Study Documentation means all records, accounts, notes, reports and data, collected, generated or used in connection with the Study, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as case report forms and all other reports and records necessary for the evaluation and reconstruction of the Study.
Examples of Study Documentation in a sentence
Upon UCBs written request, Dermira shall provide, or cause to be provided, to the relevant UCB Contact a copy of all Study Documentation and such other Information necessary or useful for UCBs preparation of Regulatory Documentation, and any supplemental application or variation generated by or on behalf of Dermira during the Development Term or during the duration of any Post-Approval Study in relation to the Development of the Product in the Development Indication in the Development Territory.
Article II Definitions 1.2 Confidential Information means all information provided by Sponsor or relating to Pegylated Apo- Filgrastim or the Study or arising out of the conduct of the Study, including Study Documentation and without limitations, any structures, models, compositions, compounds, formulations, know-how, techniques, data and processes whether or not patentable, in oral, writing, electronic, visual or any other form.
Healthcare Facility hereby irrevocably assigns, and Healthcare Facility shall cause PI and any applicable Study Staff Member to irrevocably assign, to Sponsor all of their respective Rights worldwide in and to such Study Documentation.
Regulatory Binders and Study Documentation Good Clinical Practice (GCP) guidelines require that all clinical trial information is recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified throughout the life of the trial, and after the study has been closed out (See ICH GCP E6 Section 8).
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, and in full compliance with the Protocol and all Applicable Laws.