What's involved in Data Management -
An Ongoing Series for Understanding ISO 14155 (2010)
Data management encompasses the span of time from the moment the case report forms walk in the door to the moment the final database is sent to the statistician. It involves all the activities of logging in the forms, preparing a database application to receive the data, designing in edit checks to protect against entry errors, entering the data, choosing between full and partial double-data entry, generating data queries to clean the data, validating the data, writing code for administrative reports, and exporting the data to the statistician's SAS program. Furthermore, it must be Part 11 compliant. All of this is necessary so the sponsor can claim data integrity. ISO/DIS 14155 (2009) makes it clear that that burden rests with the sponsor
In this e-conference we will discuss the “how-to” of implementing these steps.
You will receive
[x] Presentation slides
[x] An expert speaker
[x] Data Management Plan and Study Specification map
[x] Chance for QnA
[x] CEUs and certificate of attendance.
Who should attend
[x] Clinical research professionals who design clinical trials
[x] Professionals who work with clinical data
[x] Non-statisticians interested in the subject
[x] Managers who sign-off on clinical trials
[x] Executives who are planning their company’s futures.
Wessam Sonbol is the President of Clinical Systems Consultants Inc., a Clinical Data Management Organization focusing on data management activities, database development, custom solutions to automate data management processes, data management consulting and clinical data outsourcing.
Wessam graduated from the University of Minnesota’s Institute of Technology with a computer science degree. He works with medical device companies to manage their clinical data. Throughout his career he has held positions at Eminent Research/PPD, American Medical Systems and Sorin Group. He developed a global database with which he gathered data from hospitals all over the world to review cardiovascular diseases and understand the demographics of different causes. Wessam also developed http://www.tctmd.com, an informational website for doctors focusing on Trans Catheter Therapeutics; and Global View, a post-market eRegistry tool used by many organizations such as St. Jude and J&J. He also developed studies using Oracle clinical, Clindex, ERT and Rave and designed a MS Access 21 CRF 11 compliant database. He is currently working with medical device companies to assist them with their day to day data management processes – from database development to designing tools that help reduce cost and increase production. He can be reached at firstname.lastname@example.org.
The purchase is $423 for OnDemand access and $473 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.