reflected in the Listing for the sampled Physician is consistent with the value of the Payments(s) reflected in the Control Documents; and d) Whether the Control Documents reflect that GSK’s policies were followed in connection with Payment(s) reflected in the Listing (e.g., all required written approvals for the activity were obtained in accordance with GSK’s policies).
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IRO Review of Control Documents for Selected Physicians and/or Related Entities. For each physician, Related-Entity, and/or Product Decision-Maker selected as part of the sample, the IRO shall review the Control Documents identified by the IRO as necessary and sufficient to validate each Payment reflected in the Listing to evaluate the following: a) Whether Control Documents are available relating to each Payment reflected in the Listing for the sampled physician, Related Entity and/or Product Decision-Maker; b) Whether the Control Documents were completed and archived in accordance with the requirements set forth in Biovail’s policies; c) Whether the aggregate value of the Payment(s) as reflected in the Listing for the sampled physician, Related Entity, and/or Product Decision-Maker is consistent with the value of the Payments(s) reflected in the Control Documents; and d) Whether the Control Documents reflect that Biovail’s policies were followed in connection with Payment(s) reflected in the Listing (e.g, all required written approvals for the activity were obtained in accordance with Biovail’s policies.)
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