Palabras clave
LIJEKOVI, ISTRAŽIVANJE ×
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Tabla de contenido
  1. 1. Ensayo clínico
    1. 1.1. Determinación de Elegibilidad
    1. 1.2. Historial médico
    1. 1.3. Examen físico
    1. 1.4. Puntuación de evaluación
    1. 1.5. Diagnóstico aparente
    1. 1.6. Laboratorio
    1. 1.7. Patología / Histología
    1. 1.8. Consentimiento
    1. 1.9. Terapia
    1. 1.10. Informe Operativo
    1. 1.11. Acontecimiento adverso
    1. 1.12. Seguimiento
  2. 2. Documentación de rutina
  3. 3. Estudio de registro / cohorte
  4. 4. Seguro de calidad
  5. 5. Estándar de datos
  6. 6. Resultado reportado por el paciente
  7. 7. Especialidad médica
Modelos de datos seleccionados

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- 6/4/22 - 1 formulario, 16 itemgroups, 158 items, 1 idioma
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
- 17/9/21 - 1 formulario, 2 itemgroups, 12 items, 1 idioma
Itemgroups: Administrative Data, Adverse Event | Concomitant Medication | Evaluation
- 17/9/21 - 1 formulario, 8 itemgroups, 93 items, 1 idioma
Itemgroups: Administrative Data, 12-Lead ECG Abnormalities, Rhythm, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities
- 10/5/21 - 1 formulario, 17 itemgroups, 57 items, 1 idioma
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)
- 2/1/21 - 1 formulario, 33 itemgroups, 122 items, 1 idioma
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)
- 2/1/21 - 1 formulario, 21 itemgroups, 84 items, 1 idioma
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)
- 2/1/21 - 1 formulario, 16 itemgroups, 52 items, 1 idioma
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)
- 2/1/21 - 1 formulario, 20 itemgroups, 72 items, 1 idioma
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)
- 2/1/21 - 1 formulario, 21 itemgroups, 84 items, 1 idioma
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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