Membership and Participation

1.6.1 Criteria for Membership

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

1. an investigator with appropriate credentials willing to take responsibility for NCIC CTG trials management and liaison (i.e. serve as Centre Representative -- see Section 1.6.5);
2. a demonstrated commitment to providing data management dedicated to NCIC CTG trials;
3. an indication that the level of patient accrual will be sufficient to ensure continuity of data management staff;
4. an established system for ethical review of protocols (or written policy that confirms local
5. acceptance of second-party institution review, e.g. from an affiliated university);
6. access to laboratory and radiological/ nuclear medicine facilities for trial investigations to be carried out.

In addition to these basic criteria, centres interested in participating in IND trials must fulfil the following requirements:

1. presence of clinical oncologists on-site;
2. nursing support for chemotherapy;
3. clinical trials nurse/ data manager present on-site;
4. appropriate hospital facilities (intensive care and support services);
5. pharmacy knowledgeable about investigational new drugs, vertical laminar flow hood, and so on (can be addressed with training);
6. established "track record" in phase III trials (protocol adherence, data quality and timeliness);
7. permission of sponsoring agency.

No criteria exist for expelling a centre from the Group. Randomization and registration privileges may be suspended in a centre as a result of failure to meet set standards of quality assurance.

If a centre accrues no patients to NCIC CTG studies over a period of several years, membership may be annulled.

1.6.2 Centre and Investigator Responsibilities

An institution joining the Clinical Trials Group acknowledges certain responsibilities which are spelled out in a legal agreement signed by a representative of the centre and the Director of the Group. Section 1.6.3 provides the text of that agreement. All investigators participating in NCIC CTG trials within the centre are bound by the terms listed.

1.6.3 Participating Centre Study Acknowledgement

The centre agrees to participate in clinical studies coordinated by the Clinical Trials Group, Queen's University which may be submitted and agreed to by the Participating Centre from time to time. In agreeing to participate in these studies, the centre makes the following representation, acknowledgments, undertakings, and agreements:

1. We will read the protocol(s) and related materials (including, if applicable, documentation relating to preclinical and prior clinical experiences with any investigational treatments). We will resolve any questions we have relevant to the conduct of the study or to obtaining informed consent prior to its initiation in our institution.
2. We agree to conduct studies as outlined in the protocols and related materials and agree to use reasonable efforts to complete these studies within the time designated.
3. We undertake to provide full information about the conduct of these studies as required to all personnel directly participating in them with us.
4. We agree to maintain the records required by the protocols on the appropriate case report forms and to forward the case report forms to the Clinical Trials Group and, if applicable, other agencies in the manner described in the protocol. We further agree that we will not make these forms available to any individual, institutions, or organizations not mentioned in the protocols without the permission of the Director, Clinical Trials Group. This prohibition does not apply to the institution in which the patient has been registered on study. Finally, we agree that the Clinical Trials Group shall have access to all information generated by the studies.
5. We undertake to take reasonable steps consonant with professional and medical responsibility to safeguard information relating to the conduct and results of studies and we agree that any publication of the results of the studies shall be in accord with the policy on publication described in the protocols.
6. We undertake to promptly communicate to the Director, Clinical Trials Group any information that we may obtain in the course of studies related to unexpected actual or potential medical problems of whatever nature caused or thought to be caused by the treatment or the treatment protocol.
7. We acknowledge that we are responsible for ensuring that the informed consent of persons participating in this study has been obtained and that an ethical review of the studies as set out in the protocol and related materials has been conducted.
8. We acknowledge that the Clinical Trials Group acts as a coordinating agency for the trial and that as Participating Centre, we are principally and professionally responsible for the conduct of studies as it relates to patients and that in this regard we shall exercise professional and overriding medical judgment consonant with the best responsible treatment of the study patients under our care.
9. We do hereby warrant that all investigators in our centre have either current and continuing membership in the Canadian Medical Protective Association or malpractice insurance coverage for errors and omissions that might arise under the studies of the Clinical Trials Group.

1.6.4 Duties of Principal Investigators

When an institution elects to participate in a trial, it is required to designate one individual to serve as "principal investigator" (PI) who is expected to enroll on study a significant proportion of the patients entered from that centre. In addition to the responsibilities listed in 1.6.1 of all participating investigators, those of the PI are as follows:

1. to ensure the initial and continuing review of the protocol by the institution's local research ethic board (REB);
2. to report to the REB any changes to the protocol, as well as to immediately inform it of any apparent risks beyond those predicted;
3. to coordinate and otherwise take overall responsibility for the conduct of the study in the institution in accordance with the protocol, and for the accurate and complete submission of data to the NCIC CTG;
4. to ensure that all personnel involved in the study at the centre are informed on an ongoing basis about trial issues pertinent to them.

1.6.5 Duties of Centre Representative

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

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

1.6.6 Centre Codes

For convenience, all participating institutions have been assigned four-letter code names. The first two letters indicate country code, the second two letters are arbitrarily assigned, though with some rationale (e.g. MP=Princess Margaret Hospital). For a current decoded listing of these codes, see Appendix 1.A.

For further information...

1.6.7 Per Case Funding

The NCIC CTG provides funding for institutions on a per case basis. Once the documentation to confirm patient eligibility has been reviewed in the central office, the case is flagged and funding will be forwarded to the institution when the funding programme is next run (done every two months). It has been a principle of the NCIC CTG that, in general, all types of trials are to be funded at the same rate -- a rate which is reviewed annually by the Clinical Trials Committee and set in accordance with the overall Group budget picture. However, in recognition of the extra data management burden incurred when centres participate in industry- sponsored trials which involve on-site monitoring, per case funding for these types of trials negotiated after September 1999 is set at a higher rate.