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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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- 10/14/19 - 1 form, 4 itemgroups, 15 items, 1 language
Itemgroups: Administrative Data, Demography, Ethnicity, Geographic ancestry
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 and three parts. Part one includes week 1 to week 24, part two includes week 1 to week 7 and part three starts at week 8 to week 31. In the following you see the short version for each visit and part, where P represents the parts and W represents the number of week. There can be an early withdrawal at Part 1 Week 24 and Part 3 Week 31. Sreening Day 1 Part 1 Week 1 = P1W1 Part 1 Week 2 = P1W2 Part 1 Week 3 = P1W3 Part 1 Week 4 = P1W4 Part 1 Week 5 = P1W5 Part 1 Week 6 = P1W6 Part 1 Week 7 = P1W7 Part 1 Weeks 8-23 = P1W8-23 Part 1 Week 24/ Early withdrawal = P1W24/EW Part 2 Week 1 = P2W1W Part 2 Week 2 = P2W2 Part 2 Week 3 = P2W3 Part 2 Week 4 = P2W4 Part 2 Week 5 = P2W5 Part 2 Week 6 = P2W6 Part 2 Week 7 = P2W7 Part 3 Weeks 8-30 = P3W8-30 Part 3 Week 31/ Early withdrawal = P3W31/EW Follow-up Week 1 = FUW1 Follow-up Week 2 = FUW2 Follow-up Week 3 = FUW3 Follow-up Week 4 = FUW4 Follow-up Month 3 = FUM3 Follow-up Month 6 = FUM6 This document contains the demography form. It has to be filled in for screening.
- 10/14/19 - 1 form, 7 itemgroups, 81 items, 2 languages
Itemgroups: Cardiac catheter details, Right heart catheterisation, Left heart catheterisation, Myocardial biopsy, Storage diseases, Histology/Immunohistochemistry/Immunology/Virology report, Procedural complications
With permission from the DZHK administrative office. http://dzhk.de The DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung e.V.; German Center for Cardiovascular Research) is a joint cooperation of twenty-eight institutions in seven locations throughout Germany to develop a common research strategy. They developed a data catalogue with metadata and data as well as information about available biological materials from all their studies. For more information on the data catalogue and access to actual data and biosamples please visit https://dzhk.de/en/resources/data-manual/ . This version contains the metadata part only. The form Cardiac Catheter is used to document a cardiac catheter examination. This examination enables a better phenotyping of cardiomyopathies, an assessment of the degree of severity and of the prognosis. An invasive cardiac assessment is indicated according to the current guidelines. In the context of the objective, this applies especially to patients in whom cardiomyopathy has already been verified by other imaging techniques, unexplained reduced left ventricular systolic function and/or corresponding symptoms. The documentation is to be performed according to the DZHK's SOPs, which can be accessed at https://dzhk.de/en/resources/sops/ (or https://dzhk.de/ressourcen/sops/ for the German language versions). The SOP for this form is "Cardiac Catheterization. Left and rightheart examination. Left ventriculography. Left and right ventricular myocardial biopsies." (version 1.0, valid as of 01/09/2014) for the English language version, and "Herzkatheter. Links- und Rechtsherzkatheteruntersuchung. Linksventrikuläre Ventrikulographie. Entnahme von links-/ rechtsventrikulären Myokardbiopsien." (version 1.0, valid as of 01/09/2014) for the German version.