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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
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Study SHIP-TREND_TREND0_MEX - t0.ahareadoct

- 10/26/24 - 31 forms, 1 itemgroup, 18 items, 2 languages
Itemgroup: t0.ahareadoct
SHIP study https://doi.org/10.1093/ije/dyac034

t0.abstriche

1 itemgroup 25 items

t0.carotidu

1 itemgroup 24 items

t0.echoakl

1 itemgroup 14 items

t0.echomkl

1 itemgroup 14 items

t0.biames

1 itemgroup 22 items

t0.plaque

1 itemgroup 48 items

Nerventra Study Baseline

- 6/7/16 - 1 form, 14 itemgroups, 111 items, 1 language
Itemgroups: Informed Consent and Demography Data, Safety measurements, Pasat Summary Score Sheet, 9-Hole Peg test, Binocular low contrast visual acuity, MRI Scan performance, MT Scan Performance, MRS Scan Performance, Modified Fatigue Impact Scale, General Health assessment, Final eligibility, Subject disposition, Post -Dose Vital signs, Phone thrombosis questionnaire
Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

On-Study - Curative Treatment for Head and Neck Cancer - On-Study Form - 2268312v3.0 - Curative Treatment for Head and Neck Cancer - On-Study Form

- 9/20/21 - 1 form, 5 itemgroups, 48 items, 1 language
Itemgroups: CRF Header, Head & Neck: Form Administration, Head & Neck: Patient Assessment, Head & Neck: Disease Description, Head & Neck: Prior Health History - Curative
Curative Treatment for Head and Neck Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D4976276-569A-5CEB-E034-0003BA12F5E7

Baseline visit LenaMain-Study - Baseline Visit

- 3/16/16 - 1 form, 11 itemgroups, 100 items, 1 language
Itemgroups: Inclusion of Patient, Inclusion criteria, Exclusion criteria, Parameter of multiple myeloma at enrollment, Vital signs, Comorbidities, Laboratory:Protein electrophoresis, Laboratory:Hematology, Laboratory:serum chemistry, Laboratory:pregnancy test, Quality of life
A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Ewing Study Metastasen bei Diagnose DRKS00003588 - Metastasen bei Diagnose

- 8/4/14 - 1 form, 10 itemgroups, 17 items, 2 languages
Itemgroups: Show identification of patient, Metastasen bei Diagnose, Lungenmetastasen, Knochenmetastasen, Knochenmarksmetastasen, ZNS-Metastasen, Leber-Metastase(n), Lymphknotenmetastasen, Sonstige Metastasen, Sonstige Metastasenlokalisation
EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Ewing Study Untersuchungen bei Diagnose DRKS00003588 - Untersuchungen bei Diagnose

- 8/4/14 - 1 form, 5 itemgroups, 19 items, 2 languages
Itemgroups: Show identification of patient, Untersuchungen Primärtumor, Staging-Untersuchungen, Knochemark-Aspirat, Knochenmarkstanze
EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Scales, baseline signs and symptoms

- 2/23/18 - 1 form, 6 itemgroups, 25 items, 1 language
Itemgroups: Scales RLS, Vital signs, Baseline signs and symptoms, Baseline signs and symptoms , Ramos Randomisation and Dispensing, Orthostatic vital signs
Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D - study documentation

- 9/20/21 - 1 form, 47 itemgroups, 279 items, 2 languages
Itemgroups: ChecklistDemographics, Header Module, Registration Header, Registration characteristics, Contact Person For Pathology Results, Patient Demographics, Eligibility Screening Form, Randomization, Informed consent, Gynaecological examination, Patient Status, ECG, Cardiac Monitoring, Local Her2 Results, Hormonal Receptor Status, History Of Primary Breast Cancer, History Of Primary Cancer (continued), Sentinel Node Sampling, Most Extensive Primary Surgery, Axillary Node Dissection, Chemotherapy, Previous Or Current Cardiovascular Disease, ECG, Translational Research, Central Her2 Testing Form - FISH, Central Her2 Testing Form - IHC, Radiotherapy, Hormonetherapy, Concomitant Treatment, Administration of Study Drug, Post-Event-Treatment, Chemotherapy, Targeted Therapy, Hormonetherapy, Radiotherapy, Surgery, Adverse Event (AE), Second Primary Malignancy and Contralateral Breast Cancer, On Study - Years 6, 7, 8, 9, and 10, Patient Status, Cardiac Monitoring, Mammogram, Hematoly and Biochemistry, Survival Follow-Up, Treatment Completion, Additional Comments , Death Form
A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Eligibility criteria (Ein- und Ausschlusskriterien)

- 4/8/20 - 1 form, 3 itemgroups, 23 items, 1 language
Itemgroups: Administrative Data, Inclusion criteria, Exclusion criteria
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Eligibility criteria. It has to be filled in at the baseline of the study.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - General aspects Baseline (Allgemein, Baseline)

- 3/25/20 - 1 form, 7 itemgroups, 40 items, 2 languages
Itemgroups: Administrative Data, Life situation, Education and employment, Occupational status, Nicotine consumption, Alcohol consumption, Vital signs
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the General aspects Baseline form. It has to be filled in at the baseline of the study.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Demography (Demographie)

- 3/23/20 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data, Demography, Ethnic group, Native language
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Demography form. It has to be filled in at the baseline of the study.

Baseline Medical History Cardiovascular Health Study (CHS)

- 7/3/16 - 1 form, 6 itemgroups, 157 items, 1 language
Itemgroups: Medical History: Myocardical Infarction, Medical History: Congestive heart failure, Medical History: Intermittent claudication, Medical History: Angina, Medical History: Other conditions, Date of interview
Documentation part: Record 7 Baseline Medical History The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

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