This is an example of the ADLB dataset and associated metadata. This is just an example and does not mean to indicate that ADLB must be used as the dataset name, nor are the parameters described necessarily those that would be used in a particular study.
| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | USUBJID | TRTP | TRT01P | TRTA | TRT01A | ADT | ADY | AVISIT | AVISITN | PARAM | PARAMCD | PARAMN | PARCAT1 | AVAL | AVALC | BASE | CHG | PCHG | ABLFL | ANL01FL | LBSTNRC | ANRLO | ANRHI | ANRIND | LBLOINC | LBSPEC | RANDFL | SAFFL | TRTSDT | TRTEDT | LBCLSIG | LBSEQ | VISITNUM | LBDTC |
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| 1 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | Leukocytes (10^9/L) | WBC | 6 | HEMATOLOGY | 11.0 |
| 11.0 |
|
| Y | Y |
| 4.5 | 11.0 |
| 26464-8 | BLOOD | Y | Y | 2021-01-08 | 2021-01-28 |
| 1 | 1 | 2021-01-02 | | 2 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | RBC (10^12/L) | RBC | 8 | HEMATOLOGY | 5.4 |
| 5.4 |
|
| Y | Y |
| 4.7 | 6.1 |
| 33051-4 | BLOOD | Y | Y | 2021-01-08 | 2021-01-28 |
| 2 | 1 | 2021-01-02 | | 3 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | Platelets (10^9/L) | PLAT | 7 | HEMATOLOGY | 158 |
| 158 |
|
| Y | Y |
| 150 | 400 |
| 49497-1 | BLOOD | Y | Y | 2021-01-08 | 2021-01-28 |
| 3 | 1 | 2021-01-02 | | 4 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | Hemoglobin (g/dL) | HGB | 5 | HEMATOLOGY | 14.5 |
| 14.5 |
|
| Y | Y |
| 14 | 18 |
| 718-7 | BLOOD | Y | Y | 2021-01-08 | 2021-01-28 |
| 4 | 1 | 2021-01-02 | | 5 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | Cholesterol (mg/dL) | CHOL | 2 | CLINICAL CHEMISTRY | 229 |
| 229 |
|
| Y | Y |
| 200 |
|
| 2093-3 | BLOOD | Y | Y | 2021-01-08 | 2021-01-28 |
| 5 | 1 | 2021-01-02 | | 6 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | Albumin (g/L) | ALB | 1 | CLINICAL CHEMISTRY | 4.0 |
| 4.0 |
|
| Y | Y |
| 3.4 | 5.4 |
| 2862-1 | BLOOD | Y | Y | 2021-01-08 | 2021-01-28 |
| 6 | 1 | 2021-01-02 | | 7 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | Creatinine (mg/dL) | CREAT | 3 | CLINICAL CHEMISTRY | 0.8 |
| 0.8 |
|
| Y | Y |
| 0.7 | 1.3 |
| 2160-0 | BLOOD | Y | Y | 2021-01-08 | 2021-01-28 |
| 7 | 1 | 2021-01-02 | | 8 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | Urine Specific Gravity | USPGRAV | 9 | URINALYSIS |
|
|
|
|
| Y | Y |
| 1.005 | 1.030 |
| 2965-2 | URINE | Y | Y | 2021-01-08 | 2021-01-28 |
| 8 | 1 | 2021-01-02 | | 9 | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -6 | SCREENING | 1 | Cannabinoids | CANNAB | 4 | DRUG TOXICITY |
| POSITIVE |
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|
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| NEGATIVE |
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| ABNORMAL | 18282-4 | URINE | Y | Y | 2021-01-08 | 2021-01-28 | Y | 9 | 1 | 2021-01-02 |
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| Definexmltable |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADLB |
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| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADLB | Laboratory Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis visit per analysis timepoint | Analysis | STUDYID, USUBJID, PARAM, PARAMCD, AVISIT, | ADLB.xpt | ADLB.SAS/SAP | |
| Definexmltable |
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| Dataset | ADLB |
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| Level | Variable |
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| Purpose | Analysis |
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| Name | ADLB |
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|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
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| Study Identifier | Char |
| Req |
|
...
...
...
| | USUBJID | Unique Subject Identifier | Char |
| Req |
|
...
...
| | TRTP | Planned Product | Char |
| Cond | ADSL.TRT01P | | TRT01P | Planned Product for Period 01 | Char |
| Cond | ADSL.TRT01P | | TRTA | Actual Product | Char |
| Cond | ADSL.TRT01A | | TRT01A | Actual Product for Period 01 | Char |
| Cond | ADSL.TRT01A |
|
...
...
...
| Perm | LB.LBDTC captured in numeric format |
|
...
...
| Num |
| Perm | LB.LBDY | | AVISIT | Analysis Visit |
|
...
| Char |
| Cond | LB.VISIT | | AVISITN | Analysis Visit (N) |
|
...
| Num |
| Perm | LB.VISITNUM | | PARAM | Parameter |
|
...
| Char |
| Req | LB.LBTEST concatenated with LB.LBSTRESU - if PARCAT1=URINALYSIS then preface with Urine |
|
...
| | PARAMCD | Parameter Code | text |
| Req | LB.LBTESTCD - if PARCAT1=URINALYSIS then preface with U | | PARAMN | Parameter (N) |
|
...
| Num |
| Perm | Numeric representation of PARAM. Sort by PARCAT! and PARAMCD and increment by 1 for each new LBTESTCD | | PARCAT1 | Parameter Category 1 |
|
...
| Char |
| Perm | LB.LBCAT | | AVAL | Analysis Value | Num |
| Cond | LB.LBSTRESN | | AVALC |
|
...
...
| (C) | Char |
| Cond | LB.LBSTRESC where LB.LBSTRESN is null | | BASE | Baseline Value |
|
...
| Num |
| Cond | AVAL where ABLFL=Y | | CHG | Change from Baseline | Num |
| Perm | AVAL-BASE - populated on ABLFL=Y records and post-baseline records | | PCHG | Percent Change from Baseline | Num |
| Perm | derived as ((AVAL-BASE)/BASE)*100 |
|
...
| | ABLFL | Baseline Record Flag |
|
...
| Char | Y | Cond | set to Y for last pre-product value within each PARAM | | ANL01FL | Analysis Flag 01 | Char |
|
...
...
| Cond | set to Y for last value within PARAM and AVISIT | | RANDFL | Randomized Population Flag | Char | Y;N | Cond | ADSL.RANDFL | | SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL | | TRTSDT | Date of First Exposure to Product | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-192 |
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|
| Num |
| Perm | ADSL.TRTSDT | | TRTEDT | Date of Last Exposure to Product | Jira |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-190 |
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|
| Num |
| Perm | ADSL.TRTEDT | | LBSEQ | Sequence Number | Num |
| Perm | LB.LBSEQ | | VISITNUM | Visit Number | Num |
| Perm | LB.VISITNUM | | LBDTC | Date/Time of Specimen Collection | Char |
| Perm | LB.LBDTC |
|
...