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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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Multiple sclerosis studies NCT02461069 NCT02419378 - Baseline: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 9/20/21 - 18 forms, 1 itemgroup, 15 items, 1 language
Itemgroup: MRI
Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

Screening: MRI Multiple Sclerosis ALAIN01 NCT02419378

1 itemgroup 16 items

Baseline: Repitition of Assessments: MRI Multiple Sclerosis ALAIN01 NCT02419378

1 itemgroup 15 items

Baseline 1st cycle Trial Medication Multiple Sclerosis ALAIN01 NCT02419378

2 itemgroups 16 items

Baseline: CSF Multiple Sclerosis ALAIN01 NCT02419378

1 itemgroup 32 items

Discontinue Trial Medication Multiple Sclerosis ALAIN01 NCT02419378

- 5/28/16 - 1 form, 1 itemgroup, 6 items, 1 language
Itemgroup: Discontinue Trial Medication
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany

Baseline 1st cycle Trial Medication Multiple Sclerosis ALAIN01 NCT02419378

- 6/6/16 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Medication, Trial Medication RQG
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Baseline 1st cycle Trial Medication

Month 12 2nd cycle Trial Medication Multiple Sclerosis ALAIN01 NCT02419378

- 6/6/16 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Medication, Trial Medication RQG
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Month 12 2nd cycle Trial Medication

Medication Form Melanoma (NCT01274338)

- 9/20/21 - 1 form, 6 itemgroups, 35 items, 1 language
Itemgroups: Header, On Treatment Reporting Period, OFF TREATMENT, Corticosteroid Medication, Immunosuppressant Medication, Hormonal Replacement Therapy Medication
E1609 Corticosteroid/Immunosuppressant/Hormone Replacement Medication Form Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery NCT01274338 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1F0BB2E-39FF-B3FA-E040-BB89AD430140

Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - ITP Therapy, Medical/Surgical procedures

- 12/5/19 - 1 form, 3 itemgroups, 29 items, 1 language
Itemgroups: Administrative Data, Prior ITP Therapy, Medical/Surgical procedures
Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the ITP Therapy and the Medical/Surgical procedures form. It has to be filled in if any ITP Therapy has been performed prior to or during the study or any Medical/Surgical procedures have been performed during the study.

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 21) CRFs Roche FVF4168G Macular Edema NCT00473330

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, RANIBIZUMAB ADMINISTRATION FELLOW EYE (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 #: 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

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 19) CRFs Roche FVF4168G Macular Edema NCT00473330

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, RANIBIZUMAB ADMINISTRATION FELLOW EYE (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 #: 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

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 22) CRFs Roche FVF4168G Macular Edema NCT00473330

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, RANIBIZUMAB ADMINISTRATION FELLOW EYE (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 #: 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

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 20) CRFs Roche FVF4168G Macular Edema NCT00473330

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, RANIBIZUMAB ADMINISTRATION FELLOW EYE (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 #: 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

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 23) CRFs Roche FVF4168G Macular Edema NCT00473330

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, RANIBIZUMAB ADMINISTRATION FELLOW EYE (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 #: 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

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

- 7/3/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Patient administration, RANIBIZUMAB ADMINISTRATION FELLOW EYE (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 #: 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

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