Updates to process Wednesday, January 09, 2019 Privacy Breach Process This is a reminder to obscure all personal identifiers of participants from reports and correspondence sent to CCTG and to provide an update on our privacy breach process. The Canadian Cancer Trials Group has recently sent an email to Centre Representatives and Contact Clinical Research Associates on December 21, 2018 outlining how to prevent a privacy breach and what to expect if one occurs. How to prevent a Privacy Breach: Centres are required to locally obscure patient name, address, telephone number, hospital number and health card number from any supporting documents and correspondence sent to CCTG. For copies of a consent signature page submitted to CCTG, centres are expected to redact (black out) the participant’s name and signature on the submitted copy, leaving only a portion visible (e.g. initials or loops) to confirm that a person has signed but that cannot identify that individual. What to expect from CCTG if a privacy breach is identified, as of January 1, 2019: CCTG will require centres to follow their local policy for privacy breach, to retain documentation of how the privacy breach was managed on site and if applicable, to send or upload a redacted document. CCTG will issue a Notification of Privacy Breach Letter to the centre’s Qualified Investigator and the Principal Clinical Research Associate for the related trial, as well as to the sender/source of the privacy breach. If you have any questions, please contact the Ethics and Regulatory Team Leader (ertl@ctg.queensu.ca).
