Designing What Gets Collected — Infectious Disease / Vaccines

A Clinical Data Manager scenario. Setting: Data Management Plan and CRF Design. About 9 minutes.

You are working with Draft CRF and DMP, Under design review. The situation unfolds as you decide, and each choice changes what happens next.

3 scored decisions, each graded against a published rubric rather than marked right or wrong.

Competency areas assessed: D1.

Anchored to CDASH — collect data in a structure that supports the planned analysis without later transformation.; ICH E6(R3) Annex 1 §3.16.1 — data handling defined in advance, with roles and processes documented.; ICH E6(R3) Annex 1 §3.16.1 and §4.2.5 — controlled change, with data migration handled so nothing is lost..

You make the decisions and are scored on them against the global GCP standard (ICH E6(R3)). Free, no account needed to try.