Breakout Session: EDC & Data Management
The EDC & Data Management session covered three topics: a CTRP submission review and discussion, a short review of how Pat Carolan (NCI) uses the Summary 3 and Summary 4 reports with a question period, and a presentation of one center's experience with their first CCSG application. Feedback from the CTRP discussion will be taken to an NCI CTRP subcommittee by two attendees who are on the committee. There was general agreement that someone experienced with the protocol information should be assigned to do the submissions. The question period during Pat Carolan's presentation mostly focused on questions of interpreting the summary guidelines. Pat indicated to the group that she prefers to receive the unformatted version of the Summary 4 report, but that formatted and unformatted versions can be submitted together at the center's discretion. After the CCSG application presentation, there was another discussion period that focused on defining the different categories of protocols to adhere to the guidelines and show accrual numbers.
