search

cdisc-org / ddf-core-poc

This repository will contain the results from the Proof of Concept project.
MIT License
0 stars 1 forks source link

Create Rule: Every visit timing must have a window #53

Open ASL-rmarshall opened 10 months ago

ASL-rmarshall commented 10 months ago

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:

  1. Every visit must have associated timing (#52).
  2. Every visit timing must have a window (this rule).
  3. Timing windows must be fully defined (#8)
nickdedonder commented 10 months ago

Might be picked up later with aligned for M11