Guidance in section 1.3 of both the M11 Template (p22) and Tech Spec (p114) says (with bolding brackets round "trial" added by me - the Template text says "participants" instead of "trial participants" doesn't appear there in the Template text):
The schedule of activities must capture the procedures that will be accomplished at each trial visit, and all contact with [trial] participants, for example, telephone contacts. This includes any tests that are used for eligibility, participant randomisation or stratification, or decisions on trial intervention discontinuation. Allowable windows should be stated for all visits.
Based on this, there should be 3 rules:
Every visit must have associated timing (this rule).
Guidance in section 1.3 of both the M11 Template (p22) and Tech Spec (p114) says (with bolding brackets round "trial" added by me - the Template text says "participants" instead of "trial participants" doesn't appear there in the Template text):
Based on this, there should be 3 rules: