Did you know screenshots are not automatically valid source documents?

The FDA recognizes source documents to be “original documents and records or certified copies.” In order to be a certified copy, it requires more than just the information that can be included in a screenshot according to FDA guidances and ICH GCP a certified copy is—“a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the same attributes as the original.”

EPIC print outs meet this requirement because they have your sID and the date printed; typically located at the bottom of most documents printed directly from EPIC. However, screenshots (most commonly demographics or labs/scans from CareEverywhere) do not automatically include this information in the printed copy and do not meet the requirements of a certified copy or valid source document!

How can I make something a certified copy?

If a screenshot is the only available option to print a document to be placed in a shadow chart, when printing the screenshot, please sign and date the copy, thereby validating it is a copy of the original record in EPIC and making it a certified copy and valid source document.

Why is my signature important?

Your signature means you personally completed or verified the completion of a required procedure/ test/ assessment/ etc. in a clinical trial.

As with any signature, it is important to ensure you know what you’re signing and what your sign off means!

If you have any questions or concerns, please email dsmc-quality@stanford.edu

References: ICH GCP E6 1.51 and 1.52, FDA Guidance for Industry: Computerized Systems Used In Clinical Investigations, FDA Guidance for Industry: Electronic Source Data in Clinical Investigations