FDA PRO Guidance and ePRO patient reported outcomes solutions with patient eDiaries

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“In this study, patients go six months between visits. If we had used paper diaries, we may not have had any information during this time ... Perhaps most importantly, it would have been unlikely to know whether treatment patients were exhibiting early signs of an exacerbation and in need of call center intervention if they simply chose not to call when they should have.”

Carla Grabianowski, RN, BSN, CCRP
Research Nurse Coordinator (Pulmonary & Critical Care Medicine)
Temple University Hospital

Read more on what people are saying about PHT.

Realtime Data for Clinical Trials - ePRO LogPad and SitePad Systems

StudyWorks

StudyWorks is an online portal which provides real-time access to data collected using the LogPad System, SitePad or or NetPRO. With standard and custom data summaries and reports, it enables site personnel to manage compliance and enrollment, while helping sponsors stay on top of their global trial at all times.

Firsthand Knowledge

Study coordinators tell us the most valuable aspect of an ePRO solution is the ability to track and manage patient performance and diary compliance. Using StudyWorks, sites easily review data summaries each morning (or whenever they want) to monitor and evaluate patient symptom scores for safety, as well as to identify and intervene with patients who exhibit low compliance - before it becomes a trend.

Key Highlights

StudyWorks enables sponsors, site coordinators, monitors and CRAs to know what is happening to the patients in the trial:

Compliance

  • A convenient calendar view of patient diary compliance
  • Compliance alerts to notify sites when subjects drop below target level
  • SmartReports provide oversight of subject diary compliance with maps and charts to quickly identify sites and subjects that need follow up
  • SmartReports Mobile app for viewing subject compliance on any smartphone

Study Management

  • Study-specific custom dashboard
  • Eligibility reports configured for your protocol
  • Safety alerts designed for your study let coordinators, monitors and project managers know if a subject needs follow-up
  • Site-to-subject messaging

Inventory Management

  • Inventory reports on hardware in your study with automatic daily updates

Data Management

  • Site-to-subject messaging from StudyWorks to patients
  • Exclusive configurable email alerts based on symptom data and real-time calculations
  • Data transfers in SAS, CDISC XML, and Excel formats
  • Data integration with EDC, IVR, and other clinical trial systems
  • Automatic audit trail of all changes
  • Online data clarification submission, routing and approval
  • Permission-based access to all reports and data
  • Full sponsor control of user administration and authorization

Technical Support

  • Updates and data clarifications by authorized users
  • Links to PHT Support - phone, email or LIVE Chat 24/7

Data Transfers and Integration

StudyWorks provides complete access to all data collected and gives authorized users the ability to download data transfers on demand. Data available in StudyWorks can be integrated with other EDC, IVR, or other clinical trial systems as required per trial. PHT can provide transfers in SAS, CDISC Operational Data Model (ODM 1.2) XML, Excel, ASCII, and other formats at a schedule that fits your project needs.

StudyWorks Screen Shot Examples
Calendar View
Subject compliance snapshot with individual subject compliance, calculated in accordance with the sponsor's custom protocol specifications. Color coding for received and missed diaries.
Overall Compliance by Country
Comparative compliance (and enrollment) at sites across countries; enables sponsors to track global study progress
Compliance by Subject at a Site
Subjects' diary compliance at sites; enables sponsors, monitors and sites to quickly find problem subjects
Compliance Alert
Real-time notification for site follow-up and intervention if a subject's diary compliance drops below a custom limit
Inventory Reports
Inventory reports, updated automatically every night enable sponsors to ensure their sites have the right amount of equipment at the right time

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Learn More about StudyWorks

How do you handle data clarifications and data management? What EDC systems have you integrated? Contact PHT for answers to these questions or any others you may have.