Audit by Biogen and Records. The Institution shall permit Biogen and its agents during normal business hours and at mutually agreeable times, to inspect, audit, duplicate and/or make abstracts of records and reports collected and generated by the Institution and the Investigator in the course of conducting the Trial, as well any other documentation, data and information relating to the Trial, and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and the Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The Institution shall make the Investigator and other personnel following the instructions of the Investigator available to Biogen and its agents in order to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Biogen or its agents, the Institution and the Investigator shall immediately correct any errors or omissions in such records and reports. The Institution shall preserve all records relating to the Trial and the Subjects participating therein as required by the Protocol, the Applicable Laws and Regulations and Section 6(e) below, and shall, in writing, offer such records to Biogen before destroying or disposing thereof.
Appears in 3 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Audit by Biogen and Records. The Institution shall permit Biogen and its agents during normal business hours and at mutually agreeable times, to inspect, audit, duplicate and/or make abstracts of records and reports collected and generated by the Institution and the Investigator in the course of conducting the Trial, as well any other documentation, data and information relating to the Trial, and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and the Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The Institution shall make the Investigator and other personnel following the instructions of the Investigator available to Biogen and its agents in order to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Biogen or its agents, the Institution and the Investigator shall immediately correct any errors or omissions in such records and reports. The Institution shall preserve all records relating to the Trial and the Subjects participating therein as required by the Protocol, the Applicable Laws and Regulations and Section 6(e) below, and shall, in writing, offer such records to Biogen before destroying or disposing thereof.required
Appears in 1 contract
Samples: Clinical Trial Agreement