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Innehållsförteckning
  1. 1. Klinisk studie
  2. 2. Rutindokumentation
  3. 3. Register- och kohortstudier
  4. 4. Kvalitetssäkring
  5. 5. Datastandard
  6. 6. Frågeformulär för patienter
  7. 7. Medicinsk specialitet
Valda datamodeller

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- 2019-08-14 - 1 Formulär, 12 Item-grupper, 46 Dataelement, 1 Språk
Item-grupper: Date of Visit/ Assessment , Randomisation, 12-Lead ECG, 12-Lead ECG Abnormalities, Vital Signs, Investigational Product, Treatment Confirmation, Electronically Transferred Lab Data , Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time, Pharmacokinetics Blood Pre-36h (Lamotrigine), Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time, Pharmacokinetics Blood 48h - 144h (Lamotrigine)
- 2019-08-04 - 1 Formulär, 31 Item-grupper, 176 Dataelement, 1 Språk
Item-grupper: Date of Visit, Investigational Product, 12-Lead ECG Dosing date/time, 12-Lead ECG - Predose, 12-Lead ECG - 1 Hour, 12-Lead ECG - 2 Hour , 12-Lead ECG - 3 Hour, 12-Lead ECG - 5 Hour , 12-Lead ECG - 8 Hour, 12-Lead ECG - 24 Hour , 12-Lead ECG - 36 Hour, 12-Lead ECG - 48 Hour , 12-Lead ECG - Extra Scheduled Assessments Entry, Vital Signs Predose - Semi-Supine, Vital Signs - Dosing Date and Time, Vital Signs Pre-dose - Standing, Vital Signs 1 Hour - Semi-supine, Vital Signs 1 Hour - Standing , Vital Signs 2 Hour - Semi-supine , Vital Signs 2 Hour - Standing , Vital Signs 5 Hour - Semi-supine, Vital Signs 5 Hour - Standing , Vital Signs 8 Hour - Semi-supine, Vital Signs 8 Hour - Standing , Vital Signs 24 Hour - Semi-supine , Vital Signs 24 Hour - Standing, Vital Signs 36 Hour - Semi-supine, Vital Signs 36 Hour - Standing, Vital Signs 48 Hour - Semi-supine, Vital Signs 48 Hour - Standing , Vital Signs - Extra Scheduled Assessments Entry
- 2019-07-20 - 1 Formulär, 6 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: Administrative Data, Administration, Administration post interruption, Investigational Product Container Number, Treatment Confirmation, Randomisation Number
- 2019-06-11 - 1 Formulär, 16 Item-grupper, 158 Dataelement, 1 Språk
Item-grupper: 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
- 2019-05-22 - 1 Formulär, 13 Item-grupper, 188 Dataelement, 1 Språk
Item-grupper: Date of visit/ assessment, Vital Signs, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Liver Assessment, Local Laboratory - Thyroid Function, Local Laboratory - Urinalysis, Urinalysis - Local: 24 hour Protein Details, Target Lesion Summary, Confirmatory Response - Response Summary, Confirmatory Response - New Lesions, Investigatoinal Product Compliance - Pazopanib, 12-Lead ECG
- 2019-05-22 - 1 Formulär, 12 Item-grupper, 182 Dataelement, 1 Språk
Item-grupper: Date of visit/ assessment, Vital Signs, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Liver Assessment, Local Laboratory - Thyroid Function , Local Laboratory - Urinalysis, Urinalysis - Local: 24 hour Protein Details, Investigatoinal Product Compliance - Pazopanib, Target Lesion Summary, Confirmatory Response - Response Summary, Confirmatory Response - New Lesions
- 2019-05-22 - 1 Formulär, 13 Item-grupper, 188 Dataelement, 1 Språk
Item-grupper: Date of visit/ assessment, Vital Signs, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Liver Assessment, Local Laboratory - Thyroid Function, Local Laboratory - Urinalysis, Urinalysis - Local: 24 hour Protein Details, Target Lesion Summary, Confirmatory Response - Response Summary, Confirmatory Response - New Lesions, Investigatoinal Product Compliance - Pazopanib, 12-Lead ECG