IEC/IRB definition

IEC/IRB means an independent ethics committee or institutional review board.

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IEC/IRB means the Independent Ethics Committee (“IEC”), as the term is defined in ICH Guidelines and/or the Institutional Review Board (“IRB), as that term is defined under the Act, and shall include any other review board required by local law or ICH Guidelines.

Examples of IEC/IRB in a sentence

• Any amendment to the Protocol shall be notified to the relevant IEC/IRB according to local regulations.

• 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.

• Any amendment to the Protocol shall be notified to the relevant IEC/IRB and CA according to local regulations.

• Léčba KH nebude uvolněna do té doby než SCOPE obdrží kopii písemného a datovaného schválení/souhlasného stanoviska IEC/IRB a CA.

• In addition, the Institution will submit for review by the IEC/IRB and/or Regulatory Authority any amendments to the Study documentation, which may impact upon Trial Subject rights, safety and/or well-being.

• The Investigator agrees to conduct the clinical study in compliance with this protocol which was approved by the IEC/IRB in compliance with local regulatory requirements.

• Institution and Principal Investigator will ensure the full cooperation of the Research Staff and IEC/IRB members with any such inspection and will ensure timely access to applicable records and data.

• Substantial amendments will require written approval by the IEC/IRB prior to being implemented by the Investigator at the study site except under those circumstances described previously.

• Producer will bear its allocated share of Fuel and Lost and Unaccounted For Gas (collectively, “FL&U”).

• Non-substantial amendments will not require approval by the IEC/IRB unless requested by the IEC/IRB.