Clinical Protocol definition

Clinical Protocol means protocol no. [***], as well as amendments that relate to the Gap Period and the Follow Up Period (each as defined below), together with all other amendments thereto, approved by the relevant French regulatory authorities.
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Clinical Protocol means the document that specifies the testing procedures and conditions for clinical studies in accordance with applicable regulatory requirements in the form of Attachment A to the applicable Project Agreement.
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Clinical Protocol means a protocol for the conduct of Research agreed in writing between the parties
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Examples of Clinical Protocol in a sentence

  • Clinical Protocol and Quality Assurance Decision Support Software Article C.3 Reporting RequirementsThe contractor is responsible for the following reporting under the GWAC.

  • Clinical Protocol and Quality Assurance Decision Support Software Article C.3 Reporting Requirements The contractor is responsible for the following reporting under the GWAC.

  • Clinical Protocol and Quality Assurance Decision Support Software Article C.3 Reporting RequirementsAll reports required herein shall be submitted in electronic format through the Electronic Government Ordering System (e-GOS) (see Article G.5.9 for further information).

  • Clinical Protocol and Quality Assurance Decision Support Software Article C.3 Reporting RequirementsThe contractor is responsible for the following reporting on task order activity under the GWAC.

  • Heart Follow‐Up Study Clinical Protocol – Final, March 22, 2010 pg.

  • Clinical Protocol and Quality Assurance Decision Support Software Article C.3 Reporting Requirements‌The contractor is responsible for the following reporting under the GWAC.

  • The following information must be included as attachments to this form: Attachment 1: Clinical Protocol: Single PDF file named “Protocol.pdf.” The Clinical Protocol is the main body of the proposal.

  • Article 3(e) of Act XLVII of 1997, however provides for the term ‘health documentation’, which is similar to patient summary.

  • Clinical Protocol and Quality Assurance Decision Support Software ARTICLE C.3. REPORTING REQUIREMENTS The contractor is responsible for the following reporting on task order activity under the GWAC.

  • Using the CIRM CLINICAL PROTOCOL SYNOPSIS template, provide a Clinical Protocol Synopsis for each clinical study proposed (up to 8 pages).


More Definitions of Clinical Protocol

Clinical Protocol means a document outlining human subjects studies requiring IRB approval. Clinical protocols may include clinical trials1, non-interventional observational (natural history) studies, screening protocols, repository protocols and teaching and training protocols. The scientific review process includes the initial protocol review, annual and quadrennial review of the ongoing protocol, and review of substantive amendments to the protocol that pose new scientific questions or substantially alter the scientific approach. In addition, the scientific review process includes prioritization of clinical protocols utilizing scarce resources at the NIH Clinical Center (CC) to assure the best science is being supported. These reviews become part of the official protocol record and are made available to the IRB and NIH leadership.
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Clinical Protocol means the content and timing of interactions with Clinical Users and Registered Patients via the Platform, including information, instructions, assessments and messages sent to Clinical Users and Registered Patients, and (where applicable) monitored by Clinical Team Members relating to a patient’s preparation for and recovery from their treatment;
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Clinical Protocol means the document outlining human subjects research that involves engagement with the subject and for this purpose requires IRB approval. Clinical protocols may include clinical trials1, non-interventional natural history studies, screening protocols, and teaching and training protocols.
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Clinical Protocol means the specific clinical trial protocol as part of the Project;
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Related to Clinical Protocol

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Step therapy protocol means a protocol or program that establishes the specific

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Kyoto Protocol means the protocol to the UNFCCC adopted at the Third Conference of the Parties to the UNFCCC in Kyoto, Japan on 11 December 1997 as may be amended;

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Interchangeable biological product means a biological product that the U.S. Food and Drug Administration has:

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Quality system means documented organizational procedures and policies: internal audits of those policies and procedures: management review and recommendation for quality improvement.”