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This document provides information regarding a clinical study on the VLA2001 vaccine, which aims to evaluate its immunogenicity against COVID-19 in adolescents aged 12 to 15 years. It outlines the study\'s purpose, procedures, requirements for participation, and associated risks, including potential benefits and compensation for participants.
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How to fill out information sheet and assent

How to fill out information sheet and assent
01
Start by gathering all necessary personal information such as name, birthdate, and contact details.
02
Provide details about the study or project, including its purpose and duration.
03
Clearly outline the procedures involved, highlighting any risks or benefits.
04
Include sections for consent, where participants can agree to take part in the study.
05
Ensure that there is a space for the signature of the participant or their guardian, along with the date.
06
Add a section for providing questions or concerns about the study for participants to consider.
Who needs information sheet and assent?
01
Participants in clinical trials or research studies.
02
Minors who require parental or guardian approval.
03
Individuals involved in psychological or social research.
04
Research organizations and institutions conducting studies that require informed consent.
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What is information sheet and assent?
An information sheet is a document that provides essential information about an individual or entity, while assent refers to agreement or approval given by a participant or stakeholder regarding the content of the information provided.
Who is required to file information sheet and assent?
Individuals or entities involved in certain regulated activities, such as research or compliance with specific legal requirements, are typically required to file an information sheet and assent.
How to fill out information sheet and assent?
To fill out an information sheet and assent, one must provide accurate details such as name, contact information, purpose of the filing, and any required signatures, ensuring that all information is complete and truthful.
What is the purpose of information sheet and assent?
The purpose of the information sheet and assent is to ensure transparency, obtain necessary approvals, and document the agreement of participants or stakeholders regarding the information presented.
What information must be reported on information sheet and assent?
Reported information typically includes the identity of the filing individual or entity, nature and purpose of the filing, and any relevant agreements or consents from involved parties.
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