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Compliance In Focus
Posted by Brandy Chittester on Thu, Feb 18, 2021

How to Properly Make a Correction to a Clinical Research Record

Most of us have been there before.  In an attempt to get that last item completed before the end of another long day on the job in the field, we inadvertently scribe the wrong date on the clinical research record we are completing. 

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We are all human after all, and mistakes do happen from time to time.  Sometimes we know instantly and can correct ourselves. In other instances, someone else points out the discrepancy we may have overlooked.  It’s how we respond after we are made aware of the mistake that matters.

How Would You Correct A Clinical Research Record?

Put yourself in this position and answer honestly. Then, after reading the rest of this blog, answer again and see if your response changes.  If not, congratulations for being informed.  Here we go: 

Your monitor notes that your principal investigator documented examining a study subject on April 7.  You completed the paper-based case report form (CRF) for the corresponding visit and indicated that the visit took place on May 6. After review, you confirm that the visit took actually occurred on May  7 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
  3. Draw a line through the previously written date, initial and date next to it, then write the correct date 
  4. Use correction tape to go over the previous date and then write the correct date over it
  5. Leave it alone

If you chose 3, pat yourself on the back, but can you explain why?  If that’s how you were trained, or that’s what you’ve been told, that’s great.  But what do the regulations say about making a clinical research record correction?

How To Properly Correct A Clinical Research Record

21 CFR 812.140 specifies that an investigator must maintain accurate, complete, and current records.  It does not specify how an investigator or research coordinator completing a CRF should do this. One must look further to the International Conference on Harmonization Good Clinical Practice (ICH GCP E6 Part 4.9.3) for guidance. 

This guidance, now known states: 

“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).”

The guidance notes this applies to both written and electronic changes. 

Fortunately, a good electronic data capture (EDC) system  will record all changes automatically. 

What Is A Sponsor's Role In Ensuring Data Integrity?

ICH GCP E6, Part 4.9.2 further states that sponsors should have written procedures for investigators or their representatives on how to make clinical research record corrections. The investigator should endorse any changes or corrections and retain records of them. 

Sponsors must also ensure it is possible to compare the original data with the processed data. They must also use an "unambiguous subject identification code that allows identification of all the data reported for each subject." The principal investigator should maintain the link between the code and each subject in a secure location. 

What Are Best Practices For Record-Keeping? 

Good record-keeping and data management are essential to ensuring the integrity of your clinical trial. This can become more challenging as your team conducts more clinical research activities remotely. As we often say, if it wasn't documented, it wasn't done.

The acronym 'ALCOA-C' can be helpful to remember as we think about documentation and record-keeping. Our ALCOA-C checklist, based on ICH GCP E2 Rev2, is a good way to ensure you've covered all your bases, whether you are recording data, making corrections, or writing a report. 

Download it and bookmark it for reference!

ALCOA-C Checklist Download

 

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

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