§ 822.10. What must I include in my surveillance plan?
140 words·~1 min read·
/us/cfr/t21/s§ 822.10·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.