500
Tina a new CRA calls you from a site and says in a panic, "I do not know what to do I can't remember what to do when the site has a subject there is no consent in the chart for the subject?" How would you direct her? Tell me everything you would do in this situation?
I would capture the conversation on a Site Contact Form and tell Tina to instruct the site to obtain consent now from the subject, notify the IRB, gather any information on how this occurred, and tell the CRA you will notify CML and CRA manager so they can start a CAPA. Sign & date Site Contact form and send to CML for them to sign and date