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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Medical Procedures

- 03.11.17 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache
Itemgruppe: Medical Procedures
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of 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: Parkinson Disease Module: Medical Procedures

KBV Request form laboratory services Template 10A

- 06.09.17 - 1 Formular, 8 Itemgruppen, 82 Datenelemente, 1 Sprache
Itemgruppen: Header, Request form, EDTA Blood, Citrat, Serum whole blood, Glucose, Urine, Other
Muster 10A - Anforderungsschein für Laboratoriumsuntersuchungen bei Laborgemeinschaften Freigabe: 01.09.2014) - 10.2014, Formulare für die vertragsärztliche Versorgung Freigabe durch Dezernat 4 - Ärztliche Leistungen und Versorgungsstruktur Geschäftsbereich Sicherstellung und Versorgungsstruktur Abteilung Sicherstellung Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Quelle: http://www.kbv.de/html/formulare.php Forms for contract medical care Released by Department 4 - Medical treatment and structure of supply, division ensurance and structure of supply, department ensurance Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Source: http://www.kbv.de/html/formulare.php

KBV Prescription of laboratory services Template 10

- 06.09.17 - 1 Formular, 4 Itemgruppen, 33 Datenelemente, 1 Sprache
Itemgruppen: Header, Laboratory service, Medical information, Footer
Muster 10 - Überweisungsschein für Laboratoriumsuntersuchungen als Auftragsleistung (Freigabe: 01.09.2014) - 10.2014, Formulare für die vertragsärztliche Versorgung Freigabe durch Dezernat 4 - Ärztliche Leistungen und Versorgungsstruktur Geschäftsbereich Sicherstellung und Versorgungsstruktur Abteilung Sicherstellung Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Quelle: http://www.kbv.de/html/formulare.php Forms for contract medical care Released by Department 4 - Medical treatment and structure of supply, division ensurance and structure of supply, department ensurance Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Source: http://www.kbv.de/html/formulare.php

KBV Referral to investigate somatic causes before starting psychotherapy Template 7

- 06.09.17 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Header, Medical information
Muster 7 - Überweisung vor Aufnahme einer Psychotherapie zur Abklärung somatischer Ursachen (Freigabe: 01.09.2014) - 10.2014, Formulare für die vertragsärztliche Versorgung Freigabe durch Dezernat 4 - Ärztliche Leistungen und Versorgungsstruktur Geschäftsbereich Sicherstellung und Versorgungsstruktur Abteilung Sicherstellung Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Quelle: http://www.kbv.de/html/formulare.php Forms for contract medical care Released by Department 4 - Medical treatment and structure of supply, division ensurance and structure of supply, department ensurance Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Source: http://www.kbv.de/html/formulare.php

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion

- 26.08.17 - 1 Formular, 6 Itemgruppen, 42 Datenelemente, 1 Sprache
Itemgruppen: Rash / Exanthema, Rash /exanthem, Parotid / Salivary gland swelling events, Parotid / Salivary gland swelling events, Febrile convulsions - Suspected signs of meningism events, Febrile convulsions - Suspected signs of meningism events
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash/Exanthem, Parotid swelling and febrile convulsion Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

transition dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 16.08.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: administrative data, transition dyspnoea index
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

baseline dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 08.08.17 - 1 Formular, 11 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: administrative data, baseline dyspnoea index, job, housework, shopping, leisure activities, gardening, social participation, washing, dressing, at rest, other aspect, baseline dyspnoea index score, date
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

visit 1 (medical evaluation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 08.08.17 - 1 Formular, 17 Itemgruppen, 47 Datenelemente, 1 Sprache
Itemgruppen: administrative data, demography, medical condition, tobacco use, COPD, oropharyngeal candidasis examination, Chest x-ray, modified medical research council dyspnoea scale, 12-lead ECG, pulmonary function testing, pulmonary funtion testing: FEV1, pulmonary function testing: FVC, pulmonary function testing: FEV1 /FVC ratio, fat free mass, laboratory blood, St. George's respiratory questionnaire, baseline dyspnoea index
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Procedure (EHR Archetype) - openEHR-EHR-ACTION.procedure.v1

- 08.07.17 - 1 Formular, 1 Itemgruppe, 24 Datenelemente, 7 Sprachen
Itemgruppe: openEHR-EHR-ACTION.procedure.v1.xml
Derived from www.openehr.org . Use to record information about the activities required to carry out a procedure, including the planning, scheduling, performance, suspension, cancellation, documentation and completion. This is done by the recording of data against specific activities, as defined by the 'Pathway' careflow steps in this archetype. The scope of this archetype encompasses activities for a broad range of clinical procedures performed for evaluative, investigative, screening, diagnostic, curative, therapeutic or palliative purposes. Examples range from the relatively simple activities, such as insertion of an intravenous cannula, through to complex surgical operations. Additional structured and detailed information about the procedure can be captured using purpose-specific archetypes inserted into the 'Procedure detail' slot, where required. Timings related to a procedure can be managed in one of two ways: - Using the reference model - the time for performance of any pathway step will use the ACTION time attribute for each step. - Archetyped data elements: --- the 'Scheduled date/time' data element is intended to record the precise time when the procedure is planned. Note: the corresponding ACTION time attribute for the Scheduled pathway step will record the time that the procedure was scheduled into a system, not the intended date/time on which the procedure is intended to be carried out; and --- the 'Final end date/time' is intended to record the precise time when the procedure was ended. It can be used to document the complex procedures with multiple components. Note: the corresponding ACTION time attribute for the 'Procedure performed' will document the time each component performed was commenced. This 'Final end date/time' data element will record the date/time of the final active component of the procedure. This will enable a full duration of the active procedure to be calculated. Within the context of an Operation Report, this archetype will be used to record only what was done during the procedure. Separate archetypes will be used to record the other required components of the Operation Report, including the taking of tissue specimen samples, use of imaging guidance, operation findings, post-operative instructions and plans for follow up. Within the context of a Problem list or summary, this archetype may be used to represent procedures that have been performed. The EVALUATION.problem_diagnosis will be used to represent the patient's problems and diagnoses. In practice, many procedures (for example, in ambulatory care) will occur once and not be ordered in advance. The details about the procedure will be added against the pathway step, 'Procedure completed'. In some cases a recurring procedure will be ordered, and in this situation data against the 'Procedure performed' step will be recorded on each occasion, leaving the instruction in the active state. When the last occurrence is recorded the 'Procedure completed' action is recorded showing that this order is now in the completed state. In other situations, such as secondary care, there may be a formal order for a procedure using a corresponding INSTRUCTION archetype. This ACTION archetype can then be used to record the workflow of when and how the order has been carried out. Recording information using this ACTION archetype indicates that some sort of activity has actually occurred; this will usually be the procedure itself but may be a failed attempt or another activity such as postponing the procedure. If there is a formal order for the procedure, the state of this order is represented by the Pathway step against which the data is recorded. For example, using this archetype the progressing state of a Gastroscopy order may be recorded through separate entries in the EHR progress notes at each 'Pathway' step: - record the scheduled Start date/time for the gastroscopy (Procedure scheduled); and - record that the gastroscopy procedure has been completed, including information about the procedure details (Procedure completed). Please note that in the openEHR Reference Model there is a 'Time' attribute, which is intended to record the date and time at which each pathway step of the Action was performed. This is the attribute to use to record the start of the procedure (using the 'Procedure performed' pathway step) or the time that the procedure was aborted (using the 'Procedure aborted' pathway step).

Eligibility Recurrent Prostate Cancer NCT00775866

- 10.06.17 - 1 Formular, 2 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00775866

Eligibility NYHA Class III Heart Failure NCT01162707

- 04.06.17 - 1 Formular, 2 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Wireless, Intermittent Monitoring of Right Heart Pressures in HF; ODM derived from: https://clinicaltrials.gov/show/NCT01162707

Hematology Oncology Order Form, University Hospital Cologne

- 06.05.17 - 1 Formular, 1 Itemgruppe, 12 Datenelemente, 1 Sprache
Itemgruppe: Hematology/Oncology Order
Hospital Routine Documentation Subform at the University Hospital Cologne. Original Form name: HO_Anforderung

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