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Table of contents
  1. 1. Estudo clínico
  2. 2. Documentação de rotina
  3. 3. Estudos de registo/coortes
  4. 4. Garantia da qualidade
  5. 5. Padrão de dados
  6. 6. Questionário do paciente
  7. 7. Especialidade médica
    1. 7.1. Anestesia
    1. 7.2. Dermatologia
    1. 7.3. Otorrinolaringologia
    1. 7.4. Geriatria
    1. 7.5. Ginecologia/obstetrícia
    1. 7.6. Medicina interna
      1. Hematologia
      1. Infecciologia
      1. Cardiologia/angiologia
      1. Pneumologia
      1. Gastroenterologia
      1. Nefrologia
      1. Endocrinologia/metabolismo
      1. Reumatologia
    1. 7.7. Neurologia
    1. 7.8. Oftalmologia
    1. 7.9. Medicina paliativa
    1. 7.10. Patologia/medicina Legal
    1. 7.11. Pediatria
    1. 7.12. Psiquiatria/psicossomática
    1. 7.13. Radiologia
    1. 7.14. Cirurgia
      1. Cirurgia geral/abdominal
      1. Neurocirurgia
      1. Cirurgia plástica
      1. Cirurgia cardíaca/torácica
      1. Cirurgia de trauma/ortopedia
      1. Cirurgia vascular
    1. 7.15. Urologia
    1. 7.16. Odontologia/cirurgia bucomaxilofacial
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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Adverse Event and Concomitant Medication Questions

- 11/01/2019 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Administrative data, Date of Visit/Assessment, Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Pharmacokinetics RPT

- 11/01/2019 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: Administrative data, PK RPT Data
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Follow-Up: Pregnancy Information

- 11/01/2019 - 1 form, 3 itemgroups, 6 items, 1 language
Itemgroups: Administrative data, Pregnancy Information, Pregnancy Information Part 2
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Follow-Up: Study Conclusion

- 11/01/2019 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Administrative data, Study Conclusion Data
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 4: 12-lead ECG Form

- 09/01/2019 - 1 form, 3 itemgroups, 12 items, 1 language
Itemgroups: Administrative data, Dosing date and time, 12- Lead ECG
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 4: Vital Signs Form

- 09/01/2019 - 1 form, 23 itemgroups, 89 items, 1 language
Itemgroups: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 4: Pharmacokinetics Blood

- 09/01/2019 - 1 form, 20 itemgroups, 28 items, 1 language
Itemgroups: Administrative data, Dosing Date and Time, Predose, 30 Minutes, 45 Minutes, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 5 Hours, 6 Hours, 7 Hours, 8 Hours, 10 Hours, 12 Hours, 18 Hours, 24 Hours, 32 Hours, 48 Hours
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 4: Treatment Confirmation

- 09/01/2019 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Administrative data, Treatment Confirmation
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Pharmacogenetics Research Consent Withdrawal

- 11/01/2019 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Administrative data, Date of Visit/Assessment, PGx Research Withdrawal of Consent
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: 12-lead ECG Abnormalities

- 11/01/2019 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative data, 12-lead ECG Abnormalities, Record clinically significant abnormalities below. Check all that apply:
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Concomitant Medications

- 11/01/2019 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Concomitant Medications
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: 12-lead ECG Form

- 09/11/2018 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Administrative data, 12-lead/Holter/Telemetry ECG
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

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