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NotetoFile Memo To: Investigator Site File (ISF) Date: From: Study: Subject: Copies: Study Staff Signature Date Signed
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Start by opening the note-to-file form provided by donnabellas.
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Begin by entering the date on which the note is being written. Ensure that the date is accurate and aligned with the event or incident for which you are filing the note.
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Next, provide the essential details of the event or incident in the designated section. Include relevant information such as dates, times, and locations. Be specific and concise in your descriptions.
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If applicable, include the names of individuals involved in the event or incident. Provide their full names and any other relevant details, such as their job titles or roles in the organization.
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Proceed by documenting a thorough and objective account of what occurred. Use clear and precise language, avoiding any subjective opinions or biases. Stick to the facts and avoid speculation.
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In the note, be sure to include any actions taken or decisions made as a result of the event or incident. This will provide a complete picture of how the matter was addressed.
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Sign and date the note-to-file at the bottom, indicating that the information provided is accurate and true to the best of your knowledge.
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