Keywords
Drugs, Investigational ×
Show more Keywords
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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- 5/10/21 - 1 form, 17 itemgroups, 57 items, 1 language
Itemgroups: Administrative, Date of Visit/ Assessment, Randomisation (only Session 1), Vital Signs, Sitting Vital Signs - Predose, Orthostatic Vital Signs - Predose (Reading 1) - Supine for 5 mins, Orthostatic Vital Signs - Predose (Reading 2) - Sitting for 2 mins , Orthostatic Vital Signs - Predose (Reading 3) - Standing for 3 mins , Orthostatic Vital Signs - Post Dose - Sitting, Orthostatic Vital Signs - 10 Hours (Reading 1) - Supine for 5 mins, Orthostatic Vital Signs - 10 Hours (Reading 2) - Sitting for 2 mins , Orthostatic Vital Signs - 10 Hours (Reading 3) - Standing for 3 mins , Pharmacokinetics Blood - Dosing Date and Time, Pharmacokinetics Blood, Investigational Product, Treatment Confirmation, 12-Lead ECG (only Session 4)
- 1/2/21 - 1 form, 33 itemgroups, 122 items, 1 language
Itemgroups: Date of visit, Investigational Product (Dose) (Part 2 Period 2), ECG, ECG - Day 2 Dose (Part 2 Period 2), ECG - Day 2 Dose (Part 2 Period 2, ECG - Day 3 Dose (Part 2 Period 2), ECG - Day 3 Dose (Part 2 Period 2), ECG - Day 4 Dose (Part 2 Period 2), ECG - Day 4 Dose (Part 2 Period 2), ECG - Day 5 Dose (Part 2 Period 2), ECG - Day 5 Dose (Part 2 Period 2), ECG - Day 6 Dose (Part 2 Period 2), ECG - Day 6 Dose (Part 2 Period 2), Vital Signs - Day 2 Dose (Part 2 Period 2), Vital Signs - Day 2 Dose (Part 2 Period 2), Vital Signs - Day 3 Dose (Part 2 Period 2), Vital Signs - Day 3 Dose (Part 2 Period 2), Vital Signs - Day 4 Dose (Part 2 Period 2), Vital Signs - Day 4 Dose (Part 2 Period 2), Vital Signs - Day 5 Dose (Part 2 Period 2), Vital Signs - Day 5 Dose (Part 2 Period 2), Vital Signs - Day 6 Dose (Part 2 Period 2), Vital Signs - Day 6 Dose (Part 2 Period 2), Pulmonary Function Tests - Day 2 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Part 2 Period 2), Pulmonary Function Tests - Day 3 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 2), Pulmonary Function Tests - Day 4 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Part 2 Period 2), Pulmonary Function Tests - Day 5 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 2), Pulmonary Function Tests - Day 6 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Part 2 Period 2)
- 1/2/21 - 1 form, 16 itemgroups, 52 items, 1 language
Itemgroups: Date of visit, Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Investigational Product (Dose) (Part 2 Period 4), ECG (Part 2 Period 4), ECG (Part 2 Period 4), Vital Signs (Part 2 Period 4), Vital Signs (Part 2 Period 4), Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4), Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4)
- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: Date of Visit, Local Laboratory - Haematology (Period 1), Local Laboratory - Haematology (Period 1), Local Laboratory - Clinical Chemistry (Period 1), Local Laboratory - Clinical Chemistry (Period 1), Investigational Product (Dose) (Period 1), ECG (Period 1), Vital Signs (Period 1), Local Laboratory - Haematology (24Hr Lab) (Period 1), Local Laboratory - Haematology (24 Hr Lab) (Period 1), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1), Pharmacokinetics Blood (Period 1), Pharmacokinetics Blood (Period 1), Pharmacokinetics Urine (Period 1), Pharmacokinetics Urine (Period 1), Summary Holter (Period 1), Summary Holter (Period 1) (Pre-Dose - 24 hours), Holter Abnormalities (Period 1), Holter Abnormalities (Period 1), Pulmonary Function Tests (Period 1)
- 1/2/21 - 1 form, 20 itemgroups, 72 items, 1 language
Itemgroups: Date of visit, Investigational Product (Dose) (Part 2 Period 2), ECG (Part 2 Period 2), ECG (Part 2 Period 2), Vital Signs (Part 2 Period 2), Vital Signs (Part 2 Period 2), Pulmonary Function Tests (Part 2 Period 2), Pulmonary Function Tests (Part 2 Period 2), Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 2), Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 2), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 2), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 2), Pharmacokinetics Blood (Part 2 Period 2), Pharmacokinetics Blood (Part 2 Period 2), Pharmacokinetics Urine (Part 2 Period 2), Pharmacokinetics Urine (Part 2 Period 2), Summary Holter (Part 2 Period 2), Summary Holter (Part 2 Period 2) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 2), Holter Abnormalities (Part 2 Period 2)
- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: Date of Visit, Local Laboratory - Haematology (Period 3), Local Laboratory - Haematology (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Investigational Product (Dose) (Period 3), ECG (Period 3), Vital Signs (Period 3), Local Laboratory - Haematology (24Hr Lab) (Period 3), Local Laboratory - Haematology (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Urine (Period 3), Pharmacokinetics Urine (Period 3), Summary Holter (Period 3), Summary Holter (Period 3) (Pre-Dose - 24 hours), Holter Abnormalities (Period 3), Holter Abnormalities (Period 3), Pulmonary Function Tests (Period 3)
- 1/2/21 - 1 form, 16 itemgroups, 52 items, 1 language
Itemgroups: Date of visit, Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Investigational Product (Dose) (Part 2 Period 4), ECG (Part 2 Period 4), ECG (Part 2 Period 4), Vital Signs (Part 2 Period 4), Vital Signs (Part 2 Period 4), Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4), Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4)
- 1/2/21 - 1 form, 33 itemgroups, 122 items, 1 language
Itemgroups: Date of visit, Investigational Product (Dose) (Part 2 Period 4), ECG, ECG - Day 2 Dose (Part 2 Period 4), ECG - Day 2 Dose (Part 2 Period 4), ECG - Day 3 Dose (Part 2 Period 4), ECG - Day 3 Dose (Part 2 Period 4), ECG - Day 4 Dose (Part 2 Period 4), ECG - Day 4 Dose (Part 2 Period 4), ECG - Day 5 Dose (Part 2 Period 4), ECG - Day 5 Dose (Part 2 Period 4), ECG - Day 6 Dose (Part 2 Period 4), ECG - Day 6 Dose (Part 2 Period 4), Vital Signs - Day 2 Dose (Part 2 Period 4), Vital Signs - Day 2 Dose (Part 2 Period 4), Vital Signs - Day 3 Dose (Part 2 Period 4), Vital Signs - Day 3 Dose (Part 2 Period 4), Vital Signs - Day 4 Dose (Part 2 Period 4), Vital Signs - Day 4 Dose (Part 2 Period 4), Vital Signs - Day 5 Dose (Part 2 Period 4), Vital Signs - Day 5 Dose (Part 2 Period 4), Vital Signs - Day 6 Dose (Part 2 Period 4), Vital Signs - Day 6 Dose (Part 2 Period 4), Pulmonary Function Tests - Day 2 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Part 2 Period 4), Pulmonary Function Tests - Day 3 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 4), Pulmonary Function Tests - Day 4 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Part 2 Period 4), Pulmonary Function Tests - Day 5 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 4), Pulmonary Function Tests - Day 6 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Part 2 Period 4)
- 1/2/21 - 1 form, 20 itemgroups, 72 items, 1 language
Itemgroups: Date of visit, Investigational Product (Dose) (Part 2 Period 4) , Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , ECG (Part 2 Period 4) , ECG (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Summary Holter (Part 2 Period 4) , Summary Holter (Part 2 Period 4) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 4) , Holter Abnormalities (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4)
- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: Date of Visit, Local Laboratory - Haematology (Period 3), Local Laboratory - Haematology (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Investigational Product (Dose) (Period 3), ECG (Period 3), Vital Signs (Period 3), Local Laboratory - Haematology (24Hr Lab) (Period 3), Local Laboratory - Haematology (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Urine (Period 3), Pharmacokinetics Urine (Period 3), Summary Holter (Period 3), Summary Holter (Period 3) (Pre-Dose - 24 hours), Holter Abnormalities (Period 3), Holter Abnormalities (Period 3), Pulmonary Function Tests (Period 3)