Work hard to avoid clinical trial protocol amendments as they consume a great deal more resource than one imagines in staff time to prepare, review (internally and by IRBs and FDA and sometimes by the investigators), and implementation. Some vendors offer systems to minimize the number of amendments a company will need by subjecting protocols to multiple internal checks of consistency and comparisons with other protocols that have been conducted.

Mega trials require shorter protocols, shorter case report forms and less monitoring. Companies often monitor these (and other) trials more than needed.

Reimbursing for patient travel, babysitting, meals, parking or transportation and other incidentals is acceptable in most, but not all, countries for all patients in clinical trials.