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Demography ×
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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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- 4/21/18 - 1 form, 14 itemgroups, 133 items, 1 language
Itemgroups: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
- 6/20/18 - 1 form, 1 itemgroup, 5 items, 2 languages
Itemgroup: Subject Characteristics
- 6/20/18 - 1 form, 16 itemgroups, 95 items, 1 language
Itemgroups: LAB Information, CBC LAB Results – Leukocytes, CBC LAB Results – Neutrophils, CBC LAB Results – Lymphocytes, CBC LAB Results – Monocytes, CBC LAB Results – Eosinophils, CBC LAB Results – Basophils, CBC LAB Results – Erythrocytes, CBC LAB Results – Hemoglobin, CBC LAB Results – Hematocrit, CBC LAB Results - Platelet Count, CBC LAB Results - Ery. Mean Corpuscular Volume, CBC LAB Results - Mean Platelet Volume, CBC LAB Results - Ery. Mean Corpuscular Hemoglobin, CBC LAB Results - Ery. Mean Corpuscular HB Concentration, CBC LAB Results - Erythrocytes Distribution Width
- 11/10/19 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, Demography
Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to record the subject's demographics and should be filled out at Visit 1 (Screening).
- 10/17/19 - 1 form, 11 itemgroups, 91 items, 2 languages
Itemgroups: General anamnesis information, Physical Examination and Sociodemographic Data, Cardiovascular risk factors, Cardiac Diagnoses (Anamnesis and Previous Findings), Previous cardiovascular interventions, Current secondary diagnoses, Anamnesis women, Resting blood pressure, Resting heart rate, Further diagnoses, Laboratory diagnostics (blood)
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. This form contains the mandatory basic data set with 42 items, which are recorded in all of the DZHK's studies, as well as other items related to Anamnesis and Clinical Diagnosis. This form is used to accurately record known cardiovascular risk factors, previous diagnoses and interventions, enabling a detailed assessment of a patient’s cardiovascular risk. The 42 basic items are marked as mandatory. The examination 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 SOPs for this form are "Basic data - Anamnesis/Clinical Diagnoses/physical examination" (version 1.0, valid as of 01/09/2014) and "Anamnesis/Clinical Diagnoses" (version 1.0, valid as of 01/09/2014) for the English language version, and "Basisdatensatz – Anamnese/Klinische Diagnosen/Körperliche Untersuchung" (version 1.1, valid as of June 2019) and "Anamnese/Klinische Diagnosen" (version 1.0, valid as of 01/09/2014) for the German language version.
- 10/16/19 - 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, 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 demography form. It has to be filled in for screening.