Course Description

Good Documentation Practice (GDP) in clinical research is a baseline expectation; however, there are no set guidelines around what comprises GDP in a Good Clinical Practice (GCP) environment. In this web seminar, we will look closely at the key features of GDP by first examining the question: What is a document? At its core, a document is information (meaningful data) and its supporting medium, which could be in the form of paper, CD, computer files, or microfilm. Documentation is a process which comprises multiple steps: Recording of data, review of documents, approval of documents, issuance and disposal of documents, retrieval of documents, and presentation of documents. In addition, this web seminar will examine the issues identified when documentation has been subject to agency review, and the steps that can be taken to ensure that your approach to clinical trial documentation demonstrates the quality processes that have been applied to your documentation efforts.

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Learning Objectives

• Review the features of good documentation
• Identify the connection between GDP and Quality Management
• Define responsibilities in relation to GDP
• Discuss the proper procedure for identifying and correcting documentation errors

Who Should Attend

• Clinical Research Personnel who are involved with creating documents, recording data, and signing off on clinical trial documentation

Instructor

The course will be led by one of the following instructors:

Denise G. Redkar-Brown, MT

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.