All centres in Canada providing medical care/consultation to cancer patients are eligible to become Member Centres of the Canadian Cancer Trials Group. In addition, other centres within Canada can become Single Study Member Centres and are subject to the same general review and approval processes and requirements. In this instance, centres have limited approval, and may not be required to meet all the requirements of full membership (for example, a centre participating as a single study member on a surgical trial will not need to fulfill the requirements for pharmacy facilities).

The minimum requirements for membership of a Member Centre are:

• Identification of a Qualified Investigator (QI) with appropriate and current credentials willing to take responsibility for overall Canadian Cancer Trials Group trial management and serve as the Centre Representative liaison between the centre and the Canadian Cancer Trials Group Central Operations and Statistics Office (not applicable for Single Study Member Centres);
• An established (usually oncology) patient population to ensure recruitment is possible and a commitment to enrolling patients;
• Adequate resources to conduct clinical trials and an indication that the level of patient accrual will be sufficient to ensure continuity of data management staff;
• Established SOPs regarding clinical trial conduct, processes and applicable regulations;
• A demonstrated commitment to providing dedicated data management for Canadian Cancer Trials Group trials;
• An established system for ethics review of protocols and investigator brochure/safety information (or written policy that confirms local acceptance of second-party centre review, e.g. from an affiliated university);
• Access to adequate laboratory and radiological or nuclear medicine facilities for trial investigations to be carried out; and,

Centres must continue to meet these requirements and achieve set performance standards defined by central monitoring, on site auditing/monitoring, and Centre Performance Index (CPI).

Restrictions to Membership

Randomization and registration privileges may be suspended if a Centre fails to meet set standards of quality assurance. Centres that are inactive for a period of years will be required to provide written evidence of an ongoing commitment to participate in Canadian Cancer Trials Group trials; if unable to do so, the Centre be withdrawn.

Centre and Investigator Responsibilities

An institution joining the Canadian Cancer Trials Group acknowledges certain responsibilities which are outlined in a Participating Centre Agreement (PCA). One individual per centre (i.e. Centre Representative) assumes the overall responsibility for liaising with the Canadian Cancer Trials Group Central Office and is a signatory to the PCA. The duties of the Centre Representative are to:
 

• Function as overall "qualified investigator", i.e. provide intellectual and administrative leadership for Canadian Cancer Trials Group activities in the Centre;
• Serve as primary contact for communication to and from Central Office;
• Supervise the distribution of per case funding;
• Appoint, in conjunction with Central Office, Disease Site Committee members;
• Nominate investigators and clinical research associates to attend the Canadian Cancer Trials Group Annual Spring Meeting of Participants;
• Receive and respond to, as necessary, periodic Centre performance assessments provided by Central Office; and,
• Supervise the implementation of corrective measures if the Centre fails to meet minimum performance standards.

Participation: Phase III trials

Canadian Cancer Trials Group Member and/or Single Study Member Centres will be invited to participate on specific studies based on their track record in similar studies. In general, there are no limitations to Canadian Member Centres participating in Phase III studies provided the Centre is in good standing, active, and has the appropriate facilities necessary to conduct the study. Participation may be limited to select centres for certain trials such as National Cancer Institute United States (NCI US) trials and trials conducted under a Clinical Trials Application (CTA). In addition, monitoring feasibility, past accrual, and performance may be a consideration in evaluating participation.

Participation: Investigational New Drug Trials

Phase I and II trials are conducted in select Canadian Cancer Trials Group Member Centres. Phase II trials are usually restricted to 5-7 centres, generally those with an accrual track record in the tumour type of interest. Phase I trials of new anticancer agents are usually carried out in a maximum of 2-3 centres and is restricted to those centres that have the appropriate facilities and trained investigators in pharmacologic evaluation of new drugs. Centres interested in participating in Investigational New Drug (IND) trials must fulfill the following requirements:
 

• On-site clinical oncologists / investigators possessing current and valid credentials;
• Chemotherapy nursing support;
• On-site clinical trials nurse/data manager;
• Appropriate laboratory and imaging facilities;
• Appropriate hospital facilities (intensive care and support services);
• Pharmacy knowledgeable about investigational new drugs, vertical laminar flow hood, etc.;
• Ability to perform quality control measures;
• Established track record in phase III trials (protocol adherence, data quality and timeliness); and,
• Permission of sponsoring agency

Centre Applications for Member Status & Participating Centre Agreement

Centres interested in becoming a member of the Canadian Cancer Trials Group should email the Group Administrator’s Office (GAO) at cctg-gao@ctg.queensu.ca.

A teleconference will be arranged to discuss Centre requirements and an application package will be provided for completion. As part of the application process, both the Centre and the Canadian Cancer Trials Group Central Office are required to acknowledge certain responsibilities that are outlined in a Participating Centre Agreement (PCA). All investigators participating in Canadian Cancer Trials Group trials are bound by the terms listed in the PCA. Additional documents required as part of the application process includes, but is not limited to the following:

• Documentation of required roles
• Confirmation of training completion for all centre personnel (Ethics, GCP, Canadian Food and Drug Regulations Part C Division 5 as required by role)
• CVs for all Centre Investigators
• Research Ethics Board Membership List
• FWA number

(information summarized from http://www.hhs.gov/ohrp/ ) OHRP Toll-free (866) 447-4777

FWA

The Office for Human Research Protections (OHRP) in the United States (US) requires that each institution provide written assurance that it will abide by principles and procedures that meet or exceed US standards for research involving human subjects. In addition, each institution must certify to the OHRP that the research has been approved by a Research Ethics Board designated in the assurance.

Filing an FWA

Centres are required to complete the application and forward it directly to OHRP. [Detailed Instructions for completing an FWA, as well as registering an IRB can be found on the OHRP website Once a centre receives their FWA number, they must notify Canadian Cancer Trials Group. This information will be entered into the database along with the expiration date. A centre cannot be activated on an NCI US affiliated trial unless a current FWA number is on file. The FWA will expire 3 years after the approval date. Any updates to the FWA should be submitted by the centre to OHRP throughout the 3 years whenever there are changes in the information provided on the approved FWA. The OHRP lists all REB registration numbers and FWA numbers on their website. Any institution is eligible to file an FWA with the HHS/OHRP. Detailed instructions for completing an FWA application, as well as, registering an REB can be found on the following OHRP website Each legally separate entity that engages in U.S. federally-supported human subject research will need its own FWA under the new system. The institutional FWA Signatory must be an individual who has the legal authority to represent the institution named in the FWA, as well as all the institutional components listed in the FWA. Entities that the Signatory Official is not legally authorized to represent may not be covered under the FWA.

Education

Institutional Signatory Official, the Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person), the REB Chairperson(s), REB members, REB staff, and research investigators must be appropriately trained in the protection of human subjects. Upon request, they should be able to demonstrate knowledge of the FWA Terms of Assurance for Institutions Outside the United States, and of the Ethical Standards and International Codes referenced in their institution's FW

The FWA recommends that the Signatory Official, Human Protections Administrator, and the REB Chairperson complete the web-based OHRP training modules.