Common use of THE STUDY Clause in Contracts

THE STUDY. The parties must comply with, and conduct the Study in accordance with the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidances governing the conduct of clinical research in the jurisdiction of the Study; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); the NHMRC National Statement on Ethical Conduct in Human Research (2007) or replacement, and any other relevant NHMRC publication or guideline that relates or may relate to clinical trial; any Study specific and standard operating procedures provided by the CRG prior to the commencement of the Study; and any reasonable direction given by the CRG in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements. If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Institution must notify the CRG and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. From time to time, the CRG may modify the Protocol by written notice to the Institution and Principal Investigator. Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC. If the parties determine that a modification will affect the cost of the Study, the parties shall amend Schedule 2 as agreed between them. PRINCIPAL INVESTIGATOR

THE STUDY. The parties must comply with, and conduct the Study in accordance with the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidances governing the conduct of clinical research in the jurisdiction of the Study; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); the NHMRC National Statement on Ethical Conduct in Human Research (2007) or replacement, and any other relevant NHMRC publication or guideline that relates or may relate to clinical trial; any Study specific and standard operating procedures provided by the CRG CRIG prior to the commencement of the Study; and any reasonable direction given by the CRG CRIG in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements. If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Institution must notify the CRG CRIG and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. From time to time, the CRG may modify the Protocol by written notice to the Institution and Principal Investigator. Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC. If the parties determine that a modification will affect the cost of the Study, the parties shall amend Schedule 2 as agreed between them. PRINCIPAL INVESTIGATOR