FDA responses to questions regarding scanning documents in clinical investigations. Click here to access the full library of FDA responses to GCP questions regarding electronic processes in clinical investigations.
What is necessary to consider scanned files source documents?
In order to use scanned files as source documents, you should have a SOP describing how the scanned files are made, verified, and documented, making them certified copies (from 2015). Documentation in library.
What are the requirements that should be met by the system in case the site wants to destroy the primary source after scanning it into an electronic system?
The electronic system and records must comply with 21 CFR Part 11. There should be a process in place to certify that the electronic scanned copy is an accurate representation of the original paper document (from 2016). Documentation in library.
Can a patient chart that has been electronically scanned into a hospital’s EMR system be used for research monitoring purposes without any additional documentation from the hospital?
No. These files are considered shadow files, and they can be kept in study records; however; if the FDA conducts a bioresearch monitoring inspection of the study, the FDA investigator will expect to review at least a portion of the original source documents to verify the authenticity of the shadow files, even if the copies in the shadow files are certified (from 2013). Documentation in library.
Does a scanned copy of signed documents meet FDA regulations?
Yes. Those scanned documents may be considered certified copies and you should check with your sponsors to make sure they are in agreement with your process (from 2013). Documentation in library.
What are the requirements for sites scanning in documents and sending them to us electronically?
There are no clear requirements, but you should have a SOP for sites to have consistency in reporting/recording data. If you are not replacing the original documents, you don’t need to certify each copy, but you might want to verify the information matches what is at the site. If you want to go fully electronic, you need to make certify copies that are at least spot-checked by monitors/auditors to make sure that they are complete (from 2016). Documentation in library.
Can hard copies that have been scanned and double verified to ensure that they have been scanned correctly be destroyed?
Yes. Provided that the copies are certified, the FDA allows the original documents to be replaced by the copies (from 2013). Documentation in library.
Once a document with a wet ink signature is scanned and posted in the eTMF, is it necessary to keep the original in a paper file?
No, but the electronic system and records must comply with Part 11. The FDA allows for electronic scanned copies of documents without the originals as long as there is a process in place to certify that the electronic copy is an accurate representation of the original paper document (from 2016). Documentation in library.
Once I scan a copy in the eTMF with a date stamp and record of the person who uploaded it, can I shred the original?
If it is a certified copy, then yes. The electronic copy should be certified with a dated signature and you should have written procedures to ensure consistency in the certification process (from 2016). Documentation in library.
When documents are printed out from an electronic system or when scanning a document does the person who makes the copy need to sign/initial and date the copy to indicate it meets the requirements of a certified copy?
Printing out documents or scanning the original so the initial and date appears on the scanned document should not conflict with FDA regulations. You should have an SOP for how certified copies are verified and documented (from 2016). Documentation in library.
Can regulatory documents, such as the Form FDA 1572 and the Financial Disclosure Forms, be signed and scanned in for the internal files?
Scanning copies of original documents may not conflict with FDA regulations if they are consider certified copies, meaning they are verified, as indicated by a dated signature, as an exact copy having all of the same attributes and information as the original (from 2015). Documentation in library.
Click here to access the full library. The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
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