Glossary

64 terms across 6 categories. Every acronym and concept used across the platform — ALCOA+, Part 11, autonomy classes, GAMP 5, CDISC, RAG, and more.

ADaM— Analysis Data Model
Data
CDISC standard for analysis-ready clinical trial datasets. Derived from SDTM. Used by statisticians to produce the TLFs and CSR analyses.
See also: CDISC, SDTM, SAP, TLF
CDISC— Clinical Data Interchange Standards Consortium
Data
The standards body behind SDTM, ADaM, CDASH, and related clinical data models. Submission-ready data must follow CDISC standards for FDA and most other regulators.
See also: SDTM, ADaM, FDA, EMA
MedDRA— Medical Dictionary for Regulatory Activities
Data
The standardized medical terminology used to code adverse events, indications, and medical history. Licensed from MSSO; required for ICSRs.
See also: WHODrug, ICSR, PV
Provenance— Provenance event chain
Data
The append-only log (provenance_event table) recording every regulated action: who, what, when, why, with which model and prompt version. Powers ALCOA+ and inspection exports.
See also: ALCOA+, Attributable
SDTM— Study Data Tabulation Model
Data
CDISC standard for the tabulated raw clinical data submitted to regulators. Input to ADaM. Required by FDA for most NDA/BLA submissions.
See also: CDISC, ADaM, FDA
WHODrug— WHO Drug Dictionary
Data
The standardized dictionary of medicinal product names used to code concomitant medications and prior therapies in clinical trials. Counterpart to MedDRA for drugs.
See also: MedDRA, CDISC