Keywords
Case Reports ×
Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

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- 4/8/17 - 1 form, 9 itemgroups, 42 items, 1 language
Itemgroups: Subject information, Date of assessment, Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?, Liver events, Alcohol intake, Liver disease medical conditions, Drug related liver disease conditions (All drugs including Investigational Product), Other liver disease conditions, Other medical conditions
- 3/13/17 - 1 form, 13 itemgroups, 46 items, 1 language
Itemgroups: General Information, Section 1, Section 2 Seriousness, Section 3 Demography Data, Section 4, Section 5, Section 6 Relevant Medical Conditions, Section 7 Other RELEVANT Risk Factors, Section 8 RELEVANT Concomitant Medications, Section 9 Details of Investigation Product(s), Section 10 Details of RELEVANT Assessments, Section 11 Narrative Remarks, Investigator's signature