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  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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26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 9/20/21 - 13 forms, 3 itemgroups, 11 items, 1 language
Itemgroups: Global Disease Course,Red Cell Transfusion,Platelet Cell Transfusion
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Lab: Cytology/Cytogenetics/Cytochemistry

3 itemgroup 11 items

Apparatus-based Diagnostics

3 itemgroup 11 items

Lab: Immunophenotyping

3 itemgroup 11 items

Kerndatensatz Herzinsuffizienz DZHI (Core data set heart failure CHFC) - Untersuchung Herzinsuffizienz (Examination heart failure)

- 3/24/20 - 1 form, 5 itemgroups, 90 items, 2 languages
Itemgroups: Logistics ,Physical examination,ECG,6MWT,Echocardiography
Core data set on heart failure, developed by the Comprehensive Heart Failure Center (CHFC). The CHFC researches and treats the complex disease heart failure and its comorbidities in a comprehensive approach. This form contains information about the examination of an heart failure Kerndatensatz zu Herzinsuffizienz, entwickelt vom Deutschen Zentrum für Herzinsuffizienz (DZHI). Das DZHI erforscht und therapiert in einem ganzheitlichen Ansatz die Systemerkrankung Herzinsuffizienz samt ihrer Begleit- und Folgeerkrankungen. Dieses Formular enthält Informationen über die Untersuchung einer Herzinsuffizienz.

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Baseline Visit

- 11/14/17 - 1 form, 10 itemgroups, 71 items, 2 languages
Itemgroups: Physical Examination / Medical History taking,Signs and Symptoms of heart failure,Cardiovascular Diseases,Comorbidities,Current medication,Cardiovascular interventions,Implantation of a cardiac device,Hematology,ECG,Baseline visit
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Baseline Visit (BV-Form)

EHR4CR Complete Data Inventory - EHR4CR Data Inventory

- 2/10/17 - 1 form, 13 itemgroups, 122 items, 1 language
Itemgroups: Demographics,Diagnoses and Procedures,Vital Signs,Laboratory,Generic Laboratory Data,Medication,Adverse Events,Medical History,Clinical Findings,ECG,Patient Reported Outcome,Substance Use,Study Participation Status
Compilation of Feasibility, Patient Identification & Recruitment and Clinical Trial Execution data inventories. https://www.ncbi.nlm.nih.gov/pubmed/24410735 https://www.ncbi.nlm.nih.gov/pubmed/25991199 https://www.ncbi.nlm.nih.gov/pubmed/27875988

CDASH Vital Signs

- 6/20/18 - 1 form, 2 itemgroups, 14 items, 2 languages
Itemgroups: General information,Vital Sign
modified from http://www.cdisc.org

Physical examination findings (EHR Archetype) - openEHR-EHR-OBSERVATION.exam.v1

- 7/10/17 - 1 form, 1 itemgroup, 8 items, 7 languages
Itemgroup: openEHR-EHR-OBSERVATION.exam.v1.xml
Derived from www.openehr.org . Use to record details about findings on physical examination of the subject of care. This may include a narrative description of the findings, a framework in which to nest detailed CLUSTER examination archetypes, and a clinical interpretation of the findings. Examples of detailed CLUSTER examination archetypes include those that describe inspection, palpation, auscultation, percussion and movement of body systems or anatomical structures, such as CLUSTER.exam_pupils. Narrative descriptions of clinical findings from existing clinical systems may be captured using the 'Description' data element. Clinicians may sometimes want to record a summative phrase such as 'chronic otitis media' as an Interpretation of the physical examination. In the context of the physical examination archetype this should only be understood as 'physical signs are consistent with chronic otitis media'. While the summative phrase may appear to represent a diagnosis, safe and consistent querying requires a diagnosis to be recorded using the EVALUATION.problem_diagnosis archetype, even if the phrases are identical.

Visit V5_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Visit V5 (Day 140 + - 14)

- 9/27/21 - 1 form, 8 itemgroups, 49 items, 1 language
Itemgroups: Visit,Physical examination,Medical Examination Rhinoscope,Spirometry; Peak Expiratory Flow,Medication,Hematology,Biochemistry,medication Demand
Study part: Visit V5 (Day 140 + - 14). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Visit V6_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Visit V6 (Day 196 + - 14)

- 9/27/21 - 1 form, 5 itemgroups, 35 items, 1 language
Itemgroups: Visit,Physical examination,Medical Examination Rhinoscope,Spirometry; Peak Expiratory Flow,medication Demand
Study part: Visit V6 (Day 196 + - 14). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

SHORT STAY RECORD ID NOTE-ENDO - HIS

- 9/27/21 - 1 form, 4 itemgroups, 94 items, 2 languages
Itemgroups: SHORT STAY RECORD ID NOTE-ENDO,Chief Complaint,Physical Exam,Prior Medical History
Form from HIS OpenVista

Vital Signs Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Vital Signs Follow- Up (Visit 10)

- 9/27/21 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Vital Signs
Study Part: Vital Signs Follow- Up (Visit 10). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Visite 7 (Woche 20) TMP001 Multiple Sclerosis NCT02686788 - Visite 7 (Woche 20)

- 9/27/21 - 1 form, 11 itemgroups, 57 items, 1 language
Itemgroups: Administrative documentation,Vital signs; Body Temperature,study drug,Comorbidity,Adverse Events; Exacerbation of multiple sclerosis,Physical examination,Urinalysis,Laboratory,Blood sampling,Kurtzke Expanded Disability Status Scale Questionnaire,study drug
Study part: Visite 7 (Woche 20). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.

Visite 8 (Woche 24) TMP001 Multiple Sclerosis NCT02686788 - Visite 8 (Woche 24)

- 9/27/21 - 1 form, 11 itemgroups, 57 items, 1 language
Itemgroups: Administrative documentation,Vital signs; Body Temperature,study drug,Comorbidity,Adverse Events; Exacerbation of multiple sclerosis,Physical examination,Urinalysis,Laboratory,Blood sampling,Kurtzke Expanded Disability Status Scale Questionnaire,study drug
Study part: Visite 8 (Woche 24). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.

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