How are examinations by telephone call or other electronic means considered in determining when an applicable clinical trial reaches its "primary completion date" or "study completion date" under the regulation?

The final rule in 42 CFR 11.10(a) defines "[primary] completion date" for a clinical trial as the "date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated…." The final rule in 42 CFR 11.10(a) also defines "study completion date" for a clinical trial as the "date the final subject was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (e.g., last subject's last visit), whether the clinical trial concluded according to the pre-specified protocol or was terminated…." The final rule preamble addresses these definitions in greater detail in Section IV.A.5. §11.10 – "What definitions apply to this part?" (81 FR 65008) The examination of a subject or administration of an intervention for purposes of "final collection of data" can include a broad range of methods of examination, including physical examination or examination by telephone or other electronic means.