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Compliance In Focus
Posted by John Lehmann on Fri, Jul 13, 2012

Going Green in Clinical Research Trials

Going Green in Clinical TrialsIn the movement to “go green” and reduce overhead, some clinical sites are moving away from printing every piece of correspondence regarding a research study.  While this may reduce the cost for printer/paper toner, not to mention the time to print and file all correspondence, is this a wise decision?

According to the regulations, and ICH GCP direct study personnel to keep correspondence:

'A participating investigator must maintain the following accurate, complete and current records relating to the investigator’s participation in an investigation: (1) all correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports'. (CFR Title 21, Part 812.140 (a) Investigator records)

However, there is no instruction for how to keep the documents.  Some considerations:

  • If the research coordinator keeps the correspondence on his/her computer, what happens if the coordinator is no longer with the institution?  Can anyone else produce that correspondence for a FDA Auditor?
  • If a new computer virus hits the institution, can the files be reproduced?
  • If the documents are saved to a disc or thumb drive, can they be opened in the future if documentation software upgrades are made?
  • How will a FDA Auditor review the documents if they are not printed?  Will they be granted access to the site’s electronic files?  What about the monitor?
  • What if your computer system crashes on the day of a FDA visit?

Monitors are sometimes offered the “over- the- shoulder viewing” of site records. Although this is an acceptable way to view correspondence, keep in mind that this can allow more to be reviewed than intended – especially when considering how an Auditor may view records. One suggestion might be to provide the auditor/monitor with the disc/thumb drive. This ensures the correspondence is accessible, but access to non-study related data is minimized.  Just be sure the files are returned!

As technology evolves, it is only natural that there will new ways to consider doing the same task.  Before jumping ship and abandoning the “old” way of doing things, it’s important to think about the long term effects of any decision, and anticipate any potential problems.  While oftentimes the regulations don’t dictate how something is done, it’s still important to show that it was done.

Have you changed your filing system in an effort to “go green” or to take advantage of the latest technological advances?  What safeguards have you put in place to ensure long-term accessibility of records?  Please share your experiences with us.

Photo Credit: epSos.de

Topics: Monitors, Going Green, Clinical Research, Regulations

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