OpenLogistica A Sample Tracking Add-on to OpenClinica Jonathan Babbage Clinical & Translational Sciences Institute Biomedical Research Informatics Core 6/21/2013 OpenClinica Global Conference

Who we are Tools Clinical Research Management Systems Document Management I2B2 Skills Development Data Management Study Design Services Hourly Rates Percent Effort Co-Investigator Clients CDC Ohio National Guard Epidemiology Osteopathic Medicine Education

Journey Homebrew

Where we are going Adapting Observational Studies to Clinical Trial standards Training investigators on differences – Consistent protocol across subject classes – Strict CRF change standards – Adverse event tracking Expanding OpenClinica for study needs – PHI, Granulated permissions, Samples, etc.

What do we bring? What do we leave behind?

Sample Profile Who When What

Who

When Manage All Event Definitions in Study Default Study Logistica

What New Functionality

All Together Consent Form

Can we print yet? 56YG P Consent Form Enrollment Study Name

Barcode Templates

Template Items 56YG P Consent Form Enrollment

Can we print yet? 56YG P Consent Form Enrollment Study Name

Barcode Templates

Can we print yet? 56YG P Consent Form Enrollment Study Name

Adding Subjects

Creating Samples Create Samples

Sample Generation

Review Sample Profile Who, When, What Barcode Template Main record in determining how printing happens Label stock, Template items, Associated samples Template Items Set the individual data elements that are shown on a template Associated Samples Set the template the should be used for sample types Generate Samples Create the records for all samples defined in the profile

The Next Question Who When What Where

Sample Sets

00002 LIMS

Set Logistics Obtain Samples Add to Set Prepare Shipment Receive Shipment Create samples Set collected date Define status Update status Set ship date Notify receiving lab Lock sample status Lock set contents Update sample to received Update set to received Import manifest into LIMS Looking for feedback search sets, unique set, set operations, outside interfaces

Current SOAP Access to necessary OpenClinica Data Authentication through existing OpenClinica login Two changes JSP pages linking to logistics components Additional SOAP services (subject group classes) Future Expand set logistics tools Default reports Interface integration Q Source release

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