Section 822.10 - What must I include in my surveillance plan?Your surveillance plan must include a discussion of:
(a) The plan objective(s) addressing the surveillance question(s) identified in our order;(b) The subject of the study, e.g., patients, the device, animals;(c) The variables and endpoints that will be used to answer the surveillance question, e.g., clinical parameters or outcomes;(d) The surveillance approach or methodology to be used;(e) Sample size and units of observation;(f) The investigator agreement, if applicable;(g) Sources of data, e.g., hospital records;(h) The data collection plan and forms;(i) The consent document, if applicable;(j) Institutional Review Board information, if applicable;(k) The patient followup plan, if applicable;(l) The procedures for monitoring conduct and progress of the surveillance;(m) An estimate of the duration of surveillance;(n) All data analyses and statistical tests planned;(o) The content and timing of reports.