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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
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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

12- Lead ECG, Telemetry, Holter Monitoring Pazopanib Macular Degeneration MD1103367 - 12- Lead ECG, Telemetry, Holter Monitoring

- 9/27/21 - 1 form, 3 itemgroups, 18 items, 1 language
Itemgroups: 12 Lead ECG, Telemetry, 24 Hour Holter Monitoring
Study part: 12- Lead ECG, Telemetry, Holter Monitoring. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Pharmacodynamics Day 1 Pazopanib Macular Degeneration MD1103367 - Pharmacodynamics Day 1

- 9/27/21 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: pharmacodynamics predose
Study part: Pharmacodynamics Day 1. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Pharmacokinetics Pazopanib Macular Degeneration MD1103367 - Pharmacokinetics

- 9/27/21 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Pharmacokinetics blood, Pharmacokinetics urine
Study part: Pharmacokinetics. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Pharmacokinetics Blood GW786034 (PK) Pazopanib Macular Degeneration MD1103367 - Pharmacokinetics Blood GW786034 (PK)

- 9/27/21 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: Pharmacokinetics blood
Study part: Pharmacokinetics Blood GW786034 (PK). A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Demographics Screening rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2587g - Demographics Screening

- 9/20/21 - 1 form, 1 itemgroup, 6 items, 1 language
Itemgroup: Demography
Study part: Demographics Screening . A Phase III, Multicenter, Randomized, Double-Masked, Active Treatment-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne®) Photodynamic Therapy In Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration.

Administrative Data Pazopanib Macular Degeneration MD1103367 - Administrative Data

- 9/20/21 - 1 form, 4 itemgroups, 8 items, 1 language
Itemgroups: screening, enrolment, visit date, Demography
Study part: Administrative Data. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Vital Signs (VS) Screening Pazopanib Macular Degeneration MD1103367 - Vital Signs (VS) Screening

- 9/20/21 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: vital sign measurement supine, Vital signs measurements
Study part: Vital Signs (VS) Screening. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

ICHOM Cataracts - Pre- and intraoperative Clinical Form

- 9/20/21 - 1 form, 8 itemgroups, 33 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Baseline visual status, Ocular Comorbidities, Prior ophthalmic interventions, Technical Factors, Treatment Variables, Intra-operative Complications
CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. by Mats Lundström et al. This ODM-file contains the pre-operative and intra-operative clinical Form. The items are to be filled in with clinical or administrative data, collected pre- or intraoperatively. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

MARS - Muenster Aging and Retina study Age-related macular degeneration - Administrative documentation

- 9/20/21 - 17 forms, 1 itemgroup, 16 items, 1 language
Itemgroup: Administrative documentation
Age-related macular degeneration (AMD) is a retinal degenerative disease that occurs at an advanced age and is the major cause of central visual acuity loss and old-age blindness in its final stages. The aim of the MARS study is to identify factors that influence the progression and course of age-related macular degeneration in a prospective study. To date, the following studies have been carried out on the MARS cohort: MARS-I: 2001-2003; MARS-II: 2004 - 2007; MARS-III: 2007-2009; MARS +: 2010/11. The study is provided by Prof. Dr. Hense, Institute of Epidemiology and Social medicine, University Clinic of Muenster.

A. Self-assessment of visual acuity

1 itemgroup 9 items

Interview

1 itemgroup 5 items

B. Eye diseases

1 itemgroup 83 items

D. Slit lamp biomicroscopy I

1 itemgroup 18 items

H.Quality of Life

1 itemgroup 24 items

I. Family History

1 itemgroup 21 items

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