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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
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ATC A - Alimentary Tract and Metabolism

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: Alimentary Tract and Metabolism
modified from epSOS value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 http://www.epsos.eu http://www.whocc.no/atc_ddd_index/ WHO Collaborating Centre for Drug Statistics Methodology, ATC classification index with DDDs 2015. Oslo, Norway 2014 Copyright ATC index: WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway Copying and distribution for commercial purposes is not allowed. German ATC Codes: Datenquelle des amtlichen ATC-Index mit DDD-Angaben: GKV-Arzneimittelindex im Wissenschaftlichen Institut der AOK (WIdO), AOK Bundesverband GbR Stand September 2015. Nur nicht-kommerzielle Nutzung zulässig

POST-TREATMENT COUNT FINGERS (MONTH 23) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 23)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 20) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 20)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 19) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 19)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 22) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 22)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 24) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 24)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 18) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 18)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 17) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 17)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 21) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 21)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 15) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 15)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 16) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 16)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

POST-TREATMENT COUNT FINGERS (MONTH 14) CRFs Roche FVF4170G Macular Edema NCT00473382

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, POST-TREATMENT COUNT FINGERS (MONTH 14)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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