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DEPARTMENT OF MEDICINAL PRODUCTS FOR HUMAN USE Clinical Trials DivisionAnnex VIIIA Guideline for correct preparation of a model patient information sheet and informed consent form (PIS/ICF) Version
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The guideline for correct preparation outlines the steps and standards required to ensure that a document or process is prepared accurately and in compliance with relevant regulations.
Individuals or organizations that are responsible for submitting documents or completing processes that require adherence to specific standards must file the guideline for correct preparation.
To fill out the guideline for correct preparation, follow step-by-step instructions provided in the guideline, ensuring that all required information is accurately completed and that any necessary documentation is attached.
The purpose of the guideline for correct preparation is to ensure consistency, accuracy, and compliance with legal or procedural requirements in the preparation of documents.
Information that must be reported includes the preparer's details, the type of document being prepared, compliance statements, and any relevant data specific to the process.
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