Keywords
Pulmonary Medicine ×
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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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- 8/12/20 - 1 form, 10 itemgroups, 20 items, 1 language
Itemgroups: Administrative, Laboratory Result data (Haematology) - 12 Hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5), Haematology Test (Treatment Period 1, 2, 3, 4, 5), Urinalysis - 12 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5), Urinalysis (Dipstick) Test - 12 hrs (Treatment Period 1, 2, 3, 4, 5), Laboratory Result Data (Haematology) - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5), Haematology Test - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5) , Urinalysis - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5) , Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5) , Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
- 8/9/20 - 1 form, 14 itemgroups, 79 items, 1 language
Itemgroups: Administrative, Randomisation Number (Treatment Period 1), Investigational Product, Treatment Confirmation, Pharmacokinetics - Blood (Treatment Period 1), Pharmacokinetics - Blood (Treatment Period 2) , Pharmacokinetics - Blood (Treatment Period 3) , Pharmacokinetics - Blood (Treatment Period 4) , Pharmacokinetics - Blood (Treatment Period 5) , Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1), Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2) , Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3), Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4) , Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)
- 7/29/20 - 1 form, 16 itemgroups, 59 items, 1 language
Itemgroups: Administrative, Non-serious Adverse Events (AE), Non-serious Adverse Events (AE) , Serious Adverse Event (SAE), Serious Adverse Event (SAE) - Section 1, Serious Adverse Event (SAE) - Section 2 Seriousness, Serious Adverse Event (SAE) - Section 3 Demography Data, Serious Adverse Event (SAE) - Section 4, Serious Adverse Event (SAE) - Section 5 , Serious Adverse Event (SAE) - Section 6 Relevant Medical Conditions, Serious Adverse Event (SAE) - Section 7 Other relevant risk factors, Serious Adverse Event (SAE) - Section 8 Concomitant medications , Serious Adverse Event (SAE) - Section 9 Details of investigational product(s), Serious Adverse Event (SAE) - Section 10, Serious Adverse Event (SAE) - Section 11 Narrative remarks, Investigator's signature
- 7/25/20 - 1 form, 7 itemgroups, 32 items, 1 language
Itemgroups: Administrative, Pulmonary Function Tests, Pulmonary Function Tests - Investigator Calculation, Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide), Ipratropium Bromide Administration, Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide), Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Investigator Calculation