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 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 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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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.

  • Approved Investigator will submit an IND Application to the FDA to conduct the Formulary Protocol in accordance with obligations of 21 CFR Part 312, and will be responsible for all regulatory submissions to the FDA concerning the 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).

  • 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.

  • 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.

  • 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.

  • 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.


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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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.
Sample 1

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 means the Personnel who is identified as principally responsible for the performance and supervision of research associated with a Contract.

  • 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.

  • veterinary clinic means a building where animals are given medication or surgical treatment and are cared for during the time of such treatment for financial gain;

  • 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.

  • Researcher means an individual who:

  • 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;

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • 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;

  • Manufactured housing means a structural unit or units designed for occupancy and constructed in a manufacturing facility and transported, by the use of its own chassis or an independent chassis, to a building site. The term includes any type of building that is constructed at a manufacturing facility and transported to a building site where it is used for housing and may be purchased or sold by a dealer in the interim. For purposes of this section, 2 types of manufactured housing are included. Those 2 types are:

  • 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.