Reviewing HREC definition
Examples of Reviewing HREC in a sentence
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.
The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct.
The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Protocol, provided that any amendments to the Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC.
If there is a need for such a deviation the Institution must notify the Sponsor 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.
The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC.
Subject to clause 9, the Institution will allow regular monitoring visits in accordance with the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities or as specified in the Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study related materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor.
The Sponsor will cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study.
The Sponsor will provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medicines Australia Form of Indemnity for Clinical Trials as set out in Schedule 3.
The parties must comply with, and conduct the Study in accordance with the Protocol and any conditions of the Reviewing HREC.
The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study.