Medidata Services

1. Industry-Specific Client Duties with Respect to the Services
2. Service Specific Terms

The following provides easy access to terms applicable to Medidata customers and partners (“Clients”) use of the Services, as set forth in applicable Sales Order(s). Should a conflict arise between the terms of the applicable Sales Order and the terms below, the Sales Order shall control.

1. Industry-Specific Client Duties with Respect to the Services. Client shall:

• be solely responsible, and assume all liability for, all operational aspects, decisions, results and outcomes of its clinical trial(s) and related businesses including, as applicable (i) the design, structure and content of all protocols; (ii) obtaining the legal basis for Processing Client Data, such as gaining consents or providing notices for study participants and Authorized Users required under Privacy Laws or good clinical practice (GCP); (iii) the collection, quality and accuracy of Client Data, including determination of the specific data collected; (iv) data protection agreements with any other controllers; (v) the manufacture, supply, and handling of investigational products; (vi) regulatory submissions; and (vii) ensuring that Client Data accessible via the Services is accessed only by appropriate Authorized Users. For purposes of this provision, a)‘Privacy Laws’ means all laws and regulations applicable to the Processing of Personal Data under the Agreement, including the General Data Protection Regulation (Regulation (EU) 2016/679) (the “GDPR”), all as amended from time to time, and b) “Processing’ means any operation or set of operations which is performed upon Personal Data, whether or not by automatic means, including the collection, recording, organization, storage, updating, modification, retrieval, consultation, use, transfer, dissemination by means of transmission, distribution or otherwise making available, merging, linking as well as blocking, erasure or destruction.
• obtain and provide Medidata with relevant information and materials, including protocols and amendments, data, third party licenses (including for specific medical dictionaries) or consents, and timely feedback, as reasonably required in order for Medidata to provide the Services.
• be responsible for having in place backup processes and mechanisms to perform critical functions to support the safety of study participants or uninterrupted clinical trial operations in the event of an unexpected outage.
• not export or re-export, directly or indirectly, any Service or related Documentation if such export or re-export requires an export license or other governmental approval pursuant to Export Control Regulations without first obtaining such license or approval. For purposes of this provision, ‘Export Control Regulations’ means all applicable export control laws and regulations, and sanctions programs worldwide, including the United States Export Administration Regulations (EAR) and the Office of Foreign Assets Control (OFAC) Specially Designated Nationals sanctions, and the European Union Council Regulation (EC) No 428/2009.

2. Service Specific Terms:

• Grants Manager
• Patient Cloud Services (ePRO/eCOA, eConsent, myMedidata, SensorCloud, Circuit Clinical (TrialJourney, DCT Site Network) Applications; Instruments; Devices)
• Site Payments
• Data Extraction Tool
• ODM Accelerator Sample Code

Medidata Services Terms Revision History: