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.