Examples of Independent Ethics Committee in a sentence
H.2.1 Safety and Monitoring Issues Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.
Receptos will further ensure that an Institutional Review Board, an Independent Ethics Committee, or both, as applicable, established and constituted in accordance with Applicable Law, approves and oversees the conduct of any human clinical study included in the Development Plan and Budget.
Receptos will comply with the directives of the Institutional Review Board, the Independent Ethics Committee, or both, as applicable, respecting the conduct of any such clinical study, and will promptly notify AbbVie of any action or threatened action by the local Regulatory Authority or other agency that may affect continuation of such clinical study.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.
The investigator will obtain a signed Letter of Approval for the study and for the Informed Consent Form from the appropriate Independent Ethics Committee prior (IEC) to the study start and provide POI with a copy of the approval documentation.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with the annual progress report, the Contractor must submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.
BioNTech as the sponsor and Regulatory Approval holder of the Clinical Trials shall ensure that the Clinical Trial is approved by and subject to continuing oversight by an appropriate Institutional Review Board (IRB) or Independent Ethics Committee (IEC), except that BioNTech shall delegate this responsibility to Pfizer for any Clinical Trial for which Pfizer is the Lead Development Party.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before initiation of research and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.
Institutional Review Board or Independent Ethics Committee Approval Before initiating enrollment of subjects then with the annual progress report, the Contractor must submit to the CO and COR a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance number for the institution or site.
The protocol and the proposed informed consent form have to been reviewed and approved by a properly constituted Independent Ethics Committee (IEC/IRB) before study start at a particular study site.