Other

FDA responses to questions that do not fit into the other sections of electronic processes in clinical investigations. 

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

Is there a guidance about going electronic with the Regulatory Binder?

There is no requirement to use binders, the FDA only provides regulations about the records that need to be maintained (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

For electronic systems owned or managed by sponsors and other regulated entities that fall under the scope of 21 CFR part 11, what will be the FDA’s focus during inspections?

A FDA inspection will focus on the implementation of the electronic system, any changes made to the system, and documentation of validation. The FDA will also focus on source data that are transferred to another data format to ensure checks are in place and that critical data are not altered during the migration process. Additionally, they will review SOPs and support mechanisms in place to ensure that the system is functioning and being used in the manner intended (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Under 21 CFR 11.10(d), what are the FDA’s expectations regarding the use of internal and external security safeguards?

Sponsors and other regulated entities must have process to safeguard the authenticity, integrity, and confidentiality of electronic records. There should be a procedure to limit access to their electronic system to authorized users and there should be external security safeguards to prevent, detect, and mitigate effects of computer viruses and other harmful software code (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Is the electronic document management system that we use for SOPs and SOP training records required to be 21 CFR part 11 compliant?

Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations, as well as electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Who has the responsibility for ensuring that the software is part 11 compliant when a company on behalf of the sponsor provides it?

Both the software vendors and the end-users should validate the software (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Are sponsor investigators expected to adhere to Part 11 compliance with regard to the management of their multi-site studies?

Yes, except for EMRs, any electronic records should be Part 11 compliant (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can biometrics based security authentication be used in lieu of traditional passwords to be Part 11 compliant?

Yes. These biometrics must ensure that they cannot be used by anyone other than their genuine owner, that they are uniquely identified with the individual, and shouldn’t change over time (from 2016). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

If a non-US site is conducting a clinical investigation, are records required by FDA regulations subject to part 11 requirements?

If it is conducting a clinical investigation under an investigational new drug application, yes. Under an investigational device exemption, if the sites agree to comply with 21 CFR part 812, then yes as well. For foreign studies not conducted under an IND or an IDE, good clinical practice standard for electronic records and electronic systems would apply (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Is it acceptable to have consent form sent via email instead of fax to obtain consent from a LAR?

Yes. The LAR would need time to read the consent form and there would need to be a consent interview that allows for an exchange of information, including allowing the LAR to have questions answered (from 2012). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

ECG reports printed on a thermal paper have been photocopied but is a true attestation required again on the photocopy?

Yes. These copies should be certified copies (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Would FDA expect that PIs at sites query their discontinued subjects’ EMRs to obtain AE-related data?

The protocol and sponsor should provide clear information about the “when”, “where” and “how” for collection of safety data as well as follow up of any ongoing AEs/SAEs at the time of discontinuation (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Would it ever be appropriate for a PI to approach a subject’s friend/family to obtain current contact information for a discontinued subject lost to follow up without having the subject’s prior consent to do so?

Generally, the subject would have to give their consent to provide a contact person (e.g. friend/family) and then to allow the PI to contact that person on their behalf, unless there is a different process dictated in the protocol (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can we download the temperature used in the clinical trial directly to a CD/DVD instead of printing them?

Yes. You should work with the sponsor and make sure they are involved. The electronic system should be part 11 compliant (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Is there a required timeframe of when our PI or MDs have to sign off on the lab and ECG reports?

It is just determined per your SOPs or practice (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Should sensory studies be considered equivalent to clinical trials in adherence to FDA GXP regulations and validation of their computerized systems?

Any electronic system that is used to support FDA-regulated research should be validated and be part 11 compliant (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can clinical research conducted under IND be funded by donations from crowd funding websites (Gofundme.com)?

Yes, because there is no requirement to disclose funding source, unless it creates a conflict (from 2014). 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.