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:
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:
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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