This course is designed to build the foundational understanding of the identification of discrepancies in the data that are collected for a clinical trial protocol.
Query processing begins with a functional understanding of the study and study documents. There will be a sample protocol to review along with the case report forms (CRFs) which will allow you to understand the study as well as the data collection instruments. Supplemental information and the Data Management Plan (DMP), will provide the data quality checks (or “edit checks”) that will describe the data logic and information that is expected on the CRFs.
Query creation involves the identification of the data anomaly as per protocol requirements, creating a question to be sent to the investigative site for data clarification or data amendment/update. Managing query follow- up is vital to developing reliable data. Once queries have been written it is necessary to ensure appropriate responses are made and to identify when database updates are necessary.
- Examine the role of query processing in data management
- Analyze the relationship between the Schedule of Events and case report forms
- Identify necessary edit checks
- Analyze edit check content
- Describe the key elements for a good query
- Identify multiple results of query resolution
- Describe options for inappropriate query responses
- Integrate/update data amendments as a result of query resolution
- Clinical Data Managers who are beginning their careers and desire to grasp a better understanding of the query process.
Denise G. Redkar-Brown, MT
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Day 1: 8:30 a.m. – 5:00 p.m.
- Protocol review, CRFs. and the DMP. Discuss the study aspects against sample CRFs and the DMP to determine what queries may be necessary.
(Some pre-course work is necessary)
- Examine the DMP for the edit checks and output messages
- Queries-definition, elements of a good query, examples of queries
- Query Resolution and Database Updates
- Pre-class: Read protocol and DMP and review CRFs
- Identify Study Phase
- Identify Study design
Review schedule of events vs. protocol text vs. CRFs to ensure all data points are accounted for.
- Examine the edit check list in the sample protocol and compare that to the case report forms. Is the list complete? Would you add any CRFs? How would you improve the output message for this study?
- Do you understand what is being communicated in the list of edit checks? Are they written clearly enough?
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.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 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# 0778-0000-13-038-L01-P. Released 10/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.