When clinical research sites decide to take the plunge and go fully electronic in their daily operations, data collection, and regulatory workflows, there is often anxiety about exactly what they are "allowed" to make electronic and what they should keep on paper. If you are one of these sites, or if you are simply doing some spring cleaning and wondering what old papers you can finally recycle, this article will cover the important topic of Certified Copies.
Certified Copies According to the FDA
FDA regulations permit an investigator to utilize certified copies instead of original records as source documentation. When a copy is made and certified, the investigator may destroy the original paper document. If the idea of destroying an original paper copy makes you nervous, read up on the FDA guidelines (page 8) to convince yourself that you really can get rid of those piles of papers!
In CRIO's eSource system, when you upload a document, and e-sign it without marking it up, the system detects the fact there were no changes and creates the attestation, "I certify this is a true and correct copy." If you use our mark-up tools to make annotations, the system detects those changes, and creates the attestation, "I attest that this is an original." The "copy" is the uploaded version of the electronic document, and the "certification" is the eSignature and the attestation line.
Either way, you do not have to keep any paper copies of anything you have uploaded into our system as long as you have eSigned the document--the attestation line is inserted automatically.
These FDA Guidelines work the same if you have chosen to go paperless in your regulatory workflows. As long as you upload the document (the "copy") and eSign/attest (the "certification") you do not have to keep the original, paper document.
CRIO's new eRegulatory module does not have the same auto-detect feature as it does in the eSource system. Instead of a forced attestation feature, you get to choose your attestation-- one of which is that "this is a true/correct copy." The ability to choose the correct attestation further covers you under FDA Certified Copy Guidelines, as you are showing true oversight over the different needs of various regulatory documents.
Certified Copies in Practice
Under FDA Certified Copy Guidelines, theoretically, you can destroy all of your originals.
However, here at Team CRIO, we work with hundreds of research sites around the world and understand the reality of your day to day. Destroying documents is scary! As much of an advocate of paperless as we are, there are a few documents that would make us a little nervous if our clients were to destroy. In practice, you may want to keep copies of:
- The original executed Informed Consent document
- The original ECG tracing
- The original paper versions of patient reported outcomes
Additionally, you will most likely have to continue executing 1572's as original wet-ink signatures for the near future. Because this is an official FDA form, sponsors will want the signature physically inserted into the horizontal line for PI signature, instead of situated outside of the document like our eSignature feature.
Other than that, everything else can stay electronic as a Certified Copy in CRIO's system.
Happy spring cleaning! 💮🌻🌼
Anna Krauss is a Project Manager at Clinical Research IO. She has experience in the health field through her work as a Research Assistant with the MaineGeneral Hospital system, Hospital General de Agudos Bernardino Rivadavia in Argentina, and through her experiences working as an EMT.