Regulatory Flashcards
1
Q
Ex of Regulatory Documents
A
Regulatory Documents means all dossiers, filings, applications, modifications, amendments, supplements, revisions, reports, submissions, authorizations approvals, including any IND or NDA, any reports or amendments necessary to maintain Regulatory Approvals.
2
Q
3 documents in regulatory binder.
A
1572 form, pi cv , financial disclosure
3
Q
What do you do at the site if you find an ICF missing?
A
Have site staff contact the patient and if possible to come in and provide patient’s copy. If not, further investigation of the location of the signed ICF. In case of a proved missing ICF, escalation of the safety issue asap to project team.
