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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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Basic documentation B2 LeMLAR-Studie Lymphoma NCT01788189 - Basic documentation B2

- 3/15/21 - 1 form, 3 itemgroups, 26 items, 1 language
Itemgroups: medical history, Inclusion Criteria, Exclusion Criteria
Study part: Basic documentation B2 LeMLAR-Studie. LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

Eligibility Type 2 Diabetes NCT02459496

- 1/19/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Diabetological Dietary Strategies and Perspectives / DDS-P (Deutsche Diabetes-Studie Potsdam); ODM derived from: https://clinicaltrials.gov/show/NCT02459496

DESCRIBE (DZNE – Clinical Register Study of neurodegenerative Disorders) CRF Diagnostic Criteria - CRF Diagnostic Criteria

- 9/20/21 - 1 form, 20 itemgroups, 378 items, 1 language
Itemgroups: Date of visit, Mild cognitive impairment (MCI), Dementia in Alzheimer's Disease (AD), Posterior cortical atrophy (PCA), Vascular dementia, Frontotemporal dementia, behavioral variant, Primary progressive aphasia (PPA), Progressive nonfluent aphasia (PNFA), Logopenic progressive aphasia (LPA), Semantic dementia (SemD), Idiopathic Parkinson's disease (IPS), Morbus parkinson along with MCI (PD-MCI), Dementia in Parkinsons disease, Dementia with Lewy bodies (DLB), Progressive supranuclear palsy, Corticobasal degeneration (CBD), Multiple system atrophy (MSA), Essential tremor (ET), Amyotrophic lateral sclerosis (ALS), Depression
Background and Purpose: The purpose of the DESCRIBE study is to document the natural course of diseases in context of medical care of neurodegenerative disorders as well as cerebrovascular diseases and to perform phenotyping of the test persons. Disease-spanning analyses of the measured clincial data, the results of the imaging processes, results of the analysis of the biometerials including genetic analysis are planed. Principal Investigator: Prof. Klockgether, Dr. Spottke DZNE, Bonn. Source: DESCRIBE-Studie http://www.dzne.de/forschung/forschungsbereiche/klinische-forschung/studien/describe-bn006.html Participating Study Sites: Berlin, Bonn, Göttingen, Dresden, Köln, Magdeburg, München, Rostock/Greifswald, Tübingen

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Visit 1: Eligibility Criteria

- 6/6/19 - 1 form, 4 itemgroups, 6 items, 1 language
Itemgroups: Administrative data, Eligibility Check, Inclusion Criteria, Exclusion Criteria
Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This form is to be completed at Visit 1.

Genetic Screening For HLA-B*5701 n Patients with HIV Day 1 NCT00340080 - Genetic Screening For HLA-B*5701 Day 1 NCT00340080

- 6/20/17 - 1 form, 1 itemgroup, 12 items, 1 language
Itemgroup: Day 1
NCT00340080 / VIIV-CNA106030 https://clinicaltrials.gov/ct2/show/NCT00340080 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Day 1 (Cohort Study) Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Completion Period: Vital Signs

- 11/19/18 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Administrative data, Study Completion, Double-Blind Method
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Eligibility Lesions NCT00861172

- 1/17/19 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy; ODM derived from: https://clinicaltrials.gov/show/NCT00861172

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021 - Contraindications to Subsequent Vaccination

- 11/28/18 - 1 form, 9 itemgroups, 8 items, 1 language
Itemgroups: Absolute Contraindications, DTPw vaccines, GSK Biologicals' RotarixTM vaccine or its placebo, Local registered OPV, Relative Contraindications, DTPw vaccines, GSK Biologicals' RotarixTM or its placebo, Precautions for DTPw vaccines, DTPw-HBV vaccines should under no circumstances be administered intravenously
Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 1

- 1/11/19 - 1 form, 15 itemgroups, 94 items, 1 language
Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Hib Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Screen Failure Form

- 11/28/18 - 1 form, 1 itemgroup, 3 items, 1 language
Itemgroup: Screen Failure Data
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 1: Eligibility Criteria, Physical Examination, Vaccination, Non Participation, Use of Human Samples Consent

- 1/14/19 - 1 form, 18 itemgroups, 112 items, 1 language
Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation, Reason for non participation, Investigator's Data, Use of Human Samples by GSK, Investigator's Signature
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Eligibility Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors NCT00185679

- 2/5/16 - 1 form, 4 itemgroups, 53 items, 1 language
Itemgroups: Inclusion Criteria Recipient, Exclusion Criteria Recipient, Inclusion Criteria Donor, Exclusion Criteria Donor
Haploid Allogeneic Transplant Using the CliniMACS System; ODM derived from: https://clinicaltrials.gov/show/NCT00185679

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