What is it?
A collaborative opportunity to address issues before routine internal monitoring/auditing. It will include targeted review of the first patient on your new trial once they’ve surpassed their first major study time point which may be first dose, scan, survey etc. as applicable to your protocol. We’ll also review the regulatory binder and the protocol/ICF documents. After the review the study team (CRC, manager, and PI) will be provided a summary of findings with items flagged in the charts as well to assist in the resolution of findings.
For our pilot project from May 2019 through August 2019, we plan to focus on IIT’s that Stanford is the coordinating center for and NCTN trials, if successful we want this to become a routine practice for all CCTO studies.
What do you need to do?
When you receive a request review the entire email, as it has a lot of info in it detailing the pilot project! Keep OnCore up-to-date, as we’ll be notified of your first patient on the first of each month by an automated report. Provide your first patient’s chart and regulatory binder in their as-is state by the due date/time. We don’t expect you to prep charts for this beyond their current state; if we’re unable to review an item we’ll note it in the summary. Once you receive the summary of findings you should review and address findings with your PI and study team.
No responses to QA will be expected or required. Instead we ask that items be addressed by the time routine monitoring/auditing would occur. There will be at minimum at least 1 month between the summary of first-patient findings and a routine review. If items are still pending at the time of a routine review, they will then get added to the monitoring report with responses expected, which will then be presented to the DSMC for your study’s annual/bi-annual review.
Feel free to give feedback please! As this is part of a quality-improvement plan we gladly welcome the feedback to improve our own processes. Any feedback should be sent to email@example.com.
If you need access to your chart at any time during the review, please stop by QA’s desks. Post-review if there are any questions or clarifications needed, we are available to help as needed.
When does routine monitoring usually start?
New studies (Stanford IITs and NCTN) go into the routine monitoring schedule once they have accrued their first two patients and/or if six months has passed since the first patient on was enrolled, whichever comes first. The review will occur as close as possible to this time point dependent on priority of scheduling studies and bandwidth.
For any questions, please contact DSMC-Quality@stanford.edu