The initial step in receiving approval for industry-sponsored clinical research is to prepare the research protocol. This usually comes through interaction with industry and the researcher. Once the protocol is in place, the researcher:

1. Presents the protocol to the Centre for Advancement of Health or the Child Health Research Office for review by the relevant Research and Development Committee
2. Notifies Research Services to contact the sponsor to negotiate the clinical research agreement.

The Research and Development Committee determines the safety and scientific merit of the research and examines the resource utilization of the hospital. Once these reviews are successfully completed, the Research and Development Committee approve the protocol.

The Conjoint Medical Ethics Committee, who is aware of the results of the Research and Development Committee, then reviews the protocol. When the ethical review is successfully completed, the approval documents from both committees are forwarded to Research Services for authorization of the research.

Establishing a Clinical Research Account

Clinical Research accounts are established by Research & Trust Accounting in Financial Services for the purpose of conducting clinical trials research. They are established in accordance with the Clinical Research Policy.

To establish an account, Research Services generates a Clinical Trials Checklist for approval by the Investigator, the Department Head, the Associate Dean (Research) in the Faculty of Medicine and the University. The Clinical Trials Checklist is forwarded to Research and Trust Accounting in Financial Services together with a copy of the fully executed clinical research agreement. Once the Clinical Research account is opened, Research and Trust Accounting will forward the new Clinical Research Account number to the:

Investigator

Department Head

Associate Dean (Research), Faculty of Medicine

Office of Research Services

Participating Hospital

Transferring Funds

Once funds have been deposited, they may be administered through the clinical research account; or, upon request of the principal investigator, they may be transferred to and administered by the applicable hospital's financial services department.