Common use of IRO Review of Inquiries Reflected in Inquiries Database Clause in Contracts

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK conducted an Off-Label Review, and the other ten shall be Inquiries for which GSK did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine:

Appears in 4 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement

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IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of at least 10 percent but not more than 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty Eighty percent of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Par conducted an Off-Label Review, and the other ten remainder of the random sample shall be Inquiries for which GSK Par did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine:

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 20 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty Ten of the Inquiries reviewed by the IRO shall be Appendix B AtriCure, Inc. Inquiries for which GSK AtriCure conducted an Off-Label Review, and the other ten 10 shall be Inquiries for which GSK AtriCure did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine:

Appears in 1 contract

Samples: Corporate Integrity Agreement (AtriCure, Inc.)

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Amgen conducted an Off-Label Review, and the other ten shall be Inquiries for which GSK Amgen did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine:

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Allergan conducted an Off-Label Review, and the other ten 10 shall be Inquiries for which GSK Allergan did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine:

Appears in 1 contract

Samples: Corporate Integrity Agreement (Allergan Inc)

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IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of at least 10 percent but not more than 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty Seventy percent of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Baxano Surgical conducted an a review related to off-label promotion (β€œOff-Label label Review”), and the other ten remainder of the random sample shall be Inquiries for which GSK did not conduct an Off-Label Reviewthe review related to coding and reimbursement and other issues. For each Inquiry reviewed, the IRO shall determine:

Appears in 1 contract

Samples: Corporate Integrity Agreement (Baxano Surgical, Inc.)

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Endo conducted an Off-Label Improper Promotion Review, and the other ten 10 shall be Inquiries for which GSK Endo did not conduct an Off-Label Improper Promotion Review. For each Inquiry reviewed, the IRO shall determine:

Appears in 1 contract

Samples: Corporate Integrity Agreement

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