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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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- 2015-11-02 - 1 Formulär, 5 Item-grupper, 16 Dataelement, 19 Språk
Item-grupper: Identity, Diagnosis, Therapy, Study, Follow-up
- 2019-10-17 - 1 Formulär, 16 Item-grupper, 83 Dataelement, 1 Språk
Item-grupper: Administration, Follow-up studies, Study conclusion, Investigator signature, Tracking Document Safety Follow-Up, Tracking Document Safety Follow-Up , Serious adverse event safety follow-up - Administrative, Serious adverse event safety follow-up, Serious adverse event safety follow-up - Study vaccine information, Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE, Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE , Serious adverse event safety follow-up - Drug(s) used to treat this SAE , Serious adverse event safety follow-up - Surgical treatment for this SAE , Serious adverse event safety follow-up - Description , Serious adverse event safety follow-up - Comments , Serious adverse event safety follow-up - Investigator signature