NCI Collaborator definition

NCI Collaborator means the pharmaceutical or biotechnology company having a CRADA with NCI to provide Formulary Agent(s) to the NCI Formulary, as listed above.
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NCI Collaborator means a company that made available its Agent(s) for use in association with the Protocol(s). This includes agreements with NCI and/or directly with a Clinical Trial Network/Clinical Research Site. When the NCI Clinical Trial Network Protocol is also a PACT-Funded Trial Protocol, the NCI Collaborator will also be a PACT Collaborator.
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NCI Collaborator means a company having a collaborative agreement with the NCI or a Network Group to provide Agent(s) for use in association with the Protocol(s). This includes agreements with NCI and/or directly with a Clinical Trial Network/Clinical Research Site.
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Examples of NCI Collaborator in a sentence

  • 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.

  • Unless prohibited by law from doing so, Institution agrees to hold the Government and NCI Collaborator harmless and to indemnify the Government and Collaborator for all liabilities, demands, damages, expenses and losses arising out of Institution's use for any purpose of the Formulary Agent(s).

  • Approved Investigator will also include language in the informed consent stating that the NCI Collaborator will have access to all data, including raw data, from the Protocol for regulatory purposes.

  • NCI and NCI Collaborator make no representations that the use of the Formulary Agent(s) will not infringe any patent or proprietary rights of third parties.

  • 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.

  • Manuscripts to be submitted for publication and proposed abstracts or presentations by Approved Investigators will be sent to NCI’s Regulatory Affairs Branch at NCI CTEP Publications for forwarding to NCI Collaborator for review as soon as they are received and in compliance with the timelines outlined above.

  • Approved Investigator will be responsible for submitting the Formulary Protocol to ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ 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.

  • Institution and Approved Investigator further agree to make sure the informed consent form includes language providing the NCI and the NCI Collaborator with access to all data, including raw data and case report forms for regulatory purposes.

  • Recipient agrees to email a copy of each manuscript, including revised manuscripts being submitted to a different journal, arising from the RECIPIENT’s use of the DATA to ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇.▇▇▇.▇▇▇, so that NCI may send them to the NCI Collaborator for a thirty (30) day comment period prior to RECIPIENT’s submission for publication.

  • Institution will notify NCI Collaborator within twenty-four (24) hours of Approved Investigator and/or Institution receiving notification or becoming aware of any product complaint related to a Formulary Agent.


More Definitions of NCI Collaborator

NCI Collaborator means a company that made available its Agent(s) for use in association with the NCI/CTEP-approved Protocol(s).
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Related to NCI Collaborator

  • Collaborator An individual who is not under the direct supervision of the PI (e.g., not a member of the PI’s laboratory) who assists with the PI’s research project involving controlled-access data subject to the NIH GDS Policy. Internal collaborators are employees of the Requester and work at the same location/campus as the PI. External collaborators are not employees of the Requester and/or do not work at the same location as the PI, and consequently must be independently approved to access controlled-access data subject to the NIH GDS Policy.

  • Collaboration IP means Collaboration Know-How and Collaboration Patents.

  • Collaboration Know-How means all Know-How and Materials discovered, created, conceived, developed or reduced to practice in the course of performing activities under the Collaboration Program (whether solely by one Party or jointly by the Parties, in each case with their Affiliates or any Third Parties or any employees, consultants or agents of any of the foregoing which perform activities under the Collaboration Program).

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Collaboration Patent Rights means Patent Rights claiming Collaboration Know-How.