“Just write a note to file.”
How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself? The intent of the note to file (NTF) is to clarify an irregularity in trial documentation or conduct, but when used too frequently or inappropriately, NTFs can highlight unresolved problems, add confusing or extraneous information, or take the place of necessary corrective action. The FDA has taken notice of this trend and issued several well-publicized warning letters in response. Their conclusion is clear: the NTF cannot take the place of corrective action.
Why then, in light of these regulatory consequences, does industry use of NTF continue to increase? Usually the motivation behind the creation of the NTF is a clinical operations culture that is overly sensitive to risk. As a result, NTF creation is subliminally (or even overtly) incentivized through trial conduct. When a culture of risk aversion takes hold, the NTF becomes a tool to avoid making a tough choices rather than a means to improve clarity. The subsequent inaction can allow small issues to grow into insurmountable obstacles.
The only way to eliminate dependence on the NTF is to conquer this fear of decision-making. Along with the right tools and training, a culture that rewards positive risk-taking must be fostered to complete with the current culture of fear. When TMF stakeholders are made confident in their knowledge of the applicable regulation, encouraged to approach the TMF with a flexible mindset, and empowered to act, the NTF will no longer be able to take the place of good judgement.
This interactive session will provide you with the foundational background necessary to combat the formation of an “NTF-happy culture,” or correct one. Furthermore, you will learn the tools for assessing issues as they arise and taking the appropriate action. Finally, you will be provided with the necessary information to continuously improve your deviation investigations and understand when to initiate a NTF…and when not to.
At the completion of this session, you will be able to:
- Describe the general structure and most common uses for a NTF.
- Develop an informed interpretation of the NTFs relationship to existing regulation.
- Adopt a flexible TMF mindset that can help reduce the need for NTFs.
- Identify and correct unsustainable QC practices that incentivize the creation of NTFs.
- Take the first steps towards a solutions-oriented TMF culture.