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  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 20.09.21 - 1 Formular, 12 Itemgruppen, 101 Datenelemente, 1 Sprache
Itemgruppen: Administration, Demographics, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Blood Sample Conclusion, Vaccine Administration, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Vital Signs- Follow- Up Pazopanib Macular Degeneration MD1103367 - Vital Signs- Follow- Up

- 20.09.21 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache
Itemgruppe: Vital signs measurements
Study part: Vital Signs- Follow- Up. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 12 - Visit 11 or Early Withdrawal

- 20.09.21 - 1 Formular, 8 Itemgruppen, 58 Datenelemente, 1 Sprache
Itemgruppen: Early Withdrawal, Vital Signs, Physical Examination, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Quality of Life Assessment, Investigational Product Dosing
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 12 - Visit 11 or Early Withdrawal.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 14 - Visit 12: End of Down Titration

- 20.09.21 - 1 Formular, 2 Itemgruppen, 34 Datenelemente, 1 Sprache
Itemgruppen: Vital Signs, Physical Examination
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 14 - Visit 12: End of Down Titration.

Common Data Elements for Retinal Neovascular Diseases - Risk Factors or Past Medical History

- 20.09.21 - 4 Formulare, 1 Itemgruppe, 35 Datenelemente, 2 Sprachen
Itemgruppe: Risk Factors; Past Medical History
Common Data Elements for retinal neovascular diseases. The CDEs may be used in clinical routine, clinical trial, patient outcome, quality assurance and registry documentation of Age related macular degeneration (AMD), Diabetic Retinopathy (DR) and Retinal vein occlusion (RVO). The CDEs were developed by the Institute of Medical Informatics of the University Muenster in cooperation with the Department of Ophthalmology of the University Hospital Muenster.

Diagnosis and Examination

1 Itemgruppe 11 Datenelemente

Eye Examination

1 Itemgruppe 18 Datenelemente

Therapy

1 Itemgruppe 9 Datenelemente

Premedication Example 2 Routine documentation in German hospitals DMI

- 20.09.21 - 1 Formular, 20 Itemgruppen, 158 Datenelemente, 2 Sprachen
Itemgruppen: Patient data, Physical parameters, Medical procedure, Preoperative state; risk factors, ECG, heart, lungs, circulatory system, Neurology, metabolism, Other findings, Laboratory, Blood test, Anticoagulation, assessment Preoperative, instructions preoperative, Transfusion, criteria surgery, food intake, Premedication
Routine documentation in German hospitals. Source file name: TH130110_Prämedikationsprotokoll Examplary forms provided by DMI (http://www.dmi.de/)

Premedication Example 1 Routine documentation in German hospitals DMI

- 20.09.21 - 1 Formular, 9 Itemgruppen, 74 Datenelemente, 2 Sprachen
Itemgruppen: Patient data, Laboratory values, risk assessment Organ function, Preoperative assessment, Medical procedure, Checklist, Medication, Further instructions, Further information
Routine documentation in German hospitals. Source file name: TH130110_Prämedikationsprotokoll Examplary forms provided by DMI (http://www.dmi.de/)

Present aftercare Physician’s questionnaire for aftercare ABC study - Present aftercare Physician’s questionnaire for aftercare

- 20.09.21 - 1 Formular, 11 Itemgruppen, 99 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Medical Examination, Medical consultation, laboratory tests, Aftercare, medical consultation early cancer prevention, vaccination status, cardiovascular risk factor, Rehabilitation measures, Physical therapy, Medication
Study part: Present aftercare Physician’s questionnaire for aftercare ABC Study. Aftercare pattern in adult patients with blood cancer and blood cancer early stage: Impact on health related endpoints, quality of life and health resource use. University clinic essen, (Klinik für Hämatologie Uniklinik Essen, UKE), department hematology. Permission granted by Claudia Ose.

Birth sheet, obstetric sheet Routine documentation in German hospitals DMI

- 20.09.21 - 1 Formular, 6 Itemgruppen, 44 Datenelemente, 2 Sprachen
Itemgruppen: General information, Medical history, Medical examination, General findings, Current pregnancy, Current pregnancy complications
Routine documentation in German hospitals. Source file name: SD070109_Geburtenbogen. Examplary forms provided by DMI (http://www.dmi.de/)

Vital Signs Screening Ropinirole Parkinson Disease 101468/165 - Vital Signs Screening

- 20.09.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Screening. 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

Vital Signs Week 3 (Visit 7) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 3 (Visit 7)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Week 3 (Visit 7). 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

Vital Signs Week 2 PK Visit (Visit 6) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 2 PK Visit (Visit 6)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Week 2 PK Visit (Visit 6). 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

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