Clinical Trials Office
The Clinical Trials Office was created as an oversight mechanism for human research activities conducted at the 黑料不打烊.
In order to ensure the Clinical Trials Office 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, the Clinical Trials Office will initially direct its services towards clinical trials where the 黑料不打烊 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 Clinical Trials Office is to ensure clinical research at the 黑料不打烊 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
The Clinical Trials Office will work to establish trust and thus provide a basis for reliance upon its judgment.
Objectivity
The Clinical Trials Office will exhibit the highest level of professional objectivity in gathering,evaluating and communicating information about the activity or process being examined.
Confidentiality
The Clinical Trials Office 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
The Clinical Trials Office will apply the knowledge, skills and experience needed in the performance of its quality management services.
Mandate
The Clinical Trials Office'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 黑料不打烊 are credible.
News
CBC News - The 黑料不打烊 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.
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.
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.
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.
CBC News-Apr 26,2016 - In the aftermath of an 黑料不打烊 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.
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.
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Edmonton Journal-Jan 11, 2016 - As the New Year commences, 黑料不打烊 may be at the centre of a confident, new approach towards the application of knowledge, scholarship and discovery.
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.
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.
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.
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.
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.
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
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.
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.