1. ClinPortal A Clinical Data Management Solution

2. What is ClinPortal?  Web-based, data collection tool  Developed at Washington University School of Medicine  Designed for the following types of studies PI Initiated Studies Disease-oriented groups (Patient ‘databases’) Multi-institutional studies/trials  Application integration Tissue Suite CIDER  Grant Supported Standardized vocabulary Reuses clinical variables Data sharing Identified, De-Identified (HIPAA compliant)

3. What is a ClinPortal Study? ClinPortal has 2 roles: PI and Coordinator Both roles have the same privileges: full identified PHI for all participants on all forms, unless otherwise specified by PI Complete Protocol Title per IRB approval Familiar, shortened title IRB # IRB documented start date for protocol

4. Consent  Tiered Consent  Updated  Queryable  Upload signed copy

5. Participant Overview IRB approved Consent & Protocol Study Calendar ClinPortal

6. Visit Details Event Visit Form

7. Form Elements Text Box- integer Drop down list- PVlist Text-decimal (x.xx) Boolean-check box Radio Button-PV list Add More function

8. Form Elements Multi-select list- PV list Date Picker

9. Unified Model & Standardization General Study: Family History Fetal Study: Maternal Medical History 2 different studies: General Study and Fetal Study 2 different forms: General Family History and Maternal Medical History Shared attributes: Relationship and Diagnosis

10. Data Dictionary Model Forms development LoadUser Mtg Reuse Standardization Study Development Cycle

11. CSMS Administrative, Billing, Regulatory ClinPortal Data management System Integration caTissue CIDER *Lab results Demographics Medications Diagnosis Procedures Admit/DC Participant Registration Study Protocol IRB approval Encounter dates Visit information Clinical Research at WUSM

12. ClinPortal & Tissue Suite Participant Clinical Study Registration Collection Protocol Registration Clinical StudyCollection Protocol CS Event CP Event Visit SCG Form 1 Form 2 … Specimen 1 Specimen 2 … ClinPortalTissue Suite

13. How do I access ClinPortal? User Responsibilities  Follow established rules and procedures  Obtain HIPAA/IRB approval if necessary  Do NOT share user IDs and passwords  Safeguard patient privacy and protect clinical data sets.  Escalate issues/questions to application Administrator or application Helpdesk  Do NOT download, move, or copy identified/limited data sets to USB drives, CDs, DVDs, other removable devices, or servers/workstations/desktops/laptops on unsecure networks  User access will be revoked in any case of failure to follow the rules. Access  On campus: accessed from any WUCON connection  Off-campus : accessed with a VPN client  ClinPortal Administrator approved user  Users must have an approved study  Request access on homepage or by contacting our helpdesk at help@bmi.wustl.edu help@bmi.wustl.edu

14. Demonstration https://clinpd6.cbmi.wucon.wustl.edu:8443/clinportal