0

Are American Clinical Research Companies or laboratories doing analysis for clinical trials required to use relational databases or non-relational databases or Relational Database Management Systems to store and documen data clinical trial data per Food and Drug Administration regulations? The advantages of a database include logging who logged in, and logging intruders/IP addresses, user control, access control, limiting people reading, blinding investigators. An Excel spreadsheet has to be re-formatted by click and drag every time to achieve blinding, and has no access control.

No laws to regulate how companies store data or report data leads to chaos. Do bureaucrats dislike chaos? There'd be no control over whether spreadsheets by hand, Excel spreadsheets, of complicated MongoDB databases are used. I am not sure whether FDA receives raw-data, but FDA would have a diversity of file formats including scanned notebooks, Excel files, and database files.

Improve this question
10
  • Spreadsheets are not typical rational databases. There would be good security reasons to regulate the usage of spreadsheets (often only because it would be stored as a local file), but not rational databases per se. For a rational database, a query can be developed that would only return results that doesn't contain sensitive data. Thus on a server, both rational and non-relational databases, would be far more secure than spreadsheets.
    – Mark Johnson
    Aug 26, 2022 at 10:49
  • 2
    I hope this is not the case... having law mandate specific IT software generally is a very bad idea. IMHO the law should simply state that 1) they must store data in a persistent way 2) They must have certain backup policies 3) The data must be always encrypted and encrypted at rest, including backups 4) The access to said data must follow certain policies (e.g. only specific persons can access records and they can only access the records they need) 5) Every action must be audited and the audit logs must be securely stored & backuped. how precisely this is done doesn't really matter
    – GACy20
    Aug 26, 2022 at 13:16
  • 1
    And in fact how it is done will evolve in the future. So adding too many specifics can hinder innovation. The law need only specify broard principles, and if a company gets sued experts can testify on whether or not the handling met the principles described according to current technologies & practices.
    – GACy20
    Aug 26, 2022 at 13:18
  • 2
    I seriously doubt that any specific mechanism for storing results is called for. That would be up to the individual company or person performing the trials to determine. As long as whatever requirements for record keeping are met, it would not matter if they used pencil and paper, Excel, MongoDB, or Oracle. In reality I am sure that nearly all use some sort of database product but whether it's relational or not is again up to those who design the study.
    – jwh20
    Aug 26, 2022 at 14:09
  • 1
    No laws to regulate how companies store data or report data leads to chaos. this is plainly wrong.
    – Trish
    Aug 26, 2022 at 15:06

0

Reset to default

You must log in to answer this question.

Browse other questions tagged .