Notes to File (NTFs), also known as Memos to File, are commonly used as essential documentation in sponsor and site files. Many times the NTF’s content does not serve the purpose for use or serve no purpose at all. This course will discuss the appropriate and inappropriate uses of Notes to File, questions to ask to determine if a note to file would be beneficial, and what are the components of a quality note to file, if being used.
- Discuss the current overuse and misuse of NTFs, including FDA WLs noting deficiencies in interventions that include NTFs
- Identify what is an appropriate NTF, patient and non-patient specific
- Write effective NTFs, when applicable
- Reference industry tools relating to NTF
- Quality Assurance
- CRAs
- CRCs
- Investigators
- CRA Managers/PMs
Sandra SAM Sather, MS, BSN, CCRA, CCRC
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1.5 hours; 2:30 - 4:00 p.m. Eastern
August 6, 2010
$795
Includes up to 20 participants at one site. 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 sites, call 1-800-856-2556 for pricing.
Barnett 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 mail ACPE statements within three weeks of program completion. ACPE#: 778-000-08-028-L04-P. Released: 2/09.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.