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

Clinical Trials Centre

Trial Initiation:

  1. Discussions with the Clinical Trials Centre

    2. The staff of the Centre will then work with the Principal Investigator to finalize the protocol, consent and or assent forms and the budget.

  2. Submission to the Ethics Committee

    3. The protocol along with the consent, assent and other relevant forms will be submitted for review to the Ethics Committee (Institutional Review Board).

    Kindly note that should the sponsoring organization propose changes to the protocol, the revised protocol will need to be re-submitted to the Ethics Committee.

  3. Finalizing of budget between Principal Investigator and sponsoring organization

    4. After a letter of approval from the Ethics Committee and the Dean has been issued, the financial aspects of the study will be finalized with the sponsors.

  4. Preparation of draft contract for review by Dean and Legal Office

    5. On finalization of the protocol and budget, a draft Clinical Trial Agreement (CTC) between the University of the West Indies and the sponsoring organization will be prepared by the sponsor. The Dean and the Legal Department of the University will review the Agreement.

  5. Signing of the Clinical Trial Agreement

    6. After the Agreement has been approved, a letter signed by the Dean confirming the approval will be sent to the Principal requesting signature on behalf of the University of the West Indies.

    The Sponsor will sign two original agreements, one will be retained by this organization and the other will be returned to the University of the West Indies, Faculty of Medical Sciences. A copy of the Agreement will be placed in the Dean's Office and the original in the Investigator's binder.

  6. Setting up of Bursary Accounts for the Clinical Trials
    7. An account will be established in the Special Projects Unit of the Bursary and all payments will be made on the submission of an invoice.

Through-out the conduct of the clinical trials the Clinical Trials Unit will be available to provide any necessary assistance to the Principal Investigator for the successful completion of the trials.

Kindly contact the following persons in the Faculty of Medical Sciences, (876) 927 - 2556, 927 - 1620 Ext 2478/2479 for additional information:-

  1. Professor Archibald McDonald, email: medsci@uwimona.edu.jm
  2. Dr. Georgiana Gordon-Strachan, email: georgiana.gordonstrachan@uwimona.edu.jm
  3. Ms. Sharon White, email: fmsclinicaltrialscentre@uwimona.edu.jm