Stage 5 · Toolkit 5.17
Data Standards / SDTM / ADaM Readiness
Prepare study data for standardised clinical submission datasets.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Data Standards / SDTM / ADaM Readiness.
How it helps your team
Connect trial execution, evidence, and decisions across sponsor, CRO, and site responsibilities.
Designed for
Clinical Operations, Clinical Development, Data Management, Biostatistics, Safety, Quality, and vendor oversight teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- Study Data Standards Plan
- SDTM Mapping Plan
- ADaM Dataset Plan
- Define-XML Readiness Checklist
- Data Standards QC Checklist
- Dataset Readiness Decision Memo
Excel workbooks
- SDTM Mapping Tracker
- ADaM Dataset Tracker
- Define-XML Issue Tracker
- Dataset QC Tracker
- Dataset Readiness Matrix
Related toolkits
Continue within stage 5
Clinical Development Plan & Study Governance
Govern clinical development plans, studies, decisions, risks, and cross-functional actions.
5.2Protocol Development & Amendment Management
Develop, review, approve, amend, and control clinical protocols.
5.3Study Startup & Site Activation
Manage startup, essential documents, investigator packages, site activation, and green-light approval.