Written by Nicole M. Palmer
Do you cringe when you hear someone say, “Oh we can just write a Note to File?” Those exact words are like nails on a chalkboard. Often note to files are red flags for inspectors or auditors, leading them to investigate and ask more questions.
In clinical research, an effective problem-solving solution is to analyze the Root Cause Analysis (RCA). Having a well-thought-out RCA process in place is imperative to be precise in identifying and preventing future problems from arising. An individual can perform an RCA however, it’s recommended to use a team approach so that you can get multiple perspectives on identifying the true root of the problem.
When someone mentions, let’s use a Note to File to solve the problem found, it’s important to ask yourself the 5 Why’s (WHY, WHY, WHY, WHY, and WHY?). Using the 5 Why method is just as it sounds. Ask the team ‘Why’ until you reach the root of the problem.
Your site has been activated and the first patient is enrolled in your clinical trial. You are performing a periodic review of the Trial Master File (TMF) and are QC’ing the Essential Documents. You notice that a sub-investigator’s CV is missing from the TMF and found out that it was never collected before the site was activated. This is a violation of ICH GCP 8.2.10. Upon further review, you see a note to file stating that this sub-investigator’s CV was not obtained before the site was activated.
Here is an example of what the 5 Why’s could look like:
1. Why: Why was the CV not collected?
Answer: It was not collected due to human error.
2. Why: Why couldn’t you collect it?
Answer: Multiple sites were being activated at the same time.
3. Why: Why wasn’t a checklist used?
Answer: Wasn’t aware a checklist was available
4. Why: Why weren’t you aware that a checklist was available?
Answer: I don’t remember being trained on this.
5. Why: Why wasn’t this person properly trained?
Answer: Perhaps they need a refresher.
Solution: By re-training the staff member and utilizing an essential document checklist it will help you to ensure you have collected the necessary essential documents and avoid writing a note to file.
The 5 WHY technique will help you identify the core problem or the sequence of events, analyze the cause, and prevent it from reoccurring. The main goal is to prevent the problem from re-occurring in the future.
Once this issue has been identified using the RCA, an effective Corrective and Preventative Action (CAPA) plan can be created to eliminate this from happening again. By taking preventative measures, you can be sure to take action by training, monitoring, and doing mock inspections.
What would you recommend for reducing Note to Files?
As always, if you have a question or want to leave a comment, please feel free- I am happy to help and love to hear from you.