SOCRA CCRP Question Answer
Which case history documents must be at both sponsor and site?
Signed informed consent forms
Medical records
Case report forms (CRFs)
Study visit notes
ICH E6(R2) 1.11:CRFs are documents used to record protocol-required data reported to sponsor.
Sites keep originals; sponsor retains copies.Consent forms and medical records stay at site only.
TESTED 21 Oct 2025
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