The generation of queries and updating of the clinical trials database from query resolution and other external sources is a crucial step in clinical data generation. Database updates must link to the proper locations, and data must be checked for validity and consistency prior to updating the clinical trials database.
Updating existing data fields requires attention to the type of data error being corrected or incomplete data being updated. An audit trail should be used to track changes. Errors in data of primary key fields require special attention. Errors detected in data submitted by a vendor, prior to updating the clinical trials database, should be reported to the vendor for correction of the source data. Database updates from external data sources require planning and validation before the process is implemented.
This web seminar will examine the strategy for the generation of valid queries, the operational processes that govern the evaluation of query resolution, and the subsequent database updates as required.
- Discuss the rationale for query evaluation prior to issuance
- Identify external data sources commonly used to update the clinical trials database
- Detail communications, related to data processing and transfer, with external sources providing data
- Evaluate the procedures to process data from external sources prior to the clinical trials database update
- Describe error handling procedures for incomplete or erroneous data identified before the clinical trials database update
- Clinical Data Managers
- Data Associates
- Clinical Research Professionals involved with query generation or resolution
Denise G. Redkar-Brown, MT
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-12-072-L01-P. Released: 9/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.