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  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
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LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 6/28/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration,LASER ADMINISTRATION STUDY EYE
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 #: FVF4168g 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

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

- 6/11/17 - 1 form, 3 itemgroups, 12 items, 1 language
Itemgroups: Patient administration,CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12),Procedure
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

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 6/8/17 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Patient administration,SUBJECT ELIGIBILITY,Eligibility Criteria Not Met
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

SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4170G Macular Edema NCT00473382

- 9/20/21 - 1 form, 7 itemgroups, 40 items, 1 language
Itemgroups: Patient administration,SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36),Adverse Event,Serious AE,Relevant Diagnostic Tests Performed,Tests,Additional Case Details:
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

SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330

- 9/20/21 - 1 form, 7 itemgroups, 40 items, 1 language
Itemgroups: Patient administration,SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36),Adverse Event,Serious AE,Relevant Diagnostic Tests Performed,Tests,Additional Case Details:
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 #: FVF4168g 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

Eligibility NCT01319487 Diabetic Macular Edema - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 29 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01319487

Demographics Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4168g - Demographics Screening

- 9/17/21 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Demography
Study part: Demographics Screening . 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.

Demographics Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Demographics Screening

- 9/17/21 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Demography
Study part: Demographics Screening . 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.

Demographics Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Demographics Screening

- 9/17/21 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Demography
Study part: Demographics Screening . A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Physical Exam Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Physical Exam Screening

- 3/21/18 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Physical examination
Study part: Physical Exam Screening. 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.

Slitlamp Examination Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Slitlamp Examination Screening

- 3/21/18 - 1 form, 4 itemgroups, 48 items, 1 language
Itemgroups: Slitlamp Examination Right Eye,Slitlamp Examination Left Eye ,Findings of Inflammation right eye,Findings of Inflammation left eye
Study part: Slitlamp Examination Screening. 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.

Intraocular Pressure Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Intraocular Pressure Screening

- 3/21/18 - 1 form, 1 itemgroup, 9 items, 1 language
Itemgroup: Intraocular Pressure
Study part: Intraocular Pressure Screening. 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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