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Compliance In Focus
Posted by John Lehmann on Wed, Jul 31, 2013

How to Properly Make a Correction to a Research Record: What is Required?

Most of us have been there before.  In an attempt to get that last item completed before theHow to Properly Make a Correction to a Research Record end of another long day on the job in the field of clinical research we inadvertently scribe the wrong date on the research record we are completing.  We are all human after all, and mistakes do happen from time to time.  Sometimes we know instantly and can correct ourselves, and others someone else points out the discrepancy that we may have over looked.  It’s how we respond after we are made aware that we have made the mistake that I want to focus on for this blog post because there are multiple different options we can take. 

Put yourself in this position and answer honestly how you would respond.  Then, after reading the rest of this blog answer again and see if your response changes.  If not, congratulations for being informed.  If not, congratulations as well for becoming informed.  So here we go.

Your monitor notes that your principal investigator documented examining a study subject on June 7th, 2013.  You completed the paper-based case report form (CRF) for the corresponding visit and indicated that the visit took place on July 6th, 2013 (6/7/13 vs. 7/6/13).  After review, you confirm that the visit took actually occurred on June 7th, 2013 and need to correct your CRF.  Do you:

  1. Scribble out the date you wrote and then write the correct one next to it
  2. Try to change the date that you wrote by writing over the numbers to indicate 6/7/13
  3. Draw a line through the previously written date, initial and date next to it, then write the correct date of 6/7/13
  4. Use correction tape to go over the previous date and then write the correct date over it
  5. Leave it alone, the monitor doesn’t know what they are talking about

If you chose 3 pat yourself on the back, but can you explain why?  21 CFR 812.140 specifies that an investigator must maintain accurate, complete, and current records.  How an investigator, or in this case a research coordinator whom he has delegated the task of completing a CRF, is not clearly described.  One must look further to the International Conference on Harmonization Good Clinical Practice (ICH GCP E6 Part 4.9.3) for guidance.  It is here that the following recommendation can be found: “Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e. an audit trail should be maintained).”

If you chose one of the other answers but read the rest of this blog and learned the proper way to document a correction pat yourself on the back as well.  I hope this was a fun learning exercise for you.

Please respond with any stories you have about bizarre requests of how to properly rectify a mistake you may have made, or with examples of different ways you may have seen someone else make a correction.  We would love to hear about the types of things people in the trenches are seeing out there!

Photo Credit: katerha

Documentation in Devices

Topics: 21 CFR 812.140, Research Record, Case Report Form

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