1. special-purpose datasets
   1. Special-Purpose Domains
      1. Demographics (DM)
         1. describe each subject in a clinical study
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. SUBJID
            5. SITEID
            6. INVID
            7. INVNAM
            8. ARMCD
            9. ARM
            10. ACTARMCD
            11. ACTARM
            12. RFSTDTC
            13. RFENDTC
            14. RFXSTDTC
            15. RFXENDDTC
            16. RFICDTC
            17. 签了同意书（informed consent）的时间
            18. RFPENDTC
            19. BRTHDTC
            20. DTHDTC
            21. DTHFL
            22. DMDTC
            23. DMDY
            24. AGE
            25. AGEU
            26. SEX
            27. RACE
            28. ETHNIC
            29. COUNTRY
      2. Comments (CO)
         1. var
            1. STUDYID
            2. DOMAIN
            3. COSEQ
            4. 序号
            5. USUBJID
            6. RDOMAIN
            7. 该批注是写给哪个domain的
            8. IDVAR
            9. 该批注是写给哪个var的
            10. IDVARVAL
            11. 该批注是写给哪个值的
            12. COREF
            13. 在哪个位置，例如第几页、哪个visit
            14. COVAL
            15. COEVAL
            16. evalulator是谁，谁写的（头衔）
            17. CODTC
      3. Subject Elements (SE)
         1. information about the timing of each subject’s progress through the Epochs and Elements of the trial.
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. SESEQ
            5. ETCD
            6. ELEMENT
            7. EPOCH
            8. SEUPDES
            9. 如果ETCD的值是unplan，写上发生了什么
            10. SESTDTC
            11. SEENDTC
            12. TAETORD
            13. 序数
      4. Subject Visits (SV)
         1. information about the timing of subject visits
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. VISITNUM
            5. VISIT
            6. VISITDY
            7. SVSTDTC
            8. SVENDTC
            9. SVSTDY
            10. SVENDY
            11. SVUPDES
            12. ulplaned visit是怎么处理的
   2. Trial Design Model (TDM) 实验设计
      1. Trial Arms (TA)
         1. describes each planned arm in the trial
         2. var
            1. STUDYID
            2. DOMAIN
            3. ARMCD
            4. ARM
            5. TAETORD
            6. ETCD
            7. ELEMENT
            8. TABRANCH
            9. TATRANS
            10. EPOCH
      2. Trial Disease Assessment (TD)
         1. 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
         2. 确定是否与时间表相符
         3. var
            1. STUDYID
            2. DOMAIN
            3. TDORDER
            4. TDANCVAR
            5. TDSTOFF
            6. TDTGTPAI
            7. TDMINPAI
            8. TDMAXPAI
            9. TDNUMRPT
      3. Trial Elements (TE)
         1. the definitions of the elements that appear in the Trial Arms (TA) dataset
         2. var
            1. STUDYID
            2. DOMAIN
            3. ETCD
            4. ELEMENT
            5. TESTRL
            6. TEENRL
            7. TEDUR
      4. Trial Visits (TV)
         1. describes the planned Visits in a trial
         2. var
            1. STUDYID
            2. DOMAIN
            3. VISITNUM
            4. VISIT
            5. VISITDY
            6. ARMCD
            7. ARM
            8. TVSTRL
            9. TVENRL
      5. Trial Inclusion/Exclusion Criteria (TI)
         1. contains all the inclusion and exclusion criteria for the trial
         2. 包含该试验的所有纳入和排除标准
         3. var
            1. STUDYID
            2. DOMAIN
            3. IETESTCD
            4. IETEST
            5. IECAT
            6. IESCAT
            7. TIRL
            8. TIVERS
      6. Trial Summary (TS)
         1. a summary of the trial in a structured format
         2. 结构化格式的摘要
         3. var
            1. STUDYID
            2. DOMAIN
            3. TSSEQ
            4. TSGRPID
            5. TSPARMCD
            6. TSPARM
            7. TSVAL
            8. TSVALNF
            9. TSVALCD
            10. TSVCDREF
            11. TSVCDVER
   3. Relationship datasets关系
      1. Supplemental Qualifiers (SUPP-- datasets)
         1. SUPP-- represents the metadata and data for each non-standard variable/value combination
         2. SUPP-代表每个非标准变量/值组合的元数据和数据
      2. Related Records (RELREC)
         1. describe relationships between records for a subject , and relationships between datasets
         2. 描述主题记录之间的关系以及数据集之间的关系
2. general observation classes
   1. Interventions General Observation Class干预
      1. Concomitant Medications (CM)
         1. the concomitant and prior medications/therapies used by the subject
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. CMSEQ
            5. CMGRPID
            6. CMSPID
            7. CMTRT
            8. CMMODIFY
            9. CMDECOD
            10. CMCAT
            11. CMSCAT
            12. CMPRESP
            13. 预定的伴随药物
            14. CMOCCUR
            15. CMSTAT
            16. CMREASND
            17. CMINDC
            18. 用药原因，例如头痛、恶心
            19. CMCLAS
            20. CMCLASCD
            21. CMDOSE
            22. CMDOSTXT
            23. CMDOSEU
            24. CMDOFRM
            25. CMDOSFRQ
            26. CMDOSTOT
            27. 每日总剂量
            28. CMDOSRGM
            29. 计划给药方案(Intended Dose Regimen)，例如TWO WEEKS ON, TWO WEEKS OFF
            30. CMROUTE
            31. 给药途径，例如ORAL, IV
            32. CMSTDTC
            33. CMENDTC
            34. CMSTDY
            35. CMENDY
            36. CMDUR
            37. CMSTRF
            38. CMENRF
            39. CMSTRTPT
            40. CMSTTPT
            41. CMENRTPT
            42. CMENTPT
      2. Exposure (EX)
         1. the details of a subject's exposure to protocol-specified study treatment.
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. EXSEQ
            5. EXGRPID
            6. EXREFID
            7. EXSPID
            8. EXLINKID
            9. EXLINKGRP
            10. EXTRT
            11. EXCAT
            12. EXSCAT
            13. EXDOSE
            14. EXDOSTXT
            15. EXDOSU
            16. EXDOSFRM
            17. EXDOSFRQ
            18. EXDOSRGM
            19. 计划给药方案(Intended Dose Regimen)，例如TWO WEEKS ON, TWO WEEKS OFF
            20. EXROUTE
            21. 给药途径，例如ORAL, IV
            22. EXLOT
            23. 药的批号
            24. EXLOC
            25. 给药部位
            26. EXLAT
            27. Laterality，例如LEFT、RIGHT
            28. EXDIR
            29. 方位，例如LOWER、UPPER
            30. EXFAST
            31. EXADJ
            32. 剂量调整原因
            33. EPOCH
            34. EXSTDTC
            35. EXENDTC
            36. EXSTDY
            37. EXENDY
            38. EXDUR
            39. EXTPT
            40. EXTPTNUM
            41. EXELTM
            42. EXTPTREF
            43. EXRFTDTC
      3. Exposure as Collected (EC)
         1. protocol-specified study treatment administrations, as collected.
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. ECSEQ
            5. ECGRPID
            6. ECREFID
            7. ECSPID
            8. ECLNKID
            9. ECLNKGRP
            10. ECTRT
            11. ECMOOD
            12. ECCAT
            13. ECSCAT
            14. ECPRESP
            15. ECOCCUR
            16. ECDOSE
            17. ECDOSTXT
            18. ECDOSU
            19. ECDOSFRM
            20. ECDOSFRQ
            21. ECDOSTOT
            22. ECDOSRGM
            23. ECROUTE
            24. ECLOT
            25. ECLOC
            26. ECLAT
            27. ECDIR
            28. ECPORTOT
            29. ECFAST
            30. ECPSTRG
            31. ECPSTRGU
            32. ECADJ
            33. EPOCH
            34. ECSTDTC
            35. ECENDTC
            36. ECSTDY
            37. ECENDY
            38. ECDUR
            39. ECTPT
            40. ECTPTNUM
            41. ECELTM
            42. ECTPTREF
            43. ECRFTDTC
      4. Substance Use (SU)物质使用
         1. capture substance use information that may be used to assess the efficacy and/or safety of therapies that look to mitigate the effects of chronic substance use.
         2. 捕获可用于评估缓解慢性药物使用影响的疗法的功效和/或安全性的药物使用信息
      5. Procedures (PR)
         1. reflects collected details describing a subject’s therapeutic and diagnostic procedures.
         2. 反映收集的详细信息，描述受试者的治疗和诊断程序
   2. Events General Observation Class事件
      1. Adverse Events (AE)
         1. any untoward events
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. AESEQ
            5. AEGRIPID
            6. AEREFID
            7. AESPID
            8. AETERM
            9. AEMODIFY
            10. AELLT
            11. meddra中的lowest level term
            12. AELLTCD
            13. AEDECOD
            14. AEPTCD
            15. medra中的prefered term code
            16. AEHLT
            17. AEHLTCD
            18. AEHLGT
            19. AEHLGTCD
            20. AECAT
            21. AESCAT
            22. AEPRESP
            23. 预设（Pre-Specified）的AE
            24. AEBODYSYS
            25. AEBDSYCD
            26. AESOC
            27. medra中的Primary System Organ Class
            28. AESOCCD
            29. AELOC
            30. AEPATT
            31. Pattern模式，例如间歇（INTERMITTENT）、连续（CONTINUOU）、单次（SINGLE）
            32. AEOUT
            33. AESEV
            34. AESER
            35. AETOXGR
            36. AESOD
            37. Overdose是否是药物过量引起？
            38. AESCAN
            39. associated with the development of Cancer是否导致癌症
            40. AESCONG
            41. AESDISAB
            42. AESDTH
            43. AESHOSP
            44. AESLIFE
            45. AESMIE
            46. Other Medically Important Event其它严重事件
            47. AEACN
            48. Action Taken采取的措施，例如剂量调整
            49. AEACNOTH
            50. Other Action Taken其它措施，剂量调整之外的措施
            51. AECONTRT
            52. Concomitant 是否有额外trt
            53. AEREL
            54. how much related因果关系，例如相关、可能相关、不相关
            55. AERELNST
            56. Relationship to Non-Study Treatment，AE是否由研究药物之外的治疗引起。例如：“更可能与阿司匹林使用有关”。
            57. AESTDTC
            58. AEENDDTC
            59. AESTDY
            60. AEENDY
            61. AEDUR
            62. AEENRF
            63. AEENRTPT
            64. AEENTPT
      2. Clinical Events (CE)
         1. clinical events of interest that would not be classified as adverse events.
      3. Disposition (DS)
         1. 处置
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. DSSEQ
            5. DSGRPID
            6. DSREFID
            7. DSSPID
            8. DSTERM
            9. 发生了什么
            10. DSDECOD
            11. 例如：获得知情同意书、随机分组
            12. DSCAT
            13. DSSCAT
            14. EPOCH
            15. DSDTC
            16. DSSTDTC
            17. DSSTDY
      4. Protocol Deviations (DV)
         1. protocol violations and deviations during the course of the study
         2. 违规
         3. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. DVSEQ
            5. DVREFID
            6. DVSPID
            7. DVTERM
            8. DVDECOD
            9. DVCAT
            10. DVSCAT
            11. EPOCH
            12. DVSTDTC
            13. DVENDTC
      5. Healthcare Encounters (HO)
         1. inpatient and outpatient healthcare events (e.g., hospitalizations, nursing home stay, rehabilitation facility stays, ambulatory surgery)
         2. 住院和门诊医疗事件（例如住院，疗养院住宿，康复设施住宿，门诊手术）
      6. Medical History (MH)
         1. the subject's prior history at the start of the trial.
         2. 病史
         3. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. MHSEQ
            5. MHGRPID
            6. MHREFID
            7. MHSPID
            8. MHTERM
            9. MHMODIFY
            10. MHDECOD
            11. MHCAT
            12. MHSCAT
            13. MHBODSYS
            14. Body System or Organ Class，来源例如medra
            15. MHPRESP
            16. MHOCCUR
            17. MHSTAT
            18. MHREASND
            19. MHDTC
            20. MHSTDTC
            21. MHENDTC
            22. MHDY
            23. MHENRF
            24. MHENRTPT
            25. MHENTPT
   3. Findings General Observation Class结果
      1. Drug Accountability (DA)
         1. the accountability of study drug, such as information on the receipt, dispensing, return, and packaging
         2. 研究药物的责任制，例如有关收据，配药，退货和包装的信息
      2. Death Details (DD)
         1. hold supplemental data that are typically collected when a death occurs, such as the official cause of death.
         2. 保留通常在死亡发生时收集的补充数据，例如官方死因
         3. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. DDSEQ
            5. DDTESTCD
            6. DDTEST
            7. DDORRES
            8. DDSTRESC
            9. DDRESCAT
            10. DDEVAL
            11. DDDTC
            12. DDDY
      3. ECG Test Results (EG)
         1. related to the collection of ECG data
         2. 心电图
         3. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. EGSEQ
            5. EGGRPID
            6. EGREFID
            7. EGSPID
            8. EGTESTCD
            9. EGTEST
            10. EGCAT
            11. EGSCAT
            12. EGORRES
            13. original results原始结果
            14. EGORRESU
            15. EGSTRESC
            16. EGSTRESN
            17. EGSTRESU
            18. EGSTAT
            19. EGREASND
            20. EGFXN
            21. file name and path
            22. EGNAM
            23. 实验室名称
            24. EGEVAL
            25. 谁测的
            26. EGPOS
            27. EGLEAD
            28. Lead Location主要测量部位
            29. EGMETHOD
            30. EGBLFL
            31. 是否是baseline
            32. EGDRVFL
            33. 是否是Derived
            34. VISITNUM
            35. VISIT
            36. VISITDY
            37. EGDTC
            38. EGDY
            39. EGTPT
            40. EGTPTNUM
            41. EGELTM
            42. EGTPTREF
            43. EGRFTDTC
      4. Inclusion/Exclusion Criterion Not Met (IE)
         1. collect those criteria that cause the subject to be in violation of the inclusion/exclusion criteria not a response to each criterion
         2. 收集导致受试者违反纳入/排除标准的标准，而不是对每个标准的回应
         3. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. IESEQ
            5. IESPID
            6. IETESTCD
            7. IETEST
            8. IECAT
            9. IESCAT
            10. IEORRES
            11. IESTRESC
            12. VISITNUM
            13. VISIT
            14. VISITDY
            15. IEDTC
            16. IEDY
      5. Immunogenicity Specimen Assessments (IS)
         1. data collected regarding the immunogenic potential of materials under study
         2. 免疫学
      6. Laboratory Test Results (LB)
         1. Laboratory test findings
            1. 包括
            2. hematology
            3. clinical chemistry
            4. urinalysis
            5. 不包括
            6. microbiology
            7. pharmacokinetic data
         2. var
            1. STUDYID
            2. DOMAIN
            3. USUBJID
            4. LBSEQ
            5. LBGRPID
            6. LBREFID
            7. LBSPID
            8. LBTESTCD
            9. LBTEST
            10. LBCAT
            11. LBSCAT
            12. LBORRES
            13. LBORRESU
            14. LBORNRLO
            15. original lower limit参考下限
            16. LBORNRHI
            17. original high limit参考上限
            18. LBSTRESC
            19. LBSTRESN
            20. LBSTRESU
            21. LBSTNRLO
            22. standard nr low标准下限
            23. LBSTNRHI
            24. standard nr high标准上限
            25. LBSTNRC
            26. standard range in character，例如： “-1 to +1”, “NEGATIVE TO TRACE”
            27. LBNRIND
            28. Indicator，例如 NORMAL, ABNORMAL, HIGH, LOW
            29. LBSTAT
            30. LBREASND
            31. LBNAM
            32. LBLOINC
            33. LOINC编码
            34. LBSPEC
            35. Specimen样品类型，例如：血清（SERUM）、血浆（PLASMA）、尿样（URINE）
            36. LBSPCCND
            37. Specimen Condition样本状况，例如：溶血,黄疸, 脂血
            38. LBMETHOD
            39. 方法，例如：酶免疫试验、电泳法、浸量尺
            40. LBBLFL
            41. LBFAST
            42. LBDRVFL
            43. LBTOX
            44. LBTOXGR
            45. VISITNUM
            46. VISIT
            47. VISITDY
            48. LBDTC
            49. LBENDTC
            50. LBDY
            51. LBTPT
            52. LBTPTNUM
            53. LBELTM
            54. LBTPTREF
            55. LBRFTDTC
      7. Microbiology Specimen (MB)
         1. Microbiology specimen findings, including gram stain results, and organisms found
         2. 微生物标本发现，包括革兰氏染色结果和发现的生物
      8. Microbiology Susceptibility (MS)
         1. microbiology susceptibility test results, plus results of any other organism-related tests
         2. 微生物敏感性测试结果，以及任何其他与生物有关的测试结果
      9. Microscopic Findings (MI)
         1. a record for each microscopic finding observed
      10. Morphology (MO)
          1. Macroscopic results
          2. 宏观结果，比如 size, shape, color
      11. PK Concentrations (PC)
          1. Concentrations of drugs/metabolites in fluids or tissues as a function of time.
          2. 浓度随时间变化
      12. PK Parameters (PP)
          1. Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data.
          2. PC获得的药代动力学参数
      13. Physical Examination (PE)
          1. 体检结果
          2. var
             1. STUDYID
             2. DOMAIN
             3. USUBJID
             4. PESEQ
             5. PEGRPID
             6. PESPID
             7. PETESTCD
             8. PETEST
             9. PEMODIFY
             10. PECAT
             11. PESCAT
             12. PEBODSYS
             13. PEORRES
             14. PEORRESU
             15. PESTRESC
             16. PESTAT
             17. PEREASND
             18. PELOC
             19. PEMETHOD
             20. PEEVAL
             21. VISITNUM
             22. VISIT
             23. VISITDY
             24. PEDTC
             25. PEDY
      14. Questionnaires (QS)
          1. 问卷
          2. var
             1. STUDYID
             2. DOMAIN
             3. USUBJID
             4. QSSEQ
             5. QSGRPID
             6. QSSPID
             7. QSTESTCD
             8. QSTEST
             9. QSCAT
             10. QSSCAT
             11. QSORRES
             12. QSORRESU
             13. QSSTRESC
             14. QSSTRESN
             15. QSSTRESU
             16. QSSTAT
             17. QSREASND
             18. QSBLFL
             19. QSDRVFL
             20. QSEVAL
             21. VISITNUM
             22. VISIT
             23. VISITDY
             24. QSDTC
             25. QSDY
             26. QSTPT
             27. QSTPTNUM
             28. QSELTM
             29. QSTPTREF
             30. QSRFTDTC
             31. QSEVLINT
      15. Reproductive System Findings (RP)
          1. 生殖信息
      16. Subject Characteristics (SC)
          1. data not collected in other domains that is subject-related.
          2. 未在与主题相关的其他域中收集的数据
      17. Subject Status (SS)
          1. general subject characteristics that are evaluated periodically to determine if they have changed.
          2. 定期评估以确定是否已更改
          3. var
             1. STUDYID
             2. DOMAIN
             3. USUBJID
             4. SSSEQ
             5. SSGRPID
             6. SSSPID
             7. SSTESTCD
             8. SSTEST
             9. SSCAT
             10. SSSCAT
             11. SSORRES
             12. SSSTRESC
             13. SSSTAT
             14. SSREASND
             15. SSEVAL
             16. VISITNUM
             17. VISIT
             18. VISITDY
             19. SSDTC
             20. SSDY
      18. oncology
          1. Tumor Identification (TU)
             1. data that uniquely identifies tumors
             2. 唯一标识肿瘤（即恶性肿瘤和其他疾病部位，例如淋巴结）的数据
             3. var
             4. STUDYID
             5. DOMAIN
             6. USUBJID
             7. TUSEQ
             8. TUGRPID
             9. TUREFID
             10. TUSPID
             11. TULNKID
             12. TUTESTCD
             13. TUTEST
             14. TUORRES
             15. TUSTRESC
             16. TUNAM
             17. TULOC
             18. TULAT
             19. TUDIR
             20. TUPORTOT
             21. TUMETHOD
             22. TUEVAL
             23. TUEVALID
             24. TUACPTFL
             25. VISITNUM
             26. VISIT
             27. VISITDY
             28. EPOCH
             29. TUDTC
             30. TUDY
          2. Tumor Results (TR)
             1. quantitative measurements and/or qualitative assessments of the tumors
             2. 在TU域中确定的肿瘤（即恶性肿瘤和其他疾病部位，例如淋巴结）的定量测量和/或定性评估
             3. var
             4. STUDYID
             5. DOMAIN
             6. USUBJID
             7. TRSEQ
             8. TRGRPID
             9. TRREFID
             10. TRSPID
             11. TRLNKID
             12. TRLNKGRP
             13. TRTESTCD
             14. TRTEST
             15. TRORRES
             16. TRORRESU
             17. TRSTRESC
             18. TRSTRESN
             19. TRSTRESU
             20. TRSTAT
             21. TRREASND
             22. TRNAM
             23. TRMETHOD
             24. TREVAL
             25. TREVALID
             26. TRACPTFL
             27. VISITNUM
             28. VISIT
             29. VISITDY
             30. EPOCH
             31. TRDTC
             32. TRDY
          3. Disease Response (RS)
             1. the response evaluation(s) determined from the data in TR
             2. 根据TR中的数据确定的响应评估
             3. var
             4. STUDYID
             5. DOMAIN
             6. USUBJID
             7. RSSEQ
             8. RSGRPID
             9. RSREFID
             10. RSSPID
             11. RSLNKID
             12. RSLNKGRP
             13. RSTESTCD
             14. RSTEST
             15. RSCAT
             16. RSORRES
             17. RSSTRESC
             18. RSSTAT
             19. RSREASND
             20. RSNAM
             21. RSEVAL
             22. RSEVALID
             23. RSACPTFL
             24. VISITNUM
             25. VISIT
             26. VISITDY
             27. EPOCH
             28. RSDTC
             29. RSDY
      19. Vital Signs (VS)
          1. 测量包括但不限于血压，温度，呼吸，身体表面积，BMI，身高和体重
          2. var
             1. STUDYID
             2. DOMAIN
             3. USUBJID
             4. VSSEQ
             5. VSGRPID
             6. VSSPID
             7. VSTESTCD
             8. VSTEST
             9. VSCAT
             10. VSSCAT
             11. VSPOS
             12. VSORRES
             13. VSORRESU
             14. VSSTRESC
             15. VSSTRESN
             16. VSSTRESU
             17. VSSTAT
             18. VSREASND
             19. VSLOC
             20. VSLAT
             21. VSBLFL
             22. VSDRVFL
             23. VISITNUM
             24. VISIT
             25. VISITDY
             26. VSDTC
             27. VSDY
             28. VSTPT
             29. VSTPTNUM
             30. VSELTM
             31. VSTPTREF
             32. VSRFTDTC
3. Findings About domains 发现
   1. Findings About (FA)
      1. capture the findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier
      2. 补充
   2. Skin Response (SR)