-` The Faculty of Medical Sciences, The University Of The West Indies, Mona Campus

Clinical Trials Centre

Introduction

A Clinical Trial Centre has been established to provide the necessary support to investigators for protocol development, budgeting, ethical guidelines, data management and reporting.

The Clinical Trials Centre will provide standardized procedures of initiating, conducting and completing clinical trials and will be responsible for:-

  • Coordinating clinical trials conducted in the Faculty of Medical Sciences.
  • Establishing Standard Operating Procedures for the administration of the trials.
  • Creating an efficient system for the initiating and implementing of clinical trials within the project time lines.
  • Providing support to ensure that all trials are conducted in accordance with the highest ethical standards and clinical practices.
  • Providing support to ensure that all contractual, budgetary, regulatory and legal requirements are satisfied.
  • Ensuring that the University's earnings from these projects are maximized

With this new unit, initiating clinical trials will be organized and streamlined in two major stages, evaluation of the protocol and trial initiation.

Evaluation:

  1. Initial Discussions between the Faculty of Medical Sciences and the sponsoring organization.

    All individuals and organizations wishing to engage the services of the University of the West Indies, Faculty of Medical Sciences for the conduct of clinical trials should first contact the Clinical Trials Centre in the Dean's Office.

    Should a Member of this Faculty be contacted by a sponsor about a potential clinical trial, this member should notify the Clinical Trials Centre in the Dean's Office immediately.

  2. Any person employed to the University of the West Indies is considered an agent of the University and is subject to University Regulations, even if the person operates a private enterprise.

    Should the member of Faculty be asked to sign a Pre-Approval Confidentiality Agreement by the sponsor, this document should be submitted through the Dean of the Faculty to the University's attorney for approval before signing.

  3. Approval from the Dean/Head of Department

    The proposal will then be discussed with the Head of Department who will evaluate the protocol after which the protocol will be discussed with the Dean.

  4. Receipt of the Clinical Trials protocol and budget

    Upon approval by both the Head of Department and the Dean of the Faculty, the Principal Investigator will then accept the clinical trial protocol and budget.More..>>