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Monthly Centre Meetings – 2020

Monthly Centre Meeting Summary [December 04, 2020]

MONTHLY CENTRE MEETING SUMMARY [December 4, 2020]

Notices:

  • New consent template and updated Author Instruction Guide;
  • Re-issued pre-approved, centre-specific changes [adult and paediatric trials];
  • Pandemic-related changes in the conduct of the study – remote monitoring/consenting;

Reminders:

  • Upcoming submission deadlines – the submission deadline for the January 8, 2021 meeting is December 15, 2020;
  • Password protected documents;
  • Document nomenclature.

OCREB membership changes – The current and archived OCREB membership lists are posted on the OCREB website on the “Meetings and Membership” page. The list was last updated in December 2020.

New studies: submitted for the December 11, 2020 meeting (see minutes)

NOTEWORTHY ITEMS

  1. Management of clinical trials during the COVID-19 pandemic: HC Notice to clinical trial sponsors: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html
  2. The new ICTRP website: https://www.who.int/clinical-trials-registry-platform
  3. The National Institutes of Health (NIH) recently announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities that are being disproportionately affected by the COVID-19 pandemic. https://sph.unc.edu/sph-news/nih-funds-community-engagement-research-efforts-in-areas-hardest-hit-by-covid-19/?mc_cid=e6e096d946&mc_eid=3320c4be81

MONTHLY TELECONFERENCES

FRIDAY, JANUARY 1, 2021 – CANCELLED

FRIDAY, DECEMBER 4, 2020 -SCHEDULED

FRIDAY, NOVEMBER 6, 2020 – CANCELLED

Monthly Centre Meeting Summary [October 02, 2020]

Notices:

  • Release of new Main ICF Template including and Q&A
  • New Pre-Screening ICF Template
  • WOO trials
  • CTSU requirement for the inclusion of the protocol version date in the PCR approval

Reminders:

  • Managing Covid-19-related changes in the conduct of research
  • PA changes to provincial ICF documents in response to the REB review letter
  • Submission requirements for centre-specific ICFs – centre-specific ICFs do not require submission

OCREB membership changes – The current and archived OCREB membership lists are posted on the OCREB website on the “Meetings and Membership” page. The list was last updated on September 2020.

New studies: submitted for the October 9, 2020 meeting (see minutes)

NOTEWORTHY ITEMS

  • On behalf of the Panel on Research Ethics, the Secretariat on Responsible Conduct of Research is pleased to share new interpretations to support the community in applying the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, TCPS 2 (2018) during the current COVID-19 publicly declared emergency. The interpretations can be found at this link.    
  • CIRB COVID-19 information https://www.ncicirb.org/content/nci-cirb-information-about-covid-19
  • The registration of all interventional trials is a scientific, ethical and moral responsibility. https://www.who.int/ictrp/en/  – WHO International Clinical Trials Registry Platform – access to all registered trials that meet the approved registry criteria https://www.who.int/ictrp/search/externalplatforms/en/ – This page lists external search platforms that use the ICTRP data including COVID-19 trials

https://clinicaltrials.gov/ct2/home – one of the registries that meets the approved registry criteria

Friday, October 2, 2020 -SCHEDULED

Friday, September 4, 2020 -CANCELLED

Friday, August 7, 2020 – CANCELLED

Friday, July 3, 2020 -CANCELLED

Friday, June 5, 2020 – CANCELLED

Friday, May 1, 2020 -CANCELLED

Friday April 17, 2020 Teleconference (Rebooked from April 3rd, 2020)

Monthly Centre Meeting Summary [April 17, 2020 -updated]
Monthly Centre Meeting Summary [March 2020]

Notices:

NCWG ICF template 2020

  • The National Consent Wording Group is ready to release the new ICF templates – one for adults, one for paediatrics [non COG studies], and an Assent form. The roll out of the forms will be gradual giving applicants time to review the new requirements and to become familiar with the templates. More information to follow.

Reminders:

  • Physical risks in research – including lay language
  • Centre Amendments (CAMs) – requirements
  • Optional Consenting for Omni Trace and Participant Reimbursement Cards (e.g., ClinCard)

OCREB membership changes – updated February 1, 2020 (see www.ocreb.ca)

New Studies: submitted for the March 13, 2020  meeting (see minutes)

NOTEWORTHY ITEMS

  • TCPS 2 (2018) – Index added online – In response to the research community’s request, the Secretariat on Responsible Conduct of Research has created an index at the end of the PDF version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, TCPS 2 (2018). 
  • The 2020 edition of the International Compilation of Human Research Standards has been released and is now available online!
    It contains a list of over 1,000 laws, regulations, and guidelines on human participant protections in 133 countries and from many international organizations, most of which include hyperlinks to the source documents. The Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html
Monthly Centre Meeting Summary [February 2020]

Notices:

  • Survey of centres regarding resources for genetic counselling
  • Update on new consent template
  • REB of Record Agreements

Reminders:

  • Controlled honour system for ICF centre-specific forms
  • Distribution list for teleconferences and Study Contacts in CTO
  • Recruitment materials & Media releases
  • Change in REB meeting and submission date in April – Meeting April 3; submission date March 17
  • Updated REB SOPs and Addenda effective January 1, 2020

OCREB membership changes – updated February 1, 2020 (see www.ocreb.ca)

New Studies: submitted for the February 13, 2020  meeting (see minutes)

NOTEWORTHY ITEMS