Storage/Maintaining Files

FDA responses to questions regarding the storage of files in clinical investigations. 

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

Can sponsors and other regulated entities use and retain electronic copies of source documents in place of the original paper source documents?

Yes. This is allowed as long as recordkeeping and retention requirements are met (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can sponsors and other regulated entities use durable electronic storage devices to archive required records from a clinical investigation?

Yes. Sponsors and other regulated entities should ensure that the integrity of the original data and the content and meaning of the record are preserved (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can we maintain research records on a flash drive instead of keeping a paper file?

Yes, provided that all regulatory requirements under the primary rules are met and the copies of the required records preserve the content and meaning of the original records (from 2012). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Does storage of regulatory non-patient related documents need to fully comply with Part 11?

If the documents under question are for the review and archival of electronic source data in/for an FDA-regulated clinical investigation, they should be Part 11 compliant (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

If EMRs are used as source documents, how should source documents be kept at the research site?

Your EMR can be your source record, they do not need to be printed out by investigators and certified because they can be accessed if needed. If you do make certified copies of the medical records, monitors/auditors will want to at least spot check the completeness of these records at the source (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

If a sponsor develops an SOP policy; obtains a wet-ink signature on the SOP from the approvers; scans the signed document into an electronic system, PDFs the document, and stores the document electronically to allow staff accessibility, does the sponsor need to maintain the original wet-ink signed SOP/policy?

No, it is not necessary to keep hard copies if the original files can be accessed electronically (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can paper source documents be scanned, stored electronically, and originals can be shredded, or must all paper source documents be stored according to study storage requirements since they are the original source documents?

Yes, paper source documents can be scanned and used as substitutes for the originals as long as they are considered certified copies (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Which documents need to be certified copies when we are storing files electronically from a closed clinical trial site?

All records that are required to be maintained/submitted under FDA regulations should be kept as either source documents or certified copies. You should develop an SOP for this electronic storage process (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Do copies of regulatory documents with a signed version need to be kept by the sponsor?

No. FDA regulations do not specify who is to keep the originals versus copies of study documents (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Can paper originals be converted to pdf files, and the paper version destroyed, while the trial is still running?

Yes, the paper originals can be converted to pdf files while the trial is still ongoing. The paper version can then be destroyed as long as the pdf is considered a certified copy and it is recommended to have a SOP describing how these copies are made, verified and documented (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance

Is there a restriction of having an off-site backup of clinical trial data with a translation provider?

No. The records should be stored at a secured location defined in the SOP (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.