IRB of Record definition

IRB of Record. The IRB that is responsible for the ethical review of Human Research on behalf of an institution/organization or individual investigator.
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IRB of Record. A reviewing IRB that assumes IRB responsibilities for another institution and is designated to do so through an approved Federalwide Assurance on file with the federal Office for Human Research Protections.
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IRB of Record means a reviewing IRB that assumes IRB responsibilities and is designated to do so through an approved Federalwide assurance on file with the federal Office for Human Research Protections.
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Examples of IRB of Record in a sentence

  • The protocol, addendum, and/or IRB of Record application must describe the data to be disclosed to collaborators, the entities to which the data are to be disclosed, how the data are to be transmitted, and how the transmitted data will be stored, retained, destroyed, and/or further disclosed and to whom.

  • The delegation of duties between lead and relying institution and the responsibilities of each party conducting research are outlined in the Reliance Agreement and the research application submitted to the IRB of Record.

  • The IRB of Record could also be known as the Lead IRB or a single IRB of Record.

  • A Single IRB of Record is a term adopted by the Clinical Trials Transformation Initiative (CTTI).

  • PHI obtained in research for which the IRB of Record has waived the requirements to obtain a HIPAA authorization and a signed informed consent document may not be disclosed outside VA unless the VA facility Privacy Officer ensures and documents VA’s authority to disclose the PHI to another institution.

  • IRB of Record is the lead IRB who will oversee the conduct of research related activities at all research locations.

  • The protocol, addendum, and/or IRB of Record application must describe the data to be disclosed to collaborators, the entity(ies) to which the data are to be disclosed, and how the data are to be transmitted.

  • Lead Study Team has the obligation to submit the IRB application to the IRB of Record and comply with any requests and clarifications from the IRB or Record.

  • The IRB of Record assumes IRB responsibilities for oversight of research conducted at another organization, per 45 CFR 46 and/or 21 CFR 56.

  • The agreement documents the respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating site relying on the IRB of Record.


More Definitions of IRB of Record

IRB of Record. An IRB that assumes IRB responsibilities or oversight for another institution. Also referred to as the Reviewing IRB. Local Research Context: Knowledge of the institution and community environment in which human subjects’ research will be conducted. In order for an IRB to agree to serve as IRB of Record for another institution, it must have adequate knowledge of local context (e.g., state laws, understanding of cultural context).
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IRB of Record. The reviewing IRB that performs a review on behalf of one or more institutions. Relying IRB: The IRB or entity that agrees to rely upon the IRB of Record.
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Related to IRB of Record

  • Lot of record means any lot, the description of which is properly recorded with the Register of Deeds, which at the time of its recordation complied with all applicable laws, ordinances, and regulations.

  • Teacher of record means a teacher who meets all of the following:

  • Address of record means the designated address recorded

  • Version of Record is defined as the final version of the Contribution as originally published, and as may be subsequently amended following publication in a contractually compliant manner, by or on behalf of the Publisher.

  • Owner of record The meaning set forth in the System Description.

  • Retailer of Record means the Retailer who is listed in FortisAlberta’s records through the procedures outlined in the Terms and Conditions, and thereby recognized by FortisAlberta and the Settlement System Code, as a particular Customer’s Retailer for a Point of Service at a particular time;

  • Customer of Record means the person that applies for utility service and is identified in the account records of a public utility as the person responsible for payment of the public utility bill. A customer may or may not be an end user, as defined herein.

  • Shareholder of Record means the record owner of shares issued by an Investment Company or, in the case of joint ownership of such shares, all record owners, as designated (1) in the initial account application, or (2) in writing accompanied by a signature guarantee, or (3) pursuant to procedures as set forth in the Application.

  • Architect of Record means the architect licensed by the State who has the contract responsibility for the Project, who designs and prepares the construction documents from which the building is constructed, and who signs the required documents.

  • Email address of record means the designated email

  • If recorded means if the data is recorded in non-volatile memory for the purpose of subsequent downloading.

  • Authorized distributor of record means a pharmaceutical wholesaler with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drugs. An ongoing relationship is deemed to exist between such pharmaceutical wholesaler and a manufacturer, as defined in Section 1504 of the Internal Revenue Code, when the pharmaceutical wholesaler has a written agreement currently in effect with the manufacturer evidencing such ongoing relationship, and the pharmaceutical wholesaler is listed on the manufacturer's current list of authorized distributors of record.

  • Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.

  • Vital record means that term as defined in section 2805 of the public health code, 1978 PA 368, MCL 333.2805.

  • Public record or "public records" shall mean all documents, papers, letters, maps, books, photographs, films, sound recordings, magnetic or other tapes, electronic data-processing records, artifacts, or other documentary material, regardless of physical form or characteristics, made or received pursuant to law or ordinance in connection with the transaction of public business by any agency of North Carolina government or its subdivisions. Agency of North Carolina government or its subdivisions shall mean and include every public office, public officer or official (State or local, elected or appointed), institution, board, commission, bureau, council, department, authority or other unit of government of the State or of any county, unit, special district or other political subdivision of government.

  • Relevant Record Date means the date on which a Bondholder’s ownership of Bonds shall be recorded in the CSD as follows:

  • ADS Record Date shall have the meaning given to such term in Section 4.9.

  • Medical record means any document or combination of documents, except births, deaths, and the fact of admission to or discharge from a hospital, that pertains to the medical history, diagnosis, prognosis, or medical condition of a patient and that is generated and maintained in the process of medical treatment.

  • Case record means the file of personally identifiable information, whether written or electronic in form, on an individual that is collected to carry out the purposes of the division as defined in the Act and the Social Security Act. This information remains a part of the case record and is subject to these rules even when temporarily physically removed, either in whole or in part, from the file folder in which it is normally kept.

  • System of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

  • Close of Business on any given date shall mean 5:00 P.M., New York City time, on such date; provided, however, that if such date is not a Business Day it shall mean 5:00 P.M., New York City time, on the next succeeding Business Day.

  • Official record means the record prepared and maintained by the department for each offender and juvenile received into the physical care and custody of the department. The record shall include, but is not limited to, written, printed, or electronic materials, documents, or data pertaining to services, programs, and all other official actions performed on behalf of that offender or juvenile. These records are identified by the same offender or juvenile name as received on the commitment order, assigned a department number as an identifier, and compiled and maintained as part of an offender/juvenile packet.

  • Criminal record means the record of any —

  • Semi-Annual Record Date means the "Record Dates" set forth under "Summary of Essential Financial Information--Estimated Distributions--Semi-Annual Distributions" in the Prospectus Part I for a Trust.

  • Broker Dealer of Record means GWM Limited or any successor or replacement thereto or any other entity appointed as broker dealer of record in accordance with the terms of the Broker Dealer of Record Agreement.

  • Public organic record means a record that is available to the public for inspection and is: