Keywords
Pharmacokinetics ×
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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
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
Selected data models

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- 2/15/21 - 1 form, 21 itemgroups, 47 items, 1 language
Itemgroups: Administrative, Pharmacokinetics - Blood Sample (Odd Numbered Subjects) (Day 7), Pharmacokinetics - Blood Sample (Even Numbered Subjects) (Day 7) , Pharmacodynamics - Blood Sample (Day 7), Pharmacodynamics Urine Cortisol (Day 7 - Post-Dose), Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose), Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose) , Local Laboratory - Haematology (Day 7 - Pre-Dose), Local Laboratory - Haematology (Day 7 - Pre-Dose) , Urinalysis - Local (Day 7 - Pre-Dose), Urinalysis - Local (Day 7 - Pre-Dose) , Urinalysis - Microscopy (Day 7 - Pre-Dose) , Urinalysis - Microscopy (Day 7 - Pre-Dose) , Clinical Chemistry (Day 7 - Post-Dose) , Local Laboratory - Clinical Chemistry (Day 7 - Post-Dose) , Local Laboratory - Haematology (Day 7 - Post-Dose) , Local Laboratory - Haematology (Day 7 - Post-Dose), Urinalysis - Local (Day 7 - Post-Dose) , Urinalysis - Local (Day 7 - Post-Dose), Urinalysis - Microscopy (Day 7 - Post-Dose), Urinalysis - Microscopy (Day 7 - Post-Dose)
- 11/23/18 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Pharmacokinetic Blood Sampling, lnvestigational Product, lnvestigational Product Administration Worksheet
- 5/1/19 - 1 form, 16 itemgroups, 137 items, 1 language
Itemgroups: Logs ad Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Electronically Transferred Lab Data, Vital signs, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GW856553
- 4/23/19 - 1 form, 17 itemgroups, 106 items, 1 language
Itemgroups: Randomisation Number, 12 Lead ECG - Dosing Date and Time, 12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart, 12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart , 12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart , 12-Lead ECG - 30 mins, 12-Lead ECG - 1 hr, 12-Lead ECG - 24 hr , Vital Signs, Vital Signs - Pre dose, Vital Signs - 30 mins, Vital Signs - 24 hrs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product

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