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1、本文格式为Word版，下载可任意编辑SDTMIG学习总结 ? 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
2、vital signs domain. 该域存储了体检的察觉结果。可以是身体系统检查和某体检奇怪的信息。 PELOC：体检奇怪察觉部位，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 ha
3、ve 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阅历证的调 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） ? 申办方理应供给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 ch
4、aracteristics 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、教导处境、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 sur
5、face 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 accountab
6、ility 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、急救用药和打定 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
7、,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：供给试验结果的测验室或供给商名称 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
8、）：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，用来与采样时间举行对比，譬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的概括时间 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） ? 全体参数的信息（如数量指数，模型加权）应在SUPPPP数据集中递交 6.3.11 死亡处境 Death Details DD The domain is desi
9、gned 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 Cli
10、nical 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 tha
11、n 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. 死亡处境记录，譬如死因不止一个时，可细致记录。在其他域如SAE中也可能存在死亡记录。 6.3.12 免疫学评估 Immunogenicit
12、y 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 显微镜察觉 Microscopic Findings (MI) The Microscopic Findings dataset provides a record for each microscopic finding observed. There m
13、ay 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 ass
14、essed 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：假设使用生物标记，可用MITSTDTL说明 6.3.14 形态学察觉 Morphology MO Macroscopic results (e.g. size, shape, color, and abnormalities of bod
15、y 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
