Services Provided

Clinical Trial Application (CTA) Administration

All PI-initiated trials requiring a clinical trial application to Health Canada must seek the assistance of QMCR's Clinical Trial Application administrator. The administrator will guide you through the CTA process and review your application prior to obtaining Dean, Chair and Senior Executive Officer signatures

Risk Assessment

QMCR will send all PI-initiated trial protocols requiring a clinical trial application to Health Canada for review by the PI as well as independent reviewers. The resultant score will serve as the basis for determining the degree of trial monitoring that will be provided, risk based audit selection as well as data safety monitoring requirements. QMCR will provide guidance for data safety monitoring plans and board set up (DSMP/DSMB) for high risk trials.

Clinicaltrials.gov Management

QMCR provides Clincaltrials.gov support for all PI-initiated trails. The administrator will set up accounts for investigators under University of Alberta sponsorship. Investigators will be able to register trials and enter all required information. Completed records will be reviewed and approved by QMCR before being publicly released. QMCR ensures that all records are kept up to date and issues are resolved in a timely manner.

Quality Improvement (QI)

Providing leadership in research quality and implementing initiatives that promote research excellence (e.g. promoting awareness of University policies and procedures, as well as national and international regulations, guidance to PIs, Faculties, Departments etc through seminars, workshops or one-on-one consultation). QMCR will serve as a resource regarding adherence to regulatory and ethical requirements as well as the conduct of good clinical practices.

Quality Control (QC)

Monitoring Principal Investigator-initiated studies being conducted at the University, Alberta Health Services and Covenant Health (selection methods considered include volunteer basis, random or risk-based selection). QMCR will also provide, although to a lesser extent, oversight to industry-driven trials that have their own monitors.

Quality Assurance (QA)

For-cause auditing of any human research, as well as random/risk-based selection of studies to evaluate performance of quality improvement and quality control mechanisms. We will also assess and advise the Health Research Ethics Board (Panels A and B) and NACTRC, on their policies and performance.

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News/Articles

Canadian researchers who commit scientific fraud are protected by privacy laws.
Toronto Star-July 12, 2016- The publicly funded agency responsible for policing scientific fraud is keeping secret the details surrounding these researchers. Their names, where they worked, and what they did wrong is protected under privacy laws.

Health Canada 'legitimizes' natural health products, doctor says in wake of meningitis case.
CBC News-Apr 26,2016- In the aftermath of an Alberta court's guilty verdict against the parents of 19-month-old Ezekiel Stephan, who died from meningitis after they used natural remedies and didn't seek conventional medical treatment, a Toronto physician is questioning Health Canada's policies on natural products.

Clinical Drug Trial in France Sends 6 to Hospital in 'Serious Accident'.
CBC News-Jan 15, 2016-One man is brain dead and three others are facing possible permanent brain damage after volunteering to take part in a drug test in western France, the French Health Ministry said Friday.

Opinion: Alberta ideal as centre for world-class research and discovery.
Edmonton Journal-Jan 11, 2016-As the New Year commences, Alberta may be at the centre of a confident, new approach towards the application of knowledge, scholarship and discovery.

Experts Said His Cancer Research Would Save 10,000 Lives a Year. Turns Out it was Fake.
EAB-Nov 10, 2015-Anil Potti's research was hailed as the "holy grail" in cancer treatment. Now, the federal government has affirmed what many say they already suspected-that Potti fabricated the data.

Memorial University Called 'Real Villain' as BMJ Ditches Chandra Research.
CBC News-Oct 29, 2015-A prominent medical journal says Memorial University is "the real villain" in a case that's now prompted the magazine to retract a scientific paper written by a Newfoundland doctor more than 25 years ago.

16 Years Ago, a Doctor Published a Study. It was Completely Made Up, and it Made Us All Sicker.
Adam Mordecai-Dec 12, 2014-Once upon a time, a scientist named Dr. Andrew Wakefield published in the medical journal The Lancet that he had discovered a link between autism and vaccines.

Fecal Transplants are Changing Patients' lives.
Eman Bare-Nov 19, 2014-Who knew human waste could be valuable to our health? An Edmonton doctor is one of the few in Canada performing a kind of transplant with a big "ick" factor: fecal.