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Source document

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.

Clinical research professionals review and verify the accuracy and completeness of data recorded in the source documents against the data entered into the EDC study database, ensuring the reliability and quality of the trial data. Thus, it becomes handy to have the source document storage functionality embedded in EDC.

In the EDC application, all source files are stored under the Source Document tab.

Source documents of EDC
Figure 1. Source documents of EDC

Important

All files uploaded to EDC that went through auditing and have their status as Final are automatically forwarded to the eTMF storage and can be accessed in the EDC > Source Document directory of your study.

Accessing EDC source files from eTMF
Figure 2. Accessing EDC source files from eTMF

Within the Source Document page of EDC, you can perform the following actions:

Important

The ability to view and manage the Source Document page depends on the permission granted to your user role in ADMIN.

Reviewing permissions for source document handling
Figure 3. Reviewing permissions for source document handling

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.

An electronic version of a trial master file (TMF) is a type of content management system for a clinical trial used to organize and store files required for compliance with government regulatory authorities like the FDA, EMA, or others.

Get to know all the possibilities of the app with the comprehensive eTMF User Guide.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.