Understanding Clinical Data Management for the non-CDM Professional

This course will review Clinical Data Management (CDM) operations as they relate to the conduct of clinical trials. The seminar will begin with an introduction to the regulations that directly impact CDM. From there, it will provide a high level overview of CDM processes and the stages of their execution, allowing clinical research professionals to understand the interconnectivity of CDM with other trial procedures. Study startup, timeline considerations, metrics generation, and a description of the differences between electronic data capture vs. paper-based studies will also be introduced.

• Identify regulatory issues specific to CDM
• Outline the overall CDM study procedures and where they impact other research disciplines
• Explain the considerations for CDM study “start-up”
• Discuss the rationale regarding timeline differences between a paper vs. EDC study
• Describe the Data Management documentation required in clinical trial conduct

• Clinical Trial Managers
• Project Manager
• Clinical Operations Personnel
• Clinical Research Professionals associated with the conduct of clinical trials who want to have a better understanding of what is actually involved in the Clinical Data Management portion of a clinical trial

Denise G. Redkar-Brown, MT

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Day 1: 8:30 a.m. – 5:00 p.m.

• The Regulatory Environment: Overall review of the 21 CFR Part 11 regulations, e-signature requirements for FDA, EU, and Japan as they pertain to CDM
• CDM Processes: Identifying the overall CDM process within clinical trial conduct, and mapping the points of interaction with other clinical trials professionals
  CDM Documentation: What are all of those CDM documents anyway? Examine the documentation required for proper CDM conduct and understand the rationale behind document development
• Study Start-Up, Protocol Synopsis Review, eCRF Development: Examine the CDM activities associated with the study start-up in an EDC or paper CRF environment

Day 2: 8:30 a.m. – 5:00 p.m.

• CDISC/CDASH: What is it? Why is it important? How does it impact CDM?
• User Acceptance Testing (UAT): How does the application work? How do we test it or try to “break” it?
• Database Lock: Is it really just a push of the button?
• Outsourcing EDC DM Issues: Vendor outsourcing, the evaluation of vendors for total CDM projects or vendor development of eCRFs

• Map a typical clinical trial conduct and recognize the CDM contributions
• Identify CDM study start-up activities as they coincide with other study activities
• Review a Data Management Plan to identify components pertaining to potential timeline issues
• Organize tasks for database lock

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.

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Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolan at 781-972-5418 to discuss your options and take advantage of the savings.

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# 0778-0000-15-007-L01-P. Released: 5/15.

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For more information, contact Naila Ganatra at (215) 413-2471.