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Table of contents
  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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EHR4CR CTE Data Inventory

- 4/21/18 - 1 form, 14 itemgroups, 133 items, 1 language
Itemgroups: Adverse Events,Concomitant Medication,Demographics,Disease Characteristics,Disposition,ECG,Laboratory,Laboratory Data,Medical History,Patient Reported Outcome,Substance Use,Surgery,Tumor Response,Vital Signs
Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

Physician letter (short)

- 3/15/21 - 1 form, 3 itemgroups, 302 items, 1 language
Itemgroups: Current episode,Diagnosis,Current medication
derived from http://www.arztbriefmanager.de/ (Dr. Wolfram Arends, Tutzing, Germany)

CDASH Concomitant Medication - Concomitant medication

- 6/20/18 - 1 form, 2 itemgroups, 9 items, 2 languages
Itemgroups: General information,Details
translated and modified from CDASH 2011-10-24 http://www.cdisc.org

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 11/18/21 - 9 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: Subject details
Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 itemgroups 84 items

On-Treatment 2

13 itemgroups 62 items

On-Treatment 4

12 itemgroups 62 items

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Prior Medication

- 9/20/21 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Administrative,Prior Medication,Prior Medication
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Logs and Repeats and Concomitant Medications

- 9/20/21 - 1 form, 3 itemgroups, 23 items, 1 language
Itemgroups: Date of visit/ assessment,Adverse event | Concomitant Medication Ongoing | Evaluation,Pharmaceutical Preparations Concomitant Therapy
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. - Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form

- 9/20/21 - 1 form, 13 itemgroups, 56 items, 1 language
Itemgroups: Administration,Glucose Assay,Glucose Assay,Plasma Drug Assay,Plasma Drug Assay,Volunteer Completion/Withdrawal,Investigator's checklist,Investigator's Statement,Concominant Medication,Missing Data,Missing Data,Missing Data,Missing Data
https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr Study ID : 102886/003 Clinical Study ID : 102886/003 Study Title :Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. Clinicaltrials.gov Identifier : Sponsor : GlaxoSmithKline Collaborators :N/A Phase :N/A Study Recruitment Status :Completed Generic Name :halofantrine Trade Name :Halfan Study Indication Malaria

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - Logs and Repeats

- 9/20/21 - 1 form, 16 itemgroups, 156 items, 1 language
Itemgroups: Date of visit, Assessment Date,Adverse Event; Concomitant Agent; Evaluation, Repeat,Liver, Adverse Event,Non-serious Adverse Event,Serious Adverse Event,Concomitant Agent,Laboratory Procedures,Vital signs,Pharmacokinetic aspect, Blood, Repeat,Pulmonary function tests, Repeat,Holter Electrocardiography, Repeat,Holter Electrocardiography, Abnormality, Repeat,Telemetry, Repeat,Telemetry, Abnormality, Repeat,12 lead ECG, Abnormality, Repeat,12 lead ECG
Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 9/20/21 - 1 form, 18 itemgroups, 90 items, 1 language
Itemgroups: Note,Inclusion Criteria,Exclusion Criteria,Physical examination,Pregnancy test,Alcohol test,Urine drug screening,orthostatic blood pressure / Pulse - Predose,Concomitant medication,Adverse event,Patient diary,Randomization,High fat breakfast,Study Drug Dosing,Orthostatic blood pressure / pulse measurement - post dose,Adverse Event - post dosing,Pharmacokinetic sampling post dosing,Discharge
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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

PART A - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 9/20/21 - 1 form, 17 itemgroups, 88 items, 1 language
Itemgroups: Note,Inclusion Criteria,Exclusion Criteria,Physical examination,orthostatic blood pressure / Pulse - Predose,Pregnancy test,Patient diary,Alcohol test,Urine drug screening,Concomitant medication,Adverse event,Randomization,Standard Breakfast,Study Drug Dosing,Orthostatic blood pressure / pulse measurement - post dose,Adverse Event - 4 hours post dosing,Discharge
PART A - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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

Visit 3 GIMEMA CML0408 NCT00769327 - Visit 3

- 9/20/21 - 1 form, 5 itemgroups, 49 items, 2 languages
Itemgroups: Physical Examination,Complete Blood Count,NILOTINIB,Biochemistry,Electrocardiogram
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 3 Form

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Screening; Prior Medication

- 9/20/21 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Administrative Documentation,Prior Medication,Prior Medication
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

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