Heart Biomarker Evaluation in Apnea Treatment
1.1 Overview
Study visits and phone contacts should be completed within the designated timeframes. The Baseline Visit is considered day 0 and all time windows should be counted from this day (not from the immediately preceding visit/phone contact because this could cause timeframes to get very off schedule). Please note that for patients randomized to PAP, the 12 week treatment period begins when participant pressure has been set; therefore, counting of their time window for the week 1 contact and remaining contacts/visits are based on that day. (The SDCC Reading Center indicates pressure setting and projected week 1 phone contact date in an email sent to sites.)
If a visit or phone contact is completed outside these windows of time, it is considered a minor protocol deviation. The SDCC/CWRU policy is to complete an Unanticipated Problem or Protocol Deviation Checklist (U/D). At the CWRU institution it does not need to be submitted to the IRB, but should be filed. Each site should follow their institution’s policy on reporting minor deviations and use the form they provide. If your institution requires further steps, please follow them, but if your institution requires less, please at least follow the procedure of the SDCC/CWRU policy. Protocol deviation forms from your institution should be completed, filed, and a copy faxed or FTP-ed to the SDCC. The SDCC will produce periodic reports on time deviations to review and compare to the forms received from sites to ensure proper documentation is taking place.
It is understandable that in some instances, study staff will be unable to complete the visits and contacts within the time windows. For example, deviations could result from patient noncompliance issues or a visit/phone contact might be accidentally forgotten or need changed due to extenuating reasons. In all cases, documentation is important. If you are attempting to schedule visits and contacts without success, please document the times, dates, and make notes about your attempts to attach to the deviation form. If a participant misses visits and staff has to reschedule, staff should document the effort they are putting forth in trying to keep within time windows.