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Protocol title
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Edge number
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Name Principal Investigator
*
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Name contact person
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E-mail contact person
*
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Telephone contact person
*
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Contact information DPO Sponsor
Name of the Sponsor
*
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Name DPO Sponsor
*
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E-mail DPO Sponsor
*
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Retention period of study data
*
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less than 1 year
1-9 years
10-19 years
20-24 years
25-29 years
30 years or longer
Categories of personal data
*
Identification data
*
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Biometric data
*
(Optional)
Genetic data
*
(Optional)
Image recordings
*
(Optional)
Sound recordings
*
(Optional)
Health data
*
(Optional)
Data indicating race or ethnic origin
*
(Optional)
Data indicating religious or philosophical conviction
*
(Optional)
Data on somebody’s sexual behavior or sexual orientation
*
(Optional)
Other
*
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Study Type
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Prospective
Retrospective
Real World Data
Data Governance
Categories of data subjects
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Adults
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Minors
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Mentally competent person
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Mentally incompetent person
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Patient
*
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Healthy volenteer
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Patiënt representative(s)
*
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Other
*
(Optional)
Categories of receivers
()
Patient involved or study participant
*
(Optional)
Representative or confidential advisor of data subject
*
(Optional)
Treating physician of data subject
*
(Optional)
Ethical or deontological committee
*
(Optional)
Contractor sponsor (e.g. eCRF vendor, …)
*
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Other
*
(Optional)
Transfer to third countries/international organisations
*
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- None -
Yes
No
Safeguardq Adequacy
*
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SSC
BCR
Code of Conduct
Other
Third country
*
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International organisation
*
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Type of personal data
*
Identifiable personal data
*
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Pseudonymised personal data
*
(Optional)
Anonymous personal data
*
(Optional)
e-CRF systeem
*
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RedCap
Castor
Other
None
Technical and organisational security protocols
*
Safety policy
*
(Optional)
Organisation of information security
*
(Optional)
Appointment of a DPO / Security officer
*
(Optional)
Security requirements for internal collaborators
*
(Optional)
Security requirements for external collaborators
*
(Optional)
Company asset management
*
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Access security
*
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Cryptography
*
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Physical and environmental security
*
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Operational security
*
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Communication security
*
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Purchase, development and maintenance of information systems
*
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GDPR agreement with supplier and data processor
*
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Management of information security incidents
*
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Continuity management
*
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Compliance and adherence
*
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Procedure for notification of information breaches
*
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Data collection: secondary use of data collected in the context of other studies
*
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- None -
Yes
No
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