All clinical trial research contracts must be forwarded for review to  Covenant Health, Legal Council, Finance Office, c/o the Edmonton General Continuing Care Centre. The Treasury & Risk Management, Finance Office, in consultation with legal counsel, will review all contracts and provide a written acknowledgement to the Principal Investigator / Research Coordinator when approval to proceed with execution of the contract is confirmed.

 

The Edmonton General Continuing Care Centre, the Grey Nuns Community Hospital, the Misericordia Community Hospital and any other Covenant Health sites involved must be referred to by their legal name, Covenant Health, in all contracts.

 

Approved signatures on contracts include the President, Vice-President, Finance & Administration, Vice President, Operations, or Senior Operating Officer.

Any questions regarding Covenant Health Clinical Trial Agreements can be directed to: Christina Huesing, Legal Counsel (780) 342-8921

In keeping with the standard set by Alberta Health Services, industry-sponsored clinical research conducted within a Covenant Health facility is charged 30% overhead. Ten percent will be returned to the Principal Investigator upon completion of the clinical trial. The Principal Investigator is responsible for submitting a request for the 10% rebate to the Covenant Health Research Centre upon completion of the clinical trial.

 

Investigator-initiated clinical research sponsored by industry is charged 15% overhead.

 

Investigators can request a reduction of the overhead rate by submitting a written letter of request to the Covenant Health Research Centre Advisory Committee c/o the Covenant Health Research Centre.

There is currently no mandatory requirement to register a clinical trial. Health Canada has been reviewing this issue and is expected to make a formal announcement in the near future.

 

If you wish to publish in one of the journals whose editors (International Committee of Medical Journal Editors - ICMJE) require registration, then it must be done before the clinical trial begins, otherwise registration is up to the individual researcher.

 

There are two commonly used registries, both which meet the requirements of the ICMJE.

 

U.S.-based/free

 

U.K.-based/$210 Cdn. to register a trial (CIHR does require registration with this one)