Your surveillance plan must include a discussion of:

1. (a) The plan objective(s) addressing the surveillance question(s) identified in our order;
2. (b) The subject of the study, e.g., patients, the device, animals;
3. (c) The variables and endpoints that will be used to answer the surveillance question, e.g., clinical parameters or outcomes;
4. (d) The surveillance approach or methodology to be used;
5. (e) Sample size and units of observation;
6. (f) The investigator agreement, if applicable;
7. (g) Sources of data, e.g., hospital records;
8. (h) The data collection plan and forms;
9. (i) The consent document, if applicable;
10. (j) Institutional Review Board information, if applicable;
11. (k) The patient followup plan, if applicable;
12. (l) The procedures for monitoring conduct and progress of the surveillance;
13. (m) An estimate of the duration of surveillance;
14. (n) All data analyses and statistical tests planned;
15. (o) The content and timing of reports.