WP09 – Ethics and Safety Monitoring

Objectives

  • To establish Scientific Advisory Board (SAB).
  • To set up an Ethics and Safety Review Group (ESRG).
  • To ensure that the study is performed according to highest ethical standards and to secure patients safety.
  • ESRG to approve informed consent procedures
  • ESRG to approve study monitoring plan, review all monitoring reports and forward any actionable items to study coordinating centre and/or SAB
  • To develop aTrial Risk Registry
  • To review ADR, re-hospitalization and mortality rates and all adverse event (AE) data as provided by the TCC and PEPA committee

Workpackage Description

Task 1: Establishment of Scientific Advisory Board.

The composition and terms of reference for the Scientific Advisory Board (SAB) will be finalized and formally constituted as per the terms of the grant award. The SAB will provide strategic and scientific leadership, ensure ethical compliance and financial accountability of all elements of the overall project. It will approve the composition, terms of reference and reporting arrangements of all study committee/subgroups. It will consist of 5 independent members with acknowledged expertise in geriatrics, pharmacotherapy, conduct of clinical trials and research ethics and software development and 2 lay representative members. The SAB will provide final study approval to any required trial amendments.

Task 2: Establish the Ethics and Safety Review Group (ESRG).

The ESRG will consist of 3 independent experts with combined expertise in research ethics, geriatrics and pharmacotherapy. The membership will be approved by the Scientific Advisory Board.

Task 3: Approval of Trial Informed Consent Procedures and Forms.

Participating physicians at the 6 sites will be provided with informed consent prior to the start of both Phase I (Control arm) and II (Active SENATOR Arm). Phase I will be presented as a generic data collection activity with regard to development of ADRROP and while it will mention a subsequent second study phase in which the developed scale will be used, but will not discuss details of the Active SENATOR component in order to limit the introduction of bias, physicians will be re-consented with a Phase II-specific form prior to start of the Active phase. All patients will provide individual informed consent to allow their data to be collected and to give their permission for telephone follow-up post discharge. A separate consent form will be provided to allow for collection of a biorepository blood sample. This will be conducted as a separate initiative but the associated activities will require approval by the Trial management and independent ESRG.

Task 4: Approval of study monitoring.

The ESRG will approve the trial monitoring plan with regard to site initiation and trial monitoring. The monitor will report in parallel with both the TCC and the ESRG. A summary of the routine monitoring reports will be forwarded by the ESRG to the SAB every 6 months. Urgent actionable items will be forwarded directly to the SAB from the study monitor at request of the study monitor, the study PI or a majority vote of the ESRG.

Task 5: Trial Risk Registry.

The ESRG will set up and maintain a risk registry and response procedure for what needs to be done if ethical or safety issues arise during the trial. The ESRG will recommend any remedial action to the TCC or if any major study modification is required, recommend appropriate trial amendments to the SAB. Given the nature of the trial and in keeping with the opinion of the Cork Teaching Hospitals Research Ethics Committee only those events that are considered to be directly related to study participation or the use of SENATOR software will be considered as study adverse events. As the clinician remains responsible for clinical management of the patient, all adverse events that occur would be reported to appropriate authorities by the supervising clinician as per routine clinical practise.

WP Leader

Dr. Adalsteinn Gudmundsson (LUH)

Participating Partners

University College Cork (UCC)
University of East Anglia(UEA)
University of Iceland (UoI)