Study-level metadata
Define_header_metadata
|
FILEOID |
STUDYOID |
STUDYNAME |
STUDYDESCRIPTION |
PROTOCOLNAME |
STANDARD |
VERSION |
SCHEMALOCATION |
STYLESHEET |
|
XYZ123 |
123 |
XYZ123 |
XYZ123 |
SDTM |
3.1.2 |
define1-0-0.xsl |
https://github.com/Daniel-355/SAS-Clinical-Trials-Toolkit/blob/master/SDTM_METADATA.xlsx
Dataset-level metadata
TOC_METADATA
|
OID |
NAME |
REPEATING |
ISREFERENCEDATA |
PURPOSE |
LABEL |
STRUCTURE |
DOMAINKEYS |
CLASS |
ARCHIVELOCATIONID |
|
AE |
AE |
Yes |
No |
Tabulation |
Adverse Events |
Events - One
record per event per subject |
STUDYID, USUBJID,
AEDECOD, AESTDTC |
Events |
./ae |
|
DM |
DM |
No |
No |
Tabulation |
Demographics |
Special Purpose -
One record per event per subject |
STUDYID, USUBJID |
Special Purpose |
./dm |
|
EX |
EX |
Yes |
No |
Tabulation |
Exposure |
One record per
constant dosing interval per subject |
STUDYID, USUBJID,
EXTRT, EXSTDTC |
Interventions |
./ex |
|
LB |
LB |
Yes |
No |
Tabulation |
Laboratory Tests |
Findings - One
record per lab test per subject |
STUDYID, USUBJID,
LBCAT, LBTESTCD, VISITNUM |
Findings |
./lb |
|
Trial Design (Reference Data) |
Observation Data |
|
TA (Trial Arms planned treatment groups) |
EX (Exposure actual treatment received by subjects) |
|
TE (Trial Elements planned study elements) |
SE (Subject Elements elements actually experienced by
subjects) |
|
TV (Trial Visits planned visits) |
SV (Subject Visits visits actually occurred) |
|
TI (Trial Inclusion/Exclusion Criteria eligibility
rules) |
DM / MH / LB (subject-level data used to
determine whether criteria are met) |
|
TS (Trial Summary overall study design parameters) |
|
Variable-level metadata
VARIALBE_METADATA
|
DOMAIN |
VARNUM |
VARIABLE |
TYPE |
LENGTH |
LABEL |
SIGNIFICANTDIGITS |
ORIGIN |
COMMENT |
DISPLAYFORMAT |
COMPUTATIONMETHODOID |
CODELISTNAME |
MANDATORY |
ROLE |
ROLECODELIST |
VALUELISTOID |
|
AE |
1 |
STUDYID |
text |
15 |
Study
Identifier |
Derived |
Yes |
Identifier |
ROLECODE |
||||||
|
AE |
2 |
DOMAIN |
text |
2 |
Domain
Abbreviation |
Derived |
Yes |
Identifier |
ROLECODE |
||||||
|
AE |
3 |
USUBJID |
text |
25 |
Unique
Subject Identifier |
Derived |
Yes |
Identifier |
ROLECODE |
||||||
|
AE |
4 |
AESEQ |
integer |
8 |
Sequence
Number |
Derived |
Yes |
Identifier |
ROLECODE |
||||||
|
AE |
5 |
AETERM |
text |
200 |
Reported
Term for the Adverse Event |
CRF
page 6 |
Yes |
Topic |
ROLECODE |
||||||
|
AE |
6 |
AEDECOD |
text |
200 |
Dictionary-Derived
Term |
Derived |
AEDECOD |
Yes |
Synonym
Qualifier |
ROLECODE |
|||||
|
AE |
7 |
AEBODSYS |
text |
200 |
Body
System or Organ Class |
Derived |
AEBODSYS |
No |
Record
Qualifier |
ROLECODE |
|||||
|
AE |
8 |
AESEV |
text |
40 |
Severity/Intensity |
CRF
page 6 |
AESEV |
No |
Record
Qualifier |
ROLECODE |
|||||
|
AE |
9 |
AESER |
text |
40 |
Serious
Event |
CRF
page 6 |
NY |
No |
Record
Qualifier |
ROLECODE |
|||||
|
AE |
10 |
AEACN |
text |
40 |
Action
Taken with Study Treatment |
CRF
page 6 |
ACN |
No |
Record
Qualifier |
ROLECODE |
|||||
|
AE |
11 |
AEREL |
text |
40 |
Causality |
CRF
page 6 |
AEREL |
No |
Record
Qualifier |
ROLECODE |
|||||
|
AE |
12 |
AESTDTC |
date |
16 |
Start
Date/Time of Adverse Event |
CRF
page 6 |
No |
Timing |
ROLECODE |
||||||
|
AE |
13 |
AEENDTC |
date |
16 |
End
Date/Time of Adverse Event |
CRF
page 6 |
No |
Timing |
ROLECODE |
||||||
|
AE |
14 |
AESTDY |
integer |
8 |
Study
Day of Start of Adverse Event |
Derived |
No |
Timing |
ROLECODE |
||||||
|
AE |
15 |
AEENDY |
integer |
8 |
Study
Day of End of Adverse Event |
Derived |
No |
Timing |
ROLECODE |
||||||
|
DM |
1 |
STUDYID |
text |
15 |
Study
Identifier |
Derived |
Yes |
Identifier |
ROLECODE |
VALUELEVEL_METADATA
|
VALUELISTOID |
VALUENAME |
TYPE |
LENGTH |
LABEL |
SIGNIFICANTDIGITS |
ORIGIN |
COMMENT |
DISPLAYFORMAT |
COMPUTATIONMETHODOID |
CODELISTNAME |
MANDATORY |
ROLE |
ROLECODELIST |
|
LBTESTCDVALUE |
ALB |
float |
8 |
Albumin;
Microalbumin |
1 |
Central
laboratory |
4.2 |
No |
|||||
|
LBTESTCDVALUE |
ALP |
float |
8 |
Alkaline
Phosphatase |
Central
laboratory |
3. |
No |
||||||
|
LBTESTCDVALUE |
ALT |
float |
8 |
Alanine
Aminotransferase; SGPT |
Central
laboratory |
3. |
No |
CodeList / Controlled Terminology metadata
CODELISTS
|
CODELISTNAME |
RANK |
CODEDVALUE |
TRANSLATED |
TYPE |
CODELISTDICTIONARY |
CODELISTVERSION |
sourcedataset |
sourcevariable |
sourcevalue |
sourcetype |
|
ACN |
1 |
DOSE
INCREASED |
DOSE
INCREASED |
TEXT |
adverse |
aeaction |
3 |
number |
||
|
ACN |
2 |
DOSE
NOT CHANGED |
DOSE
NOT CHANGED |
TEXT |
adverse |
aeaction |
4 |
number |
||
|
ACN |
3 |
DOSE
REDUCED |
DOSE
REDUCED |
TEXT |
adverse |
aeaction |
2 |
number |
||
|
ACN |
4 |
DRUG
INTERRUPTED |
DRUG
INTERRUPTED |
TEXT |
adverse |
aeaction |
1 |
number |
||
|
ACN |
5 |
DRUG
WITHDRAWN |
DRUG
WITHDRAWN |
TEXT |
adverse |
aeaction |
number |
|||
|
ACN |
6 |
NOT
APPLICABLE |
NA |
TEXT |
adverse |
aeaction |
number |
|||
|
ACN |
7 |
UNKNOWN |
U;
Unknown |
TEXT |
adverse |
aeaction |
5 |
number |
||
|
AEBODSYS |
1 |
TEXT |
MedDRA |
7.0 |
||||||
|
AEDECOD |
1 |
TEXT |
MedDRA |
7.0 |
Derivation metadata
COMPUTATION_METHOD
|
COMPUTATIONMETHODOID |
COMPUTATIONMETHOD |
|
AGECALCULATION |
integer
value of (BRTHDT - RFSTDTC)/365.25 |
If needed,
Internal Traceability metadata
|
Source Dataset (Raw/CRF) |
Source Variable |
CRF Page / Description |
SDTM Domain |
SDTM Variable |
SDTM Origin |
ADaM Dataset |
ADaM Variable |
Derivation Type |
Derivation Logic / Notes |
|
AE_CRF |
AE_TERM |
AE CRF Page 12 |
AE |
AEDECOD |
Collected |
ADAE |
AETERM |
Copied |
Verbatim AE term copied |
|
AE_CRF |
AE_START_DATE |
AE CRF Page 12 |
AE |
AESTDTC |
Collected |
ADAE |
ASTDT |
Converted |
ISO date converted to numeric |
|
AE_CRF |
AE_END_DATE |
AE CRF Page 12 |
AE |
AEENDTC |
Collected |
ADAE |
AENDT |
Converted |
ISO date converted to numeric |
|
AE_CRF |
AE_SEVERITY |
AE CRF Page 12 |
AE |
AESEV |
Collected |
ADAE |
AESEV |
Copied |
|
|
AE_CRF |
AE_REL |
AE CRF Page 13 |
AE |
AEREL |
Collected |
ADAE |
AEREL |
Copied |
|
|
|
|
|
AE |
AESEQ |
Derived |
ADAE |
AESEQ |
Copied |
Sequence assigned in SDTM |
|
|
|
|
AE |
AESTDY |
Derived |
ADAE |
AESTDY |
Copied |
Derived in SDTM |
Trial Design metadata
Trial Elements（TE）
|
STUDYID |
ETCD |
ELEMENT |
ELEMENTDESC |
|
XYZ123 |
SCR |
Screening |
Screening period |
|
XYZ123 |
TRT |
Treatment |
Double-blind treatment |
|
XYZ123 |
FU |
Follow-up |
Safety follow-up |
Trial Visits（TV）
|
STUDYID |
VISITNUM |
VISIT |
VISITDY |
|
XYZ123 |
1 |
Screening |
−14 |
|
XYZ123 |
2 |
Baseline |
1 |
|
XYZ123 |
3 |
Week 4 |
28 |
|
XYZ123 |
4 |
Week 8 |
56 |
|
XYZ123 |
5 |
Week 12 |
84 |
|
XYZ123 |
6 |
Follow-up |
112 |
Origin / CRF metadata
|
Variable |
Origin Type |
Origin Description |
CRF Reference |
|
AEDECOD |
Collected |
Collected on AE CRF |
AE CRF, Page 12 |
|
AESTDTC |
Collected |
Collected on AE CRF |
AE CRF, Page 12 |
|
AEENDTC |
Collected |
Collected on AE CRF |
AE CRF, Page 12 |
|
AESEV |
Collected |
Collected on AE CRF |
AE CRF, Page 12 |
|
AEREL |
Collected |
Collected on AE CRF |
AE CRF, Page 13 |
|
AEACN |
Collected |
Collected on AE CRF |
AE CRF, Page 14 |
|
AESEQ |
Derived |
Sequential number assigned within subject |
|
|
AESTDY |
Derived |
Derived from AESTDTC and RFSTDTC |
|
Reviewers Guide metadata
Unless it's a native Pinnacle 21 field name, you must manually map the fields during import; however, this mapping usually only needs to be done once and can be reused afterward.
SDTM metadata includes at least Study-level, Dataset-level, Variable-level, and CodeList information; building upon this, Value-level, Origin, Derivation, and Trial Design metadata constitute the "complete define.xml" expected by the FDA.