Trial Information

CCG-LTFI: A Groupwide Protocol for Collecting Follow- up Data

Children's Cancer Group clinical trials are conducted to improve understanding of the
biology and treatment of childhood cancers. Protocols are developed by expert committees and
distributed from the Group Operations Center to the member institutions. Before a protocol
can be opened to patient accrual at a CCG institution, the protocol, consent form and any
activation amendments are reviewed and approved by the local Institutional Review Board
QRB).

Protocols remain open to patient accrual until sufficient evaluable patients have been
entered to answer the study questions. During this time, the protocol and any new amendments
are reviewed annually by the IRB. When the study has been closed to patient accrual it
remains open solely for the purpose of collecting life status and occurrence of adverse
events. The IRB must continue its annual review as long as a patient treated on the protocol
is alive and follow-up data are being collected. The CCG Long Term Follow-up protocol
(CCG-LTF1) is meant to allow continued collective review of all protocols that meet the
following criteria: (a) It is closed to patient accrual, (b) all patients have completed
treatment, and (c) there are patients who are alive and being followed. The protocols that
meet these criteria will be listed as being aggregated under CCG-LTF1 such that an IRB
review of CCG-LTF1 will constitute a review of that protocol.