DM

Demographics

DM.XPT

One record per subject

Tabulation

STUDYID, USUBJID

CO

Comments

CO.XPT

One record per comment per subject

Tabulation

STUDYID, USUBJID, COSEQ

CM

Concomitant Medications

CM.XPT

One record per medication intervention episode per subject

Tabulation

STUDYID, USUBJID, CMTRT, CMSTDTC

All prior surgeries, medication, and procedures from history;
All concurrent therapies on MH, AE, CM and dosing CRF pages

EX

Exposure

EX.XPT

One record per infusion per subject

Tabulation

STUDYID, USUBJID, EXTRT, EXSTDTC

SU

Substance Use

SU.XPT

One record per substance type per subject

Tabulation

STUDYID, USUBJID, SUTRT

AE

Adverse Events

AE.XPT

One record per event per subject

Tabulation

STUDYID, USUBJID, AETERM, AESTDTC

DS

Disposition

DS.XPT

One record per disposition status or protocol milestone per subject

Tabulation

STUDYID, USUBJID, DSTERM, DSDTC

Consent; I/E exemption Y/N;

MH

Medical History

MH.XPT

One record per medical history event per subject

Tabulation

STUDYID, USUBJID, MHTERM

II

Infusion Interruption

II.XPT

One record per infusion per subject

Tabulation

STUDYID, USUBJID, IITERM, IISEQ

DD

Death Report

DD.XPT

One record per contact/death date per subject

Tabulation

STUDYID, USUBJID, DDTERM, DDDTC, DDSEQ

Death or follow-up contact

HO

Hospitalization

HO.XPT

One record per event per subject

Tabulation

STUDYID, USUBJID, HOTERM, HOSEQ

PG

Pregnancy Test

PG.XPT

One record per pregnancy test result per subject

Tabulation

STUDYID, USUBJID, PGTESTCD,  PGSEQ

EG

ECG

EG.XPT

One record per ECG measurement per subject

Tabulation

STUDYID, USUBJID, VISITNUM, EGTESTCD,  EGSEQ

IE

Inclusion/Exclusion Exceptions

IE.XPT

One record per I/E criteria not met per subject

Tabulation

STUDYID, USUBJID, IETESTCD

Smoking History

LB

Laboratory Tests

LB.XPT

One record per lab test per subject

Tabulation

STUDYID, USUBJID, VISITNUM, LBTESTCD

PC

PK Concentration

PC.XPT

One record per PK sampling time point per subject

Tabulation

STUDYID, USUBJID, VISITNUM, PCTPTNUM, PCTESTCD

PP

PK Parameters

PP.XPT

One record per PK parameter per subject

Tabulation

STUDYID, USUBJID, PPTESTCD

HA

Anti–DRUG-B

Antibody

HA.XPT

One record per HAHA sampling time point per subject

Tabulation

STUDYID, USUBJID, VISITNUM, HATPTNUM, HATESTCD

PE

Physical Exam

PE.XPT

One record per subject or body system or body system finding

Tabulation

STUDYID, USUBJID, VISITNUM, PETESTCD, PESEQ

PS

Performance Status

PS.XPT

One record per subject

Tabulation

STUDYID, USUBJID, VISITNUM, PSTESTCD, PSSEQ

SC

Subject Characteristics

SC.XPT

One record per subject Characteristic

Tabulation

STUDYID, USUBJID, SCTESTCD, SCSEQ

VS

Vital Signs

VS.XPT

One record per vital sign per measurement per subject

Tabulation

STUDYID, USUBJID, VISITNUM, VSTPTNUM, VSTESTCD, VSSEQ

RG

Radiographic Report

RR.XPT

One record per radiographic exam per subject

Tabulation

STUDYID, USUBJID, VISITNUM, RGTESTCD, RGSEQ

LS

Tumor Measurements

LS.XPT

One record per tumor measurement/description per subject, Tabulation

Tabulation

STUDYID, USUBJID, VISITNUM, LSTESTCD, LSSEQ

DR

Disease Response

DR.XPT

One record per response assessment type per evaluator per subject, Tabulation

Tabulation

STUDYID, USUBJID, VISITNUM, DRTESTCD, DRSEQ

TE

Trial Elements

TE.XPT

One record per element

Tabulation

STUDYID, ETCD

TA

Trial Arms

TA.XPT

One record per element per arm

Tabulation

STUDYID, ARMCD, ETCD

TV

Trial Visits

TV.XPT

One record per visit per arm

Tabulation

STUDYID, VISITNUM, ARMCD

SE

Subject Elements

SE.XPT

One record per actual element per subject

Tabulation

STUDYID, USUBJID; ETCD

SV

Subject Visits

SV.XPT

One record per subject per actual visit

Tabulation

STUDYID, USUBJID, VISITNUM

TI

Trial Inclusion/Exclusion Criteria

TI.XPT

One record per I/E criterion

Tabulation

STUDYID, IETESTCD

TS

Trial Summary

TI.XPT

One record per trial summary parameter

Tabulation

STUDYID, TSTESTCD, TSSEQ

RELREC

Related Records

RELREC.XPT

One record per relationship

Tabulation

STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID

SUPPQUAL

Supplemental Qualifiers

SUPPQUAL.XPT

One record per qualifier value

Tabulation

STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

DM, $2

Derived

Identifier

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

SUBJID

Subject Identifier for the Study

Char

$4

CRF

Topic

Patient number in CRF

RFSTDTC

Subject Reference Start Date/Time

Char

yyyy-mm-dd, $10

Sponsor Defined

Timing

Date of first treatment dose
ISO 8601

RFENDTC

Subject Reference End Date/Time

Char

yyyy-mm-dd, $10

Sponsor Defined

Timing

Date of last treatment dose
ISO 8601

SITEID

Study Site Identifier

Char

$3

CRF

Record Qualifier

Unique site number within the submission

INVNAM

Investigator Name

Char

Last name, first initial, $20

Derived

Synonym Qualifier

COUNTRY

Country

Char

US, $2

Derived

Result Qualifier

ISO 3166

BRTHDTC

Date/Time of Birth

Char

yyyy-mm-dd, $10

CRF

Result Qualifier

ISO 8601

AGE

Age in AGEU at Reference Date/Time

Num

N5.1

Derived

Result Qualifier

(RFSTDTC - BRTHDTC + 1)/365.25

AGEU

Age Units

Char

years, $5

Derived

Variable Qualifier

SEX

Sex

Char

M, F, U, $1

CRF

Result Qualifier

M, F, U for Male, Female, Unknown

RACE

Race

Char

$8

CRF

Result Qualifier

WHITE (for Caucasian), BLACK, ASIAN, HISPANIC, OTHER

ARMCD

Planned Arm Code

Char

COHORT 1
…

COHORT n, $8

CRF/ Derived

Result Qualifier

ARM

Description of Planned Arm

Char

$20

CRF/ Derived

Synonym Qualifier

Dose Level 2.0 mg/kg, 4.0 mg/kg, etc.

SUBJINIT

Subject Initials

Char

$3

CRF

SC domain

PROTVER

Protocol Version

Char

$20

CRF

SUPPQUAL domain

RACEOTH

Race Other Specify

Char

$20

CRF

SUPPQUAL domain

ICDTC

Informed Consent Date/Time

Char

yyyy-mm-dd, $10

CRF

DS domain variable DSDTC with DSTERM of ‘INFORMED CONSENT OBTAINED’.

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

CO, $2

Derived

Identifier

RDOMAIN

Related Domain Abbreviation

Char

$2

Derived

Identifier

Refer to Section 2.1.2.1.

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

COSEQ

Sequence Number

Num

N3.0

Derived

Identifier

IDVAR

Identifier Variable Name

Char

$8

Derived

Identifier

Refer to Section 2.1.2.1.

IDVARVAL

Identifier Variable

Char

$50

Derived

Identifier

Refer to Section 2.1.2.1.

COREF

Comment Reference

Char

$50

CRF

Record Qualifier

CRF page number, page name, or both. Refer to Section 2.1.2.1.

CODTC

Date/Time of Comment

Char

yyyy-mm-dd

CRF

Timing

A date or null, ISO 8601

COVAL

Comment

Char

$200

CRF

Result Qualifier

Cannot be Null, for the first 200 characters of comment

COVAL1

Comment1

Char

$200

CRF

Result Qualifier

Next 200 characters or null

…

COVALn

Commentn

Char

$200

CRF

Result Qualifier

Last up to 200 characters or null

COEVAL

Evaluator

Char

$50

Derived

Record Qualifier

PRINCIPAL INVESTIGATOR
CLINICAL COORDINATOR
INDEPENDENT REVIEW COMMITTEE
ADJUDICATION COMMITTEE
STATISTICIAN
DATABASE ADMINISTRATOR
etc.

DS

DSTERM

INCL/EXEL EXEMPTION GRANTED

CRF PAGE 1

AE

AETERM

(Adverse event verbatim)

CRF PAGE 200.___

COREF needs 2^nd part of actual AE page number.

CM

CMSPID

CONCURRENT THERAPY PAGE

CRF PAGE 400.___

COREF needs 2^nd part of actual CM page number.

EG

EGORRES

ABNORMAL-CLINICALLY SIGNIFICANT

CRF PAGE 4

EG

EGORRES

ABNORMAL-NOT CLINICALLY SIGNIFICANT

CRF PAGE 4

PE

PEORRES

ABNORMAL

CRF PAGE 9, etc.

II

IIREL

ADVERSE EVENT

CRF PAGE 18, etc.

II

IIREL

OTHER

CRF PAGE 18, etc.

RG

RGMETHOD

OTHER

CRF PAGE 13 PART 1,
CRF PAGE 13 PART 2,
etc.

For radiographic report page, top part is referred to as PART 1, and the bottom part for additional radiographic test is referred to as PART 2.

RG

RGORRES

ABNORMAL-CLINICALLY SIGNIFICANT

CRF PAGE 13 PART 1,
CRF PAGE 13 PART 2,
etc.

For radiographic report page, top part is referred to as PART 1, and the bottom part for additional radiographic test is referred to as PART 2.

RG

RGORRES

ABNORMAL-NOT CLINICALLY SIGNIFICANT

CRF PAGE 13 PART 1,
CRF PAGE 13 PART 2,
etc.

For radiographic report page, top part is referred to as PART 1, and the bottom part for additional radiographic test is referred to as PART 2.

LS

VISIT

BASELINE
END OF TREATMENT CYCLE 1
…
END OF THERAPY

CRF PAGE 26
CRF PAGE 62

CRF PAGE 95

DS

DSTERM

ADVERSE EVENT

CRF PAGE 87

DS

DSTERM

WITHDRAWAL OF CONSENT

CRF PAGE 87

REASON: (verbatim)

DS

DSTERM

OTHER

CRF PAGE 87

HO

HORELNST

ADVERSE EVENT

CRF PAGE 100.___

COREF needs 2^nd part of actual HO page number.

HO

HORELNST

OTHER

CRF PAGE 100.___

COREF needs 2^nd part of actual HO page number.

DD

DDREL

ADVERSE EVENT

CRF PAGE 102

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

CM, $2

Derived

Identifier

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

CMSEQ

Sequence Number

Num

N3

Derived

Identifier

In the order of start date or order of records on the Medical History page

CMGRPID

Group ID

Char

$50

Sponsor Defined

Identifier

Refer to Section 2.2.1.1.

CMSPID

Sponsor ID

Char

CRF PAGE __ LINE __, $50

Sponsor Defined

Record Qualifier

Printed or DM assigned line number.

CMOCCUR

CM Occurrence

Char

Y, N, Null, $1

Sponsor Defined

Result Qualifier

Refer to Section 2.2.1.1.

CMTRT

Reported Name of Drug, Med, or Therapy

Char

$200

CRF

Topic

Refer to Section 2.2.1.1.

CMMODIFY

Modified Reported Name

Char

$200

Sponsor Defined

Synonym Qualifier

CMDECOD

Standardized Medication Name

Char

$50

Derived

Synonym Qualifier

WHO drug version ???

CMCLAS

Medication Class

Char

$50

Derived

Variable Qualifier

Null, if WHO Drug used to code CM

CMCAT

Category for Medication

Char

$50

Sponsor Defined

Grouping Qualifier

Refer to Section 2.2.1.1.

To be determined by Clinical

CMSCAT

Subcategory for Medication

Char

$50

Sponsor Defined

Grouping Qualifier

Refer to Section 2.2.1.1.

CMINDC

Indication

Char

$50

CRF

Record Qualifier

‘Prophylaxis - ______’, if CM page INDICATION prophylaxis box ticked

CMDOSTXT

Dose Description

Char

$50

CRF

Result Qualifier

Premedication DOSE or null

CMDOSREG

Intended Dose Regimen

Char

$200

CRF

Result Qualifier

Central VAD History ANTICOAGULANT USE – NA or
ANTICOAGULANT USE ____

or null

CMSTDTC

Start Date/Time of Medication

Char

yyyy-mm-dd,
yyyy-mm-ddThh:mm,
Null, $16

CRF

Timing

Use study treatment dosing date, if record from dosing page; ISO 8601

CMENDTC

End Date/Time of Medication

Char

yyyy-mm-dd, Null, $10

CRF

Timing

For transfusion, enter date of last transfusion; ISO 8601

CMSTRF

Start Relative to Reference Period

Char

BEFORE, DURING, AFTER, Null, $6

Derived

Timing

Compare CMSTDTC to RFSTDTC in DM domain

CMENRF

End Relative to Reference Period

Char

BEFORE, DURING, AFTER, Null, $6

Derived

Timing

Compare CMENDTC to RFENDTC in DM domain

= AFTER, if CM page DATE DISCONTIUNED if continuing box ticked, or if AE CRF page DATE COMPLETED if continuing box ticked

TRANSFUSION HISTORY

CRF PAGE 5

TRANSFUSION

PACKED RED BLOOD CELLS
PLATELETS
OTHER (- verbatim)

N, Null

CENTRAL VENOUS ACCESS DEVICE HISTORY

CRF PAGE 5

PROCEDURE

CENTRAL VENOUS ACCESS DEVICE

HICKMAN
GROSHONG
PORT
PICC
OTHER (- verbatim)

N, Null

MEDICAL HISTORY PAGE

CRF PAGE 7.__

MEDICATION/ TRANSFUSION/ PROCEDURE

(Verbatim)

Y (if MEDICATED box ticked),
Null

PRIOR DISEASE RELATED THERAPY

CRF PAGE 8

MEDICATION

CHEMOTHERAPY
HORMONAL
IMMUNOTHERAPY
RADIOTHERAPY
INVESTIGATIONAL AGENT
OTHER

(Verbatim)

N, Null

PRIOR DISEASE RELATED SURGERY

CRF PAGE 8

SURGERY

(Verbatim)

N, Null

PREMEDICATION ON TREATMENT ADMINISTRATION PAGE

CRF PAGE 18, etc.

MEDICATION

(Verbatim)

N, Null

ADVERSE EVENT PAGE

CRF PAGE 200.__(.___)

MEDICATION/ TRANSFUSION/ PROCEDURE

(Verbatim)

Null

CONCURRENT THERAPY PAGE

CRF PAGE 400.__

MEDICATION/ TRANSFUSION/ PROCEDURE

(Verbatim)

N, Null

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

EX, $2

Derived

Identifier

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

EXOCCUR

Dosing Occurrence

Char

Y, N, $1

CRF

Result Qualifier

Y, if Administered box is ticked; N, if Held or Not Done box is ticked

EXSTAT

Dosing Status

Char

NOT DONE, Null $8

CRF

Result Qualifier

Not Done, if Not Done box is ticked

EXREASND

Reason Dosing Not Done

Char

$200

CRF

Record Qualifier

‘Held - _____’ if Held box ticked and reason given; ‘Not Done - _______’, if Not Done box ticked and reason given

EXSEQ

Sequence Number

Num

N3

Derived

Identifier

In the order of infusion date

EXGRPID

Group ID

Char

PK SAMPLING
CYCLE 1
…
CYCLE n, $50

Sponsor Defined

Identifier

EXSPID

Sponsor Reference Number

Char

CRF PAGE __, $20

CRF

Identifier

CRF page number

EXTRT

Name of Actual Treatment

Char

DRUG-B, $10

CRF

Topic

EXDOSE

Dose per Administration

Num

N8.2

CRF

Result Qualifier

Total Dose Administered (mg)

EXDOSTXT

Dose Description

Char

$12

CRF

Result Qualifier

e.g. 2.0 mg/kg

EXDOSU

Dose Units

Char

mg, $2

CRF

Variable Qualifier

EXDOSFRM

Dose Form

Char

INJECTABLE

Sponsor Defined

Result Qualifier

EXDOSTOT

Total Daily Dose Using EXDOSU

Num

N8.2

Derived

Result Qualifier

= EXDOSE

EXROUTE

Route of Administration

Char

IV – INFUSION, $20

Sponsor Defined

Result Qualifier

EXLOT

Lot Number

Char

$20

CRF

Record Qualifier

EXSTDTC

Start Date/Time of Treatment

Char

yyyy-mm-ddThh:mm, $16

CRF

Timing

Date and time, ISO 8601

EXENDTC

End Date/Time of Treatment

Char

yyyy-mm-ddThh:mm, $16

CRF

Timing

Date and time, ISO 8601

VISIT

Visit Name

Char

$50

CRF

Timing

Refer to Section 2.5.1.

VISITNUM

Visit Number

Num

N6.2

Derived

Timing

Refer to Section 2.5.1.

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

SU, $2

Derived

Identifier

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

SUOCCUR

SU Occurrence

Char

Y, N, Null $1

CRF

Result Qualifier

N, Never Smoked box ticked; Y, Current Smoker or Past Smoker box ticked

SUSEQ

Sequence Number

Num

1

Derived

Identifier

SUSPID

Sponsor Reference Number

Char

SMOKING HISTORY, $20

Sponsor Defined

Record Qualifier

SUTRT

Name of Substance

Char

TOBACCO, $10

CRF

Topic

SUDOSE

Substance Use Consumption

Num

N4.1

CRF

Result Qualifier

Number of packs per day

SUDOSTXT

Substance Use Consumption Text