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.

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.

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, and repository protocols. The scientific review process includes the initial protocol review, annual and quadrennial review of the ongoing protocol, and review of substantive modifications 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.

Examples of Clinical Protocol in a sentence

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

• The UDN Clinical Protocols Working Group developed this Clinical Protocol as part of the Manual of Operations and with input from the UDN Steering Committee will continue to refine it.

• We have implemented both the Prefix and Clumping algorithms for the Single-Row Problem, as well as the swapping heuristic for improv- ing the row ordering.

• The clinical protocol must address the required components described in Section V, Clinical Protocol and Supporting Clinical Documentation.• Attachment 2: Supporting Documentation.

• International Breastfeeding JournalEglash, A., Simon, L., & The Academy of Breastfeeding Medicine (2017) Clinical ABM Clinical Protocol #8: Human Milk Storage Information for Home Use for Full-Term Infants, Revised 2017 Breastfeeding Medicine; Volume 12: Number 7Europeristat Project with SCPE and EUROCAT.

• Multi-institutional Clinical Trials: If the proposed clinical trial is multi-institutional, plans for communication and data transfer between the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the Clinical Protocol.

• ABM Clinical Protocol #24: Allergic Proctocolitis in the Exclusively Breastfed Infant.

• Confidential Page 45 of 92Testing Protocol version 5 _13May2015_final Clinical Protocol: TESTING Study Version5.0Protocol GI-R-01-2011 13May2015 Table 7.

• The Clinical Protocol must be submitted as a single PDF file named “Protocol.pdf.” Provide a copy of the approved clinical protocol(s) for all projects involving an ongoing clinical study.

• CUMC requires that oncology studies managed through the Clinical Protocol & Data Management Office name an individual (Investigator) who will provide clinical coverage for when the PI is traveling or otherwise unavailable.

More Definitions of Clinical Protocol

Clinical Protocol means a protocol for the conduct of Clinical Research agreed in writing between the Parties.

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;

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.

Clinical Protocol means the specific clinical trial protocol as part of the Project;