Unclean PK, and a committee that meets on Thursday

A Clinical Data Manager scenario. Setting: Phase 1 dose escalation — safety review committee data cut, cohort 3. About 8 minutes.

You are working with Sponsor Biostatistician, PK/PD lead. The situation unfolds as you decide, and each choice changes what happens next.

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

Competency areas assessed: D3, D5.

Anchored to ICH E6(R3) §4.2 — data used for a decision must have known provenance and quality. An unqualified dataset invites a decision on data whose limits are invisible.; ICH E6(R3) §4.1 and §4.2 — SAE reconciliation exists because two systems holding one event will diverge. The source record decides, not the newer entry..

Trial phase: 1.

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