Training
Investigator / Coordinator Clinical Research Orientation
This one-day event designed to orient clinician researchers, coordinators, and other interested stakeholders to the key administrative and support services neccessary and available for conducting both industry-sponsored and investigator-initiated clinical trials at the University of Alberta.
Topics covered will include: deciphering the acronyms in this announcment, obtaining project design and methods consultation, devloping a protocol and case report forms, introduction to the U of A ethics process, submitting a Health Canada application, setting up a research account, submitting a clinical trial research agreement, obtaining AHS operational and administrative approvals, submitting requests for AHS health data access and disclosure, and obtaining study coordination and monitoring services.
Next course date scheduled Spring 2020.
For more information, please contact Scott Jamieson at scott.jamieson@ualberta.ca
Health Information Act Training Course (FREE)
University of Alberta Faculty of Medicine and Dentistry Health Information Act Training Course.
Begin ICH E6 R2-GCP training or NEW Refresher Course (FREE)
The Office for Quality Management in Clinical Research (QMCR) is pleased to announce the release of the ICH E6 R2-GCP updated Good Clinical Practice (GCP) Basic Course. The 10-module course is now available through the Collaborative Institutional Training Initiative (CITI). Click on the links below and be sure to navigate to "Canadian Institutions" and choose "University of Alberta" prior to choosing your desired course(s). Take the courses at your own pace and recieve a certificate upon successful completion that you can file in your personnel files.
ACRP Ethics and Human Subject Protection
After registering select Pricing Without Contacts Hours
Note: there is currently not the ability to generate a completion certificate, instead participants are instructed to take a screenshot of the transcripts area that indicates they have taken the course
Sometime in November, ACRP will launch the Refresher course (about 45 minutes in length) to this topic.
Begin ACRP Ethics and Human Subject Protection
Clinical Research Coordinator (CRC) training AND Biosafety/Biosecurity (BSS) training is now available for all UofA affiliated researchers and research staff
As a member of N2, the University of Alberta is pleased to announce the release of the CITI Clinical Research Coordinator (CRC) course and Biosafety/Biosecurity (BSS) training at no cost.
Click on the link below and be sure to navigate to "Canadian Institutions" and choose "University of Alberta" prior to choosing any training courses:
CRC Course Description: The CRC series provides foundational training specifically focused on operational and regulatory elements necessary for the ethical conduct of clinical research, while at the same time, it is tailored to the needs of clinical research professionals. It offers learners a foundation that expands beyond, but is directly connected to, Good Clinical Practice (GCP) training.
BSS Series: The BSS series covers a variety of biosafety and biosecurity topics, and addresses basic information for multiple regulations, standards, and guidelines. BSS content is suitable for a broad range of audiences ranging from researchers working in laboratories that handle biohazards to persons who serve in biosafety offices.
Division 5 Course is LIVE for UofA staff and students
As a member of N2, the University of Alberta is pleased to announce the release of the CITI-Canada HEALTH CANADA DIVISION 5 Course.
Course Description: The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. Specifically, Part C, Division 5 of the Regulationsaddresses drugs for clinical trials involving human subjects. It is Health Canada's position that the Qualified Investigator must ensure compliance with the Regulations and the International Conference on HarmonisationGood Clinical Practice (ICH-GCP E6) Guideline (incorporated in the Regulations) from every person involved in the conduct of the clinical trial at their site. To that end, there should be evidence of satisfactory training of personnel involved in these processes. The successful completion of this CITI-Canada course can be used as evidence of training in Division 5 Regulations. This "Division 5" course covers all research conducted under Division 5Regulations and it provides practical solutions and methods for complying with the Regulations.
Click on the link below and be sure to navigate to "Canadian Institutions" and choose "University of Alberta" prior to choosing Division 5 training:
Responsible Conduct of Research
The Biomedical Research Ethics Tutorial
Social and Behavioral Research Course
Transportation of Dangerous Goods TDG/IATA Course
The Collaborative Institutional Training Initiative (CITI) was founded in March 2000 as a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a web based training program in human research subjects protections. In response to the June 2000 education policy announcement, the collaboration was expanded to include content experts from 10 institutions who provided the content for the first 12 biomedical modules. In addition to the "Basic" content, the CITI model provides the opportunity for institutions to post additional instructional materials specific to their institution. The first version of the CITI Course in The Protection of Human Research Subjects, hosted at the University of Miami, was rolled out to the participants on September 3, 2000. In December 2000, the CITI Course site was made available to institutions by subscription.
In Spring 2004, the CITI Program was migrated to a new software platform developed at the VA by Mike Fallon, DVM, PhD, and Stephanie Manuel, MSME. subsequent upgrades in hardware and software were made in 2007 and 2009 to permit the program to broaden it's scope and to expand the courses offered to participating institutions and organizations around the world.
The CITI Program, co-founded by Karen Hansen and Paul Braunschweiger Ph.D, is now on it's 10th iteration and includes:
- Basic Courses in the Protection of Human Research Subjects.
- Good Clinical Practice Courses.
- Health Information Privacy and Security Course (HIPS) including HITECH
- Laboratory Animal Research Courses For Investigators and IACUC Members
- Responsible Conduct of Research (RCR) Courses.
- Bio-Safety and Bio-Security
A multi-language course site, with materials in Spanish, Portuguese, French, Chinese, Thai, Japanese and Russian languages is now available for our international participants. Additional Non-English content is being added every year.
As of May 2010, the CITI Program is used by over 1130 participating institutions and facilities from around the world. Over 1,300,000 people have registered and completed a CITI course since September 2000 and now more than 35,000 new learners complete a CITI Program course every month. The CITI Program could not remain dynamic and responsive to the needs of our participants without the unselfish efforts of theCITI Developers Group. The Group meets semi-annually to review the courses, make editorial changes and to develop new initiatives for the CITI Program. The CoFounders are provided guidance and advice from the CITI Executive Advisory Committee chaired by Ernest Prentice Ph.D.
Inquires about the CITI Program should be directed to the CITI Office at the University of Miami at 305 243-7970 or by email to citisupport@med.miami.edu.