CDISC
ADaM
ADaM: Analysis Data Model
- Define Dataset and metadata standards that support:
- efficient generation, replication, and review of clinical trial statistical analyses, and
- traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).
- standardize and organize data for statistical analysis, enabling efficient, accurate, and reproducible research by ensuring a clear lineage from raw data (SDTM) to analysis results.
- Define Dataset and metadata standards that support:
Why are they use ADaM dataset in Clinical trials?
- Standardization and Consistency
- ADaM provides a consistent framework for creating analysis datasets, which reduces variability and ensures that data is prepared for analysis in the same way across different trials.
- Analysis Readiness
- It ensures that data is in a format that is ready for statistical analysis, which streamlines the generation of tables, listings, and figures (TLFs).
- Traceability
- ADaM establishes a clear lineage between the analysis results, the analysis datasets, and the source data in SDTM, allowing reviewers to quickly understand and validate the data.
- Reproducibility
- The standardized structure and clear definitions in ADaM allow for the replication of statistical analyses, promoting confidence in the study findings.
- Regulatory Compliance
- Regulatory agencies like the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) require clinical trial data to adhere to ADaM standards for submission.
- Interoperability and Collaboration
- Standardized ADaM datasets facilitate data exchange and integration between different systems and organizations, improving collaboration among statisticians, programmers, and researchers.
- Efficiency
- By providing a predictable and consistent data structure, ADaM helps statistical programmers efficiently develop TLFs and reuse programming code across projects.
- Standardization and Consistency
ADSL: Subject-Level Analysis Dataset
- ADSL
BDS: Basic Data Structure
- ADLB
- ADEFF
- ADTTE
OCCDS: Occurrence Data Structure
- ADAE
- ADCM
Other
- ADMV
ADSL
SDTM Domain
- DM(Demographics)
- EX(Exposure)
- DS(Disposition)
- SV(Subject Visits)
- CM(Concomitent Medicine)
- CMYN
- MH(Medical History)
- MHYN
| Variable | Label | Type | Codelist / Controlled Terms | Source / Derivation / Comment |
|---|---|---|---|---|
| STUDYID | Study Identifier | text | Unique identifier for the study; copied from DM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | Concatenation of STUDYID and SUBJECT ID; copied from DM.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | Copied from DM.SUBJID | |
| SITEID | Investigator Site Identifier | text | Copied from DM.SITEID | |
| AGE | Age | integer | Copied from DM.AGE or derived as (RFSTDTC - BRTHDTC) | |
| AGEU | Age Units | text | YEARS | Copied from DM.AGEU |
| SEX | Sex | text | M, F, U | Copied from DM.SEX |
| RACE | Race | text | White, Black, Asian, Other | Copied from DM.RACE |
| ARM | Description of Planned Arm | text | Copied from DM.ARM | |
| ARMCD | Planned Arm Code | text | Copied from DM.ARMCD | |
| ACTARM | Description of Actual Arm | text | Copied from DM.ACTARM | |
| ACTARMCD | Actual Arm Code | text | Copied from DM.ACTARMCD | |
| COUNTRY | Country | text | Copied from DM.COUNTRY | |
| RFSTDTC | Date/Time of First Exposure | date | Derived from EX.EXSTDTC (earliest date) | |
| RFENDTC | Date/Time of Last Exposure | date | Derived from EX.EXENDTC (latest date) | |
| RFXSTDTC | Date/Time of First Study Treatment | date | Derived from EX dataset | |
| RFXENDTC | Date/Time of Last Study Treatment | date | Derived from EX dataset | |
| SAFFL | Safety Population Flag | text | Y / N | Y if subject received at least one dose of study drug |
| FASFL | Full Analysis Set Flag | text | Y / N | Y if subject is in the full analysis population per SAP |
| ITTFL | Intent-to-Treat Flag | text | Y / N | Y if subject is randomized and received at least one dose |
| PPSFL | Per-Protocol Flag | text | Y / N | Y if subject met per-protocol criteria |
| COMPFL | Completion Flag | text | Y / N | Y if subject completed study as planned |
| DTHFL | Death Flag | text | Y / N | Y if subject died during the study |
| DTHDTC | Date of Death | date | Derived from DS dataset | |
| RFICDTC | Informed Consent Date | date | Copied from DM.RFICDTC | |
| RFPENDTC | End of Participation Date | date | Derived from DS dataset | |
| DURDAYS | Study Duration (days) | integer | Derived as RFENDTC - RFSTDTC + 1 | |
| AGEGRP | Age Group | text | e.g., <65, ≥65 | Derived based on age category per SAP |
- BDS
- ADLB
| Variable | Label | Type | Codelist / Controlled Terms | Source / Derivation / Comment |
|---|---|---|---|---|
| STUDYID | Study Identifier | text | Copied from ADSL or SDTM.DM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | Copied from ADSL or SDTM.DM.USUBJID | |
| PARAM | Parameter | text | Descriptive name of laboratory test (e.g., Hemoglobin (g/dL)) | |
| PARAMCD | Parameter Code | text | Short name of test (e.g., HGB) | |
| AVISIT | Analysis Visit | text | Derived visit name (e.g., Week 4, Week 12) | |
| AVISITN | Analysis Visit (N) | integer | Numeric representation of AVISIT | |
| AVAL | Analysis Value | float | Derived from LBSTRESN (numeric result) | |
| AVALC | Analysis Value (Character) | text | Derived from LBSTRESC (character result) | |
| BASE | Baseline Value | float | AVAL where ABLFL = Y, per PARAMCD | |
| CHG | Change from Baseline | float | AVAL – BASE | |
| PCHG | Percent Change from Baseline | float | ((AVAL – BASE) / BASE) × 100 | |
| ABLFL | Baseline Record Flag | text | Y | Y for record used as baseline (usually AVISIT = “Baseline”) |
| DTYPE | Derivation Type | text | e.g., LOCF, NRI | Used to indicate imputation or derivation method |
| ANRLO | Analysis Normal Range – Low | float | Copied from LBSTNRLO or derived from reference range dataset | |
| ANRHI | Analysis Normal Range – High | float | Copied from LBSTNRHI or derived from reference range dataset | |
| ANRIND | Analysis Reference Range Indicator | text | LOW, NORMAL, HIGH | Derived based on AVAL, ANRLO, ANRHI |
| BNRIND | Baseline Reference Range Indicator | text | LOW, NORMAL, HIGH | Derived using BASE, ANRLO, ANRHI |
| SHIFT1 | Baseline to Post-Baseline Shift | text | e.g., NORMAL→HIGH | Derived comparison between BNRIND and ANRIND |
| ONTRTFL | On-Treatment Record Flag | text | Y / N | Y if result occurred during treatment period |
| SRCDOM | Source Domain | text | Usually “LB” (Laboratory Domain) | |
| SRCVAR | Source Variable | text | Source variable (e.g., LBSTRESN) used for derivation | |
| SRCSEQ | Source Sequence Number | float | Sequence number from LB domain (LBSEQ) |
- OCCDS
- ADAE
| Variable | Label | Type | Codelist / Controlled Terms | Source / Derivation / Comment |
|---|---|---|---|---|
| STUDYID | Study Identifier | text | Copied from SDTM.DM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | Copied from SDTM.DM.USUBJID | |
| AESEQ | Sequence Number | integer | Copied from SDTM.AE.AESEQ | |
| AETERM | Reported Term for the Adverse Event | text | Copied from AE.AETERM | |
| AEDECOD | Dictionary-Derived Term | text | Coded term (e.g., MedDRA Preferred Term) | |
| AESOC | System Organ Class | text | Coded from MedDRA SOC | |
| AEHLT | High Level Term | text | From MedDRA hierarchy | |
| AEHLGT | High Level Group Term | text | From MedDRA hierarchy | |
| AEBODSYS | Body System or Organ Class | text | Usually matches AESOC | |
| AESTDTC | Start Date/Time of Adverse Event | date | Copied from AE.AESTDTC | |
| AEENDTC | End Date/Time of Adverse Event | date | Copied from AE.AEENDTC | |
| AESEV | Severity / Intensity | text | MILD, MODERATE, SEVERE | Copied from AE.AESEV |
| AESER | Serious Event | text | Y / N | Copied from AE.AESER |
| AEREL | Causality | text | RELATED, NOT RELATED | Copied from AE.AEREL |
| AEACN | Action Taken with Study Treatment | text | DOSE REDUCED, DRUG WITHDRAWN, NONE | Copied from AE.AEACN |
| AEOUT | Outcome of Adverse Event | text | RECOVERED, NOT RECOVERED, FATAL, etc. | Copied from AE.AEOUT |
| AETOXGR | Toxicity Grade | text | 1–5 | Derived from AE or external CTCAE grading |
| AESCONG | Congenital Anomaly or Birth Defect | text | Y / N | Copied from AE.AESCONG |
| AESDISAB | Persisting Disability | text | Y / N | Copied from AE.AESDISAB |
| AESDTH | Results in Death | text | Y / N | Copied from AE.AESDTH |
| AESLIFE | Life-Threatening | text | Y / N | Copied from AE.AESLIFE |
| AESHOSP | Requires/Prolongs Hospitalization | text | Y / N | Copied from AE.AESHOSP |
| AERELNST | Investigator’s Causality Assessment | text | Optional; if multiple assessors | |
| TRTEMFL | On-Treatment Flag | text | Y / N | Y if AE start date between treatment start and end (from ADSL.RFSTDTC / RFENDTC) |
| AOCCUR | Occurrence Flag | text | Y / N | Derived flag for analysis subset |
| ASEV | Analysis Severity | text | Derived, e.g., highest AESEV per subject | |
| ADURN | Duration of AE (in days) | float | Derived: AEENDTC – AESTDTC + 1 | |
| SAFFL | Safety Population Flag | text | Y / N | From ADSL.SAFFL |
| TRTA | Actual Treatment | text | From ADSL.ACTARM or ADSL.TRTA | |
| SRCDOM | Source Domain | text | Usually “AE” | |
| SRCVAR | Source Variable | text | Variable in AE domain (e.g., AESTDTC, AESEV) | |
| SRCSEQ | Source Sequence Number | float | AESEQ from AE domain |