ABR Electronic Data Capture (EDC) – ClinPlus® Data Management
ABR has extensive experience in traditional paper CRF solutions, using Oracle Clinical™ and several electronic data capture (EDC) solutions, including Phase Forward InForm, etrials eClinical, and pharmaceutical customized EDC software applications. Until recently, EDC solutions have often been prohibitively expensive for many smaller biopharmaceutical companies to employ in Phase 2 and 3 clinical studies. ABR has partnered with ClinPlus to offer a cost-effective web-based Electronic Data Capture (EDC) system, ClinPlus Data Management 3.0, for clinical data management to achieve fully integrated study control and data management and reduce the time from start of study to database lock. We believe this EDC system, coupled with the ABR Study Tracker™, ABR’s proprietary clinical trials management tool, are essential components to enable us to meet the aggressive study timelines for critical studies. The EDC system benefits include: • • • • • • • • • • • Web-based access for data entry and review via the internet using Citrix technologies. Data entered directly from study sites Reduced paper handling by allowing data entry into electronic CRFs (eCRFs) Reduced data entry errors by eliminating paper CRFs Error checking during data entry at the sites allowing early detection and correction of errors including direct checking against source documents Conduct electronic queries and responses at sites Optional paper data entry (PDE) with traditional CRFs, e.g., if a particular site does not have internet access or data entry personnel available Comprehensive programmed data validation and edit checks on all study data Central database management with database located at CRO facilities Real time access to data at sites and from central data management location Sponsor access to study status and reports
The EDC system has been developed by professionals with backgrounds in Information Technology, Regulatory, and Clinical Management from both ClinPlus and ABR. The overriding concern has been duality and compliance, and to develop the system to include technological solutions and regulatory standards and regulations.
Relevant regulatory standards and regulations addressed include: • • • • • • US FDA: Title 21 CFR Part 11, Electronic Records and Electronic Signature US FDA: Guidance for Industry for Computerized Systems Used in Clinical Trials US FDA: Title 21 CFR Good Clinical Practices (GCPs) International Conference on Harmonization (ICH) E6 GCP Guidelines Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7) Coding conventions Datasets readily convertible to XML, CDISC and SAS formats
System features include: • • • • • Intuitive use based upon Microsoft® products Ease of Learning Easy integration into existing standard data platforms Compliant with all regulatory requirements set by FDA, ICH and CDISC Drag and Drop building ability which facilitates rapid deployment of this EDC tool for clinical studies
Partnering to Provide an Accelerated, Cost-Effective, Worldwide, Web-based EDC Solution for Clinical Studies
ClinPlus® Data Management Software (CPDM 3.0) provides role based security. Data access control down to the variable level. Separate system login with time-out feature. Full read, write, and alter password protection. All implemented in compliance with 21 CFR Part 11 requirements. Remote Electronic Data Capture (EDC) is easily accomplished, by extending the ClinPlus Data Management Application to the Internet via Citrix technology.
Data entry screens use dynamic frames allowing screens to be built using common objects like drop down lists, radio boxes, check boxes, etc. Screens may also include images making t possible to scan a CRD and overlay entry fields on the image to produce a data entry screen that is identical to the paper CRF. Custom controls and functionality may be added, e.g., to link to custom help for the current screen.
Image Support permits studies to be set up to do side-by-side data entry from CRF images. Images are scanned, faxed, or provided through third party software, such as Teleforms, then displayed during data entry.
Data Resolution Management: CPDM 3.0 allows users to define query work flows through the use of levels, e.g. “Pending DM review” to a query. Printed queries (DRFs) are easily accessed for review. Custom DRF templates can be designed without programming. Links between resolved queries and changes to the clinical data are captured in the audit trail allowing the ability to track and monitor the query resolution process.