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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
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- 2019-06-20 - 1 Formulär, 19 Item-grupper, 70 Dataelement, 1 Språk
Item-grupper: Administrative, Concomitant Medications, Concomitant Medications, Non-Serious Adverse Events, Non-Serious Adverse Events , Serious Adverse Event, Serious Adverse Event - Section 1, Serious Adverse Event - Section 2 Seriousness, Serious Adverse Event - Section 3 Demography Data, Serious Adverse Event - Section 4, Serious Adverse Event - Section 5, Serious Adverse Event - Section 6 Medical Conditions, Serious Adverse Event - Section 7, Serious Adverse Event - Section 8 Relevant Concomitant Medication, Serious Adverse Event - Section 9, Was treatment blind broken at investigational site?, Serious Adverse Event - Section 10, Serious Adverse Event - Section 11, Serious Adverse Event - lnvestigator's signature
- 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