Download Functionalitis of the database

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
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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
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4
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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]