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Source document tracker report

Source documents are original records or certified copies of records that provide evidence of the existence, activities, and results of a clinical trial or study. Some of the source documents that can be related to data verification and documentation review are case report forms (CRFs), medical records, informed consent forms, pharmacy records, adverse event reports, regulatory documents, and so on.

For analysis purposes, you also have a comprehensive source document tracker report that outlines the current state of document acquisition in your study under the Source Document module. Use this report to understand the missing document ratio and the work needed to fill the gaps.

For convenience, the report comprises two tabs:

  • Tracker Summary: depicts statistics of source document upload per study and site via graphic charts.

  • Tracker Details: depicts statistics of source document audit statuses per site and subject via the comprehensive table.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.