Common use of Data and Safety Reporting Clause in Contracts

Data and Safety Reporting. 2.3.1 Institution/Principal Investigator shall submit written reports, in accordance with all laws, regulations and guidelines including the Ethics Committee standards, to Sponsor and the EC regarding the Study being conducted at the Institution on request. 2.3.2 In case Electronic Data Capture ("EDC") is used for the Study: Institution/Principal Investigator will submit Study data using the electronic system provided by the Sponsor. Institution/Principal Investigator shall also comply with Sponsor’s instructions for data entry into the system, which includes that investigational staff using the system understands that their electronic signatures are the legally binding equivalent of handwritten signatures, and they attest to the accuracy and completeness of the data entered.