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1. Study Information: Title of the research study, protocol number, and principal investigator details
2. Purpose of the Research: Brief, clear explanation of the research objectives and why the participant is being asked to participate
3. Research Procedures: Description of what participation involves, including time commitment and specific activities
4. Risks and Discomforts: Clear explanation of potential risks or discomforts associated with participation
5. Benefits: Description of potential benefits to the participant and/or society
6. Data Protection and Privacy: GDPR-compliant explanation of how personal data will be collected, used, stored, and protected
7. Voluntary Participation: Statement that participation is voluntary and can be withdrawn at any time
8. Contact Information: Details of who to contact for questions about the research or participants' rights
9. Declaration of Consent: Formal statement of consent with space for participant signature and date
1. Compensation: Details of any payment or reimbursement, included when participants will receive compensation
2. Future Research Use: Information about potential future use of data/samples, included when applicable
3. Commercial Development: Information about potential commercial applications, included when research has commercial possibilities
4. Genetic Testing: Specific information about genetic analysis, included when genetic testing is part of the research
5. Audio/Video Recording: Details about recording procedures and usage, included when recordings will be made
6. Medical Treatment: Information about medical procedures and treatment, included for clinical research
7. Costs: Information about any costs to participants, included when participants might incur expenses
1. Participant Information Sheet: Detailed information about the study in lay language
2. GDPR Privacy Notice: Detailed information about data processing and privacy rights
3. Emergency Contact Form: Form for emergency contact details when required by study type
4. Withdrawal Form: Template form for withdrawing from the study
5. Schedule of Procedures: Detailed timeline of study procedures when applicable
Principal Investigator
Research Participant
Personal Data
Special Category Personal Data
Research Institution
Study Procedures
Medical Ethics Committee
Informed Consent
Data Controller
Data Processing
Anonymization
Pseudonymization
Study Protocol
Withdrawal
Research Team
Biological Samples
Confidentiality
Data Protection Officer
Research Results
Data Protection
Privacy
Confidentiality
Research Procedures
Risk Disclosure
Benefits
Withdrawal Rights
Compensation
Emergency Procedures
Information Storage
Data Sharing
Participant Rights
Contact Information
Declaration of Consent
Medical Treatment
Costs and Reimbursement
Future Research Use
Publication Rights
Insurance Coverage
Healthcare
Academic Research
Pharmaceutical
Biotechnology
Psychology
Social Sciences
Market Research
Medical Devices
Clinical Trials
Educational Research
Public Health
Environmental Research
Research & Development
Legal
Compliance
Ethics
Clinical Operations
Data Protection
Medical Affairs
Academic Affairs
Regulatory Affairs
Human Resources
Quality Assurance
Research Director
Principal Investigator
Research Coordinator
Clinical Trial Manager
Ethics Committee Member
Data Protection Officer
Research Ethics Officer
Legal Counsel
Compliance Officer
Research Administrator
Study Coordinator
Medical Director
Research Scientist
Research Nurse
Project Manager
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