Use of Notes to File in Clinical Trial Essential Documentation

Course DescriptionNotes to File (NTF), also known as Memo to File, are commonly used as essential documentation in sponsor and site files. Many times the content of the NTF does not serve the purpose for use or serves no purpose at all. This web seminar will discuss the appropriate and inappropriate uses of NTF, the questions to ask to determine if NTF would be beneficial, and the components of a quality NTF, if being used.Learning Objectives Discuss the current overuse and misuse of NTF, including FDA Warning Letters noting deficiencies in interventions that include NTF Identify what is an appropriate NTF, patient and non-patient specific Compose an effective NTF, when applicable Describe reference industry tools relating to NTF Who Should Attend Quality Assurance Personnel Clinical Research Associates Clinical Research Coordinators Investigators Clinical Research Associate Managers Project Managers InstructorJanet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.Click here for complete trainer biographiesRegistration Fees$835**Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for "Certificates of Attendance," and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.Accreditation InformationBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-23-070-L99-P. Released: 7/23. Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.