Clinical Trial ×
Adverse event ×
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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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- 11/6/19 - 1 form, 10 itemgroups, 61 items, 1 language
Itemgroups: Serious Adverse Event Report, Type, Serious Adverse Event, Randomization, Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Disease, Risk factor, Serious Adverse Event, Diagnostic procedure, Result, Serious Adverse Event, Experimental drug, Serious Adverse Event, Comment, Serious Adverse Event, Nonclinical Overview
- 10/30/19 - 1 form, 19 itemgroups, 82 items, 1 language
Itemgroups: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Results, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, PK Sampling - Plasma Samples, Study Treatment Compliance (Return) , New Adverse Events and Concomitant Treatment