Common use of RECORDKEEPING; REPORTING; ACCESS Clause in Contracts

RECORDKEEPING; REPORTING; ACCESS. Authorized representatives of Sponsor and/or PRA have the right during the performance of the Study and after the termination of the Study, upon reasonable advance notice, and during regular business hours, to: (i) audit and examine the Site’s facilities required for performance of the Study; (ii) review all data, records and work products (including portions of other Patient records for all patients in the Study) relating to the Study, and if necessary, make copies of such data, records and work products, provided such copies do not include any unauthorized individually-identifiable information of a Study Patient; (iii) provide information and instruction on the execution of the Study; and (iv) assess and/or confirm that the Study is being conducted by the Site in accordance to the standards agreed upon herein. The Site shall maintain complete and accurate records related to the Study, and shall retain all such records resulting from the Study in accordance with ICH GCP for the time required by applicable laws and regulations. The Sponsor will retain the rights described in this section (a) after the termination of the Study at the Institution.

RECORDKEEPING; REPORTING; ACCESS. (a) Authorized representatives of Sponsor and/or PRA have the right during the performance of the Study and after the termination of the Study, upon reasonable advance notice, and during regular business hours, to: (i) audit and examine the Site’s facilities required for performance of the Study; (ii) review all data, records and work products (including portions of other Patient records for all patients in the Study) relating to the Study, and if necessary, make copies of such data, records and work products, provided such copies do not include any unauthorized individually-identifiable information of a Study Patient; (iii) provide information and instruction on the execution of the Study; and (iv) assess and/or confirm that the Study is being conducted by the Site in accordance to the standards agreed upon herein. The Site shall maintain complete and accurate records related to the Study, and shall retain all such records resulting from the Study in accordance with ICH GCP for the time required by applicable laws and regulations. The Sponsor will retain the rights described in this section (a) after the termination of the Study at the Institution.