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Tabla de contenido
  1. 1. Ensayo clínico
  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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- 29/10/20 - 1 formulario, 43 itemgroups, 93 items, 1 idioma
Itemgroups: Administrative, Check for Study Continuation (Visit 1), Check for Study Continuation (Visit 2) , Check for Study Continuation (Visit 3) , Check for Study Continuation (Visit 4), Check for Study Continuation (Visit 5) , Check for Study Continuation (Visit 6) , Check for Study Continuation (Visit 7) , Check for Study Continuation (Visit 8) , Check for Study Continuation (Visit 9) , Check for Study Continuation (Visit 10) , Check for Study Continuation (Visit 11) , Check for Study Continuation (Visit 12) , Check for Study Continuation (Visit 13), Check for Study Continuation (Visit 14), Check for Study Continuation (Visit 15) , Check for Study Continuation (Visit 16) , Check for Study Continuation (Visit 17) , Check for Study Continuation (Visit 18) , Check for Study Continuation (Visit 19) , Check for Study Continuation (Visit 20) , Check for Study Continuation (Visit 21) , Check for Study Continuation (Visit 22), Check for Study Continuation (Visit 23) , Check for Study Continuation (Visit 24) , Check for Study Continuation (Visit 25), Check for Study Continuation (Visit 26), Check for Study Continuation (Visit 27), Check for Study Continuation (Visit 28) , Check for Study Continuation (Follow-Up) , Physical Examination (Visit 1), Physical Examination (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 28), Physical Examination (Follow-Up) , Weight (Visit 1 - 6, 8 - 13, 15 - 18, 20 - 28, Follow-Up), Laboratory Tests (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28), Haematology (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28), Hepatic Function (Visit 1, 3, 6, 8, 10, 14 -18, 21, 23 - 28), Biochemistry (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28), Renal Function (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28), Humoral Immunity (Serum) (Visit 1, 3, 7, 14, 19, 21, 23 - 28, Follow-Up), Cellular Immunity (PBMC) (Visit 1, 7, 14, 19, 21, 23 - 26, 28, Follow-Up), HCG Urine or Blood Pregnancy Test (Visit 7, 11, 15, 17, 20 - 27), End of follow-up
- 3/9/20 - 1 formulario, 3 itemgroups, 46 items, 1 idioma
Itemgroups: Administrative Data, Vital Signs, Pre-treatment physical exam
Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Post-Treatment Physical Exam Form is used to record the physical examination prior to initiation of treatment. For patients receiving Argatroban for no more than 14 days, complete within 24 hours of final infusion completion. For patients receiving Argatroban for more than 14 days [continuing with non-study Argatroban], complete within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.
- 3/9/20 - 1 formulario, 3 itemgroups, 46 items, 1 idioma
Itemgroups: Administrative Data, Vital Signs, Pre-treatment physical exam

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