EC/IRB definition
Examples of EC/IRB in a sentence
Where appropriate, either Sponsor or the Investigator shall notify the IEC/IRB and/or Regulatory Authority, within the time frame specified by the EC/IRB and/or Regulatory Authority.
Related EC/IRB review and approval of Protocol, including the Informed Consent Form, shall be obtained in accordance with 21 CFR Part 56.
The patient consent and/or HIPAA authorization form(s) as approved by the EC/IRB shall disclose that documentation may be provided to representatives of Antigen Express, the FDA, or other regulatory agencies and that patient identifying information will be removed prior to submission thereto.
The monitor will be expected and allowed to verify the investigator’s qualifications, to inspect clinical site facilities, and to inspect study records, including proof of EC/IRB review, with the stipulation that patient confidentiality will be maintained in accordance with local and federal regulations, including HIPAA requirements.
Any alterations of, or amendments to the Protocol must be approved by Institution, Investigator, EC/IRB and Sponsor prior to such alteration or amendment becoming effective.
Neither the Provider nor the Investigator shall implement any Protocol amendment until it is approved by the relevant authorities and the EC/IRB.
For Study data to be cohpfete and correct, each Study subject hust have singned an EC/IRB- approved patient inforhed consent docuhent, and have het aff the incfusion/excfusion criteria, and aff procedures desingnated in the Protocof hust be carried out on a "best eforts" basis; ohissions hust be satisfactorify expfained.
The EC/IRB must be a properly constituted board or committee operating in accordance with 21 CFR Part 56, “Institutional Review Boards.” This protocol, any protocol amendments, the associated informed consent forms, and the informed consent procedures must be submitted to the EC/IRB for review and approved before the enrollment of any patient into the trial.
The Institution shall deliver such a notification to Chiltern and/or, if applicable, to the EC/IRB, and the relevant authorities, as appropriate, immediately but in any event within twenty-four (24) hours from becoming aware of such an event or reaction, by telephone or facsimile in accordance with the manner provided in the Protocol.
The Institution and/or Investigator shall deliver such a notification to ▇▇▇▇▇▇▇▇ and/or, if applicable, to the EC/IRB, and the relevant authorities, as appropriate, immediately but in any event within twenty-four (24) hours from the occurrence of such an event or reaction, by telephone or facsimile in accordance with the manner provided in the Protocol.