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Appendix 9: AX 02/SOP 06/V2.2 Template for Participant Information Sheet (PIS) and Participant Informed Consent Form (ICF) Informed Consent Document: Part I Participant Information Sheet (PIS) [Instructions
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How to fill out templates participant information sheets
How to fill out templates participant information sheets
01
Obtain a copy of the participant information sheet template.
02
Read through the template to understand what information is required.
03
Fill in the participant's personal details such as name, age, contact information, etc.
04
Provide any relevant information about the study or research project that the participant needs to be aware of.
05
Include any confidentiality or data protection statements as necessary.
06
Review the completed participant information sheet for accuracy and completeness.
07
Obtain any necessary signatures from the participant acknowledging receipt and understanding of the information provided.
08
File the completed participant information sheet for reference and future use.
Who needs templates participant information sheets?
01
Researchers conducting studies or research projects that involve human participants.
02
Institutional review boards or ethics committees overseeing research involving human subjects.
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What is templates participant information sheets?
Templates participant information sheets are standardized documents that collect essential information about participants in a specific study or project, facilitating data management and compliance.
Who is required to file templates participant information sheets?
Researchers, project coordinators, and organizations conducting studies involving participants are required to file templates participant information sheets.
How to fill out templates participant information sheets?
To fill out templates participant information sheets, gather accurate participant information, complete each section of the template as required, and ensure all necessary signatures are collected before submission.
What is the purpose of templates participant information sheets?
The purpose of templates participant information sheets is to provide a clear and organized method for documenting participant data, ensuring compliance with legal and ethical standards.
What information must be reported on templates participant information sheets?
The information that must be reported includes participant identification details, contact information, consent status, and any relevant demographic or health data necessary for the study.
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