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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  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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Ewing Study Nierenfunktion DRKS00003588 - Nierenfunktion

- 8/4/14 - 1 form, 2 itemgroups, 10 items, 2 languages
Itemgroups: Show identification of patient, Untersuchung der Nierenfunktion
EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Ewing Study Referenzmolekularbiologie DRKS00003588 - Referenzmolekularbiologie

- 8/4/14 - 1 form, 3 itemgroups, 13 items, 2 languages
Itemgroups: Show identification of patient, Zytogenetik, Molekularbiologie
EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

On-Study - Agent Interruption/Modification - 2803972v1.0 - Agent Interruption/Modification

- 1/9/15 - 1 form, 4 itemgroups, 23 items, 1 language
Itemgroups: DCP Template Header, Agent Interruptions, Agent Modifications, DCP Template Footer
The Division of Cancer Prevention's agent interruption/modification case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C33C988-5236-20C3-E044-0003BA3F9857

On-Study - Specimen Acquistion Blood - 2804141v1.0 - Specimen Acquistion Blood

- 1/9/15 - 1 form, 3 itemgroups, 25 items, 1 language
Itemgroups: DCP Template Header, Specimen Acquisition Blood, DCP Template Footer
The Division of Cancer Prevention's specimen acquisition case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C376129-787E-5E04-E044-0003BA3F9857

On-Study - Specimen Acquisition Urine - 2804182v1.0 - Specimen Acquisition Urine

- 1/9/15 - 1 form, 3 itemgroups, 31 items, 1 language
Itemgroups: DCP Template Header, Specimen Acquisition Urine, DCP Template Footer
The Division of Cancer Prevention's specimen acquisition urine case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C36B035-791B-735D-E044-0003BA3F9857

PSA results GSK study Prostatic neoplasms NCT00883909

- 11/26/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Administrative data, PSA results
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 - Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis)

- 5/15/20 - 1 form, 5 itemgroups, 50 items, 1 language
Itemgroups: Administrative Data, Local Laboratory Result Data - Clinical Chemistry, Laboratory result data - Haematology, Urinalysis (Dipstick) Test, Urinalysis (Microscopy) Test
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 Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis) Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever further assesments are done during the study (Unscheduled).

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

- 9/20/21 - 1 form, 11 itemgroups, 99 items, 1 language
Itemgroups: 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.

On-Study - Clinical Laboratory Data Urine - 2804305v1.0 - Clinical Laboratory Data Urine

- 1/9/15 - 1 form, 3 itemgroups, 18 items, 1 language
Itemgroups: DCP Template Header, Clinical Laboratory Data Urine, DCP Template Footer
The Division of Cancer Prevention's clinical laboratory data urine case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C379CCC-6B7F-26D0-E044-0003BA3F9857

Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

- 1/3/18 - 1 form, 1 itemgroup, 6 items, 1 language
Itemgroup: PK blood sample
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Pharmacokinetics - Repeating form (Scheduled visits)

Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192 - Study Conclusion

- 3/15/19 - 1 form, 4 itemgroups, 46 items, 1 language
Itemgroups: Administrative data, Study Conclusion, Serious Adverse Experiences, Laboratory
Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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 The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the study conclusion form. It has to be filled in for the end of study or for early withdrawal.

Pregnancy Information Study Conclusion Mepolizumab HES NCT00086658 - Pregnancy Information Study Conclusion

- 6/5/17 - 1 form, 1 itemgroup, 1 item, 1 language
Itemgroup: PREGNANCY INFORMATION
Study part: Pregnancy Information Study Conclusion.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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