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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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PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 6/8/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES RetDQoL (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 6/8/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 6/8/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES RetDQoL (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 6/8/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Language Used for Patient- Reported Outcome Questionnaires Day 0 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Language Used for Patient- Reported Outcome Questionnaires Day 0

- 3/18/18 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: language
Study part: Language Used for Patient- Reported Outcome Questionnaires Day 0. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

visit 2 & 3-4 Patient's Daily Diary starting dose of ropinirole Parkinson's Disease 101468/166

- 9/4/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: administrative data, report of health related events
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Patient's diary - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 10/15/17 - 1 form, 4 itemgroups, 19 items, 1 language
Itemgroups: Patient's daily diary, Health related event, Study drug, Concomitant medication
Patient's diary - 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

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Diary Cards for Dose 2 (Primary)

- 1/10/19 - 1 form, 18 itemgroups, 79 items, 1 language
Itemgroups: Administrative data, Dose 2 - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 2 - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 2 - Other Local Symptoms, Dose 2 - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Dose 2 - Other General Symptoms, Dose 2 - Medication, Reminder
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

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Diary Cards for Booster Dose (Local and General Symptoms)

- 1/10/19 - 1 form, 18 itemgroups, 78 items, 1 language
Itemgroups: Administrative data, Booster Dose - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Booster Dose - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Booster Dose - Other Local Symptoms, Booster Dose - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Booster Dose - Other General Symptoms, Booster Dose - Medication, Reminder
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

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876

- 8/24/17 - 1 form, 6 itemgroups, 73 items, 1 language
Itemgroups: Study administration, LOCAL SYMPTOMS, Other Local Symptoms, MEDICATION, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, Other General Symptoms
Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876

Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021 - Diary Card for General and Local Symptoms

- 8/24/21 - 1 form, 10 itemgroups, 37 items, 1 language
Itemgroups: Administrative, Local Symptoms (at Injection Sites), Local Symptoms (at Injection Site), Other Local Symptoms, Pharmaceutical preparation, General Symptoms, General Symptoms, General Symptoms, Other General Symptoms, Administrative
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. Parents/guardians are asked to fill in the Diary Card during the one-week period subsequent to each vaccination (i.e., post visit 2 [dose 1], visit 4 [dose 2], and visit 5 [dose 3]). Note that informed consent has to be obtained prior to any study procedure.

Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393 - Diary Card for General and Local Symptoms

- 8/11/21 - 1 form, 10 itemgroups, 37 items, 1 language
Itemgroups: Administrative, Local Symptoms (at Injection Site), Local Symptoms (at Injection Site), Other Local Symptoms, Pharmaceutical preparation, General Symptoms, General Symptoms, General Symptoms, Other General Symptoms, Administrative
Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). Parents/guardians are asked to fill in the Diary Card during the one-week period subsequent to each vaccination (i.e., post visit 2 [dose 1], visit 3 [dose 2], and visit 4 [dose 3]). Note that informed consent has to be obtained prior to any study procedure.

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