e-Source Data Management for Clinical Trials - Basic criteria and challenges for complying with e-source data management compliance
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- Why Regulatory Compliance risk is the number ONE rated risk by the global firms across several sectors?
- How companies that are operating in highly regulated industries, particularly on a global level, face a myriad of challenges in keeping pace with fluid regulatory changes?
- How a well-planned technology plan that encompasses automation and BPM can help companies stay focused on their core business while managing compliance risk?
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The FDA developed and issued a Guidance for Industry document titled, Electronic Source Data in Clinical Investigations. The guidance addresses five general areas:
- Source data originators
- Data element identifiers
- Capture of source data into the e-CRF
- Clinical investigator responsibilities for reviewing and retaining electronic data.
- Use and description of computerized systems in clinical investigations.
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