Examples of Study Documentation in a sentence
The Study Documentation and any information disclosed to the Healthcare Service Provider by Vertex or by Vertex’s representatives (including a designated CRO as defined below) is considered as confidential information owned by Vertex (“Confidential Information”).
The Healthcare Service Provider will fully disclose to Vertex all work, reports, writings, designs, methods, computer software and data recorded in any form, including but not limited to the Study Documentation, that are created, developed, written, conceived or made by the Healthcare Service Provider, Study Staff or any other person involved in the Study as a result of or in connection with the Study or the performance of their obligations under this Agreement (collectively, “Study Work”).
For each Study, the Institution and the Principal Investigator shall prepare, maintain and retain complete, current, accurate, organized and legible Study Documentation (as defined below) in a manner acceptable for the collection of data for submission to, or review by, the FDA and other regulatory or governmental authorities as applicable, and in full compliance with the applicable Protocol and all Applicable Laws.
Study Documentation shall not include Subjects' medical records and other original source documents.
The Institution shall turn over all Study Documentation and materials in its possession associated with the Study, including all Work Product, Inventions and Materials, as expeditiously as possible, shall handle the Study Device in accordance with Section 9 and the instructions of SPONSOR and shall provide such other assistance as is necessary to ensure a smooth and orderly transition of the Study that will not involve any disruption of the Protocol.