Canada’s second National Health Ethics Week is being held from March 2 to March 8, 2015. This event is being coordinated by the Canadian Bioethics Society (CBS), in collaboration with various organizations across Canada.
In conjunction with this event, Veritas IRB Inc. is releasing the iBook version of The Investigator’s Manual, a Complete Guide to Conducting Clinical Research in North America. The publication of this manual is part of Veritas IRB Inc.’s commitment to promote best practices in clinical research. In its iBook format, Veritas IRB’s Investigator’s Manual allows for accessible, easy and interactive reading on an iPad or iPad mini. The Manual will also be available in ePUB format.
Even with the proper training, clinical investigators and their staff may feel overwhelmed when faced with the daily pressures of recruiting the right participants, ensuring compliance with the study protocol as well as properly managing, reporting and documenting the numerous events that may occur during a clinical trial. The Investigator’s Manual puts answers to frequent questions that arise during the conduct of clinical trials at researchers’ fingertips – questions such as:
• What are my responsibilities as an investigator?
• How do I recruit my first research participant?
• How do I obtain free and informed consent?
• What is the difference between a protocol deviation and a protocol violation?
• What adverse events do I need to report to the IRB?
With its glossary, diagrams, tables and checklists, the Investigator’s Manual is an indispensable tool in preventing some of the most common regulatory agency non-compliance findings:
• Failure to follow the study protocol and/or regulations
• Inadequate communication with the REB/IRB
• Inadequate study documentation and record-keeping
• Inadequate supervision of clinical trials
• Inadequate participant protection – including lack of free and informed consent
• Inadequate accountability for the investigational product
While the Investigator’s Manual is geared towards clinical trial investigators and their personnel, it also represents a valuable, pertinent reference and training document for monitoring clinical research associates and quality assurance professionals.
The Investigator Manual is a living document that, like clinical trials designs and the ethics of conducting them, will evolve as researchers challenge traditional research paradigms in search of targeted therapies.
We hope you find it useful, and welcome your feedback.
