FDA responses to questions regarding the source of documents in clinical investigations. Click here to access the full library of FDA responses to GCP questions regarding electronic processes in clinical investigations.
Can original source paper documents being used for a current active trial be shipped to off site storage?
Yes. There should be SOPs for the storage of these documents so that the agency can be assured the records aren’t being tampered with (from 2013). Documentation in library.
Can the eCRF be the only source data in a clinical trial and how do you check source data?
Yes. Data can be directly entered into the eCRF and the eCRF is considered the source. To check the source data, the FDA could request other documents to corroborate a direct entry of data into the eCRF (from 2013). Documentation in library.
When using images for source data, do we need to ask the investigator to save the images to a back-up disk in case of the computer system breaking down and losing the images?
If you are concerned that eSource data may be lost, misplaced, or deleted, you should put in place a system to eliminate this situation. You can copy the images to a disk and have it as a certified copy, in which case, it could be used if the eSource data is lost. You should establish SOPs in this case so that there is a clear procedure for this process (from 2013). Documentation in library.
Is it an acceptable process for a clinical investigator to type the subject visit information into a Microsoft Word document, print the document, sign and date it, save the document in Word for some period of time, and then eventually delete the document?
Yes. This process is using a computer as a typewriter so the use of computer systems in the generation of paper records would not trigger part 11 (from 2014). Documentation in library.
Does the email correspondence from the site, containing source data to respond to queries, be considered by FDA to comply with Part 11 requirements for electronic records?
Yes. To determine if it is compliant depends on what the site is using, because some email is just text that can be easily changed. Additionally, if it’s not secure, the sender of the email is a concern and you should be able to identify the source creator (from 2015). Documentation in library.
Can data be sent as an email, printed out, and then retained with source documents? Does it need to comply with part 11 in this instance?
In this instance, it is important to have clear SOPs in order to have flexibility in handling documents as long as everyone follows them. Since the email correspondence is considered the source document and can be accessed electronically, it should not conflict with FDA regulations as long as it follows protocol (from 2015). Documentation in library.
If you are using a personal computer to type study-related information into an excel spreadsheet and then print it out to use the paper printout as the source document for the study record, does the computer system fall under the scope of part 11?
No (from 2016). Documentation in library.
Can the PI sign a paper document that states the source data given the data entry was accurate instead of completing the training to access and review the eCRFs?
The PI and/or sub-PIs can’t sign off on data if they have not seen or reviewed it. All parties should be trained as the guidance outlines in Part 11 if you are using eCRFs (from 2015). Documentation in library.
When a site uses images in their study, is there a guidance on whether the print-out or a copy on a CD should be used as the source?
No. Either can be considered the source, and the sponsor and clinical site must determine which they consider the source (from 2013). 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.
Florence is a team of clinicians, research professionals and technologists working to improve clinical trial efficiency from startup to closeout.
Our solution eliminates workflow bottlenecks at the site, tracks study and site progress, and provides remote monitoring capabilities to sponsors — thus reducing uncertainty between visits, delivering cost savings, increasing compliance, and improving site-sponsor relationships.