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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- 4/6/22 - 1 form, 16 itemgroups, 158 items, 1 language
Itemgroups: Administrative,Vital Signs,12-Lead ECG,Laboratory Results Data (Haematology) - Pre-Dose,Laboratory Results Data (Clinical Chemistry) - Pre-Dose,Urinalysis - Pre-Dose,Randomisation Number,Investigational Product,Treatment Confirmation,PET Scan (2),fMRI Scan - Post-PET Scan,PET Scan (3),Pharmacokinetics - Blood,Laboratory Results Data (Haematology) - 24hrs Post-Dose,Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose,Urinalysis - 24hrs Post-Dose
- 9/17/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Administrative Data,Adverse Event | Concomitant Medication | Evaluation
- 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)

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