clinical trial protocol definition
clinical trial protocol means a document containing the background, objective, rationale, design, methodology including matters concerning performance, management, conduct, analysis, adverse event, withdrawal, statistical consideration and record keeping pertaining to clinical trial;
clinical trial protocol means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial and includes any successive versions of the protocol and protocol amendments;
clinical trial protocol means the protocol governing the UHN Planned Trial. The Clinical Trial Protocol may be amended from time to time by agreement of the Parties subject to funding being available to support the costs of changes as required by the amendment.
More Definitions of clinical trial protocol
clinical trial protocol means a written summary description of one or more Clinical Trial(s), which generally includes information on the objectives, design, methodology, statistical considerations and organization of the Clinical Trial (and including amendments to such description).
clinical trial protocol means a written description of one or more Clinical Trial(s), which generally includes information on the objectives, design, methodology, statistical considerations and organization of the Clinical Trial (and including amendments to such description). Janssen or its Affiliates may amend the Clinical Trial Protocol from time to time in its sole discretion and promptly inform BTO of any amendments that would materially affect the Development of the BTO CDx.
clinical trial protocol means protocol(s) of the Clinical Trial being conducted under the Final Plan. The Clinical Trial Protocol shall include the Phase III Protocol.
clinical trial protocol means the Clinical Trial action plan used by each research center in the Clinical Trial and describing the objectives, design, methodology, statistical considerations and organization of the Clinical Trial, including (1) how many people are in the trial, (2) who is eligible to participate in the trial, (3) what drugs participants will take, (4) what medical tests they will have and how often, and (5) what information will be gathered during the trial.
clinical trial protocol means a document explaining the background, rationale and the objectives of the clinical trial and describes its design, methodology and the organization which is involved in such clinical trial and shall include the statistical considerations, the conditions under which the clinical trial is to be carried out and managed. The clinical trial protocol shall be dated and signed by the investigator, the institution involved in such clinical trial and the sponsor;