RRO News
NAGANO Training workshop
Thursday, September 23, 2021 from 1 to 3 pm.
To register, please contact Jordan: cer@jgh.mcgill.ca
2021 : Two new features to harmonize the evaluation of clinical trials across Quebec :
- Updated "Standard Legal Clauses of Information and Consent Forms in Clinical Trials" (
MSSS,2021).
- Updated multicenter evaluation process in Nagano (March 15, 2021). Consult the video clips intended for researchers and research teams:
http://formations.nagano.ca/
How to conduct research at a distance? - RRISIQ event•March 10 2021
Conducting research in the context of the current pandemic is challenging. Many traditional research practices are no longer viable as research must frequently be conducted at a distance. How do researchers adapt or change these practices and ensure the highest ethical standards are maintained? How are recruitment strategies implemented? How is the consent process conducted? What information should be included in consent forms? How can data be collected? What are the best methods to store these different types of data? What type of challenges may researchers encounter with these new practices? In this presentation, these questions will be addressed and practical solutions proposed. The ethical principles that underlie best ethical practices will be highlighted.
Consult the presentation by Dr. Linda Furlini* :
« At a Distance : Changing and Adapting Research Practices Ethically During a Pandemic »
*The information contained in this presentation excludes research falling under the jurisdiction of Health Canada, such as drug and medical device clinical trials.
Public web conference on ICH E6
On behalf of the International Council for Harmonisation (ICH), the ICH E6 Guideline for Good Clinical Practice (GCP) Expert Working Group (EWG) will hold a free public web conference on May 18-19, 2021 to provide an update on the progress to revise this important and impactful guideline. The web conference will be convened by the Clinical Trials Transformation Initiative (CTTI).
There will be two similar meetings on Tuesday, May 18 from 8-11 a.m. EDT and Wednesday, May 19 from 5-8 a.m. EDT to reach a broad global audience across time zones. The same topics will be presented each day with speakers from different regions to represent the global effort. All information and presentations will be provided in English.
ICH E6 guideline for good clinical practice (GCP) is the international ethical, scientific, and quality standard for the conduct of clinical trials for the development of new drugs and biologics involving human participants intended to support regulatory applications. Due to the wide impact of this important guideline, the ICH Management Committee is taking this unique step to provide a status update on the revisions to this guideline.
In this web conference, members of the EWG will discuss the work-in-progress to develop principles and annexes for ICH E6 GCP (third version or R3) that are intended to be responsive across clinical trial types and settings and remain relevant as technology and methodologies advance. The draft, work-in-progress principles that were made public by the ICH on April 19 are designed to be flexible and applicable to a broad range of clinical trials. View the principles on the ICH website. The EWG is not taking public comments on the principles at this stage. However, once the ICH E6 guideline achieves step 3 of the ICH guideline development process, the EWG will invite and consider public input.
For more information and to register for the web conference:
Day 1 Registration: duke.zoom.us/webinar/register/WN_6MVjr6qsQxSgYrCuJ-6Xyw
Day 2 Registration: duke.zoom.us/webinar/register/WN_OzK4XPh_Shq-XniAxpKKJw