Updating the clinical trials database from external sources is one of
the most sensitive steps in clinical data generation. Database updates
must link to the proper locations in the clinical trials database. In
addition, data must be checked for validity and consistency prior to
updating the clinical trials database. Individual fields as well as
entire records may be updated. The process to update existing data
fields requires attention to the type of data error being corrected or
incomplete data being updated. An audit trail should be employed to
track all changes. Errors in data of primary key fields require special
attention. Errors detected in data submitted from an external vendor,
prior to updating the clinical trials database, should be reported back
to the vendor for correction of the source data. Database updates from
external data sources require planning and validation before the process
is put into production.
1. Describe external data sources commonly used to update clinical trials databases.
2. Detail communications, related to data processing and transfer, with external sources providing data.
3. Describe the procedures to process data from external sources prior to clinical trial database update.
4. Describe error handling procedures for incomplete or erroneous data identified before clinical trial database update.
Who Should Attend:
Clinical Data Managers – new and intermediate
Meet the Instructor
Denise Redkar-Brown is the Principal at Sunburst
Clinical Solutions dedicated to consultation in the area of Clinical
Data Management training and auditing capabilities. Her last assignment
in the corporate area was as Director of Scientific Affairs, Data
Management at Cetero Research in Fargo, North Dakota. She is also a
frequent contributor to the GCDMP and chairs SCDM's sub-taskforce on
Electronic Learning. Denise began her career as a Medical Technologist
working in a hospital laboratory environment. She made the transition to
the pharmaceutical industry, and after more than 20 years, she has held
positions in basic and clinical research. She is published in the
European Journal of Pharmacology for her work in Pharmacology while at
AstraZeneca and contributed to the successful submission for Accolate®,
the first leukotriene antagonist for asthma therapy as well as other
drugs and vaccines. Her latest publication was in the Good Clinical
Practices journal (GCPj) in 2008 describing the evolving role of
Clinical Data Managers.
Participants are eligible to receive CEUs upon attendance and successful
completion of a web-based assessment within 30 days after the webinar.
CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
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