Canadian Cancer Trials Group Bulletins

Trial Management Group


Withdrawal of Consent Policy

Protocol-specified follow-up of participants enrolled on study is critical to the conduct and analysis of our clinical trials. From time to time, a patient may choose to withdraw his/her consent to continue to participate in the clinical trial. Canadian Cancer Trials Group has developed a new Withdrawal of Consent Policy that we are now pleased to roll out to centres.

A patient is considered to have withdrawn his/her consent to participate in a clinical trial when the patient no longer wishes to participate in the study and does not want any future clinical data submitted to the coordinating group.

Withdrawal of Consent case report forms for both paper trials and EDC trials have been developed. These forms are available for paper trials immediately and will be available for EDC trials over the next month. If you have any questions about the implementation for specific trials, please contact the relevant trial team.

For further information on this new policy and for details on how to designate a patient as withdrawn, please visit this link: http://www.ctg.queensu.ca/trials/NCICCTGWithdrawalofConsentPolicy.pdf

If you have any questions on this policy, please do not hesitate to contact the relevant trial teams.