DIPARMCD, DIPARM, and DIVAL is represented in the table.
Device-in-Use (DU) data example related to MO results for the MRI device This example shows data from one subject collected at two visits regarding parameters from an MRI imaging protocol. DUGRPID is used to facilitate the creation of a RELREC relationship to the morphological result(s) (see table below).
6.3.15 生殖系统发现 Reproductive System Findings RP
The Reproductive System Findings domain captures all Reproductive information related to a subject.
This domain will contain information regarding, for example, the subject’s reproductive ability, reproductive history such as number of previous pregnancies and number of births, pregnant during the study, etc.” 受控术语：RPTEST/RPTESTCD
6.3.16 受试者状态 Subject Status (SS)
Subject Status is for data relating to general subject characteristics that are evaluated periodically to determine if they have changed.
Subject Status must not contain data that belong in another domain. Periodic data collection is not the sole criteria for storing data in SS. The criterion is whether the test reflects the subject’s status at a point in time. It is not for recording clinical test results, event terms, treatment names or other data which belong elsewhere 受控术语：SSTEST/SSTESTCD/SSSTRESC
6.3.17 癌症相关域 Oncology Domains: TU, TR and RS
Tumor Identification TU
The TU domain represents data that uniquely identifies tumors (i.e. malignant tumors and other sites of disease, e.g. lymph nodes). The tumors are identified by an investigator and/or independent assessor and classified according to the disease assessment criteria. In RECIST terms this equates to the identification of Target,
Non-Target or New tumors. A record in the TU domain contains the following information: a unique tumor ID value; anatomical location of the tumor; method used to identify the tumor; role of the individual identifying the tumor; and timing information.
TUTEST：Tumor Identification Test Name，受控术语，TUTEST(Tumor Identification、Tumor Merged和Tumor Split)
TUTESTCD：受控术语，TUTESTCD(TUMERGE，TUMIDENT,TUSPLIT) TUSTRESC：原始数据，数字型 受控术语，TUMEDENT TULOC：肿瘤部位，受控术语LOC TULAT：左右，受控术语LAT TUDIR：位置，受控术语DIR
TUPORTOT：部分或全部，受控术语PORTOT TUMETHOD：肿瘤诊断方法，受控术语 METHOD TUEVAL：评价者，受控术语，EVAL
TUEVALID：评估者标志 受控术语，MEDEVAL
TUACPTFL（Accepted Record Flag）：如果有多人评价，TUACPTFL表明接受的是哪个评价 TU域假设
? 肿瘤位置等信息不必每次随访都记录。Post-baseline可能记录：新发肿瘤；
肿瘤split；split肿瘤合并；
? 如果只关注肿瘤的发生，则TUTEST=tumor identification；TUORRES=new，
TULNKID用于连接TR域
? 如果还关注肿瘤的解剖信息，可加入TULOC等
TR域 Tumor Results
The TR domain represents quantitative measurements and/or qualitative assessments of the tumors identified in the TU domain. These measurements are usually taken at baseline and then at each subsequent assessment to support response evaluations. A record in the TR domain contains the following information: a unique tumor ID value; test and result; method used; role of the individual assessing the tumor; and timing information. TRTEST：检测名称，受控术语，TRTEST TRTESTCD：缩写，受控术语，TRTESTCD TRMETHOD：受控术语，METHOD TREVAL：受控术语，EVAL TREVALID：受控术语，MEDEVAL
? 新增LNKID用于TR和TU域之间的连接，因为GRPID,REFID and SPID可能全
做其他用途
? TRLNKGRP用于连接TR和RS域
? 如果肿瘤太小，可用固定值5mm（基于RECIST的研究） RS域 disease response
The RS domain represents the response evaluation(s) determined from the data in TR. Data from other sources (in other SDTM domains) might also be used in an assessment of response.
受控术语：RSTEST/RSTESTCD/EVAL/MEDEVAL
? 有示例文档excel
6.4 Findings About Events or Interventions
Findings About Events or Interventions is a specialization of the Findings General Observation Class. As such, it shares all qualities and conventions of Findings
observations but is specialized by the addition of the --OBJ variable.
7. 1 试验分组 Trial Arms TA
The trial arms table describes each planned arm in the trial. An arm is described as an ordered sequence of elements STUDYID, DOMAIN
ARM：计划分组描述，分组或治疗的名称 受控术语 ARMCD：ARM的代码 TAETORD：元素顺序
ELEMENT：元素描述，受控术语 ETCD：元素代码，受控术语 TABRANCH：分叉条件 TATRANS：过渡规则 EPOCH：时期
? 分支与过渡的区别：分支就是试验中的随机分组；过渡是有条件的进展，如
如果疾病进展则过渡到随访期。
7.2 试验元素Trial Elements TE STUDYID, DOMAIN
ELEMENT：元素的描述 受控术语 ETCD：元素代码 受控术语 TESTRL：元素开始规则
TEENRL：元素结束规则 TEDUR：元素计划持续时间
? 元素之间没有间隔，一个元素结束，下一个元素马上开始 ? 元素开始和结束比较难定义
7.3 试验访视 Trial Visits TV
The Trial Visits (TV) dataset describes the planned Visits in a trial. Visits are defined as \and VISITDY.
7.4 试验疾病评价Trial Disease Assessments (TD)
The TD domain provides information on the protocol-specified disease assessment schedule, and will be used for comparison with the actual occurrence of the efficacy assessments in order to determine whether there was good compliance with the schedule. 定期疾病评估域
8.1 相关记录域 relrec 8.2 补充修饰 supp
作用：SDTM不允许增加新变量， 采集没有被列入常规域中的数据 ?
? 何时需要SUPP
? SUPP中每条记录凭借STUDYID，ROMAIN，USUBJID，IDVAR/IDVARVAL与源
纪录相连接