Progress report of the ESID online registry Bodo Grimbacher, MD Head of ESID patient registries .

Progress report of the ESID online registry

Progress report of the ESID online registry

Bodo Grimbacher, MD

Head of ESID patient registries

www.esid-registry.orgwww.esid-registry.org

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)

• SSL encrypted data transmission

• Secure Server Net (audited Firewall of the Hospital of Freiburg)

• User-Role Authentication

• Passwords are stored in encrypted form

• Multiple-User-Roles restrict views and presented data

• Patient randomization (patient ID’s)

• Only coded data allowed (ONLY the patient’s physician can match a 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’

Thereof follows:

- Signed consent form from patients

- Positive statement of ethics and data protection

- Agreement between ESID and documenting centre e.g. on core dataset (red fields) etc.

Security and DataprotectionConcept and architecture of an internet based ESID database network

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 OnlinePatient- and Research-Registry”. This is a pseudo-anonymous internet database with password-protected access. Pseudo-anonymity means thatthe data obtained from the database are anonymous for the receiver i.e. the confidentiality of records identifying the subject will be maintained. In amedical emergency the treating doctors could retrieve a specific patient’s data using a highly protected encryption code. Patient data relating to amedical 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 thepatient.

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 apassword-protected internet database. These pseudo-anonymous data can be made available to centers that specialize in treating PID (PrimaryImmunodeficiency disease) patients, to laboratories that are researching the cause of PID (Primary Immunodeficiency diseases), to pharmaceuticalcompanies developing or improving medication, or to epidemiologists for evaluation.

Participation in this research project is voluntary. Refusal to participate will involve no penalty or loss of benefits to the subject, and the subject maydiscontinue 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

Consent form for patients

available in 17

languages

not unreasonably withheld this consent. Any publications approved by ESID have to be in accor-dance with the ICMJE guidelines (International Committee of Medical Journal Editors;www.icmje.org/index.html).

5. The Documenting Centre may register different persons of its organisation as users of theESID 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 passwordshall enable the registration of data within the ESID Online Database, access to the provideddata, and extended access to data of other documenting centres, if this has been agreedbetween the Documenting Centre and the documenting centres that owns the data.

6. The Documenting Centre shall guarantee that the user names and passwords are treatedabsolutely confidentially and are not used for any other purposes than those defined herein.The Documenting Centre shall immediately inform ESID about any unauthorized disclosureof the user names and / or passwords of the users of its organisation as well as about theexpiry 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 conditionshereunder by all users of the ESID Online Database within the Documenting Centre’s or-ganisation.

7. With the ESID Online Database ESID only offers a forum for data collection and/or data ex-change and does not assume any responsibility for the operativeness and usability of theESID Online Database or for the correctness and /or usability of the data therein or the grantof access rights to third parties.

8. Both parties may terminate this agreement by giving one month’s prior written notice to theother party. The Documenting Centre acknowledges that after the termination of this agree-ment ESID shall on the conditions as stipulated hereunder be entitled to continue to use thedata 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 bethe exclusive place of venue for all disputes arising out of or in connection with the presentagreement.

Place, Date ……………………………………… ……………………………………………………..Signature of the Director of theDocumenting Centre

Place, Date ……………………………………… ……………………………………………………..Bodo Grimbacher, Head of ESID registry

Please send the signed application form to:

Head: Dr. Bodo GrimbacherDepartment of Rheumatology and Clinical ImmunologyAlbert-Ludwigs-Universität Freiburg, Medical CentreHugstetter Straße 55, 79106 Freiburg, Germany

Agreement between the European Society for Immunodeficiencies (ESID)and a Documenting Center regarding the ESID Online Registry

Name of the Documenting CentreDepartmentAddressName of Director + TitlePhone number(s)Fax numberE-Mail

ESID has set up an online database system for research purposes for the collection and exchangeof data of patients with primary immune deficiency diseases (“PID”). The design, realization andmaintenance of the aforesaid online database (”ESID Online Database“) will be financially sup-ported by sponsors who shall have a specifically defined access to a clearly defined subset of datawithin the ESID Online Database (“Red Fields”) for only defined purposes. The Documenting Cen-tre intends to participate in the ESID Online Database system by providing coded data of patientswith PID and by receiving a right of access to the ESID Online Database.

By signing the present application form, I agree to the following terms and conditions

1. ESID will pay to the Documenting Centre a compensation of EUR 10 for the provision ofeach patient‘s data who at least completes a core dataset as predetermined by the “RedFields” of the ESID Online Database (provided the Documenting Centre has complied withall applicable data protection regulations) by June 30th of each year. The accumulated com-pensation is due on September, 15 of each year.

2. The Documenting Centre shall be and remain the owner of any data it has provided to theESID Online Database. ESID shall be entitled to make available the “Red Field”-data to thesponsors of the ESID Online Registry for the following purposes: to enable genetic andtherapeutic research across different authorized users; for genetic and therapeutic trials; forthe treatment and care of patients; for the development and improvement of medication; forevaluations of epidemiologists. The receiving parties of such data ensure to use the data forinternal use only, unless they have obtained the prior written consent from ESID to publishthem or to use them for publication,Other participating documenting centres shall only have access to the data provided by theDocumenting Centre if the enquiring documenting centre submits to ESID a respective appli-cation in writing, and if the Documenting Centre gives its written consent. Unless otherwisespecified, the authorized documenting centre shall be entitled to use the data provided bythe Documenting Centre to the same extent and for the same purposes as the sponsors ofESID.ESID shall ensure that the sponsors obtain access to the ESID Online Database only for thepurposes as stipulated hereunder and that the access granted to other documenting centrescorresponds to the written consent given by the Documenting Centre. Moreover, ESID shallobligate all authorized users of the ESID Online Registry not to disclose the data of suchdatabase to any unauthorized third party.

3. The Documenting Centre ensures to observe the European data protection regulations aswell as the data protection regulations applicable at its location.In particular, the Documenting Centre shall procure the necessary consent of the patientsconcerned to the use of the data as stipulated hereunder. The Documenting Centre shall notrecord any patient’s personal data into the ESID Online Database, but solely into the Docu-menting Centre’s local system if available. The Documenting Centre acknowledges that it isresponsible to ensure the observance of data protection regulations on an organizational aswell as on a technical level, particularly with regard to confidentiality, integrity, availability,authenticity and reliability of the collected data.

4. The use by the Documenting Centre of data provided by other documenting centres is re-stricted to the purpose as agreed with the respective other documenting centre. Publicationsregarding the ESID Online Database require the prior written consent of ESID. ESID shall

Signed by 46 documenting centers from 24

countries

Agreement ESID Documenting Center

http://www.esid-registry.org

The ESIDMain

Registry

http://www.esid-registry.org

The ESIDMain

Registry

Show all Patients

The ESIDMain

Registry

The ESIDMain

Registry

Building up

lists

The ESIDMain

Registry

Please document EITHER the core

dataset (red fields are subject to

financial compensation) OR the

complete patient chart below.

ESID-main vs. ESID-subregistries

ESID Main Registry & Subregistries

ESID Main Patient Registry

CVID Subregistry

DGS Subregistry

NBS Subregistry

XLA Subregistry

HIGM Subregistry

SCID Subregistry

Neutropenia Subregistry

...additional Subregistries

TheDGS

Subregistry

Time scheduleJune 15th, 2004 ESID main registry onlineOctober 2004 CVID subregistry onlineOctober 2004 DGS subregistry onlineOctober 2004 IPEX subregistry onlineJanuary 2005 NBS subregistry onlineJanuary 2005 ICF subregistry onlineFebruary 2005 HIES subregistry onlineFebruary 2005 ICOS subregistry onlineFebruary 2005 drug-induced hypogamma online

Summer 2005 SCID subregistry TEST onlineSummer 2005 XLA subregistry TEST onlineSummer 2005 HIGM subregistry TEST onlineSummer 2005 IgAD subregistry TEST online Summer 2005 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

TheCVID

Subregistry






Color coding active






[+]

and

[?]






Color coding active






TheIPEX

Subregistry

ESID Mutation Web Service






Color coding active


Report-generation Tool 06/2005









Color coding active






please send an Email to:[email protected]






Color coding active






Documentalist/Physician/User

Web Application

Patient List (PL) coded Data (cD)

Accesses Web App Sends data collectionto user

WebApp retrieves patient data from the PL Database

WebApp retrieves data from the cD Database

DB Server 1 DB Server 2

Application Server

Firewall 1 Firewall 2






Color coding active






7875

20

11 10 9 8 6 4 4 3 2 10

10

20

30

40

50

60

70

80

90

Center

Nu

mb

er o

f P

atie

nts

total number of patients: 231

Number of Patients per Documenting Center

105

27

12 12 9 8 7 7 6 6 5 4 4 3 3 3 2 2 1 1 1 1 10

20

40

60

80

100

120

CVID

CGD x-

linke

d (C

YBB)SCN

HIGM

unk

nown

CD 40L

unkn

own

PID AIDIL

7RBLN

K

µ-ch

ain d

efici

ency

ICO

SLA

D1

Diagnosis

Nu

mb

er

of

Pa

tie

nts

Number of entries per diagnosis

58%

6%10%

1%

23%

2%

Predominantly Antibody Disorders Predominantly T-Cell Deficiencies

Phagocytic Disorders Complement Deficiencies

Other well defined PIDs Unclassified PIDs

Subregistries

Info for ESID members

Bonus system:

Compensation for secretarial assistance (EUR 10 per patient per year if documented by Jun.30th, 2005)

Publication award 2005 of max. EUR 15.000 for the best publications using data of the ESID Registry

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

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 .....

The database network

taking clinical patient registries to the next level .....

Bodo Grimbacher, MDUniversity Hospital Freiburg

Head of ESID patient [email protected]

Progress report of the ESID online registry Bodo Grimbacher, MD Head of ESID patient registries .

Documents