Long-term Follow-up of Patients Enrolled on Children's Oncology Group Sponsored Research
The administrative procedure proposed here includes two parts. First, iRB approved protocols will remain active as long as (1) the cooperative group continues to enroll subjects and (2) patients diagnosed at Children's Medical Center (and its affiliate hospitals) continue to receive treatment. once the cooperative group has completed accrual to a particular study, and all local patients have completed protocol-specified therapy, an iRB protocol file will be considered permanently inactive. Follow-up patients (both patients continuing on study and those removed from study) will be reported annually to CoG through an administrative mechanism. This process will assure continued progress reports for all patients who have participated in cooperative group research. included in the annual report will be the following information: Cooperative group study number, iRB file number, subject's gender, race, date of registration on study, date protocol treatment was completed, date of removal from study, and comments about disease status, adverse events, or reason for removal from study.
When a CoG protocol is closed to accrual, and all patients who were registered on this specific protocol are in follow-up, that protocol is eligible for inclusion on the LTFu study. The Pi of this protocol, Patrick Leavey, MD, will determine whether the study should be included under the LTFu study (based on the inclusion criteria noted in Section 3.1 of the protocol), or whether it should continue to be reviewed separately. Prior to the annual review of the LTFu, all the studies which the Pi has determined to be included will be added to the LTFu via a modification to the study. also, studies that are permanently closed and the follow-up phase is complete will be removed from the LTFu via the same modification. The [Quote]LTFu Report Form[Quote] attached in the protocol will be submitted to the iRB with the modification.
The responsible study coordinator will continue to submit follow-up data to CoG on all patients as dictated by the specific protocol. if there are any changes to a study that require iRB review, they will be submitted to the iRB via a modification. The [Quote]LTFu included Studies List[Quote] attached in the protocol will be submitted to the iRB with the annual review.
-- The study is closed
-- Patients registered onto COG studies at Children's have completed therapy.
-- There are patients in follow-up, and
-- All follow-up data can be reported on the general follow-up form using standard follow-up procedures.
The data to be collected for follow-up of patients is on these aggregated studies are only those data elements specified by the protocol. The follow-up data will remain within the database for each study included under the administrative umbrella of this Long Term Follow-up Protocol.