At last, the FDA has published guidance and recommendations that will take the uncertainty out of using electronic source documentation in clinical trial records.

Now there are answers that will clear up the questions that for years have plagued sponsors and CROs attempting to shift to an all-electronic environment.

This new report is designed especially to help you clarify the FDA’s recommendations — and put them into action. Read on.

It’s the first guide available on electronic source documentation ... and the onlyguide you’ll need to get up to speed without wasted motion.

Discover the answers you need to the questions you’ve been asking:

• How the FDA defines electronic source data
• How to address electronic source data in protocol submissions
• Recommendations for enhancing security and integrity of ESD
• Guidance for the protection of original source data
• How to confront real-world barriers to using ESD
• Recommendations for real-time source data usage

Electronic Source Documentation in Clinical Trials will also help you interpret the FDA guidance and explain what it means for clinical trial sponsors and research sites.

It offers invaluable specific examples of how to handle IT implementations that involve electronic health records, images and test results, FDA inspection requirements and more.

You’ll gain understanding of what the FDA expects on critical electronic documentation issues such as:

• Eliminating unnecessary duplication of data
• Reducing opportunities for transcription errors
• Promoting real-time entry of electronic source data during subject visits
• Ensuring accuracy and completeness of data (e.g., through the use of electronic prompts for missing or inconsistent data)
• And muchmore

Electronic source documentation is here and eventually will affect every organization involved in clinical trials — drug and device companies, CROs and data management centers. Don’t put off your education process in this critical area.

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Offered in print or PDF format for $377 each.

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