Using the following Regulatory Binder Template, you can create your own binder selecting the appropriate document templates to serve the purpose of your study.
QMCR Regulatory Binder Template and Table of Contents
Interventional Protocol Template
Observational Protocol Template
Qualified Investigator Undertaking (QIU)
Data Safety Monitoring Board (DSMB)
Delegation of Responsibility Log
Adverse Event Log
Drug Temperature Monitoring
Subject Visit Tracking Log
Case Report Form Samples
Investigational Product Accountability
Screening and Enrollment Log
Screen Failures/Lost to Follow-up
Serious Adverse Event Reporting
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.