Participants List & Participants List Change Form
|We wanted to remind centre staff about important information regarding the completion of the Canadian Cancer Trials Group Participants List & Participants List Change Form. (Please note the Participants List is submitted at the time of local activation. Any staff changes taking place after local activation must be submitted using the Participants List Change Form.)
According to ICH-GCP Section 4.1.5, for each trial conducted at the centre, the qualified investigator should maintain a list of appropriately-qualified persons to whom the investigator has delegated significant trial-related duties. The Canadian Cancer Trials Group Participants List and Participants List Change Form are documents that are used to fulfill this ICH-GCP requirement. In addition, these forms are used to collect centre and participant-specific information and to keep our membership roster up-to-date. It is essential that these documents be completed accurately to prevent delays in activation or randomizations. These lists must also be accurately maintained; therefore, changes must be provided to Canadian Cancer Trials Group as quickly as possible.
Participating centres should have SOP's delineating their policies regarding delegation of study-related duties at their centre. In addition, guidance on Canadian Cancer Trials Group's policy on the delegation of significant trial-related duties is available in the Guidance for Investigators - Delegation of Significant Trial-Related Duties (http://www.ctg.queensu.ca/trials/generic_forms_public/PL_PLCF/AMG-REF-0012_guidance_for_investigators.pdf). Duties which may not be delegated are clearly defined for investigator guidance.
- Each participant must have a role assigned which must match the options at the bottom of the form. Please do not leave blank or add your own role code.
- Delegation of duties must be clearly indicated for each role. Please do not leave blank. Please ensure investigator-only duties are not assigned to CRAs or others.
- Trial roles must include a Principal Investigator (PI), Principal CRA (PCRA), Ethic CRA (ECRA) and, for studies involving investigational agents, a Principal Pharmacist (PPHARM);
- All investigators must have a current CV, and have completed NIH ethics education and GCP training to be added to the Canadian Cancer Trials Group roster.
- All Participants Lists and Change Forms must be signed by the PI;
- Trial ID and Canadian Cancer Trials Group centre code must be clearly indicated on every page of the form (you can find Canadian Cancer Trials Group centre codes at http://www.ctg.queensu.ca/public/about/centre_codes.html);
- Forms are e-fillable or can be completed by hand (if so, please print clearly);
- If a participant moves within a role (e.g. AI changing to PI, ACRA changing to PCRA) it is not necessary to indicate the removal (e.g. remove AI, remove ACRA).
For new centre participants, please refer to Registration Information for New Centre Participants at http://www.ctg.queensu.ca/public/Clinical_Trials/InformationforNewCentreStaff.pdf.
Please direct questions regarding Participants Lists and Change Forms to firstname.lastname@example.org.