Trial Protocol definition

Trial Protocol means a protocol for the conduct of a Clinical Trial.

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Trial Protocol means a protocol for the conduct of a Clinical Trial as may be developed by MEPL from time to time.

Trial Protocol as defined in Preamble clause “a”, and appended hereto as Appendix “A” to this Agreement, as may be modified or updated from time to time subject to the consent of the Fund and the Company in writing and in advance.

Examples of Trial Protocol in a sentence

• For the avoidance of doubt, it is hereby clarified that the Monitors shall be entitled to monitor and/or inspect among others the Trial Documents and Trial Data as well as to insure compliance with the Trial Protocol.

• Serious Adverse As defined in the Trial Protocol and in the Guidelines.

• Treatment Visit Any Visit, as defined below, of visits 1-6, 8-10, 12-14, and 16-18 as these visits are numbered and defined in the Trial Protocol.

• Investigator Brochure A document, which is submitted along with the Trial Protocol to the relevant Helsinki Committee and FDA, and the content of which is outlined in the GCP Guidelines.

• The Trial Protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.

• The Trial Protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of the Trial.

• The Subjects A group of persons chosen by the Principal Investigator to participate in the Trial and who signed a written informed consent for the participation in the Trial, all according to the criteria established in the Trial Protocol.

• Notices will include reference to the Trial Protocol number and be forwarded to the following: Oznámení.

• Participating Subject A Subject who that has undergone Screening, as defined below, and was determined to meet the requirements specified in the Trial protocol and who is participating in the Trial according to the terms and conditions of the Trial Protocol Screening A series of tests and examinations as defined in table 4 of the Trial Protocol designed to evaluate a Subject’s suitability for participating in the Trial, as detailed in the Trial Protocol.

• Throughout this Agreement the term Trial Protocol refers to the protocol and its amendments, which are attached to this Agreement as Appendix A.

More Definitions of Trial Protocol

Trial Protocol. As defined in Preamble clause "a", and appended hereto as Appendix "A" to this Agreement.

Trial Protocol means the protocol for a Clinical Research Trial describing Eligible Patient, Screening and Enrollment criterion and processes, specifying the data or information that must be collected from Eligible Patients.

Trial Protocol as defined in Preamble clause "a", and appended hereto as Appendix A to this Agreement. "Trial Plan" the plan that has been and/or will be approved by the Ministry of Health, containing a Schedule for conducting the Trial and the Budget for the Trial derived from the activity necessary for performing the Trial, and which is attached to this Agreement as Appendix A. the "IRB" the Internal Review Board appointed pursuant to the National Health Regulations, the role of which is to approve any medical experiment on human subjects that will be conducted by the Fund. conducting the Trial, including the Principal Investigator. criteria established in the Trial Protocol. "GCP" Ethical and scientific quality standards for designing, conducting, recording, and reporting trials which involve the participation of human subjects, as customized by the Fund. 1980.