CLIN-301 End-to-End Production Release
Run the whole clinical programming lifecycle as one controlled project
Deliver and defend a compact submission package from protocol extraction through datasets, analyses, TLFs, CSR handoff and reviewer response.
CLIN-301 protocol/SAP excerpts, aCRF, raw EDC and vendor transfers
Portfolio-ready capstone release with traceability demonstration and retrospective
Real course content
6 chapters
Each chapter contains instructional sections, a CLIN-301 worked workflow, failure modes, a concrete deliverable, and an assessment.
The scenario
The trial on one page: indication, design, randomization/blinding, endpoints, populations, protocol & SAP excerpts.
Chapter 1 of 6
CRF → SDTM
The CLIN-301 aCRF; build DM, EX, CM, AE, LB, VS, DS plus trial-design domains; validate with Pinnacle 21.
Chapter 2 of 6
SDTM → ADaM
ADSL with populations and treatment variables, ADVS/ADLB, ADAE, ADTTE, and a traceability check.
Chapter 3 of 6
ADaM → TLFs, part 1: the standard set
Demographics and baseline, disposition, exposure and compliance, concomitant medications.
Chapter 4 of 6
ADaM → TLFs, part 2: efficacy & safety
The primary endpoint (MMRM) plus secondary/exploratory, AE/SAE tables, lab shift and vitals, KM and forest figures.
Chapter 5 of 6
Assemble the submission
define.xml, SDRG/ADRG, packaging the analysis programs, eCTD placement, final traceability and QC pass.
Chapter 6 of 6