This program will explore the evolution of Clinical Data Management from a paper case report form (CRF) process to the “real time” data review capable world of electronic data capture (EDC). We will review the specific regulations that govern the electronic data capture and electronic signature requirements, and examine the changing role of the Data Manager in an environment where the technology drives the process. Although the basic data management principles remain the same, for example good CRF design and ensuring
the integrity of the data, the timelines and tasks surrounding today’s EDC are not interpreted exactly as the paper CRF process has previously dictated. The understanding of how the technology has changed the process will enable today’s Data Managers to move forward in the discipline and ensure their place as viable members of the clinical study team. As electronic data capture utilized as patient e-source or eCRF becomes more the routine, it is important that the CDM be fully aware of the capabilities of the EDC application
in order to ensure a comprehensive data management component in the clinical trial conduct.
- Assess the impact of the regulations on Data Management
- Discuss the rationale and enhancements regarding the utilization of EDC
- Discuss in-depth the changing role of the Clinical Data Manager
- Outline the CDM focus on protocol review and CRF design
- Employ “best practices” for eCRF design
- Describe the Data Management documentation required in clinical trial conduct
- Identify EDC system enhancements for the industry
- Clinical Operations and Project Management Personnel who need to familiarize themselves with the process of EDC set-up requirements and the role that utilizing EDC plays in the conduct of clinical trials.
- Clinical Data Managers (CDMs) who are involved in the transition of paper CRF process to EDC
- CDMs new to the EDC process
- EDC developers who require a better understanding of the CDM process and role
The course will be led by one of the following instructors:
Denise G. Redkar-Brown, MT
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Day 1: 8:30 a.m. – 5:00 p.m.
- The Regulatory Environment for the Utilization/Consideration of EDC: Overall review of the 21 CFR Part 11 regulations; e-signature requirements for FDA, EU, and Japan
- Transitioning from Paper CRF to EDC: Examine the considerations surrounding the adoption of EDC while still working in a paper environment
- The Changing Role of the CDM: The CDM was process driven, whereas the EDC environment has moved the focus from process to Project Management
- Study Start-up, Protocol Synopsis Review, eCRF Development: Examine the activities associated with the study start-up in an EDC environment;discuss eCRF development and also the impact that CDISC/CDASH may have on future CDM endeavors
- Best Practices in eCRF Development: Review the best practices as they relate to EDC activities and the issues surrounding eCRF creation/testing
Day 2: 8:30 a.m. – 5:00 p.m.
- User Acceptance Testing (UAT): How does the application work? How do we test it or try to “break” it?
- Creating the Data Management Plan: The documentation required for a robust DMP when utilizing an EDC application; reviewing the components of the DMP as described by the Society of Clinical Data Management Good Clinical Data Management Practices (SCDM GCDMP)
- Ancillary Documentation for EDC: What do we need for training the users in the application? Navigation documentation, query resolution hints, report generation
- External Electronic Data: Lab data, ECG data – can the application accept data uploads?
- Outsourcing EDC DM Issues: Vendor outsourcing, discussion surrounding evaluation of vendors for total CDM projects or vendor development of eCRFs
- Review a simple protocol synopsis and plan to design a simple eCRF
- Utilize a “training” database in an EDC application to review navigation and discuss site training issues
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-12-043-L01-P. Released: 10/12.
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For more information, contact Naila Ganatra at (215) 413-2471.