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.