S1316 Data Submission Roxanne Topacio, CCRP SWOG Data Operations Center Seattle, WA October 24, 2014

Overview General form submission timelines Special form submission timelines Submitting data in Rave 2 October 24, 2014S1316 Training

S1316 General Form Submission: Where are these guidelines found? S1316 Protocol –Section 7.5 Study Schedule for All Patients –Section 9.0 Study Calendar –Section 14.4 Data Submission Overview and Time points Handouts for S1316 Study Forms and Procedures packet –S1316 Study Flow (handout pgs. 2-4) –S1316 Forms & Documents Overview (handout pgs ) 3 October 24, 2014S1316 Training

S1316 General Form Submission: Patient Contact Schedule Registration is Day 0 Use to plan for weekly follow-up through Week 53 Weeks 1 – 13 Site calls patient for weekly assessments Weeks 17 – 53 Site calls patient every 4 weeks for assessments 4 October 24, 2014S1316 Training

S1316 General Form Submission: standard forms Baseline data –Submit within 7 days of registration Weekly follow-up data (Weeks 1-13) –Submit within 7 days of assessment ** If the patient is HOSPITALIZED, then also collect Hospitalization data (Weeks 1-13) –Submit within 14 days after discharge 5 October 24, 2014S1316 Training

S1316 General Form Submission: more standard forms Hospitalization Days Record –Submit ONE time only –Submit within 14 days after Week 13 Follow-up data every 4 weeks (Weeks 17-53) –Submit within 14 days of assessment 6 October 24, 2014S1316 Training

Two ‘special’ forms with non-standard timing S1316 Dietary Recall Contact Form – to the Arizona Diet, Behavior and Quality of Life Assessment Lab within 24 hours of registration S1316 Off Protocol Notice –Submit within 3 days of removal from follow-up (Section 7.6) 7 October 24, 2014S1316 Training

Rave: How data is submitted Nearly all study data submitted via Rave EDC Exceptions –Registration data submitted via OPEN –S1316 Dietary Recall Contact Form submitted to the Arizona Diet, Behavior and QOL Assessment Lab 8 October 24, 2014S1316 Training

Rave: How to Access Rave link in the SWOG CRA Workbench Rave link in CTSU.org 9 October 24, 2014S1316 Training

Rave: Things to know Rave forms look different than the paper forms in the forms packet Rave can show only relevant folders, forms, or parts of a form Some Rave forms appear conditionally 10 October 24, 2014S1316 Training

Rave: Hospitalization Days Record – 2 views Rave forms look different than their paper CRF counterparts 11 Paper version RAVERAVE October 24, 2014S1316 Training

Rave: Submitting Source Documentation 12 October 24, 2014S1316 Training

Summary The protocol is your source for what to submit and when (Sections 7, 9 and 14) Two forms require quick submission Dietary Recall Contact form - Arizona Lab within 24 hours of registration Off Protocol Notice - Submit online within 3 days (Section 7.6) Data submitted through Rave 13 October 24, 2014S1316 Training

Rave: Help with Access? Rave Technical Support CTSU Help Desk :30am-8:30pm ET - 14 October 24, 2014S1316 Training

Questions on Data Submission Contact SWOG Data Operations Center By By phone: (206) :30 AM – 4:00 PM PT 15 October 24, 2014S1316 Training