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Note-To-File (or not)

Note-To-File (or not). Uses and Abuses Connie Dagon, Lucy Miller, Christy Yoder, and Beth Zwickl. Solutions Newsletter – Carl Anderson. What regulations require NTFs? Can an NTF be a positive practice? What are the specific elements of a useful NTF?

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Note-To-File (or not)

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  1. Note-To-File(or not) Uses and Abuses Connie Dagon, Lucy Miller, Christy Yoder, and Beth Zwickl

  2. Solutions Newsletter – Carl Anderson • What regulations require NTFs? • Can an NTF be a positive practice? • What are the specific elements of a useful NTF? • What requires documentation when a mistake is made? • What can be done to avoid NTFs? It’s a handout!

  3. NTFs Abused • FDA and the Aventis Warning Letter “Aventis’s method for securing compliance (i.e., the generation of more than 125 memos to file for protocol and informed consent deviations noted at the site) was not adequate.” pg. 4 www.fda.gov and use search engine warning letters

  4. Notes-To-File • Should not be used exclusively as devices to explain discrepancies • Should not be used exclusively to explain missing or incomplete data • Do Not replace “adequate and accurate case histories” (21 CFR 312.62) • Are Increasingly requested by sponsor monitoring staff - not generally temporally associated • Can be Red Flags

  5. Essential Document? “….those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.” And “….serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice” Generally a note or memo to file is for clarification, but does it indicate compliance?

  6. Standard Operating Procedures/Regulatory Guidance For Notes-To-File? • IRB – No • VA – No • FDA – No • NIH – No • GCP – No

  7. What’s a Coordinator to do?

  8. NTF – Location of Documents NOTE TO FILE Date: July 3, 2008 To: Evaluation of isogenic mutants in experimental human infection with Haemophilusducreyi (DMID# 06-0027) From: Sheila Ellinger, RN, MSN, CCRP, Indiana University _________________________________________ Re: Location of Annual Reports to the FDA and Appendix to the 2008 Report for BB-IND No. 13064, “Experimental infection with Haemophilusducreyi strain 35000HP and/or its isogenic mutants in healthy adult volunteers” Issue: For submission to the DMID SMC, Dr. Spinola sent the FDA 2007 and 2008 Annual Reports plus an Appendix to the 2008 Annual Report to DMID Protocol Champion, Hagit David PhD. Copies of these documents are located in the IND binders under Serial 0007 and Serial 0013.

  9. Deviations – Minor & Major • Minor deviations - Keep a log – missed visits, noncompliance with meds, incomplete data. • Report major deviations • Report all noncompliance • Continuing Review – summarize – attach log

  10. Deviation Log • For reporting deviations that do not, in the opinion of the PI, impact subject safety, affect the integrity of study data and/or affect subject’s willingness to participate in the study: • Subject ID • Event Date • Event Description • Action Taken (both corrective and preventive) • Documentation of PI review and assessment

  11. IRB • Are you compliant?  Be knowledgeable about and refer often to the IUPUI Standard Operating Procedures (SOPs) for Research Involving Human Participants as one of your main resources for human subjects research related requirements. • They are located here: http://researchadmin.iu.edu/Forms/human_subjects/hs_iupui/Standard+Operating+Procedures+(05.01.09).pdf.  • The table of contents can be used to identify the SOPs applicable to your work. • http://researchadmin.iu.edu/HumanSubjects/IUPUI/hs_forms.html • Prompt Reporting Form • Noncompliance Reporting Form • Continuing Review - Deviation Log

  12. Note To File • Be generated on a case-by-case basis • Include the subject and protocol it refers to • Be signed and dated by the individual who is writing it • Be legible if handwritten • Explain clearly and specifically the reason for the error/omission/discrepancy or process/policy it aims to address. • Should include any corrective and preventative action or follow-up when applicable. • Be filed with the document, subject file or behind the study binder tab to which it applies

  13. Focus on NTF Prevention • The sponsor should be involved at such a level that true NTFs are rarely necessary • Educate research team initially and on an ongoing basis so that situations that may require a NTF are prevented in the first place • Correct errors in data appropriately and in a timely manner to prevent the need for numerous NTFs (single line through with date and initial of person correcting with a corresponding explanation if not obvious)

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