General Requirements for NCIC CTG Member Centres
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:
Phase I and II trials are conducted in a subset of NCIC CTG participating centres. Criteria for approving a centre for IND Programme 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
which have the appropriate facilities and trained investigators in
evaluation of new drugs. To expedite decision making in an
Phase I trial, the NCIC CTG office requires FAX information from Phase
I participants and, following discussion with the principal
will open/close dose levels as necessary. Phase I trials of drug
Centres interested in participating in IND programme trials must fulfill the following requirements:
In addition to the requirements listed above, centres that are
on NCI US affiliated trials are also required to have a current Federalwide Assurance (FWA) by making an
to the Office for Human Research Protections (OHRP). Once approved, the FWA is valid for 3 years.
For additional information on this website, please click on:FWA . Or, you may visit the OHRP website at http://www.hhs.gov/ohrp/assurances/assurances_index.htm .All the necessary applications and instructions are provided online on the OHRP site.
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:
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:
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.