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Records and Reports | Midpage
Collections
Code of Federal Regulations
Title 21
Chapter I
Subchapter H
Part 822
Subpart G
Records and Reports
822.31
What records am I required to keep?
822.32
What records are the investigators in my surveillance plan required to keep?
822.33
How long must we keep the records?
822.34
What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
822.35
Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
822.36
Can you inspect and copy the records related to my postmarket surveillance plan?
822.37
Under what circumstances would you inspect records identifying subjects?
822.38
What reports must I submit to you?