Canadian Cancer Trials Group Bulletins

Ethics Regulatory


Changes to Canadian Cancer Trials Group Informed Consent Policies

In compliance with ICH-GCP and to facilitate compliance with local REB policy, signature of the patient and the person conducting the informed consent discussion are now the minimum requirements (previously, the required signatures were those of the patient and an investigator).

Alternate wording to this signature block will be permitted (i.e. signature of investigator,
signature of doctor/physician, signature of person obtaining informed consent). All signatures, regardless of block, must be prior to patient enrollment (i.e. registration or randomization, whichever is first).

Clinical Investigators (CI), Principal Researchers (PR), and Clinical Research Associates (CRA) may conduct the informed consent discussion and obtain consent provided that:
(1) this is within the local REB policy;
(2) they are delegated the duty on the Participant List; and
(3) the delegation is clearly outlined in local standard operating procedures and these are available for on-site monitoring.

It is no longer mandatory that the whole patient Informed Consent form be submitted to Central Office. Canadian Cancer Trials Group will accept submission of the Informed Consent form signature page(s) and completed checkbox page(s) (for optional components of the study) provided the page(s) contain the version date of the local informed consent form. If the signature/checkbox page does not indicate the version date, centres must continue submitting the entire patient consent form.

A memo outlining these changes can be found on the ER website at http://www.ctg.queensu.ca/private/ethics/MemoToCentresReSignaturesFINAL.pdf.

Questions about these changes should be directed to Erin Bell, ER Team Leader, at 613-533-6430 or ebell@ctg.queensu.ca.