Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase.
Please notefile registration#
Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Each course purchase includes a completion certificate issued to the participant after the course. Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training.
Our webinar platform combines the convenience of online training with the live interactivity of the classroom. To access the course, you need only a computer with internet access and the log-in credentials. Access to the on-demand webinar will be made available via email within 1 business day after your purchase. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Take the first steps towards a solutions-oriented TMF culture.Identify and correct unsustainable QC practices that incentivize the creation of NTFs.Adopt a flexible TMF mindset that can help reduce the need for NTFs.Develop an informed interpretation of the NTFs relationship to existing regulation.Describe the general structure and most common uses for a NTF.LEARNING OBJECTIVESĪt the completion of this session, you will be able to: 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. Furthermore, you will learn the tools for assessing issues as they arise and taking the appropriate action. This interactive session will provide you with the foundational background necessary to combat the formation of an “NTF-happy culture,” or correct one. 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. 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. The only way to eliminate dependence on the NTF is to conquer this fear of decision-making.
The subsequent inaction can allow small issues to grow into insurmountable obstacles. 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.
Please notefile trial#
As a result, NTF creation is subliminally (or even overtly) incentivized through trial conduct. 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. Their conclusion is clear: the NTF cannot take the place of corrective action. The FDA has taken notice of this trend and issued several well-publicized warning letters in response. 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.
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