Database Updates - An Introduction
1 part webinar
60-minute presentation followed by 30-minute Q&A
Presenters
Denise Redkar-Brown is associate director of scientific affairs, data management, at Cetero Research, in Fargo, ND. She 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 has been published in the European Journal of Pharmacology for her work in pharmacology while at AstraZeneca and contributed to the successful submissions for Accolate® (the first leukotriene antagonist for asthma therapy) and Seroquel® (serotonin receptor compound for treatment of schizophrenia and bipolar disorder). Redkar-Brown also worked at Dupont Pharma (immunology), Knoll (Humira®), and Sanofi (vaccines).
Overview
One of the most common reasons for failing a database audit is inappropriate database updates. 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. Primary key field errors require special attention. An audit trail should be employed to track all changes. 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.
Outcomes
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.
Level
Beginner
Target Audience
CEOs, chief learning officers and trainers, clinical data managers, managers of data groups, quality control and quality assurance statisticians, biostatisticians, and project managers working within the clinical trials industry.
CDM Competencies addressed
Overall Clinical Trials Process, Roles and Responsibilities
Clinical Database Design/Relational Databases
Processing Lab Data
Database Updates
GCDMP Chapters addressed
Assuring Data Quality
Laboratory and Other External Data
Continuing Education Credit Opportunity
Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.
SCDM is authorized by IACET to offer .2 CEUs for this program.
