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  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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Follow-Up - Follow-Up Oncology

- 11/2/15 - 1 form, 5 itemgroups, 16 items, 19 languages
Itemgroups: Identity,Diagnosis,Therapy,Study,Follow-up
Follow Up Dokumentation zur automatischen Berechnung von Kaplan-Meier Kurven.

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Follow- Up

- 1/31/22 - 1 form, 8 itemgroups, 44 items, 1 language
Itemgroups: Date of physical examination,Visit Week physical examination,B- Symptoms,Physical Examination,Organ/ System,Visit Week laboratory,Hematology,Chemistry
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Follow-up AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML) - Follow-up AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

- 11/17/21 - 1 form, 5 itemgroups, 22 items, 1 language
Itemgroups: Follow-up,Concomitant Disease,Therapy,Allogenic Transplantation,Signature
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

Breast Cancer NCT01101438 Follow-Up - NCIC MA.32 Telephone Follow-Up Report - 3025096v1.0 - NCIC MA.32 Telephone Follow-Up Report

- 9/27/21 - 1 form, 5 itemgroups, 17 items, 1 language
Itemgroups: TIMING OF REPORT - TELEPHONE FOLLOW-UP,METFORMIN/PLACEBO ADMINISTRATION,SERIOUS ADVERSE EVENT - QUESTION,ADVERSE EVENTS ON TREATMENT - QUESTION,ADVERSE EVENTS
NCIC MA.32 Telephone Follow-Up Report A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81DC7457-3943-EA84-E040-BB89AD43055B

Follow-Up - Phase II Lung Cancer - Advanced Disease Follow-Up Form - 2399268v1.0 - Phase II Lung Cancer - Advanced Disease Follow-Up Form

- 9/27/21 - 1 form, 9 itemgroups, 36 items, 1 language
Itemgroups: CRF Header,Form Administration,Lung: Vital Status,Lung: Disease Follow-Up Status,Lung: Notice of Progression/Site,Lung: Subsequent Non-Protocol Therapy,Lung: Notice of New Primary,Lung: Long-Term Toxicity,Comments
Phase II Consortium Phase II Lung Cancer - Advanced Disease Follow-Up Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF8E0C9E-44F2-3242-E034-0003BA3F9857

Follow-Up - Phase II Lung Cancer - Localized Disease Follow-Up Form - 2402852v1.0 - Phase II Lung Cancer - Localized Disease Follow-Up Form

- 9/27/21 - 1 form, 9 itemgroups, 38 items, 1 language
Itemgroups: CRF Header,Form Administration,Lung: Vital Status,Lung: Disease Follow-Up Status,Lung: Notice of Progression/Site,Lung: Subsequent Non-Protocol Therapy,Lung: Notice of New Primary,Lung: Long-Term Toxicity,Comments
Phase II Consortium Phase II Lung Cancer - Localized Disease Follow-Up Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=00212490-27A3-4F0A-E044-0003BA3F9857

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Visit 2: Laboratory Tests

- 9/27/21 - 1 form, 4 itemgroups, 12 items, 1 language
Itemgroups: Administrative data,Blood Sample for Antibodies to CS,Blood Sample for Antibodies to HBs,Blood Sample for Hematocrit
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 document is to be completed at Visit 2.

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Visit 3: Laboratory Tests

- 9/27/21 - 1 form, 4 itemgroups, 12 items, 1 language
Itemgroups: Administrative data,Blood Sample for Antibodies to CS,Blood Sample for Antibodies to HBs,Blood Sample for Hematocrit
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/after Visit 3.

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 28 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 11, Year 8) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 28 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 9, Year 6) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

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