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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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Study Medication Administration

- 10/9/17 - 1 form, 3 itemgroups, 23 items, 1 language
Itemgroups: Study Medication Administration, Study Drug Missed, Comments
Study Drug form for C3D 3.12 Adopter Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF055E17-C215-4937-E034-0003BA3F9857

Study SHIP-NEXT_metadata_20240913_NEXT|NEXT0|PHA - x0.pha_quest

- 10/8/24 - 4 forms, 1 itemgroup, 6 items, 2 languages
Itemgroup: x0.pha_quest
Item catalog SHIP-NEXT part 8

x0.pha_ident

1 itemgroup 20 items

x0.pha_take

1 itemgroup 7 items

x0.pha_odm

1 itemgroup 5 items

AMC-070 Off-Study Summary Form (F50)

- 10/9/17 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: Off-Study Summary
AMC-070 Off-Study Summary Form (F50) Lenalidomide in Treating Patients With AIDS-Related Kaposi Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E448E8-A18B-E89F-E040-BB89AD433766

Visit 2 after study drug administration HOMe aFers 1 NCT02905539

- 12/17/17 - 1 form, 3 itemgroups, 6 items, 1 language
Itemgroups: Adverse events, Collection of biological samples_visit 2_after study drug administration, Signature for Visit 2
Visit 2 after study drug administration form Visite 2 – nach Verabreichung der Studienmedikation NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 2 study drug administration form HOMe aFers 1 NCT02905539

- 12/17/17 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Reconstitution, Surveillance protocol
Visit 2 study drug administration form Visite 2 – Verabreichung der Studienmedikation NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 2 before study drug administration HOMe aFers 1 NCT02905539

- 12/17/17 - 1 form, 11 itemgroups, 33 items, 1 language
Itemgroups: Administrative data, Intercurrent diseases, Concomitant therapy, Questionnaire 1, Questionnaire 2, Questionnaire 3, Vital parameters, Anthropometric Data, 12-lead ECG, Echocardiography, Collection of biological samples_Visit 2_ before study drug administration
Visit 2 before study drug administration form Visite 2 - vor Verabreichung der Studienmedikation NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Yearly Follow-up contact; Anti Cancer Therapy (Report Final and Annex Report 2 Final)

- 10/30/20 - 1 form, 5 itemgroups, 11 items, 1 language
Itemgroups: Adminstrative, Yearly Follow-up - Check for Follow-up contact, End of yearly Follow-up contact, Anti-cancer therapy(ies) following last study treatment administration, Subsequent treatment
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Study Drug Compliance Ropinirole in Parkinson's Disease GSK 101468/196

- 10/18/17 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Patient Information, Study Drug Compliance
Study ID: 101468/196 Clinical Study ID: 101468/196 Study Title: 101468/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00650104 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Parkinson DiseaseA Long-Term, Open-Label Continuation Study of Once Daily Adminstration of Ropinirole CR Tablets to Patients with Parkinson's Disease Who Completed the Previous Ropinirole CR Studies - 167 & 164 Study Drug Compliance

CDASH Drug accountability(1) - Drug accountability (1)

- 6/20/18 - 1 form, 3 itemgroups, 5 items, 1 language
Itemgroups: General information, Study Treatment – Returned Amount, Study Treatment – Dispensed Amount
modified from http://www.cdisc.org

CDASH Drug accountability (2) - Drug accountability (2)

- 6/20/18 - 1 form, 4 itemgroups, 8 items, 1 language
Itemgroups: Study Treatment – Returned, Study Treatment – Returned Amount, Study Treatment – Dispensed, Study Treatment – Dispensed Amount
modified from http://www.cdisc.org

CDASH Drug accountability (3) - Drug accountability (3)

- 6/20/18 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: General information, Study Treatment
modified from http://www.cdisc.org

Follow-Up GSK Ropinirole Restless Legs Syndrome 101468

- 9/13/17 - 1 form, 11 itemgroups, 77 items, 1 language
Itemgroups: Patient Information, Pregnancy Test, Vital Signs, 12 Lead ECG, Clinical Chemistry & Hematology, Drug Screening (Urine), Urinanalysis, Pregnancy, Study Conclusion, Adverse Event, Investigator's Statement
Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). 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 : Restless Legs Syndrome Follow-Up

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