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) 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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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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Examples of Approved Investigator 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.

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

  • 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.

  • 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.

  • If Approved Investigator and/or Institution are unwilling to delay the publication or presentation, Approved Investigator/Institution will remove from the publication or presentation the information which NCI Collaborator has specified it reasonably believes would jeopardize its intellectual property interests.

  • In accordance with the Formulary Protocol, the Approved Investigator will submit the required data elements, at the specified intervals, to the specified NCI clinical data reporting system, which will be made available to NCI and the NCI Collaborator.

  • Further, Approved Investigator agrees to keep data and results generated under this Agreement confidential until published and agrees that NCI and NCI Collaborator will have the right to use any and all such data and results for any lawful purposes including regulatory filing and patent applications.

  • NCI Collaborator may request in writing that a proposed publication be delayed for up to sixty (60) additional days as necessary to file, or request Approved Investigator, and/or Institution to file a patent application or other action to protect NCI Collaborator’s intellectual property interests.

  • 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).

  • Of the 399 crew member and 99 passenger case-patients with data on age, median age was 31 years (range 20–63 years) and 11 years (range 3 months–72 years), respectively.


More Definitions of Approved Investigator

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.

  • Private investigator means any individual who engages in the business of, or accepts employment

  • 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.

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

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

  • Independent educational evaluation means an evaluation conducted by a qualified examiner who is not employed by the public agency responsible for the education of the child in question.

  • 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.

  • 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.

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

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

  • Medical evaluation means the process of assessing an individual's health status that includes a medical history and a physical examination of an individual conducted by a licensed medical practitioner operating within the scope of his license.

  • Remedial investigation means a process to determine the nature and extent of a discharge of a contaminant at a site or a discharge of a contaminant that has migrated or is migrating from the site and the problems presented by a discharge, and may include data collected, site characterization, sampling, monitoring, and the gathering of any other sufficient and relevant information necessary to determine the necessity for remedial action and to support the evaluation of remedial actions if necessary;

  • Certified pharmacy technician or “certified technician” means an individual who holds a valid current national certification and who has registered with the board as a certified pharmacy technician.

  • 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;

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Contractor Representative means any of the following:

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Credentialed Evaluator For purposes of this policy, each teacher subject to evaluation will be evaluated by a person who:

  • 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;

  • 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;

  • Specialist medical practitioner means a specialist as defined in section 3 of the Health Insurance Act 1973.

  • Medical management technique means a practice which is used to control the cost or utilization of health care services or prescription drug use. The term includes, without limitation, the use of step therapy, prior authorization or categorizing drugs and devices based on cost, type or method of administration.