Results to Be Included Sample Clauses

Results to Be Included. The following results shall be included in each Promotional and Product Services Transactions Review Report: a. a description of each type of sample unit reviewed, including the number of each type of sample reviewed (i, e., the number of Inquiries) and an identification of the types of documents and information reviewed for the Inquiries; b. for each Inquiry sample unit, the IRO shall summarize the information contained in the Medical Affairs Inquiry Database about the Inquiry; c. for each Inquiry sample unit, the IRO shall state its findings and supporting rationale, as to whether: (i) each item of information listed in Section III.A.1.a is reflected in the Medical Affairs Inquiries Database for each reviewed Inquiry; and (ii) for each Inquiry for which the Compliance Officer conducted an Off-Label Review, the basis for suspecting that improper off-label promotion may have occurred; the steps undertaken as part of the Off-Label Review; the findings of the Compliance Officer as a result of the Off-Label Review; and any follow-up actions taken by InterMune as a result of the Compliance Officer’s findings; d. the findings and supporting rationale regarding any weaknesses in InterMune’s systems, processes, policies, and practices relating to the Inquiries, if any; and e. recommendations for improvement in InterMune’s systems, processes, policies, and practices relating to the Inquiries, if any.

Results to Be Included i. the lRO shall state its findings and supporting rationale as to whether: (I) all required documentation exist; (2) each document was complete and maintained in accordance with all requirements set forth in the applicable Xxx Xxxxx policy; (3) each document reflects that Xxx Xxxxx'x policies were fol lowed in connection with the underlying activity reflected in the document (e.g., all required approvals were obtained); and (4) any disciplinary action was taken in those instances in which an Xxx Xxxxx policy was not followed; ii. for each document reviewed; the IRO shall identifY all exceptions discovered. For the exceptions, the IRO shall describe in general terms what the errors were. The lRO shall describe those situations where corrective action was taken prior to the lRO review, including a description ofthe circumstances requiring corrective action and the nature ofthe corrective action;