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CDASH Vital Signs

- 20/06/2018 - 1 Formulaire, 2 Groupes Item, 14 Eléments de données, 2 Langues
Groupes Item: General information, Vital Sign
modified from http://www.cdisc.org

Sentinel Common Data Model Vital Signs

- 25/08/2019 - 1 Formulaire, 1 Groupe Item, 12 Eléments de données, 1 Langue
Groupe Item: Vital signs
Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal of Sentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Vital Signs Table contains one record per result/entry.

NINDS CDE Vital Signs Multiple Sclerosis - Vital Signs

- 20/09/2021 - 1 Formulaire, 2 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Vital Signs, Pediatric
NINDS Common Data Elements, Multiple Sclerosis Vital Signs Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Vital Signs Friedreich´s Ataxia - Vital Signs

- 29/04/2016 - 1 Formulaire, 1 Groupe Item, 16 Eléments de données, 1 Langue
Groupe Item: Vital Signs
NINDS Common Data Elements (Vital Signs Friedreich´s Ataxia) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

CDASH Vital Signs (fine 1)

- 20/06/2018 - 1 Formulaire, 6 Groupes Item, 24 Eléments de données, 1 Langue
Groupes Item: Height, Weight, Blood pressure, Pulse, Temperature, Body Frame Size
modified from http://www.cdisc.org

NINDS CDE Vital Signs Headache - Vital Signs

- 20/06/2016 - 1 Formulaire, 1 Groupe Item, 35 Eléments de données, 1 Langue
Groupe Item: Vital Signs
NINDS Common Data Elements [Vital Signs][Headache] Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Vital Signs Amyotrophic Lateral Sclerosis - Vital Signs

- 21/03/2016 - 1 Formulaire, 1 Groupe Item, 16 Eléments de données, 1 Langue
Groupe Item: Vital Signs
NINDS Common Data Elements (Vital Signs Amyotrophic Lateral Sclerosis) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

German Center for Diabetes Research (DZD) - Core Data Set - Base set

- 15/07/2024 - 2 Formulaires, 8 Groupes Item, 147 Eléments de données, 2 Langues
Groupes Item: IG.1, IG.2, IG.3, IG.4, IG.5, IG.6, IG.7, Fragebogen
The German Center for Diabetes Research (DZD) has created a core data set for research on diabetes. It is published with permission by the DZD. The complete metadata and SOP are registered at DOI 10.5281/zenodo.7360000 For more information on the work of the DZD see: www.dzd-ev.de/en or contact: studien@dzd-ev.de German Center for Diabetes Research (DZD) Head Office at Helmholtz Zentrum München Ingolstädter Landstr. 1 85764 Neuherberg, Germany The German and English version of the Baecke Questionnaire in this core data set is based on the original paper by Baecke et al (https://doi.org/10.1093/ajcn/36.5.936), redistributed by ten Velde et al. (https://doi.org/10.1371/journal.pone.0256448), and the German translation and modification by Wagner & Singer (2003). The questionnaire was selectively modified by the German Diabetes Center (DDZ). Changes in this version 4 (15.07.2024) compared to version 3 (26.02.2024) include the addition of the parameters defined in the core data set of the German Centers for Health Research (DZG) (ID of MDM entry: 45851), the addition of laterality-specific blindness and an update of the terminology coding. The coding of the DZG parameters is currently under revision and not included in this current version. The coding of those DZG parameters that were already included in the DZD CDS will be provisionally retained.

Optional Set

3 Groupes Item 46 Eléments de données

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Screening Visit: Vital Signs Form

- 14/11/2018 - 1 Formulaire, 2 Groupes Item, 20 Eléments de données, 1 Langue
Groupes Item: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Early Term: Vital Signs Form

- 19/11/2018 - 1 Formulaire, 2 Groupes Item, 20 Eléments de données, 1 Langue
Groupes Item: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Follow-Up GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/2017 - 1 Formulaire, 8 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: General Information, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 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: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the mandatory 7 day follow-up assessment form.

Week 2 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/2017 - 1 Formulaire, 12 Groupes Item, 15 Eléments de données, 1 Langue
Groupes Item: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, WPAI, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX, CLINICAL GLOBAL IMPRESSION, DOSE REDUCTION BETWEEN SCHEDULED VISITS, RAMOS RANDOMISATION AND DISPENSING
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 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: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Week 2 form.

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