Quality Management in Clinical Research

The Quality Management in Clinical Research (QMCR) Department was created as an oversight mechanism for human research activities conducted at the University of Alberta.

In order to ensure QMCR has an arms' length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services.

While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.

Mission

The mission of the Quality Management in Clinical Research unit is to ensure clinical research at the University of Alberta is conducted according to the highest scientific and ethical standards, complies with local, national, and international policies as well as governing statutes and regulations, and that internal quality systems are comprehensive, appropriate, and effective.

Values

Society places a trust in scholars and researchers to pursue knowledge in a manner that respects the values of beneficence, freedom from exploitation, honesty, fairness and justice. These values will be characterized by a dedication to excellence demonstrated through:

Integrity

QMCR will work to establish trust and thus provide a basis for reliance upon its judgment.

Objectivity

QMCR will exhibit the highest level of professional objectivity in gathering,evaluating and communicating information about the activity or process being examined.

Confidentiality

QMCR will respect the value and ownership of information received and not disclose information without appropriate authority unless there is a legal or professional obligation to do so.

Competency

QMCR will apply the knowledge, skills and experience needed in the performance of its quality management services.

Mandate

QMCR's mandate is to take an integrated approach to assuring that the rights, safety and well-being of trial subjects are protected and that clinical data generated at the University of Alberta are credible.

The QMCR Department was created as an oversight mechanism for human research activities conducted at the University of Alberta.

In order to ensure QMCR has an arms' length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services.

While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.

The QMCR Department was created as an oversight mechanism for human research activities conducted at the University of Alberta.

In order to ensure QMCR has an arms' length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services.

While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.

The QMCR Department was created as an oversight mechanism for human research activities conducted at the University of Alberta.

In order to ensure QMCR has an arms' length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services.

While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.


News

Private Health, Public Risk? How the Alberta government allowed a private foundation to offer an unproven "experimental" health program to its citizens
CBC News - The Alberta government has for years allowed the foundation of wealthy Calgary oilman Allan Markin to offer a private, unproven alternative health program, which some experts say is effectively a research "experiment" that has potentially risked the health of tens of thousands of people, including the homeless, addicted and seniors.

80% of China's clinical trial data are fraudulent, investigation finds
BMJ-Oct 5, 2016 - Just over 80% of clinical trial data submitted to support new drug registrations in China have been revealed as fraudulent or substandard by the country's drug regulator.

European Drug Regulator Releases Clinical Trail Data
The Scientist-October, 2016 - In the initial steps of a campaign to make clinical reports publicly available, the European Medicines Agency has published data on two recently approved drugs.

Canada funding agency bans researcher for fraud, and in first, reveals her name
Retraction Watch-July 19, 2016 - The Canadian Institutes of Health Research (CIHR) has banned a bone researcher for life following a finding of misconduct. And in a first, the agency has named her, in their report out today.

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.

Toronto doctor says it's time to lock up research miscreants
Margartet Munro-Jul 15, 2014 - A leading Toronto doctor has reignited debate over research fraud saying doctors and academics who fudge and fabricate data should be locked up.

Settlement reached in U.S Pradaxa lawsuits
Steve Buist-May 29, 2014 - Pharmaceutical giant Boehringer Ingelheim has agreed to pay $650 million US to settle about 4,000 lawsuits in the United States related to Pradaxa

Trial and errors? Mac, HHS sued over drug safety
Steve Buist-Feb 15, 2014 - In an unprecedented case, McMaster University and Hamilton Health Sciences are facing lawsuits in the United States over the safety of the drug Pradaxa.

Ottawa dentist Khaled Hashem banned after botched procedures
Andrew Foote-Oct 17, 2013-CBC News: An Ottawa man could face criminal charges if it's found he tried to perform dentistry work, the latest punishment for "professional misconduct" that included cementing human teeth into another patient.