Keywords
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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
Selected data models

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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.
- 10/11/19 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data, Transcranial Magnetic Stimulation, TMS - Location of stimulation, TMS - Recruitment Curve
- 10/7/19 - 1 form, 8 itemgroups, 94 items, 1 language
Itemgroups: Administrative data, 12 Lead ECG abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other abnormalities
- 10/5/19 - 1 form, 10 itemgroups, 67 items, 1 language
Itemgroups: Administrative Data, Type of report, SAE, Serious adverse events, Seriousness, Relevant Concomitant/treatment medications, Relevant medical conditions/Risk factors, Relevant diagnostic results, Investigational Products, General Narrative Comments, Non Clinical