Conduct↦Quality and Risk↦Deviation Documentation↦Note to File
What is it? Why is it important?
A Note-to-File (NF) is a useful way to document an issue or discrepancy in the conduct of a study. It also allows one to document the action taken to correct it.
A NF contains:
- A factual description of the problem or issue
- A route cause analysis
- A description of corrective measures to prevent reoccurrence
- A confirmation that corrective action(s) have resolved the problem, or what procedures were implement if the issue could not be solved
- Applicable dates and signatures
NFs are generated on a case-by-case basis. The content explains why things were done and the way they were done. NF provide important information to monitors during monitoring visits, during communication with SP-INV, and potential regulatory inspections (e.g. Swissmedic).
NF should not be misused to avoid a protocol amendments. Repeated protocol deviation require an amendment.
NF should be limited to major errors (e.g. protocol deviations). Minor errors are usually corrected and documented elsewhere (e.g. eCRF entry corrections such as a change in recorded participant weight).
Who authors the NF depends whether the event or issue relates to:
- Site performance: the respective site delegated person writes the note
- Site-INV responsibilities: the Site-INV writes and signs the note (e.g. participant safety, data quality)
- Actions taken by SP-INV or monitor: the SP-INV or delegated person writes and signs the note
What do I need to do?
A NF is initiated and authored by the individual or organisation responsible for its content. The management of NFs requires that:
- A problem or deviation is explained and corrective actions are described
- Applicable study staff is trained to prevent deviation reoccurrence
- The NF is printed on institutional paper with letterhead
- An index is maintained that summarised all NFs according to topic, and where they can be located (e.g. filed in TMF and ISF)
- Serious deviations are reported to EC and RA (e.g. Swissmedic), as applicable
Errors or deviations can be classified according to level of seriousness. Unfortunately, there are no official guidelines that provide help on how to classify deviations. When deciding on seriousness, the SP-INV and Site-INV carry the responsibility and must use common sense, pragmatism and study experience.
For more information refer to Documents in this Trial Guide
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 5.0 Quality management
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)