Strategies for Ensuring Good Documentation Practices (GDP)

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.

• 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

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

Denise G. Redkar-Brown, MT 

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$695

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 +1 781.972.5400 or toll-free in the U.S. 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 1.5 hours (0.15 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#:0778-0000-15-019-L01-P.  Released: 3/15. 

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