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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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AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102 - nach 2. Induktionstherapie

- 9/27/21 - 25 forms, 8 itemgroups, 84 items, 1 language
Itemgroups: Shipping of Material,Blood count,Clinical Chemistry,Bone Marrow Morphology,Treatment outcome evaluation,Risk group,Planned first post remission treatment,Planned first post remission treatment
NCT00180102 AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. Phase 4 Study Type:Interventional Study Design:Allocation: Randomized Intervention Model:Factorial Assignment Masking:None (Open Label) Primary Purpose:Treatment Medical Department I, University Hospital Carl Gustav Carus Dresden, Germany, 01307 Sponsors and Collaborators Technische Universität Dresden Principal Investigator:Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden

nach 1. Induktionstherapie

8 itemgroups 79 items

Ersterhebung

7 itemgroups 38 items

2. Induktionstherapie - Unerwünschte Ereignisse CTC 3.0 -

2 itemgroups 13 items

Chimerism Studies NHLBI - Lab Chimerism Studies

- 9/20/21 - 1 form, 10 itemgroups, 52 items, 1 language
Itemgroups: Registry Use Only,Identification Data,HSCT Type,Product Type,Follow Up Visit,Vital Status,Chimerism Studies,Single Donor,Multiple Donors,Author Information
2451 Revision 1 - Chimerism Studies Lab - 2451 Revision 1 - Chimerism Studies - 3160257v1.0 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9542E77F-E1D1-5D08-E040-BB89AD435C29

Infectious Disease Markers NHLBI - Lab Infectious Disease Markers ISO Date Format Version 1 2004

- 9/20/21 - 1 form, 14 itemgroups, 48 items, 1 language
Itemgroups: Registry Use Only,Identification Data,HSCT Type ,Product Type,Source Information,Hepatitis B Virus,Hepatitis C Virus,Human T-Lymphotropic Virus,Human Immunodeficiency Virus,Syphilis,Cytomegalovirus,West Nile Virus,Infectious Disease Marker,Author Information
Infectious Disease Markers Uses The ISO Date Format Version 1 Lab - 2004 - Infectious Disease Markers ISO Date Format Version 1 - 2884169v1.0 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6A861230-7A94-FE96-E040-BB89AD434611

MS Anmeld Stammzellgewinnung - composer University Hospital Muenster (UKM)

- 9/20/21 - 1 form, 5 itemgroups, 37 items, 1 language
Itemgroups: Stem cell derivation,Patient Data,Stem cell donor,Stem Cell Transplantation,Request
Hospital Routine Documentation Form at the University Hospital Muenster. Original Form name: MS Anmeld Stammzellgewinnung - composer.

Follow-Up for Greater Than Two Years Post-HSCT Data

- 9/20/21 - 1 form, 14 itemgroups, 255 items, 1 language
Itemgroups: Registry Use Only,Identification Data,HSCT Type,Product Type,Follow Up Visit,Vital Status,Functional Status,Acute GVHD,Chronic GVHD,New Malignancy,Other Organ Impairment,Subsequent HSCT,Donor Cellular Infusion,Author Information
2300 Revision 2 - Yearly Follow-Up for Greater Than Two Years Post-HSCT Data Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=849DFDB6-D6C2-FF34-E040-BB89AD431324

Hematopoietic Stem Cell Transplantation - Post-HSCT Data (100 Days) 2100 Revision 2

- 9/20/21 - 1 form, 24 itemgroups, 397 items, 1 language
Itemgroups: Registry Use Only,Identification Data,HSCT Type,Vital Status,Hematopoietic Reconstitution,Granulopoiesis / Neutrophil Recovery,Megakaryopoiesis / Platelet Recovery,Hematology findings,Immune Reconstitution,Chimerism analysis post transplantation,Chimerism Studies - Single Donor,Chimerism Studies - Multiple Donors,Engraftment Syndrome,Acute GVHD,Chronic GVHD,Infection,Pulmonary Function,Liver,Other Organ Impairment,New malignancy,Functional Status,Subsequent HSCT,Donor Cellular Infusion,Author Information
2100 Revision 2 - 100 Days Post-HSCT Data Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9FB3D5BF-EA64-EEEB-E040-BB89AD4331BD

2005 Confirmation of HLA typing - NHLBI

- 9/20/21 - 1 form, 12 itemgroups, 81 items, 1 language
Itemgroups: Registry Use Only,Identification Data,HSCT,Product Type,HLA Typing Source,HLA Typing by DNA Technology,HLA Typing by DNA Technology: Class I ,HLA Typing by DNA Technology: Class I ,HLA Typing by DNA Technology: Class II (Optional) ,Antigens Defined by Serologic Typing ,Optional Antigen Reporting: Antigens Defined by Serologic Typing ,Author Information
Confirmation of HLA Typing Uses The ISO Date Format Version 1 This form must be completed for all non-NMDP allogeneic or syngeneic donors or recipients, or non-NMDP cord blood units. If the donor, recipient, or cord blood unit was secured through the NMDP, then report HLA typing on the appropriate NMDP forms. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AA94BD8-0ED4-61A3-E040-BB89AD434BE8

HSCT recipients - Cause of death

- 9/20/21 - 1 form, 9 itemgroups, 24 items, 1 language
Itemgroups: Registry Use Only,Identification Data,HSCT Type ,Product Type,Death Date,Autopsy report,Primary Cause of Death,Secondary Cause of Death,Author Information
To define the primary and contributing causes of death for HSCT recipients reported as dead on follow up forms 2900 - RECIPIENT DEATH DATA Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6B9DD88E-9E08-08A7-E040-BB89AD430716

100 days past HSCT EBMT

- 9/20/21 - 1 form, 20 itemgroups, 200 items, 1 language
Itemgroups: CENTRE IDENTIFICATION,PATIENT DATA,DISEASE,HSCT,STEM CELLS (autograft or allograft),HSCT,AFTER HSCT,ADDITIONAL TREATMENT INCLUDING CELL THERAPY,DISEASE STATUS,Date of last follow up or death,DISEASE PRESENCE/DETECTION AT LAST CONTACT,PATIENT STATUS AT LAST CONTACT,COVER PAGE FOR HISTOCOMPATIBILITY REPORTS,HSCT - Minimum Essential Data - A First report - 100 days after HSCT - APPENDIX,DISEASE OF SECONDARY ORIGIN,THERAPY GIVEN PRIOR TO THIS HSCT,Comorbidity,HSCT - Minimum Essential Data - A First report - 100 days after HSCT - APPENDIX,HSCT - Minimum Essential Data - A First report - 100 days after HSCT - APPENDIX,HSCT - Minimum Essential Data - A First report - 100 days after HSCT DISEASE CLASSIFICATION SHEET 1
ODM form derived from 100days past HSCT EBMT. please refer to: http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx HLA typing results of patient and donor should be attached and sent: - to your NATIONAL REGISTRY if - you normally report to your National Registry and - you are based in the Netherlands, Switzerland, Turkey or the UK - to the EBMT REGISTRY OFFICE in London for any other centre Contact: Shelley Hewerdine EBMT Registry Office 4th Floor, Tabard House Guy's Hospital Great Maze Pond London SE1 9RT United Kingdom Phone: 00 44-207-188-8409 Fax: 00 44-207-188-8411 Email: shelley.hewerdine@ebmt.org

Eligibility Acute Leukemia NCT01020175

- 9/20/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT01020175

Eligibility NCT00682396 Myelodysplastic Syndrome - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 28 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00682396

Patient identification Stem-Cell Transplantation CASLAMB NCT00148148

- 9/17/21 - 1 form, 2 itemgroups, 17 items, 2 languages
Itemgroups: Patient demographics,Information about primary diseases
A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell Transplantation NCT00148148

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