Child Health Research Office - Industry Sponsored Clinical Trials

The Research Proposal - Industry Sponsored Clinical Trials

In this section, we hope to provide you with some assistance for your submission of an Industry Sponsored Clinical Trial. Please note that these guidelines are for research involving subjects less than 18 years of age at any CHR site. If your project involves adults only, please contact the Office of Medical Bioethics at 220-7990.

Definition of Industry Sponsored Research

The protocol must be approved by the Therapeutic Products Programme (TPP) of Health Canada or currently be in their review process and/or the study must be developed by a sponsor who controls the details of the protocol. (If you have a study for which you have received a grant from industry where you will retain the proprietary rights to the information, please see the section, "Submitting a locally generated research study with an industry grant.) Protocols in the first classification fall into one of two categories regulated by the Food and Drug Act, i.e. Therapeutic Products Program (TPP), Health Canada :

Investigational New Drug ( IND ) - These products undergo regulatory review as outlined in the "Clinical Trial Review and Approval Policy" by the TPP and include pre-market (safety, efficacy and quality) and post-approval (safety and license renewal) phase I-IV human studies.
Products that are regulated by the Medical Devices Regulations, including any new device not previously imported or sold in Canada as of July 1, 1998 , a licensed device modified from the original license type, or a device previously authorized for investigational testing that is now offered for general use.

How do I Submit?

Industry Sponsored Clinical Trials are reviewed on an ongoing basis, i.e. there are no deadlines for submission. The reviews are carried out within three weeks of submission, although approval is not guaranteed in this time. You make your submission to the Child Health Research Office (CHRO). You submission must include:

Original + 5 copies of the application form
Original + 5 copies of the study protocol
Original + 5 copies of the consent form (templates available on CHREB website)
1 copy of the investigator's brochure (if applicable)
$2,000 application fee

The $2,000 fee can be made in the following ways:

A cheque payable to the University of Calgary account #75-2488. If you would like an invoice issued to the sponsoring company, please contact the Child Health Research Office. Please note that the CHRO will issue the invoice and will send it to you to forward to the sponsor.
a memo authorizing a transfer of funds from an existing residual account to the University of Calgary account #75-2488. Please note that you may only use a residual account, if you are unsure if the account you have specified is eligible, please contact University of Calgary Research & Trust Accounting at 220-3036.

Upon receipt of your submission, the CHRO will forward 2 copies to the Office of Medical Bioethics and will retain 2 copies for scientific, and institutional impact review. Should your protocol require a review for compliance with the Health Information Act, the CHRO will also forward a copy to the Calgary Health Region Information and Privacy Office.

What Happens in the Review Process?

All proposed Industry Sponsored Clinical Trials are reviewed for institutional impact, scientific and ethical concerns. If applicable, the protocol will also be submitted to the CHR Information and Privacy Office to assess compliance with the Health Information Act. (For more information, please see Health Information Act section on the CAH website. )

Scientific Review

In general, the Child Health Scientific Review Committee (CHSRC) reviewers look for the following criteria when judging your proposal on scientific validity and administrative impact:

Research questions and/or objectives that are clear and attainable.
Background information and literature review, which justify the conduct of the study.
A research design that is adequate for the objectives and (where applicable) the hypotheses to be tested.
Research methods that are appropriate for the study, including: subject selection (sampling, recruitment, inclusion and exclusion criteria, methods of assignment to groups), statistical consideration (sample size and data analysis), data collection (study variables, procedures, measures/instruments), and time frame of the study.
Itemised, detailed budget information including source of funding and overhead information.
Protection of human rights and attention to ethical issues (addressed by the CHREB).
Practical significance and feasibility of the study given the qualifications of the investigator.
Interventions proposed and patient safety.

Administrative Review

All investigators must submit a list indicating departments or divisions where operations may be affected by the proposed study and obtain signatures of the appropriate Department Head(s) or Officer(s) indicating they have reviewed the project and its budget. This list is included in your application package on page 2. The study budget will be assessed for completeness, appropriate pricing and to ensure all research related costs are covered. Administrative review will be conducted by the Child Health Scientific Review Committee (CHSRC).

Ethical Review

For all submissions, ethics approval is obtained from the Conjoint Health Research Ethics Board (CHREB), University of Calgary . Proposals are forwarded directly to the CHREB by the CHRO upon receipt. It is important to include a copy of the consent form with your submission to the CHRO.

Sample CHREB consent forms are available from the Office of Medical Bioethics or on their website . If there are ethics concerns, the investigator will be contacted by an ethics reviewer or Chair of the CHREB.

Approvals

Industry Developed Applications that are approved will receive 2 approval letters:

Institutional approval from the CHRO (issued before CHREB approval but is contingent on the study receiving CHREB approval)
Ethics approval from the CHREB

Both approvals must be obtained prior to commencement of your research.

If you have any questions, please contact the CHRO at 955-7241.