Electronic Records

FDA responses to questions about the use of electronic records in clinical investigations. 

From Florence’s Complete Library of FDA eRegulatory and eSource Guidance

Does part 11 apply to electronic health records?

No; however, there should be controls in place to assess the quality and reliability of the EHRs and other authorities may regulate the EHRs (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Are hospital EMRs required to be compliant with part 11?

No, but there should be adequate controls to ensure confidence in the reliability, quality, and integrity of electronic source data (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Would FDA expect a site to grant monitors access to subject electronic records without additional steps (e.g. signing an access request form)?

Yes. Direct access to records is not necessary; study staff can bring up records for printing and viewing for the FDA investigators. A confidentiality agreement is not a usual requirement of the investigators (from 2012). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

What is the guidance behind placing study documents into a subject’s EMR?

It is recommended by the FDA to do this (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Is there any issue of confidentiality involved regarding placing study documents into a subject’s EMR?

No. EMRs need to be maintained to at least the same amount of confidentiality as study records (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Is it appropriate to scan the informed consent research into the EMR?

Yes. These could be considered certified copies and you can develop clear SOPs to assist in the assessing which documents follow this process (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

If copies of EMRs are printed out, do they need to be certified if access can be given to the EMR to verify it?

No, this is not necessary since the originals would be accessible if an investigation were to occur (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can a monitor review EMRs if a site provides complete EMR access to all patients seen at an institution/facility instead of limited access to their system for only the subject who have signed an informed consent form to participate in a study?

This most likely violates HIPAA regulations and should be directed to them. The FDA does not endorse any specific scenario for allowing monitors and auditors to review EMR data on study subjects (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Is the sponsor or sponsor representative (CRO) required to ensure that the EHR system used to collect source data is validated or meets part 11 requirements?

No, the CROs should just assure that all applicable regulatory requirements in 21 CFR can be fulfilled (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can an investigative site only provide certified copies of EMRs and not direct access to the study monitor or FDA inspector?

No. The EMRs are considered the source records and in order to make certified copies of the medical records of study subjects, monitors and auditors will at least spot-check the completeness of the records at the source (EMR). This is can be done at your discretion (common examples are looking over the should of a study staff member or having limited access to the medical records). During an inspection, the FDA may need to view at least a portion of the original source documents (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Is a clinical investigator required to document on each individual record printed from an EMR that it is a certified copy?

No because a certified copy is not necessary when copies of EMRs are produced and the originals are generally accessible if a FDA inspection were to occur. If there are certified copies or copies of the EMR, the monitors/auditors will want to spot check the completeness of these records at the source (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Do the Part 11 regulations for representation forms and eSignatures apply for EHRs?

No, if an EHR is used to obtain an electronic signature, then the part 11 requirements for eSignatures would not be assessed. EHRs won’t be assessed for Part 11 compliance, but the sponsor should have adequate control to ensure the reliability and integrity of the data/record. Part 11 only applies when data from a record enters an electronic system under the control of the sponsor (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

If data are not to be submitted to the FDA, does 21 CFR Part 11 apply to our electronic data records?

Yes. Electronic records in an FDA-regulated clinical trial that will be submitted in a marketing application to the agency should be Part 11 compliant except EMRs (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Should the site monitor compare print-outs that are signed and dated by the sub-investigator from the EHRs system against the EHRs?

Yes. The site monitor needs to compare at least a sampling of the print-outs with the EHR in order to verify that the data is complete and accurate (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

From Florence’s Complete Library of FDA eRegulatory and eSource Guidance

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.