Transcript OnCore®

OnCore®
Clinical Trial Management
Software
OnCore®
• Implemented at Wayne State University and
Karmanos Cancer Center as well as numerous
academic and research institutions and
hospitals internationally.
• Provides ability to manage all components of
a clinical trial in one central location.
OnCore®
• Web based application that can be accessed
anywhere internet access is available
• Security of data is ensured through the
assignment of specific roles and privileges to
all study personnel
OnCore® Organization:
Consoles
• Study Information is managed in individual
consoles each of which apply to specific
functions
PC Console
• The starting point for protocol entry to the
system
• Central Repository for all protocol information
PC Console:
Protocol Information
PC console
• Provides the ability to track study staff,
regulatory documents and IRB information.
• The next slide shows a screen shot that
displays the organization of the IRB reviews
and documents.
PC Console:
IRB Tracking
CRA Console
• The CRA console records all relevant
information regarding the study subject and
links to the protocol in the PC console
CRA Console
• In this console you have the ability to:
– Register all new study subjects onto the study
– Add the informed consent information
– Determine eligibility for study participation
– Place patients on study and on treatment
– Verify study visits
– Enter study data via data collection forms
attached to the calendar and then exported to
Excel or SAS.
CRA Console:
Register new study subjects
CRA Console:
Add Informed consent information
CRA Console:
Determine subject eligibility
CRA Console:
Enter and track study visits
Enter data via forms
Additional Functionality
• Additional consoles include those for:
– Financial Management
– Biospecimen tracking
– Data Management
– Reporting capacity both delivered reports and
custom development
To Use OnCore®
• To request the use of OnCore® or for more
information
– Complete the OnCore® use request form on the
MACTS web site
– Email the OnCore® Coordinator at
[email protected]
• Training sessions are scheduled monthly with
additional times added as needed
• All personnel must be trained in the use of the
software prior to access being granted