CDRN
Clinical Data Readiness Navigator; a cross-functional readiness platform that turns milestone context, dependencies, risks, handoffs, and evidence expectations into role-specific action plans.
Terminology
Clinical data readiness glossary.
Quick definitions for terms used across Navigator, Field Guide, Practice Exchange, and submission-readiness content.
Readiness gap
An unresolved decision, dependency, handoff, review, risk, or evidence item that can prevent a milestone from being genuinely ready even when most planned work appears complete.
ADaM
Analysis Data Model; CDISC standards for analysis-ready datasets with traceability to source/tabulation data.
ADRG
Analysis Data Reviewer’s Guide; reviewer-facing documentation describing analysis data and important implementation details.
CDISC
Clinical Data Interchange Standards Consortium, which develops data standards used across clinical research.
CDOR
Clinical Data Operational Readiness Framework, the CDRN method for converting milestone context into readiness actions.
CTD
Common Technical Document; harmonized structure for regulatory dossiers.
Database freeze
A controlled data state before final lock; exact meaning and process are sponsor/study specific.
Database lock
The controlled point after which the clinical database is formally locked according to the study process.
Define-XML
Machine-readable metadata describing submitted datasets, variables, codelists, origins, methods, and related metadata.
Dry run
A planned rehearsal used to test data, analysis, programming, review, integration, or submission readiness before a later gate.
eCTD
Electronic Common Technical Document; the electronic format/lifecycle used for many regulatory submissions, with regional implementation requirements.
Estimand
A precise description of the treatment effect to be estimated, including population, variable, intercurrent-event strategy, summary measure, and treatment condition.
External/vendor data
Data produced outside the core clinical database, such as central lab, ECG, imaging, PK, biomarker, adjudication, or other vendor sources.
Health authority request
A request or question from a regulatory authority that may require clarification, analysis, data, outputs, or supporting documentation.
Interim analysis
An analysis performed before final study completion according to the study plan and applicable access/governance controls.
ISS / ISE
Integrated Summary of Safety / Integrated Summary of Effectiveness; integrated analyses commonly associated with certain regulatory submissions.
Milestone
A delivery or decision point that changes the operating state, such as dry run, database lock, interim analysis, response due date, or submission handoff.
P21 / validation finding
A finding from a data/metadata validation tool such as Pinnacle 21; findings require investigation and appropriate correction or documented disposition.
QC
Quality control; independent or otherwise controlled checks intended to verify implementation, results, structure, or presentation against requirements.
Readiness evidence
A record demonstrating that a readiness action is complete, reviewed, accepted, or consciously excepted.
Regression check
A check that intended changes occurred while important unaffected behavior/results remained stable.
SDRG
Study Data Reviewer’s Guide; reviewer-facing documentation describing submitted tabulation data and important context.
SDTM
Study Data Tabulation Model; CDISC model used to organize standardized clinical study data for tabulation/submission.
TLF
Tables, Listings, and Figures used to summarize, review, and communicate clinical study results.
Traceability
The ability to follow information from source through transformations/analysis to a reported result and supporting metadata.
Treatment-emergent
A study-defined concept describing events or observations relative to treatment exposure; the exact rule must come from the approved analysis definition.