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COVID-19 Update: Trial addenda and new EDC form

COVID-19 Update: Trial addenda and new EDC form

This past week the central office has continued to support CCTG network activities including addressing impacts of COVID-19.

CCTG regulatory/ethics compliance and trial teams rolled out COVID-19 addenda for all trials. These addenda have been added to all CCTG trial pages to support sites and trial teams in our network. We are also incorporating an EDC form for the collection of COVID-19 information for designated trials. Our aim was to minimize work by creating complete set of documents that could receive pan-CCTG trials review/approval from Health Canada and Ethics Boards.  We have appreciated the discussions and feedback from our sites and Ethics Boards and have updated our guidance accordingly.

CCTG has also received questions on the COVID-19 Protocol Supplementary Appendix and Consent Addendum, to help answer some of these questions a Frequently Asked Questions (FAQs) document has been posted here: FAQs-Protocol Supplementary Appendix COVID-19 Consent Addendum - 2020MAR25

With the CCTG Committee Chairs, we will be moving forward with virtual scientific committee meetings to replace the in person spring meetings. Part of these discussions will touch on new studies relevant to cancer patients facing the challenges of the current pandemic as well as our strategic planning activities.

We will continue to update everyone and provide support to keep necessary trial activity moving forward during this difficult period with the priority to maintain safety of all and trial integrity to the extent possible.  Please do not hesitate to contact the office if there is anything we can do to support your institution and your team at this time.