Study-level metadata
Define_header_metadata
|
FILEOID |
STUDYOID |
STUDYNAME |
STUDYDESCRIPTION |
PROTOCOLNAME |
STANDARD |
VERSION |
SCHEMALOCATION |
STYLESHEET |
|
XYZ123 |
123 |
XYZ123 |
XYZ123 |
ADaM |
1.2 |
define-v1-updated-html.xsl |
https://github.com/Daniel-355/SAS-Clinical-Trials-Toolkit/blob/master/ADAM_METADATA.xlsx
Dataset-level metadata
TOC_METADATA
|
OID |
NAME |
REPEATING |
ISREFERENCEDATA |
PURPOSE |
LABEL |
STRUCTURE |
DOMAINKEYS |
CLASS |
ARCHIVELOCATIONID |
DOCUMENTATION |
|
ADAE |
ADAE |
Yes |
No |
Analysis |
Adverse Events
Analysis Datasets |
ADAE - One record
per event per subject |
STUDYID, USUBJID,
AEDECOD, ASTDT |
ADAE |
./ADAE |
Primarily derived
from SDTM.AE |
|
ADSL |
ADSL |
No |
No |
Analysis |
Subject Level
Analysis Dataset |
ADSL - One record
per subject |
STUDYID, USUBJID |
ADSL |
./ADSL |
Derived from
multiple SDTM domains |
|
ADEF |
ADEF |
Yes |
No |
Analysis |
Efficacy/Pain
Scores Analysis Dataset |
One record per
subject per visit |
STUDYID, USUBJID,
PARAMCD, AVISITN |
BDS |
./ADEF |
Primarily derived
from SDTM.XP |
|
ADTTE |
ADTTE |
No |
No |
Analysis |
Time-to-Pain
Relief Analysis Dataset |
One record per
subject |
STUDYID, USUBJID |
BDS |
./ADTTE |
Primarily derived
from ADaM.ADAE |
Variable-level metadata
VARIALBE_METADATA
|
DOMAIN |
VARNUM |
VARIABLE |
TYPE |
LENGTH |
LABEL |
SIGNIFICANTDIGITS |
ORIGIN |
COMMENT |
DISPLAYFORMAT |
COMPUTATIONMETHODOID |
CODELISTNAME |
MANDATORY |
ROLE |
ROLECODELIST |
VALUELISTOID |
|
ADSL |
1 |
STUDYID |
text |
15 |
Study Identifier |
DM |
Yes |
Identifier |
ROLECODE |
||||||
|
ADSL |
3 |
USUBJID |
text |
25 |
Unique Subject
Identifier |
DM |
Yes |
Identifier |
ROLECODE |
||||||
|
ADSL |
4 |
SUBJID |
text |
7 |
Subject Identifier
for the Study |
DM |
Yes |
Identifier |
ROLECODE |
||||||
|
ADSL |
7 |
SITEID |
text |
7 |
Study Site
Identifier |
DM |
Yes |
Record Qualifier |
ROLECODE |
||||||
|
ADSL |
15 |
COUNTRY |
text |
3 |
Country |
Derived |
COUNTRY |
Yes |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
8 |
BRTHDT |
integer |
8 |
Date of Birth |
Derived |
No |
Record Qualifier |
ROLECODE |
||||||
|
ADSL |
9 |
AGE |
integer |
8 |
Age |
DM |
3.0 |
Yes |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
10 |
AGEU |
text |
5 |
Age Units |
DM |
AGEU |
Yes |
Variable Qualifier |
ROLECODE |
|||||
|
ADSL |
10 |
AGEGR1 |
text |
40 |
Pooled
Age Group 1 |
Derived |
AGEGR1 |
No |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
10 |
AGEGR1N |
integer |
8 |
Pooled
Age Group 1 (N) |
Derived |
AGEGR1N |
No |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
11 |
SEX |
text |
1 |
Sex |
DM |
SEX |
Yes |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
12 |
RACE |
text |
40 |
Race |
DM |
RACE |
Yes |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
12 |
RACEOTH |
text |
40 |
Race, Other,
Specify |
DM |
No |
Record Qualifier |
ROLECODE |
||||||
|
ADSL |
5 |
RANDDT |
integer |
8 |
Date of
Randomization |
Derived |
No |
Record Qualifier |
ROLECODE |
||||||
|
ADSL |
5 |
TRTSDT |
integer |
8 |
Date of First
Exposure to Treatment |
Derived |
Yes |
Record Qualifier |
ROLECODE |
||||||
|
ADSL |
6 |
TRTEDT |
integer |
8 |
Date of Last
Exposure to Treatment |
Derived |
Yes |
Record Qualifier |
ROLECODE |
||||||
|
ADSL |
13 |
ARM |
text |
40 |
Description of
Planned Arm |
DM |
ARM |
Yes |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
13 |
TRT01P |
text |
40 |
Planned Treatment
for Period 01 |
Derived |
ARM |
Yes |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
13 |
TRT01A |
text |
40 |
Actual Treatment
for Period 01 |
Derived |
ARM |
Yes |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
13 |
TRT01PN |
integer |
8 |
Planned Treatment
for Period 01 (N) |
Derived |
ARMN |
No |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
13 |
TRT01AN |
integer |
8 |
Actual Treatment
for Period 01 (N) |
Derived |
ARMN |
No |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
15 |
ITTFL |
text |
1 |
Intent-To-Treat
Population Flag |
Derived |
_0N1Y |
No |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
15 |
SAFFL |
text |
1 |
Safety
Population Flag |
Derived |
_0N1Y |
No |
Record Qualifier |
ROLECODE |
|||||
|
ADSL |
15 |
RESPFL |
text |
1 |
Efficacy
Responder Flag |
Derived |
_0N1Y |
No |
Record Qualifier |
ROLECODE |
|||||
|
ADEF |
1 |
STUDYID |
text |
15 |
Study Identifier |
ADSL.STUDYID |
Yes |
Identifier |
ROLECODE |
VALUELEVEL_METADATA
|
VALUELISTOID |
VALUENAME |
TYPE |
LENGTH |
LABEL |
SIGNIFICANTDIGITS |
ORIGIN |
COMMENT |
DISPLAYFORMAT |
COMPUTATIONMETHODOID |
CODELISTNAME |
MANDATORY |
ROLE |
ROLECODELIST |
|
XPTESTCDVALUE |
XPPAIN |
integer |
8 |
Pain Score |
1 |
XP.XPSTRESN |
1. |
PAINSCORE |
No |
||||
|
CRIT1VALUE |
XPPAIN |
char |
51 |
Pain Score |
Assignment per the
codelist |
$52. |
CRIT1VALUES |
No |
|||||
|
CRIT1FLVALUE |
XPPAIN |
char |
1 |
Pain Score |
$1. |
RESPONDER |
_0N1Y |
No |
CodeList / Controlled Terminology metadata
CODELISTS
|
CODELISTNAME |
RANK |
CODEDVALUE |
TRANSLATED |
TYPE |
CODELISTDICTIONARY |
CODELISTVERSION |
|
ACN |
1 |
DOSE
INCREASED |
DOSE
INCREASED |
TEXT |
||
|
ACN |
2 |
DOSE
NOT CHANGED |
DOSE
NOT CHANGED |
TEXT |
||
|
ACN |
3 |
DOSE
REDUCED |
DOSE
REDUCED |
TEXT |
||
|
ACN |
4 |
DRUG
INTERRUPTED |
DRUG
INTERRUPTED |
TEXT |
||
|
ACN |
5 |
DRUG
WITHDRAWN |
DRUG
WITHDRAWN |
TEXT |
||
|
ACN |
6 |
NOT
APPLICABLE |
NA |
TEXT |
||
|
ACN |
7 |
UNKNOWN |
U;
Unknown |
TEXT |
||
|
AEBODSYS |
1 |
TEXT |
MedDRA |
7.0 |
||
|
AEDECOD |
1 |
TEXT |
MedDRA |
7.0 |
Derivation metadata
COMPUTATION_METHOD
|
COMPUTATIONMETHODOID |
COMPUTATIONMETHOD |
|
CHANGEFROMBASELINE |
AVAL-BASE |
|
RESPONDER |
IF (.Z<CHG<=-2)
THEN CRIT1FL='Y' ELSE CRIT1FL='N'
|
If needed,
ANALYSIS_RESULTS
|
DISPLAYID |
DISPLAYNAME |
RESULTID |
REASON |
PARAMLIST |
ANALYSISVARIABLES |
ANALYSISDATASET |
SELECTIONCRITERIA |
DOCUMENTATION |
PROGRAMMINGCODE |
PROGRAM |
|
Table_14.1.1 |
Summary of
Demographics (ITT Population) |
Summary of
Demographics |
Comparisons of
baseline characteristics by treatment group |
AGE, AGEGR1, SEX,
RACE |
ADSL |
Where ITTFL='Y' |
[r]SAP_Section_9.1.1[\r] |
PROC FREQ
DATA=ADSL; where ittfl='Y'; tables
trt01pn * (agegr1 sex race) / cmh; |
||
|
Figure_14.2.1 |
Time to Pain
Relief Analysis by Treatment Group |
Time to Pain
Relief Kaplan Meier Analysis |
Pre-specified in
SAP |
TTPNRELF/Time to
First Pain Relief (Days) |
AVAL |
ADTTE |
Where ITTFL='Y' |
[r]SAP_Section_9.2.2[\r] |
proc lifetest data = adtte plots=s; where ittfl = 'Y' and paramcd =
'TTPNRELF'; id usubjid; strata trtpn; time aval*cnsr (1 2 3); test trtpn; run; |
EXTERNAL_LINKS
The place in csr
|
LeafID |
LeafRelPath |
Title |
|
SAP_Section_9.1.1 |
..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf#nameddest=SAP_SEC_9.1.1 |
SAP Section 9.1.1 |
|
Table_14.1.1 |
..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf#page=302 |
Table 14.1.1 |
|
Table_14.2.1 |
..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf#page=352 |
Table 14.2.1 |
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 |
Reviewer’s 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.
The core of ADaM metadata consists of Dataset-level, Variable-level, and Value-level tables, which organically connect SDTM with the final analysis results through Derivation, Origin, and Traceability information.