Ethical Conduct of the Study. The study will be conducted in accordance with applicable national and international laws and regulations, the ICH-GCP guideline and the ethics principles that have their origins in the Declaration of Helsinki. The protocol and the proposed informed consent form must be reviewed and approved by a properly constituted IEC/IRB before study start at a particular study site. Prior to study start, the Principal Investigator is required to sign the protocol signature page (page 3 of this study protocol) confirming his/her agreement to conduct the study in accordance with these documents and all of the instructions and procedures found in this protocol, and to give access to all relevant data and records to monitors, auditors, IRBs/IECs, and regulatory authorities as required.
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Ethical Conduct of the Study. The study will be conducted in accordance with applicable national and international laws and regulations, the ICH-GCP guideline and the ethics principles that have their origins in the Declaration of Helsinki. The protocol and the proposed informed consent form must be have to been reviewed and approved by a properly constituted Independent Ethics Committee (IEC/IRB IRB) before study start at a particular study site. Prior to study start, the Principal Investigator principal investigator is required to sign the protocol signature page (page 3 of this study protocol) confirming his/her his agreement to conduct the study in accordance with these documents and all of the instructions and procedures found in this protocol, protocol and to give access to all relevant data and records to monitors, auditors, IRBs/IECs, and regulatory authorities as required.
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