学习笔记_SDTM Domains _ Demographics (DM)

Description/Overview

Demographics (DM)

• 包含受试者基本信息的数据集，每个受试者一条记录。
• 是所有其他临床试验domain的父集，应最先生成，供其他domain调用。

Specification

Varibable Name	Variable Label	Origin	Notes	Core
STUDYID	Study Identifier	Protocol	Unique identifier for a study	Req
DOMAIN	Domain Abbreviation	Assigned	Two-character abbreviation	Req
USUBJID	Unique Subject Identifier	Dirived	STUDYID-SITEID-SUBJID	Req
SUBJID	Subject Identifier for the Study	CRF[Subject Identification]	ID of the subject	Req
RFSTDTC	Subject Reference Start Date/Time	Derived[Drug Administration]	Usually = date of first exposure to trt	Exp
RFENDTC	Subject Reference End Date/Time	Derived[Date of visit]	Usually = date of last exposure to trt	Exp
RFXSTDTC	Date/Time of First Study Treatment	Dericed	First date/time of exposure to any protocol-specified treatment or therapy, = first EXSTDTC	Exp
RFXENDTC	Date/Time of Last Study Treatment	Derived	Last date/time of exposure to any protocol-specified treatment or therapy, = latest EXENDTC (or EXSTDTC)	Exp
RFCSTDTC	Date/Time of First Challenge Agent Admin	Derived	= earliest value of AGSTDTC for the challenge agent	Perm
RFCENDTC	Date/Time of Last Challenge Agent Admin	Derived	= latest value of AGENDTC (or AGSTDTC) for the challenge agent	Perm
RFICDTC	Date/Time of Informed Consent	CRF[Informed Consent]	Informed Consent Date	Exp
RFPENDTC	Date/Time of End of Participation	Derived[Study Treatment Discontinuation]	= last known date of contact (completion date, withdrawal date, last follow-up, date recorded for lost to follow up, and death date…）	Exp
DTHDTC	Date/Time of Death	CRF[Death]	Date of Death	Exp
DTHFL	Subject Death Flag	Derived	= “Y” or null	Exp
SITEID	Study Site Identifier	CRF[Subject Identification]	Unique identifier for a site within a study	Req
INVID	Investigator Identifier	Derived	An identifier to describe the Investigator for the study (Not needed if SITEID is equivalent to INVID)	Perm
INVNAM	Investigator Name	CRF	Name of the investigator for a site.	Perm
BRTHDTC	Date/Time of Birth	CRF[Demographics]		Perm
AGE	Age	CRF[Demographics]		Exp
AGEU	Age Units	CRF/Assigned[Demographics]	Units associated with AGE	Exp
SEX	Sex	CRF[Demographics]		Req
RACE	RACE	CRF[Demographics]		Exp
ETHNIC	Ethnicity	CRF[Demographics]		Perm
ARMCD	Planned Arm Code	Derived	limited to 20 characters	Exp
ARM	Description of Planned Arm	CRF(IRT)	Name of the arm to which the subject was assigned	Exp
ACTARMCD	Actual Arm Code	Derived		Exp
ACTARM	Description of Actual Arm[Randomization]	Derived		Exp
ARMNRS	Reason Arm and/or Actual Arm is Null	Derived	coded reason(“SCREEN FAILURE”, “NOT ASSIGNED”, “ASSIGNED, NOT TREATED”, “UNPLANNED TREATMENT”)	Exp
ACTARMUD	Description of Unplanned Actual Arm	?		Exp
COUNTRY	Country	Derived		Req
DMDTC	Date/Time of Collection	?	Date/time of demographic data collection	Perm
DMDY	Study Day of Collection	?	Study day of collection measured as integer days	Perm

Assumptions

1. Every subject in a study must have a subject identifier (SUBJID). In some cases a subject may participate in more than 1 study. To identify a subject uniquely across all studies for all applications or submissions involving the product, a unique identifier (USUBJID) must be included in all datasets. The Supplemental Qualifiers dataset may be used if appropriate to provide additional information.
2. With the exception of trials that use multistage processes to assign subjects to arms described below, ARM and ACTARM must be populated with ARM values from the Trial Arms (TA) dataset and ARMCD and ACTARMCD must be populated with ARMCD values from the TA dataset or be null. The ARM and ARMCD values in the TA dataset have a one-to-one relationship, and that one-to-one relationship must be preserved in the values used to populate ARM and ARMCD in DM, and to populate the values of ACTARM and ACTARMCD in DM.
   a. Rules for the arm-related variables:
   i. If ARMCD is null, then ARM must be null and ARMNRS must be populated with the reason ARMCD is null.
   ii. If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated with the reason ACTARMCD is null. Both ARMCD and ACTARMCD will be null for subjects who were not assigned to treatment.
   iii. ARMNRS may not be populated if both ARMCD and ACTARMCD are populated.
   iv. If ARMNRS is populated with “UNPLANNED TREATMENT”, ACTARMUD should be populated with a description of the unplanned treatment received.
   b. Multistage assignment to treatment: Some trials use a multistage process for assigning a subject to an arm. In such a case, best practice is to create ARMCD values composed of codes representing the results of the multiple stages of the treatment assignment process. If a subject is partially assigned, then truncated codes representing the stages completed can be used in ARMCD, and similar truncated codes can be used in ACTARMCD. The descriptions used to populate ARM and ACTARM should be similarly truncated, and the one-to-one relationship between these truncated codes should be maintained for all affected subjects in the trial.
3. Submission of multiple race responses should be represented in the Demographics (DM) domain and Supplemental Qualifiers (SUPPDM) dataset as described in Section 4.2.8.3, Multiple Values for a Nonresult Qualifier Variable. If multiple races are collected, then the value of RACE should be “MULTIPLE” and the additional information will be included in the Supplemental Qualifiers dataset.
4. RFICDTC:

SAS Coding

Struture: Oner record per subject

Variabes:

• Keys: STUYID, USUBJID
• Assigned：DOMAIN = DM
• Subject: AGE, SEX, RACE, ETHNIC, BRTHDTC, COUNTRY
• Dose: RFXSTDTC, RFXENDTC
• Trial: RFICDTC, DTHDTC
• Site: SITEID, INVID, INVNAM
• Arm: ARM, ARMCD, ACTARM, ACTARMCD
• Time: RFSTDTC, RFENDTC, RFPENDTC