note to file form
Portuguese translation: observação no formulário de arquivo
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| 14:16 Jul 20, 2020 |
| English to Portuguese translations [PRO] Other | |||||
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|  Selected response from: Paulinho Fonseca Brazil Local time: 20:24 | ||||
Grading comment
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Answers
7 mins confidence: 
nota para o formulário do arquivo Explanation: Sugestao |
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7 mins confidence:
nota referente/sobre o formulário do arquivo Explanation: Sugestão! |
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17 mins confidence: peer agreement (net): +1
peer agreement (net): +1formulário de registro e descrição da ocorrência (problema) Explanation: 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: |
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27 mins confidence: peer agreement (net): +2
peer agreement (net): +2observação no formulário de arquivo Explanation: Mais uma sugestão. |
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35 mins confidence:
2 hrs confidence: peer agreement (net): +2
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