I'd like to extend a very big compliment to the Committee for tackling this particularly thorny subject that has been bothering me during a large part of my career as a clinical epidemiologist advising clinical researchers. The text is concise and appropriately deals with description, justification and measurement of UC and (subtly) addresses the need for reduction in UC variability.

Here are the issues that struck me when reading the document:
1. The terms 'efficacy' and 'effectiveness' are both used. You may consider using effectiveness only.
2. The sentence reading "describe and justify the importance of the selection..." may perhaps be shortened to "justify the selection".
3. The phrase "if there is equipoise" may perhaps be rephrased into something like "why the researchers think there is equipoise". In fact, this seems to be part of the justification issue addressed earlier in the text.
4. May "utilization and penetration" be replaced by "utilization"? How are these two terms different?
5. Use of the term 'retrospective studies' in "Please note that this step may not be relevant to retrospective studies" is discouraged by the authors of the book Modern Epidemiology (Rothman, Greenland and Lash; page 95-97, 2nd Ed, 2008) since it causes confusion and is often unjustifiably used in a negative way.
6. In the sentence "Justification of the known and potential risks and benefits to patients/participants of employing the usual care practice." Justification may be replaced by the term 'Description'. Additionally researchers may be asked to justify why these risks are deemed acceptable.
Gerben ter Riet
Amsterdam University Applied Sciences
Researcher, health/medical
Representing my own views