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A CRA has come to a site and found that subject 001 has not signed an Informed Consent. What action should the CRA take?
The CRA should instruct the site to try to obtain informed consent now. The CRA should contact their trial team and begin CAPA process. The CRA may begin completing Non-Compliance Alert Form. The CRA captures in TRIP report that they found Non-Compliance and that trial team notified. THEY DO NOT DOCUMENT CAPA IN TRIP REPORT