Rights of the Sponsor. The representatives of the SPONSOR shall have the right to gain access to the Study site and the patient records and other documents related to the Study in order to ensure correctness of the Study records and the proper conduct of the Study. The informed consent of the participants is required for the use of documents containing their personal data. The investigators shall co-operate with the SPONSOR relating to the aforementioned monitoring visits and audits. No separate compensation shall be paid to the investigators for the potential additional work due to monitoring and audits.
Appears in 4 contracts
Samples: Clinical Study Agreement, Clinical Study Agreement, Clinical Study Agreement