Information for New Centre Participants

Federalwide Assurance

Investigator Requirements

Centre Requirements

MEMBERSHIP REQUIREMENTS

All institutions in Canada providing care to cancer patients are potentially eligible to be ongoing member centres of the NCIC CTG.

The basic requirements for centre membership in the Clinical Trials Group are as follows:

• an investigator with appropriate credentials willing to take responsibility for NCIC CTG trials management and liaison (i.e. serve as Centre Representative)
• a demonstrated commitment to providing data management dedicated to NCIC CTG trials;
• an indication that the level of patient accrual will be sufficient to ensure continuity of data management staff;
• an established system for ethical review of protocols (or written policy that confirms local acceptance of second-party institution review, e.g. from an affiliated university);
• access to laboratory and radiological/nuclear medicine facilities for trial investigations to be carried out.

Participation on IND Trials

Phase I and II trials are conducted in a subset of NCIC CTG participating centres. Criteria for approving a centre for IND trials were created by the IND Committee some years ago.

Phase II trials are usually restricted to 5-7 institutions, generally those who have a track record of accrual in that tumor type. Exceptions to this number are made in the case of very rare tumors where accrual would otherwise be an issue. In these cases up to 10 centres are activated.

Phase I trials of new anticancer agents are carried out in a maximum of two institutions. Participation is restricted to Canadian centres which have the appropriate facilities and trained investigators in pharmacologic evaluation of new drugs. To expedite decision making in an ongoing Phase I trial, the NCIC CTG office requires FAX information from Phase I participants and, following discussion with the principal investigators will open/close dose levels as necessary. Phase I trials of drug combinations that are tumor targeted may run in up to four centres depending on the rarity of the tumor.

Centres interested in participating in IND trials must fulfill the following requirements:

• presence of clinical oncologists on-site
• nursing support for chemotherapy
• clinical trials nurse/data manager present on-site
• appropriate lab and imaging facilities
• appropriate hospital facilities (intensive care and support services)
• pharmacy knowledgeable about investigational new drugs, vertical laminar flow hood, and so on (can be addressed with training)
• the centre must have the wherewithal to have quality control performed
• established "track record" in phase III trials (protocol adherence, data quality and timeliness)
• permission of sponsoring agency

Restrictions to Membership

Randomization and registration privileges may be suspended in a centre as a result of failure to meet set standards of quality assurance. Centres which are inactive for a period of years are required to provide written evidence of an ongoing commitment to participate in NCIC CTG trials, otherwise membership may be annulled.

Centre Applications for Member Status

The following documentation is sent to an institution wishing to become a member centre with NCIC CTG:

• Cover letter welcoming their participation
• Sections from the NCIC CTG participant's manual (on hold until updated)
• New Centre Information Sheet
• Objectives & Obligations signature form
• Participating Centre Study Agreement
• REB Membership Information form

If a centre plans to accrue patients to US intergroup trials or trials otherwise involving the invocation of US regulations they also need to apply for an Federalwide Assurance number (FWA).

Centre and Investigator Responsibilities

An institution joining the Clinical Trials Group acknowledges certain responsibilities which are spelled out in an agreement signed by a representative of the centre and the Director of the Group. All investigators participating in NCIC CTG trials within the centre are bound by the terms listed in the Participating Centre Study Agreement. The Operations office of the NCIC CTG should be contacted regarding centre agreements and other financial issues such as per case funding.

One individual per centre (i.e. centre representative) assumes the overall responsibility for liaising between the centre and the Group. The duties of the Centre Representative are as follows:

• to function as overall "principal investigator", i.e. provide intellectual and administrative leadership for NCIC CTG activities in the centre;
• to serve as focus for communication to and from the NCIC Clinical Trials Group;
• to supervise the establishment of a mechanism for distributing per case funding;
• to appoint, in conjunction with the central office, committee and subcommittee members;
• to participate in the nomination of investigators and clinical research associates to be supported for attendance at the participant's meetings;
• to receive and, if necessary, respond to the periodic assessments of centre performance produced by the central office;
• to supervise the implementation of corrective measures if the centre fails to meet minimum performance standards.

Single Study Centres

Institutions which do not wish to be NCIC CTG member centres but are interested in participating in a particular study are asked to sign a Single Study Investigator Agreement Document. It contains the same pledges as the Centre Agreement Documents, but the terms apply to the single study and particular investigator(s) named rather than to the menu of NCIC CTG trials and all investigators at the institution.