Clinical Trial Documentation definition

Clinical Trial Documentation means all records, accounts, notes, reports, data, ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Clinical Trial that are not Clinical Trial Data, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as case report forms (“CRFs”) or electronic case report forms (“e-CRFs”), the Protocol, Investigator’s Brochure, and all other reports and records necessary for the evaluation and reconstruction of the Clinical Trial, but excludes source documents and records of Personal Information and medical records, which shall remain the confidential and proprietary property of Institution;

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Clinical Trial Documentation means all records, accounts, notes, reports, data, ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Clinical Trial that are not Clinical Trial Data, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as case report forms (“CRFs”) or electronic case report forms (“e-CRFs”), the Protocol, Investigator’s Brochure [NTD: Delete if not applicable], and all other reports and records necessary for the evaluation and reconstruction of the Clinical Trial, but excludes source documents and records of Personal Information and medical records, which shall remain the confidential and proprietary property of Institution;

Clinical Trial Documentation means all records, accounts, notes, reports, data, ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Clinical Trial that are not Clinical Trial Data, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as CRFs, the Protocol, the Investigator Brochure, and all other reports and records necessary for the evaluation and reconstruction of the Clinical Trial, but excluding source documents and records of patient personal health information which shall remain the confidential and proprietary property of the Institution;

Examples of Clinical Trial Documentation in a sentence

• Institution shall use reasonable efforts to give [choose Sponsor or CRO to match contracting party] notice before destroying the Clinical Trial Documentation and Clinical Trial Data.

• The Recipient grants BMS, Ono, their respective Affiliates and (sub)licensees a Right of Cross-Reference to the Recipient Regulatory Documentation and the Combined Therapy Clinical Trial Documentation for the Recipient Study Drug or the Combined Therapy for the sole purpose of enabling BMS, Ono and their Affiliates and sublicensees to exercise its rights under clause (1) of this Section 8.3(b), which right shall survive any expiration or termination of this Agreement.

• The Institution or the Investigator may prepare material for publication or presentation derived from the Clinical Trial Data and Clinical Trial Documentation.

• The Recipient grants BMS and its Affiliates and (sub)licensees a Right of Cross-Reference to the Recipient Regulatory Documentation and the Combined Therapy Clinical Trial Documentation for the Recipient Study Drug or the Combined Therapy for the sole purpose of enabling BMS and its Affiliates and sublicensees to exercise its rights under clause (1) of this Section 8.3(b), which right shall survive any expiration or termination of this Agreement.

• At Sponsor’s request and expense, the Institution or the Investigator shall retain the Clinical Trial Documentation and Clinical Trial Data after the expiry of the Retention Period.

• The Institution shall use reasonable efforts to give Sponsor notice before destroying the Clinical Trial Documentation and Clinical Trial Data.