Filing the Site Document Batch

A Clinical Research Coordinator scenario. Setting: Investigator Site File — Weekly Filing Sweep. About 12 minutes.

You are working with Sponsor TMF Lead, Available for routing questions. The situation unfolds as you decide, and each choice changes what happens next.

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

Competency areas assessed: D1, D3, D6.

Anchored to DIA TMF Reference Model v3.0 defines zones (Trial Management, Central Trial Documents, Regulatory, IRB/IEC, Site Management, IP & Trial Supplies, Safety Reporting, Central & Local Testing, Third Parties, Data Management, Statistics).; ICH E6(R3) §2.3 (PI signature on delegation) & Appendix C (essential records must be current). Filing defective essentials is worse than not filing them — it manufactures false completeness.; TMF exchange plan (per ICH E6(R3) §3.16.1) defines document ownership. Site keeps working copies of sponsor-owned docs; the sponsor holds the master.; ICH E6(R3) §2.1, Appendix C, §3.11.2 — delegated tasks require current credentials. Expired essentials pause the associated delegation until remediated.; ICH E6(R3) Appendix C — the TMF must be complete and current. Reconciliation between ISF and sponsor TMF is a site-quality behavior, not a monitoring one..

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