Per IRB protocol #12099: Limited patient, event, PCAC and survival outcome data is entered by each site into a protected electronic database which is managed and stored using the research-focused electronic web-based data capture system (REDCap), under an agreement with the software’s development consortium, led by Vanderbilt University. Data backup is performed nightly via a dedicated backup system. The access is password protected. Each site investigator and/or data coordinator will have access to their local data only.
pediRES-Q data entered into REDCap will be abstracted by the DCC (CHOP) to generate a coded dataset. The DCC will not have capability to identify events or patients at any study site. The DCC will never request readily identifiable information from any of the participating sites or investigators. All other data are non-identifiable.
Data Management Requirements:
Any staff at respective sites that will be entering data into REDCap as part of that site's contribution to the pediRES-Q database must:
have current protection of Human Subjects in Research training and certification (CITI)
be listed as a member of the study staff on their local IRB-approved protocol (#12099)
complete a 1-hour one-on-one webinar training session with the DCC
DATA COMPLIANCE PLAN:
A compliance plan has been developed and will be adhered to as follows:
Event Data Entry [demographics, cardiac arrest data, hot debrief]: must be complete by the 15th of the following month (ex. cardiac arrest event is on Jan 10; demographics, event and debrief data entry must be completed by Feb 15)
Discharge Data Entry [discharge items (ICU discharge, SHD]: must be complete 45 days post-event to be included in that quarter’s report.
QI Bundle Entry [High-Risk Identification - number of days screened and number of patients identified; Rolling Refresher - number of staff Refreshed]: must be completely entered by the 5th of the following month.