Approved Investigator definition

Approved Investigator is an Institution investigator who has current investigator registration documents on file with the Pharmaceutical Management Branch (PMB) of NCI. To be an Approved Investigator for this Agreement the Institution investigator must be from an NCI-Designated Cancer Center that has been audited by NCI in the past 3 years and specifically approved by NCI to participate in the NCI Formulary. “Formulary Agent” may be a Food and Drug Administration (FDA) approved drug or an Investigational New Drug (IND) or an Investigational Agent, in accordance with the definition in 21 C.F.R. § 312.3, or a new drug or biological drug that is to be used in a clinical investigation. For this Agreement, Formulary Agent means any agent, provided by or on behalf of the NCI Collaborator under a Cooperative Research and Development Agreement (CRADA) between NCI and the NCI Collaborator. The Formulary Agent(s) may also be used in non-clinical, preclinical lab studies (“Proposals”) under this Agreement.
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Approved Investigator means an investigator responsible for serving as the lead researcher of a clinical or non-clinical study and who (i) has current investigator registration documents on file with the PMB, NCI; (ii) is approved to participate in the NCI Formulary and in the case of an extramural investigator, has (or will have) executed a NCI Formulary Material Transfer Agreement in the form attached hereto as Appendix B; (iii) has (or will have) executed a NCI Formulary Material Transfer Agreement in the form attached as Appendix B (“MTA”); (iv) in the case of a clinical Study, is a Clinical Investigator who (or the Institution employer of such Investigator) will be the Sponsor for such Study/Protocol; and (v) has submitted a Protocol/Proposal which is approved by Collaborator in accordance with Section 3.2.
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Approved Investigator means an investigator responsible for serving as the lead researcher of a clinical or non-clinical study and who (i) is not an NCI employee; (ii) is approved to participate in the NCI Formulary; (iii) has (or will have) executed a NCI Formulary Material Transfer Agreement in the form attached as Appendix B (“MTA”); (iv) in the case of a clinical Study, is a Clinical Investigator as well as the Sponsor for such Study/Protocol; and (v) has submitted a Protocol/Proposal which is approved by Collaborator in accordance with Section 3.2.
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Examples of Approved Investigator in a sentence

  • An example of typical terms for an MTA for the transfer of Investigational Agent from NCI to Approved Investigator for conducting any approved Protocol or Proposal is attached as Appendix B.

  • Approved Investigator will cross-file on Collaborator’s IND and/or DMF, to the extent applicable, and will be responsible for all applicable regulatory information.

  • Collaborator will inform Approved Investigators three (3) months prior to such a suspension and allow the Approved Investigator to take corrective action.

  • NCI shall require that Approved Investigator will provide to Collaborator a final report of their clinical or non-clinical Study results within six (6) months after the completion or termination of each Study under this CRADA.


More Definitions of Approved Investigator

Approved Investigator means a Clinical Investigator who (i) is not an NCI employee and has current investigator registration documents on file with the PMB, NCI; (ii) is approved by NCI to participate in the NCI Formulary and has (or will have) executed a NCI Formulary Material Transfer Agreement in the form attached as Appendix B (“MTA”); (iii) is the Sponsor for the applicable Study/Protocol; and (iv) submits a Protocol which is approved by Collaborator in accordance with Section 3.2.
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Approved Investigator is an investigator responsible for serving as the lead researcher of a clinical or non-clinical study and who (i) has current investigator registration documents on file with the PMB, NCI; (ii) is approved to participate in the NCI Formulary; (iii) has (or will have) executed an NCI Formulary Material Transfer Agreement; (iv) in the case of a clinical study, (A) is a Clinical Investigator and (B) is or the Institution employer of such investigator is the Sponsor for the applicable Study/Protocol; and (v) submits a Protocol/Proposal which is approved by Collaborator. “Formulary Agent” may be a Food and Drug Administration (FDA) approved drug or an Investigational New Drug (IND) or an Investigational Agent, in accordance with the definition in 21 C.F.R. § 312.3, or a new drug or biological drug that is to be used in a clinical investigation. For this Agreement, Formulary Agent means any agent, provided by or on behalf of the NCI Collaborator under a Cooperative Research and Development Agreement (CRADA) between NCI and the NCI Collaborator. The Formulary Agent(s) may also be used in non-clinical, preclinical lab studies (“Proposals”) under this Agreement.
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Related to Approved Investigator

  • Investigator means an individual who is:

  • Investigators means those persons authorised, appointed, consulted or approached by the Chairman of the Audit Committee and includes the Auditors of the Company and the Police.

  • Principal Investigator or “PI” is the person, designated by University, and accepted by Sponsor, who is directly responsible for executing, directing, overseeing and reporting a Sponsored Project under this Agreement.

  • Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Collaborating physician means the physician who,

  • Contractor Related Parties means any affliates of the Contractor and the Contractor's executive officers, Pennsylvania officers and directors, or owners of 5 percent or more interest in the Contractor.

  • Screening means the evaluation process used to identify an individual's ability to perform activities of daily living and address health and safety concerns.

  • Researcher means a person appointed by us to carry out research into theoperation of this Contract;

  • Contractor Representative means any of the following:

  • 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;