Meet Your Data Mgrs 05-2016 - Alliance - Home... · Meet Your Data Manager Jenny Darcy –...
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CRP Data Manager: Meet Your Data Manager Jenny Darcy – Associate Director Alliance Julie Moriarity – IT Liaison (Alliance Service Center) Chelsea Schultz – IT Liaison (Alliance Service Center) Tiffany Schafer – Data Manager Supervisor Alliance Spring Group Meeting - May 12, 2016
Transcript of Meet Your Data Mgrs 05-2016 - Alliance - Home... · Meet Your Data Manager Jenny Darcy –...
CRP Data Manager: Meet Your Data Manager
Jenny Darcy – Associate Director Alliance Julie Moriarity – IT Liaison (Alliance Service Center)
Chelsea Schultz – IT Liaison (Alliance Service Center) Tiffany Schafer – Data Manager Supervisor
Alliance Spring Group Meeting - May 12, 2016
Please note: This is merely an outline of the presentation. If clarification or further education on a particular part of the presentation is needed, please
reach out to the Alliance Service Center.
Presentation Objectives l Provide a high level overview of the Alliance Data
Management team l Introduce each attending Data Manager l Provide Rave Tips l Provide a high level overview of Overdue Reports l Provide Terminated Legacy CALGB studies link
Data Management Team
From Back to Front: Left to Right: Razan, Zack, Marcia, Andy, Ryan K., Luke, Craig, Tracy, Kayla, Lisa
Left to Right: Cristina, Deb, Emma, Pam, Carla, Janet, Joyce, Jenny, Tiffany W., Amy, Barb, Tasha Left to Right: Pat K., Pat M., Jordan, Tiffany S., Natalie, Ryan P., Jen, Jenny
Left to Right: Becky, Gina, Jennifer, Sasha, Chelsea
Marcia Wilson l Coordinator – Research Operations –
Data Management Unit
Phone: 507-538-1760 Fax: 507-284-1902
Email: [email protected]
Jenny Darcy l Associate Director Alliance
Phone: 507-284-8074 Fax: 507-284-1902
Email: [email protected]
Carla Hilton l A041401 l A071402 l A071101 l N107C l N1174 l N057K l N0572 l N0574 l N0577 l N0872 l N0874 l N0877 Phone: 507-284-1370
Fax: 507-284-1902 Email: [email protected]
Amy Hrtanek l A051301 l A061202 l CALGB 10403 l CALGB 10603
Phone: 507-284-3088 Fax: 507-284-1902
Email: [email protected]
Tasha McDevitt l CALGB 140503 l CALGB 90203
l Gina, Janet & Tasha
Phone: 507-293-7339 Fax: 507-284-1902
Email: [email protected]
Ryan Potaracke l A021101 l A081105 l A151216 l CALGB 80701 l CALGB 80702
Phone: 507-538-4370 Fax: 507-284-1902
Email: [email protected]
Tiffany Schafer l A031201 l CALGB 90401 l CALGB 90802
Phone: 507-538-1538 Fax: 507-284-1902
Email: [email protected]
Lisa Schreurs l A031102 l A091302 l A091305 l A091404
Phone: 507-538-1610 Fax: 507-284-1902
Email: [email protected]
Gina Squires l CALGB140503
l transitioning to Tasha McDevitt l CALGB 90203
l Gina, Janet and Tasha l CALGB 30607 l CALGB 140202
l temporarily
Phone: 507-266-8919 Fax: 507-284-1902
Email: [email protected]
Rave Tips and Tools
l Queries in Rave l Calendar vs Grid View (DSS) l Institutional Contact Form l Dictionary vs Free Text Fields l Help Text vs Instructional Text
Queries in Rave Response Box vs Data Field l Response Box
l Found below the query text l Used to provide further clarification
l Data Field l Found to the right of the question l Used for the actual data
Data Submission Schedule
l Found on Alliance and CTSU website l No longer found within the Alliance protocols
l Allows for data submission schedule updates to be streamlined
Institutional Contact Form
l Who the Data Manager will contact at the site l Lives in the “Baseline” folder within Rave l Updated by the site
Help Text vs Instructional Text
l Help text appears next to applicable field l Instructional text appears above the
applicable section of the form
Attachments l Attachments should be on individual log lines
l Protocol calls for a Pathology Report and an Operative. There should be a Pathology Report on one log line and an Operative Report on the next log line.
l Attachments should be de-identified l This will be queried if found to have visible identifiers. The site will
be responsible to re-upload the document correctly de-identified.
l Attachments should include patient ID
Delinquency Tip
l If you feel there is an error in your report, reach out to the Alliance Service Center.
Teleform Submission Workflow l Site enters data on CRF online l Site clicks “Submit” l Site is prompted to print the CRF l Site clicks “Submit to CALGB” l Site receives “Confirmation of Submission” l Form goes to Teleform Verifiers
l Team of DMs l Data from the form is then sent to tables in
the database **The overall submission timeline is >24 hours
Reason forms fail with confirmation
l Export Fails l Submitted an amendment online l Submitted with wrong study ID l Submitted with wrong patient ID l Double data entry
l Same form/same dates entered multiple times l Start and/or End dates missing
l mm/dd/yyyy l Required fields left blank
l Some studies error until you complete these fields
A031201- Prostate l PCWG2 (Section 13.1)
l Visceral and lymph node lesions will be assessed using a modified form of RECIST 1.1 criteria l Report longest diameter for all soft tissue lesions, including nodes
l Brief Pain Index (Section 4.6.3) Appendix II l Asymptomatic or mildly symptomatic from prostate
cancer. l A score of 0-1 on BPI-SF Question #3 is considered asymptomatic l score of 2-3 will be considered mildly symptomatic l ≥ 4 the patient is ineligible
Take Home Message l CALGB has completed its transition to the Alliance Statistical
and Data Center l All amended forms/supporting documentation should be mailed to:
ALLIANCE Attn: <insert study> RO_FF_03_24-CC/NW Clinic 200 First Street SW Rochester, MN 55906
l Direct any and all questions to the Alliance Service Center: l 1-877-442-2542 l [email protected]
Questions?
