Sugestao

Sugestão!

A Note to File (NTF), also known as a File Note, is a useful tool; it allows you to document an issue in the conduct of the study or a discrepancy (for example a missing data item or a missing date on a consent form). It also provides a forum for you to document the action taken to correct this.
(Where applicable) you should also:
• address the root cause of the discrepancy/issue



INSTRUCTIONS for use of NOTE TO FILE TEMPLATE

This form is not controlled; this means you can amend it as needed.
Note that text enclosed with is a placeholder for a specific detail (e.g., )so replace as appropriate.
Background
A Note to File (NTF), also known as a File Note, is a useful tool; it allows you to document an issue in the conduct of the study or a discrepancy (for example a missing data item or a missing date on a consent form). It also provides a forum for you to document the action taken to correct this.
(Where applicable) you should also:
• address the root cause of the discrepancy/issue
• record the corrective action taken to prevent its recurrence
• document that the corrective action has resolved the problem.
A NTF can be recorded for an issue or discrepancy that applies to a single participant, multiple participants or applies to the study as a whole.
Filing of the NTF
Where the NTF refers to a study participant, the complete, signed NTF should be filed with the participant’s study records.
Where the NTF refers to a study-level issue, the NTF should be filed in the Study Binder in the section it is relevant to.


NOTE TO FILE TEMPLATE

STUDY PROTOCOL #/NAME:

SITE NAME/NUMBER:

PARTICIPANT ID (if this Note to File pertains to a participant):

ISSUE:


Record information here (i.e. issue description, action taken)



















REPORTED BY: ROLE IN STUDY: :

SIGNATURE: DATE:

Sugestão. Sem mais contexto é difícil

Considerando-se que "file" aqui é um verbo e não um substantivo.

Um formulário usado para solicitar anotações e comentários em documentos já colocados no arquivo do estudo.