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  1. 1. Klinische Studie
    1. 1.1. Ein-/Ausschluss
    1. 1.2. Anamnese
    1. 1.3. Körperliche Untersuchung
    1. 1.4. Score
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    1. 1.6. Labor
    1. 1.7. Pathologie/Histologie
    1. 1.8. Aufklärung/Einverständis
    1. 1.9. Therapie
    1. 1.10. Operationsbericht
    1. 1.11. Unerwünschtes Ereignis
    1. 1.12. Follow-Up
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
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ODM Example Study - ODM Example

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 2 Sprachen
Itemgruppe: Example Itemgroup
Test of ODM muss man machen

A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 - Eligibility

- 20.09.21 - 1 Formular, 2 Itemgruppen, 27 Datenelemente, 2 Sprachen
Itemgruppen: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00640016

Eligibility Cardiovascular Health Study (CHS)

- 20.09.21 - 1 Formular, 3 Itemgruppen, 82 Datenelemente, 1 Sprache
Itemgruppen: Adminstrative data, Eligibility Form, Date of interview
Documentation part: Record 1 Eligibility The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

German Hodgkin Study Group Study HD16/HD17/HD18 In-/Exclusion Criteria DRKS00003455 DRKS00003457 - Deutsche Hodgkin Studiengruppe: Ein-/Ausschlusskriterien (G6EA)

- 01.11.18 - 1 Formular, 4 Itemgruppen, 37 Datenelemente, 1 Sprache
Itemgruppen: Form Header, Inclusion criteria, Exclusion criteria, Signature
HD16 NCT Nr.: NCT00736320 HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET. This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS). HD17 NCT Nr.: NCT01356680 HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma.This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS). HD18 NCT Nr.: NCT00515554 HD18 for Advanced Stages in Hodgkins Lymphoma. This study is designed to test: in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS. Permission granted by: Andreas Engert, M.D. Chairman, German Hodgkin Study Group Professor for Internal Medicine Hematology & Oncology University Hospital of Cologne Department of Internal Medicine I Kerpener Str. 62 D-50924 Köln Phone: +49-221-478-5933/5966 Fax: +49-221-478-3778 a.engert@uni-koeln.de

Rotavirus Vaccine RIX4414 Study NCT00289172 - Visit 1

- 04.04.18 - 1 Formular, 12 Itemgruppen, 53 Datenelemente, 1 Sprache
Itemgruppen: Header, Informed consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation/ Treatment Allocation, General Medical History / Physical Examination, General medical history / physical examination, Laboratory tests, Vaccine administration, Unsolicited Adverse Events
A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Study ID:103792 Clinical Study ID:103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus CRF Seiten: 375-430

On-Study - Specimen Acquisition Tissue - 2804222v1.0 - Specimen Acquisition Tissue

- 09.01.15 - 1 Formular, 3 Itemgruppen, 26 Datenelemente, 1 Sprache
Itemgruppen: DCP Template Header, Specimen Acquisition Tissue, DCP Template Footer
The Division of Cancer Prevention's specimen acquisition tissue case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C36F2B6-6DB3-0999-E044-0003BA3F9857

Study of Alzheimer's Disease in Down Syndrome NCT02141971 - Eligibility

- 20.09.21 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Non-randomized natural history study involving 12 subjects with Down Syndrome, who are aged 30-60 years old. This study will observe 3 different groups: four non-demented subjects between ages 30-40 years old, four non-demented subjects between ages 40-50 years old, and four demented subjects 50-60 years old. ODM derived from: https://clinicaltrials.gov/show/NCT02141971

Screen visit GSK study Prostatic neoplasms NCT00883909

- 26.11.17 - 1 Formular, 6 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Subject number Previous, Inclusion Exclusion Criteria, Inclusion/Exclusion Criteria, Eligibility Criteria, Investigator Statement
Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate CRF Seiten: 934-977

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Eligibility Criteria

- 07.06.20 - 1 Formular, 4 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Eligibility Question, Inclusion Criteria, Exclusion Criteria
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Eligibility Criteria Form has to be filled in at the screening visit. It determines the eligibility of the subject to participate in the study. Confirm that the subject is eligible to participate in the study and if not, that all the failed criteria have been marked.

Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis - Eligibility

- 04.06.17 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00195507

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Eligibility Check

- 23.02.18 - 1 Formular, 2 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Inclusion criteria, Exclusion criteria
Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Eligibility Check 2

- 23.02.18 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Inclusion criteria, Exclusion criteria
Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

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