Marriott Harbor Beach Resort
October 18 at 1:00 p.m.




TrialBuilder Workshop:

Time                            Title Contents

1:00 p.m.-2:00 p.m.    

Advanced Trial Design Techniques
  • Locked plane editing -- a boon to productivity.
  • Dynamic visit schedules -- ideal for oncology trials.
  • Data value advice vs. data value change.
  • Cross-form edit checks -- how they are executed by the Validation Task Service.
  • Clever uses for dynamic code lists.

2:00 p.m.-3:00 p.m.     

Data Grids: Real-Time Reporting
  • How to build a data grid containing clinical data.
  • How to build a data grid for page status and queries.
  • Security for data grids.
  • Viewing data grids in TrialMaster.
  • How to turn a data grid into SAS export.

3:00 p.m.-3:30 p.m.


3:30 p.m.-4:30 p.m.

Mid-Study Changes: How Do They Really Work?
  • The mechanics of changes and testing in a development environment.
  • How the change is propagated to QA, UAT and production.
  • Overview of the processing logic. What happens if you add an item or a row, delete something, change edit checks?
  • Protecting against form status reversions.
  • What does the Validation Task Service do after the mid-study change is complete?

4:30 p.m.-5:30 p.m.    

ePRO and Foreign Languages
  • How to include ePRO forms in the trial design.
  • Setting time window for allowable patient entry.
  • Understanding the security model.
  • How patients get notifications when data is due.
  • Patient data entry.
  • Extracting text for translation (the whole protocol or just the patient-specific forms).
  • The translation life cycle – auto translation, manual correction, verification and locking.
  • Using TrialMaster when languages are enabled.


TrialMaster Workshop:

Time                     Title Contents
1:00 p.m.-2:00 p.m. Risk-Based Monitoring
  • How dynamic monitoring works.
  • Typical randomization schemes.
  • Viewing and overriding a patient’s monitoring level.
  • Using the Task List to determine forms to monitor.
  • The “optional monitor” capability.
  • Signing and locking when dynamic monitoring is enabled.
  • Some statistics from production trials.
2:00 p.m.-3:00 p.m. TrialMaster Security
  • Overview of user and role security.
  • Sites and site-level security.
  • Form and item-level security.
  • Overriding default permissions for a user.
  • Password management.
  • Utilities to transfer users and roles across trials.
  • Standard reports on user permissions.
3:00 p.m.-3:30 p.m. BREAK  
3:30 p.m.-4:30 p.m. Interesting Corners of TrialMaster
  • Task List – locked iCRFs to update.
  • Task List – iCRFs repeatedly processed.
  • Custom report filters – saving your favorites.
  • The “Auto Next” feature for sites and monitors.
  • Electronic signature and break signature features.
  • Casebooks and trial archive – what do the sites and regulatory agencies receive?
4:30 p.m.-5:30 p.m. Preparing for the Next TrialMaster Release
  • New features for site personnel.
  • New features for query management.
  • New workflow capabilities, such as partially monitoring an incomplete form.
  • New batch features, such as running a casebook for multiple patients.
  • Upgrade considerations.

 TrialOne Workshop:

Time                  Title Contents
1:00 p.m.-2:00 p.m. Urine Collection Best Practices
  • New functionality in 4.3.7 to handle collection and void containers.
  • Setting up calculations.
  • Filter creation for sample organization.
2:00 p.m.-2:20 p.m. Managing Study Treatments and Blinding in TrialOne
  • Refresher on setting up dose treatments.
  • Blinding best practices.
  • Dosing across multiple visits.
2:20 p.m.-2:30 p.m. BREAK  
2:30 p.m.-3:00 p.m. Availability Status for Managing Volunteer  
  • Best Practices for choosing and setting up your Availability Status.
  • Refresher on Export and Campaign Tags
3:00 p.m.-3:30 p.m. Quicklists: Current and Future State
  • How to currently set-up your Quicklists
  • Best Practices in 4.3.6 and 4.3.7
3:30 p.m.-4:00 p.m. Getting the most out of Tracker Batches
  • Sample Processing Pathway Suggestions
  • Using Container Batches for Shipment
  • Reusing medical history data across recruit and data collection.
  • Managing linked lists.
4:00 p.m-4:10 p.m. BREAK  
4:10 p.m.-4:40 p.m. Device Best Practices  
4:40 p.m.-5:10 p.m. Label Printing in 4.3.7
  • Covering new functionality in 4.3.7