? LBTPT为样本采集时间的描述，LBTPTREF是参照点的描述
6.3.4 体格检查 Physical Examination PE
Findings collected during a physical examination of the subject. It has findings that are discovered that are related to body systems. Does not include vital signs measurements, which are stored in the vital signs domain.
该域存储了体检的发现结果。可以是身体系统检查和某体检异常的信息。 PELOC：体检异常发现部位，受控术语，LOC
PEMETHOD：测试或检查的方法，受控术语，METHOD PEEVAL：评估人员，受控术语，EVAL 6.3.5 调查量表 Questionnaires QS
Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis.
受控术语：QSTESTCD, QSTEST, QSCAT, UNIT, EVAL
? 调查量表域可能包括但不限于受试者报告的结果以及验证或未经验证的调
查量表
? 单项得分测量或结果可以放在调查量表中（例如，APACHE得分，ECOG） ? 申办方应该提供元数据中验证过的调查量表的版本信息
6.3.6 受试者特征 Subject Characters SC
SC是与受试者相关的没有被采集到其它域中的数据。例如：受试者姓名英文首字母、眼睛颜色、生育状况，等。
The subject characteristics domain is for data not collected in other domains that is subject-related.
SCTESTCD：受试者特征简称，受控术语，SCTESTCD，母乳喂养、惯用手、教育情况、工作、工资、肤色等。
SCTEST：受试者特征，受控术语，SCTEST，SCTESTCD的全称 6.3.7 生命体征 visual sign VS
Measurements including but not limited to blood pressure, temperature, respiration, body surface area, BMI, height and weight.
CRF中采集的生命体征测量值，如：血压、身高、体重、脉搏、体温等测量，或由此衍生的数据如体质指数 (BMI)。
VSTESTCD：生命特征检测简称 受控术语 VSTESTCD VSTEST：生命特征检测名称 受控术语 VSTEST
VSPOS：受试者生命特征检测的体位，受控术语 POSITION VSORRESU：单位，受控术语，VSRESU
VSLAT(laterity)：左右，受控术语，LAT 6.3.8 药物分发记录 Drug Accountability DA
Data regarding the accountability of study drug, such as information on the receipt, dispensing, return, and packaging.
DA是关于研究药物收发等的数据，例如：药物的接收、分发、返回和包装的信息。
? DACAT是申办者用于区分不同类型药物（例如：研究用药、急救用药和准备
用药等）的一种方法。 6.3.9 微生物学域 MB MS
6.3.10 药代动力学浓度 Pharmacokinetics Concentrations PC 必需变量：STUDYID, DOMAIN USUBJID, PCSEQ, PCTEST, PCTESTCD,PCSPEC 预期变量：PCORRES, PCORRESU, PCSTRESC, PCSTRESN, PCSTRESU, PCNAM, PCLLOQ, PCULOQ, PCDTC 许可变量：若干
PCSPEC(Specimen Material Type )：标本种类（如血清、血浆） PCSPCCND：样本状况
PCNAM：提供试验结果的实验室或供应商名称
PCLLOQ（Lower Limit of Quantitation ）：量化指标的下限
PCULOQ：量化指标的上限
PCEVLINT（Evaluation Interval）：评估间隔
PCTPT（Planned Time Point）：样本采集时间的描述 PCTPTNUM：PCTPT的数字版本
PCTPTREF：固定的参考时间点的名称，用来与采样时间进行比较，比如用于区分服药前和服药后的采样
PCELTM（Elapsed Time）：距离PCTPTREF的时间 PCRFTDTC：为PCTPTREF的具体时间
药代动力学参数 Pharmacokinetics parameters PP
? 描述PC数据（如曲线下面积、最大浓度和峰值时间-浓度曲线参数的数据） ? 所有参数的信息（如数量指数，模型加权）应在SUPPPP数据集中递交 6.3.11 死亡情况 Death Details DD
The domain is designed to hold supplemental data that are typically collected when a death occurs, such as the official cause of death. It does not replace existing data such as the SAE details in AE. Furthermore, it does not introduce a new requirement to collect information that is not already indicated as Good Clinical Practice or defined in regulatory guidelines. Instead, it provides a consistent place within SDTM to hold information that previously did not have a clearly defined home.
This domain captures information pertaining to the death of a subject, including the causes of death. There may be more than one causes. If so, these may be separated into primary and secondary causes and/or other appropriate designations. DD may also include other details about the death, such as where the death occurred and whether it was witnessed. 死亡情况记录，比如死因不止一个时，可详细记录。在其他域如SAE中也可能存在死亡记录。
6.3.12 免疫学评估 Immunogenicity Specimen Assessment IS The IS domain is intended to be used only for data collected regarding the immunogenic potential of materials under study. 免疫学检测结果，例如抗原抗体等
6.3.13 显微镜发现 Microscopic Findings (MI)
The Microscopic Findings dataset provides a record for each microscopic finding observed. There may be multiple microscopic tests on a subject or specimen. 受控术语：MITEST/MITESTCD
This domain holds findings resulting from the microscopic examination of tissue samples. These examinations are performed on a specimen, which has been prepared with some type of stain.
Tests classified as \Biomarkers assessed by histologic or histopathological examination (by employing cytochemical / immunocytochemical stains) will be stored in the MI domain. ? MIRESCAT可用于记录结果分类，如肿瘤的良恶性 ? MITSTDTL：如果使用生物标记，可用MITSTDTL说明
6.3.14 形态学发现 Morphology MO
Macroscopic results (e.g. size, shape, color, and abnormalities of body parts or specimens) that are seen by the naked eye or observed via procedures such as imaging modalities, endoscopy, or other technologies. Many morphology results are obtained from a procedure, although information about the procedure may or may not be collected.
受控术语：MOTEST/MOTESTCD/DIR/LAT/LOC/PORTOT/METHOD/EVAL
DI Domain
The example below shows a Device Identifiers (DI) domain record based on the MRI device used for the brain measurement. A prerequisite for any Device domain is that there will be at least one record in DI. The standard controlled terminology for