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Progress report of the ESID online registry www.esid-registry.org Bodo Grimbacher, MD Head of ESID patient registries Security and Dataprotection Concept and architecture of an internet based ESID database network Input requires a positive statement from the local data protection officer and a signed consent from the patient(s) or legal tutor (approved form provided in 9 languages) Thereof follows: • SSL encrypted data transmission • Secure Server Net (audited Firewall of the Hospital of Freiburg) - Signed consent form from patients • User-Role Authentication • Passwords are stored in encrypted form - Positive statement of ethics and data protection • Multiple-User-Roles restrict views and presented data • Patient randomization (patient ID’s) - Agreement between ESID and documenting centre • Only coded data allowed (ONLY the patient’s physician can match a e.g. on core dataset (red fields) etc. specific data-set with his patients) • No demographical data or ‘free text’ that potentially directly identifies the patient is stored in the system • Implementation of the ‘2-server solution’ Consent form for patients Statement of consent for the maintenance of patient data on an internet database for research (Informed Consent) The Department of Rheumatology and Clinical Immunology of the University Hospital Freiburg participates in the research project “ESID Online Patient- and Research-Registry”. This is a pseudo-anonymous internet database with password-protected access. Pseudo-anonymity means that the data obtained from the database are anonymous for the receiver i.e. the confidentiality of records identifying the subject will be maintained. In a medical emergency the treating doctors could retrieve a specific patient’s data using a highly protected encryption code. Patient data relating to a medical condition are saved and stored automatically without the patients personal data. The aim of this project is to compile clinical and laboratory data in order to provide improved diagnosis, classification, prognosis and therapy for the patient. The aim of the database is a continuous long-term compilation of data on PID (Primary Immunodeficiency disease) patients. Therefore, the patient data obtained in the course of their treatment is not deleted but instead stored in a pseudo-anonymous and coded form in a password-protected internet database. These pseudo-anonymous data can be made available to centers that specialize in treating PID (Primary Immunodeficiency disease) patients, to laboratories that are researching the cause of PID (Primary Immunodeficiency diseases), to pharmaceutical companies developing or improving medication, or to epidemiologists for evaluation. available in 17 languages Participation in this research project is voluntary. Refusal to participate will involve no penalty or loss of benefits to the subject, and the subject may discontinue participation at any time without penalty or loss of benefits. I give my consent that confidential data relating to my PID (Primary Immunodeficiency disease), obtained in the course of the research project “ESID Online Patient- and Research-Registry”, can be compiled and evaluated as described above. Date: Patient’s name and DOB: Name of doctor involved: Doctor’s Signature Patient’s Signature Agreement ESID Documenting Center Agreement between the European Society for Immunodeficiencies (ESID) and a Documenting Center regarding the ESID Online Registry not unreasonably withheld this consent. Any publications approved by ESID have to be in accordance with the ICMJE guidelines (International Committee of Medical Journal Editors; www.icmje.org/index.html). Name of the Documenting Centre Department Address Name of Director + Title Phone number(s) Fax number E-Mail ESID has set up an online database system for research purposes for the collection and exchange of data of patients with primary immune deficiency diseases (“PID”). The design, realization and maintenance of the aforesaid online database (”ESID Online Database“) will be financially supported by sponsors who shall have a specifically defined access to a clearly defined subset of data within the ESID Online Database (“Red Fields”) for only defined purposes. The Documenting Centre intends to participate in the ESID Online Database system by providing coded data of patients with PID and by receiving a right of access to the ESID Online Database. 5. The Documenting Centre may register different persons of its organisation as users of the ESID Online Database by submitting a written application to ESID (see application form). Each of these users shall receive from ESID a user name and a password. The password shall enable the registration of data within the ESID Online Database, access to the provided data, and extended access to data of other documenting centres, if this has been agreed between the Documenting Centre and the documenting centres that owns the data. 6. The Documenting Centre shall guarantee that the user names and passwords are treated absolutely confidentially and are not used for any other purposes than those defined herein. The Documenting Centre shall immediately inform ESID about any unauthorized disclosure of the user names and / or passwords of the users of its organisation as well as about the expiry of the right of single users within its organisation to use the ESID Online Database. The Documenting Centre shall be responsible for the observance of all terms and conditions hereunder by all users of the ESID Online Database within the Documenting Centre’s organisation. 7. With the ESID Online Database ESID only offers a forum for data collection and/or data exchange and does not assume any responsibility for the operativeness and usability of the ESID Online Database or for the correctness and /or usability of the data therein or the grant of access rights to third parties. 8. Both parties may terminate this agreement by giving one month’s prior written notice to the other party. The Documenting Centre acknowledges that after the termination of this agreement ESID shall on the conditions as stipulated hereunder be entitled to continue to use the data which have been provided to the ESID Online Database until the date of termination. 9. This agreement shall be governed by German law. Landgericht Freiburg, Germany, shall be the exclusive place of venue for all disputes arising out of or in connection with the present agreement. By signing the present application form, I agree to the following terms and conditions 1. 2. 3. 4. Signed by 46 documenting centers from 24 countries ESID will pay to the Documenting Centre a compensation of EUR 10 for the provision of each patient‘s data who at least completes a core dataset as predetermined by the “Red Fields” of the ESID Online Database (provided the Documenting Centre has complied with all applicable data protection regulations) by June 30 th of each year. The accumulated compensation is due on September, 15 of each year. The Documenting Centre shall be and remain the owner of any data it has provided to the ESID Online Database. ESID shall be entitled to make available the “Red Field”-data to the sponsors of the ESID Online Registry for the following purposes: to enable genetic and therapeutic research across different authorized users; for genetic and therapeutic trials; for the treatment and care of patients; for the development and improvement of medication; for evaluations of epidemiologists. The receiving parties of such data ensure to use the data for internal use only, unless they have obtained the prior written consent from ESID to publish them or to use them for publication, Other participating documenting centres shall only have access to the data provided by the Documenting Centre if the enquiring documenting centre submits to ESID a respective application in writing, and if the Documenting Centre gives its written consent. Unless otherwise specified, the authorized documenting centre shall be entitled to use the data provided by the Documenting Centre to the same extent and for the same purposes as the sponsors of ESID. ESID shall ensure that the sponsors obtain access to the ESID Online Database only for the purposes as stipulated hereunder and that the access granted to other documenting centres corresponds to the written consent given by the Documenting Centre. Moreover, ESID shall obligate all authorized users of the ESID Online Registry not to disclose the data of such database to any unauthorized third party. The Documenting Centre ensures to observe the European data protection regulations as well as the data protection regulations applicable at its location. In particular, the Documenting Centre shall procure the necessary consent of the patients concerned to the use of the data as stipulated hereunder. The Documenting Centre shall not record any patient’s personal data into the ESID Online Database, but solely into the Documenting Centre’s local system if available. The Documenting Centre acknowledges that it is responsible to ensure the observance of data protection regulations on an organizational as well as on a technical level, particularly with regard to confidentiality, integrity, availability, authenticity and reliability of the collected data. The use by the Documenting Centre of data provided by other documenting centres is restricted to the purpose as agreed with the respective other documenting centre. Publications regarding the ESID Online Database require the prior written consent of ESID. ESID shall Place, Date ……………………………………… …………………………………………………….. Signature of the Director of the Documenting Centre Place, Date ……………………………………… …………………………………………………….. Bodo Grimbacher, Head of ESID registry Please send the signed application form to: Head: Dr. Bodo Grimbacher Department of Rheumatology and Clinical Immunology Albert-Ludwigs-Universität Freiburg, Medical Centre Hugstetter Straße 55, 79106 Freiburg, Germany http://www.esid-registry.org The ESID Main Registry http://www.esid-registry.org The ESID Main Registry Show all Patients The ESID Main Registry The ESID Main Registry Building up lists The ESID Main Registry ESID-main vs. ESID-subregistries Please document EITHER the core dataset (red fields are subject to financial compensation) OR the complete patient chart below. ESID Main Registry & Subregistries CVID Subregistry DGS Subregistry ESID Main Patient Registry NBS Subregistry XLA Subregistry HIGM Subregistry SCID Subregistry Neutropenia Subregistry ...additional Subregistries The DGS Subregistry Time schedule June 15th, 2004 October 2004 October 2004 October 2004 January 2005 January 2005 February 2005 February 2005 February 2005 ESID main registry online CVID subregistry online DGS subregistry online IPEX subregistry online NBS subregistry online ICF subregistry online HIES subregistry online ICOS subregistry online drug-induced hypogamma online Summer 2005 Summer 2005 Summer 2005 Summer 2005 Summer 2005 SCID subregistry TEST online XLA subregistry TEST online HIGM subregistry TEST online IgAD subregistry TEST online Osteopetrosis subregistry TEST online http://www.esid-registry.org/TEST.jsp Functionalitis of the database ICD-10 code implementation active Extensible drop-downs [+] active Tool-Tips: exact definition of fields [?] active Mutation detection Tool active Color coding active Report-generation Tool active SQL query Tool active Recall-function 06/2005 Query by Example Tool 06/2005 Easy doable Free-Query tool 2006 The CVID Subregistry Functionalitis of the database ICD-10 code implementation active Extensible drop-downs [+] active Tool-Tips: exact definition of fields [?] active Mutation detection Tool active Color coding active Report-generation Tool active SQL query Tool active Recall-function 06/2005 Query by Example Tool 06/2005 Easy doable Free-Query tool 2006 [+] and [?] Functionalitis of the database ICD-10 code implementation active Extensible drop-downs [+] active Tool-Tips: exact definition of fields [?] active Mutation detection Tool active Color coding active Report-generation Tool active SQL query Tool active Recall-function 06/2005 Query by Example Tool 06/2005 Easy doable Free-Query tool 2006 The IPEX Subregistry ESID Mutation Web Service Functionalitis of the database ICD-10 code implementation active Extensible drop-downs [+] active Tool-Tips: exact definition of fields [?] active Mutation detection Tool active Color coding active SQL query Tool active Report-generation Tool 06/2005 Recall-function 06/2005 Query by Example Tool 06/2005 Easy doable Free-Query tool 2006 Functionalitis of the database ICD-10 code implementation active Extensible drop-downs [+] active Tool-Tips: exact definition of fields [?] active please send an Email to: Mutation detection Tool [email protected] active Color coding active SQL query Tool active Report-generation Tool 06/2005 Recall-function 06/2005 Query by Example Tool 06/2005 Easy doable Free-Query tool 2006 Functionalitis of the database ICD-10 code implementation active Extensible drop-downs [+] active Tool-Tips: exact definition of fields [?] active Mutation detection Tool active Color coding active SQL query Tool active Report-generation Tool 09/2005 Recall-function 10/2005 Query by Example Tool 12/2005 Easy doable Free-Query tool 2006 Documentalist/Physician/User Accesses Web App Firewall 1 WebApp retrieves patient data from the PL Database Patient List (PL) DB Server 1 Sends data collection to user Web Application Application Server Firewall 2 WebApp retrieves data from the cD Database coded Data (cD) DB Server 2 Functionalitis of the database ICD-10 code implementation active Extensible drop-downs [+] active Tool-Tips: exact definition of fields [?] active Mutation detection Tool active Color coding active SQL query Tool active Report-generation Tool 09/2005 Recall-function 10/2005 Query by Example Tool 12/2005 Easy doable Free-Query tool 2006 an y, F rei bu rg Ad ults Po lan d, Wa rsa w T Se urk rbi ey, a& An Mo kar nte a ne gro ,B elg rad e Ital y, N ap Tu les rke y, B urs a-G örü Cz kle ec hR ep ub lic, Brn o Eg ypt ,K Gr air ee o ce Th es sa lon iki I Fra nc e, Na Gr nc ee y ce ,T he Ge ss rm alo an nik y, F i II rei bu rg, Ch ildr en Cr oa tia, Za gre b Ge rm Number of Patients Number of Patients per Documenting Center 90 80 20 10 78 75 total number of patients: 231 70 60 50 40 30 20 11 10 9 Center 8 6 4 4 3 2 1 0 CG n Diagnosis 4 3 3 3 2 2 1 1 1 LA D1 4 S 5 IC O 6 y 6 de fic ie nc 7 BL NK 7 IL 7R 8 AI D 9 CD un kn ow 12 40 un L kn ow n PI D M 12 SC N (C YB B) CV ID 20 HI G xlin ke d 40 µch ai n D Number of Patients Number of entries per diagnosis 120 105 100 80 60 27 1 0 1 Subregistries 2% 58% 23% 1% 10% Predominantly Antibody Disorders Phagocytic Disorders Other well defined PIDs 6% Predominantly T-Cell Deficiencies Complement Deficiencies Unclassified PIDs Info for ESID members Bonus system: Compensation for secretarial assistance (EUR 10 per patient per year if documented by Jun.30th, 2005) 2005 Travel grants to ESID meetings and summer school: 3 x EUR 500 for the center with the most registered patients 2 x EUR 500 for the center with the second most registered patients 1 x EUR 500 for the center with the third most registered patients Publication award 2005 of max. EUR 15.000 for the best publications using data of the ESID Registry Extra EUR 2000 for the first 15 centers to reach 50 fully documented patients The database network taking clinical patient registries to the next level ..... Bodo Grimbacher, MD University Hospital Freiburg Head of ESID patient registries [email protected]