Keywords
Trial screening ×
Clinical Trial ×
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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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- 6/14/20 - 1 form, 19 itemgroups, 296 items, 1 language
Itemgroups: Screening procedure, Enrollment, Date of visit, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, Echocardiography, Multiple gated acquisition scanning, Disease, Disease Characteristic, cancer treatment, Prior Therapy, Therapeutic radiology procedure, cancer treatment, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Randomisation, Numbers, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Clinical Trial Subject Unique Identifier
- 5/31/20 - 1 form, 19 itemgroups, 203 items, 1 language
Itemgroups: Screening procedure, Enrollment, Date of visit, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, Clinical Trial Subject Unique Identifier, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Ejaculation, Response Latency, Time, Intravaginal
- 3/23/20 - 1 form, 5 itemgroups, 15 items, 1 language
Itemgroups: Administrative Data, Screening diagnosis based on prior examinations: SCD, Screening diagnosis based on preliminary examinations: MCI, Screening diagnosis based on preliminary examinations: AD, Screening diagnosis based on preliminary examinations: healthy control
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the screening diagnosis. It has to be filled in at the baseline of the study.
- 12/15/19 - 1 form, 23 itemgroups, 125 items, 1 language
Itemgroups: Administrative documentation, Demography, Vital signs, Disease, Physical Examination, Allen test, Alcohol consumption, Urine drug screening; Ethanol measurement, breath test expired carbon monoxide, Serologic tests, Mini International Neuropsychiatric Interview, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Laboratory Procedures, Renal function, Blood, Laboratory Procedures, Renal function, Urine, 12 lead ECG, Holter Electrocardiography, Eligibility Determination, Inclusion, Exclusion Criteria, 12 lead ECG, Abnormality, Holter Electrocardiography, Abnormality
- 12/1/19 - 1 form, 16 itemgroups, 103 items, 1 language
Itemgroups: Administrative documentation, Demography, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Disease, Physical Examination, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, HIV Seropositivity, hepatitis b serology, hepatitis C serology test, Urine drug screening; Ethanol measurement, Serum pregnancy test (B-HCG), Eligibility Determination, Inclusion, Exclusion Criteria