ClinEDC
ClinDM介绍
法规指南
GCP
药物GCP
医疗器械GCP
ICH GCP
ISO 14155
数据管理
数管理法规
GCDMP
21CRF Part11
SDTMIG V3.2
Trial Design Domains
Trial Arms (TA)
Trial Elements (TE)
Trial Visits (TV)
Trial Inclusion/Exclusion Criteria (TI)
Trial Disease Assessment (TD)
Trial Summary (TS)
Special-Purpose Domains
Demographics (DM)
Comments (CO)
Subject Visits (SV)
Subject Elements (SE)
Interventions General Observation
Concomitant Medications (CM)
Exposure as Collected (EC)
Exposure (EX)
Substance Use (SU)
Procedures (PR)
Events General Observation
Adverse Events (AE)
Clinical Events (CE)
Disposition (DS)
Protocol Deviations (DV)
Healthcare Encounters (HO)
Medical History (MH)
Findings General Observation
Drug Accountability (DA)
Death Details (DD)
ECG Test Results (EG)
Inclusion/Exclusion Criterion Not Met (IE)
Immunogenicity Specimen Assessments (IS)
Laboratory Test Results (LB)
Microbiology Specimen (MB)
Microscopic Findings (MI)
Morphology (MO)
Microbiology Susceptibility Test (MS)
PK Concentrations (PC)
PK Parameters (PP)
Physical Examination (PE)
Questionnaires (QS)
Reproductive System Findings (RP)
Disease Response (RS)
Subject Characteristics (SC)
Subject Status (SS)
Tumor Identification (TU)
Tumor Results (TR)
Vital Signs (VS)
Findings About
Findings About (FA)
Skin Response (SR)
Relationship Datasets
Supplemental Qualifiers (SUPP-- datasets)
Related Records (RELREC)
SDTMIG V3.3 (New*)
Trial Design Domains
Trial Arms (TA)
Trial Elements (TE)
Trial Visits (TV)
Trial Inclusion/Exclusion Criteria (TI)
Trial Disease Assessment (TD)
Trial Disease Milestones (TM)
Trial Summary (TS)
Special-Purpose Domains
Demographics (DM)
Comments (CO)
Subject Visits (SV)
Subject Elements (SE)
Subject Disease Milestones (SM)
Interventions General Observation
Procedure Agents (AG)
Concomitant Medications (CM)
Exposure as Collected (EC)
Exposure (EX)
Meal Data (ML)
Substance Use (SU)
Procedures (PR)
Events General Observation
Adverse Events (AE)
Clinical Events (CE)
Disposition (DS)
Protocol Deviations (DV)
Healthcare Encounters (HO)
Medical History (MH)
Findings General Observation
Drug Accountability (DA)
Death Details (DD)
ECG Test Results (EG)
Functional Tests (FT)
Inclusion/Exclusion Criterion Not Met (IE)
Immunogenicity Specimen Assessments (IS)
Laboratory Test Results (LB)
Microbiology Specimen (MB)
Microscopic Findings (MI)
Musculoskeletal System Findings (MK)
Morphology (MO)
Microbiology Susceptibility Test (MS)
Nervous System Findings (NV)
Ophthalmic Examinations (OE)
PK Concentrations (PC)
PK Parameters (PP)
Physical Examination (PE)
Questionnaires (QS)
Respiratory System Findings (RE)
Reproductive System Findings (RP)
Disease Response (RS)
Subject Characteristics (SC)
Subject Status (SS)
Tumor Identification (TU)
Tumor Results (TR)
Vital Signs (VS)
Findings About
Findings About (FA)
Skin Response (SR)
Relationship Datasets
Related Records
Related Subjects
Supplemental Qualifiers (SUPP-- datasets)
SDTMIG-MD V1.0
DEVICE IDENTIFIERS
DEVICE IN-USE
DEVICE EXPOSURE
DEVICE EVENTS
DEVICE TRACKING AND DISPOSITION
DEVICE-SUBJECT RELATIONSHIPS
DEVICE PROPERTIES
SDTMIG-MD V1.1 (New*)
DEVICE IDENTIFIERS
DEVICE IN-USE
DEVICE EXPOSURE
DEVICE EVENTS
DEVICE TRACKING AND DISPOSITION
DEVICE-SUBJECT RELATIONSHIPS
DEVICE PROPERTIES
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Data Management, EDC, CDASH, SDTM, ADaM