SUBPART G—Records and Reports (§822.31 to §822.38)
- 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?