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 the Florence Library of FDA eRegulatory and eSource Guidance
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?
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 the Florence Library of FDA eRegulatory and eSource Guidance
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?
The summaries presented in our library are for informational purposes only, they are not for implementation in operations.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.