Study Design, Documents & Data Acquisition
Understand the trial before touching a dataset
Translate the protocol, SAP, CRF and operational data flow into a programming-ready study blueprint.
Protocol concept, endpoints and operational design
Approved programming blueprint, source inventory and data-cut plan
Real course content
5 chapters
Each chapter contains instructional sections, a CLIN-301 worked workflow, failure modes, a concrete deliverable, and an assessment.
The protocol — the contract for the trial
What a programmer extracts from a protocol on first read: objectives, endpoints, design, schedule of assessments, populations.
Chapter 1 of 5
The Statistical Analysis Plan (SAP)
The programmer’s primary specification: how a SAP maps to outputs, estimands, analysis populations, and TLF shells.
Chapter 2 of 5
The Case Report Form (CRF)
Where the data is born: anatomy of CRF pages (DM, AE, VS, labs, ConMeds), edit checks, and a worked dummy CRF booklet.
Chapter 3 of 5
CRF annotation (aCRF)
The bridge from collection to SDTM: annotation conventions, annotating a page to SDTM, and CDASH as the collection standard.
Chapter 4 of 5
EDC, data flow & database lock
From site entry to a locked, analysis-ready database: EDC systems, queries and cleaning, soft/hard lock, and unblinding.
Chapter 5 of 5