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Good Clinical Practice (GCP) through Good Documentation Practices (GDPs)
Program Code:
387
Date:
Wednesday, June 27, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Paul has over 40 years scientific experience with the first 9 years doing clinical research and then moving to pre-clinical research for another 10 years before founding Quality Associates 26 years ago. Paul has been working in the QA GLP world for 30 years and in the QA GCP world for 10 years
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PRESENTER
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Ms. Butler has worked in quality assurance for over 7 years in both GLP and GCP settings. Her experience includes a global initiative to identify and archive GCP regulatory documents and retrospective clinical trial audits. Currently she acts as project manager for QA contracts across the country.
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Description
The requirements for providing credibility to clinical study data require that each site assure full reconstructibility of the data that is generated by each of its personnel. Good Documentation Practices (GDPs) require attributes of data that will be defined and explained. They include not only recording the data directly and promptly, but assuring legibility, attributability, and durability. The reconstructibility of records will be shown to include linking study-specific data to site-specific records, such as which equipment was used for each subject, temperature logs, calibration records, qualification and training records, and addressing data recording issues in the subject's diary. Proper correction techniques will be described for manual data entries. Examples will illustrate gaps that auditors routinely identify in clinical data. **Due to workshop format, seating will be limited and will be available on a first come, first served basis. The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
Learning Objectives:
Discuss how to assure full reconstructibility of clinical data and reported results
Describe to be certain the FDA will accept your documentation
Identify how to properly correct manual and electronic data entries.