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Source Document Verification




Validating electronic source data clinical trials

Validating electronic source data clinical trials


This varies from paper questionnaires sent by conventional mail, patient-reported diaries, telephone interviews, clinical or home interviews and to online, web-based questionnaires [36,37]. Despite this, few regulations talk about data validation directly. Why does Clinical Data need Validation? Investigators like the flexibility and versatility of pen and paper, and they perceive computerized systems as a drain on their productivity. Copies and transformations of the data are accurate and complete, do not overwrite original data, and are traceable back to original data. On-site storage can present many logistics challenges such as data corruption or loss, SOPs, software validation plan, restricted access and many others. However, paper is still prevalent at clinical sites, as the FDA requires record retention for CRF supporting data that is typically stored in source documents. Regulations and guidances that do mention clinical data validation, or a part of the process, are listed below. An important concern in moving to electronic source data is the validation of such data. However, despite the many benefits, esourced documents can still be challenged from a GCP compliance perspective. Ronald G Marks Abstract The clinical trials industry relies heavily on paper-based source documents as the foundation for the collection of its clinical research data from human subjects and medical records.

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Validating electronic source data clinical trials. Validating electronic source data in clinical trials.

Validating electronic source data clinical trials


This varies from paper questionnaires sent by conventional mail, patient-reported diaries, telephone interviews, clinical or home interviews and to online, web-based questionnaires [36,37]. Despite this, few regulations talk about data validation directly. Why does Clinical Data need Validation? Investigators like the flexibility and versatility of pen and paper, and they perceive computerized systems as a drain on their productivity. Copies and transformations of the data are accurate and complete, do not overwrite original data, and are traceable back to original data. On-site storage can present many logistics challenges such as data corruption or loss, SOPs, software validation plan, restricted access and many others. However, paper is still prevalent at clinical sites, as the FDA requires record retention for CRF supporting data that is typically stored in source documents. Regulations and guidances that do mention clinical data validation, or a part of the process, are listed below. An important concern in moving to electronic source data is the validation of such data. However, despite the many benefits, esourced documents can still be challenged from a GCP compliance perspective. Ronald G Marks Abstract The clinical trials industry relies heavily on paper-based source documents as the foundation for the collection of its clinical research data from human subjects and medical records.

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2 thoughts on “Validating electronic source data clinical trials

  1. [RANDKEYWORD
    Vukree

    What is the Validation Process?

  2. [RANDKEYWORD
    Nikozilkree

    Database Lock When no more updates or changes to the data are expected the database is locked. The source data are recorded when they are generated.

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