Common use of Completion of Source Documents and Case Report Forms Clause in Contracts

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the Study Sponsor and are independent of study site staff.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the Study Sponsor study sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study.