Who Keeps? Flashcards
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Investigator
Should be on file before the trial formally starts
Signed agreements between the sponsor and CRO
sponsor!
Should be on file before the trial formally starts
SAMPLE OF LABEL(S) ATTACHED TO
INVESTIGATIONAL PRODUCT CONTAINER(S)
sponsor!
Should be on file before the trial formally starts
CERTIFICATE(S) OF ANALYSIS OF
INVESTIGATIONAL PRODUCT(S) SHIPPED
sponsor!
Should be on file before the trial formally starts
Master randomization list
sponsor!
Should be on file before the trial formally starts
third party if applicable
PRE-TRIAL MONITORING REPORT
sponsor!
Should be on file before the trial formally starts
CERTIFICATE(S) OF ANALYSIS FOR NEW
BATCHES OF INVESTIGATIONAL PRODUCTS
sponsor!
Should be on file during the trial
Monitoring visit reports
sponsor!
Should be on file during the trial
signed informed consent forms
investigator
Should be on file during the trial
source documents
investigator
Should be on file during the trial
SIGNED, DATED, AND COMPLETED CASE
REPORT FORMS (CRF)
investigator keeps a copy, sponsor keeps the original
should be on file during the trial
DOCUMENTATION OF CRF CORRECTIONS
investigator keeps a copy, sponsor keeps the original
should be on file during the trial
SUBJECT IDENTIFICATION CODE LIST
investigator
Should be on file during the trial
SUBJECT ENROLMENT LOG
investigator
Should be on file during the trial
DOCUMENTATION OF
INVESTIGATIONAL PRODUCT
DESTRUCTION
sponsor, investigator if destroyed at site
should be on file after completion/termination of the study
