Formulary Protocol definition

Formulary Protocol for clinical studies under this Agreement is the FDA, and applicable institutional review board (IRB), approved protocol to be used for any clinical research that will be undertaken using the Formulary Agent(s) as listed in Attachment A.
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Formulary Protocol means the clinical investigation in which a drug is administered or dispensed to, or used involving, one or more human subjects. It describes the objective(s), design, methodology, statistical considerations, and organization of a trial. For the purposes of this CRADA, such Protocol, for clinical research involving Human Subjects, shall include any and all associated documents, including informed consent forms, to be provided to Human Subjects and potential participants in the study.
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Examples of Formulary Protocol in a sentence

  • Approved Investigator will be responsible for submitting the Formulary Protocol to xxxxxxxxxxxxxx.xxx within twenty-one (21) days of initiating patient enrollment, and providing the results reporting as required, it being understood that no such submission will be made until after the Formulary Protocol is approved by NCI Collaborator.

  • An initial draft version of the Formulary Protocol must be submitted to the NCI at the same time it is provided to NCI Collaborator for Formulary Agent forecasting purposes.

  • Approved Investigator will submit, or arrange for submission of, the Formulary Protocol to all appropriate IRBs, and ensure that the IRBs are notified of the role of NCI Collaborator in providing the Formulary Agent(s) for the research by including NCI Formulary standard protocol language into the final Formulary Protocol.

  • The IND must be in effect prior to beginning the Formulary Protocol.

  • In addition to the Formulary Protocol, all associated documents, including informational documents and advertisements, must be reviewed and approved by the appropriate IRB(s) before starting the Formulary Protocol.

  • Approved Investigator will provide NCI and NCI Collaborator with a copy of, the IND Safe-to-Proceed letter, the version of the Formulary Protocol on which the letter is based, and all applicable IRB approvals, all prior to NCI approval of the Formulary Protocol and shipment of the Formulary Agent(s) by the NCI’s Pharmaceutical Management Branch (PMB).

  • A copy of the NCI Collaborator-approved protocol and NCI Collaborator’s approval notification must be submitted to NCI for NCI approval of Formulary Protocol.

  • For any Study that involve a Formulary Protocol, the Institution agrees as follows: Approved Investigator will develop Formulary Protocol and obtain NCI Collaborator approval of a Formulary Protocol.

  • The Approved Investigator will notify NCI Collaborator of all significant meetings and communications with the FDA concerning the Formulary Protocol and the Formulary Agent(s).

  • Approved Investigator further agrees that the Formulary Agent(s) will be used only in accordance with the FDA approved Formulary Protocol and in accordance with FDA IND regulations and all Federal laws and regulations that govern the use of investigational agents in clinical trials.

Related to Formulary Protocol

  • 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;

  • Participating Prescription Drug Provider means an independent retail Pharmacy, chain of retail Pharmacies, mail-order Pharmacy or specialty drug Pharmacy which has entered into an agreement to provide pharmaceutical services to participants in the benefit program. A retail Participating Pharmacy may or may not be a select Participating Pharmacy as that term is used in the Vaccinations Obtained Through Participating Pharmacies section.

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • Managed care plan means a health benefit plan that either requires a covered person to use, or

  • Maintenance Programme shall have the meaning set forth in Clause 14.3; “Maintenance Period” shall have the meaning set forth in Clause 14.1; “Maintenance Requirements” shall have the meaning set forth in Clause 14.2;

  • Video programming means programming provided by, or generally considered comparable to programming provided by, a television broadcast station.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following: