Special Technical Specifications
DEVELOPMENT AND MAINTENANCE OF A REGISTRY OF CLINICAL
DATA AND ASSOCIATED SERVICES IN THE FRAMEWORK OF THE
EUROPEAN PROJECT NEUROPED
Coordinator: Hospices Civils de Lyon
1.1 The nEUroped Project
The HOSPICES CIVILS DE LYON are the coordinator of the nEUroped project
funded by the European Commission (Executive Agency for Health and
The “European Network on Rare Pediatric Neurological Diseases” (nEUroped) is a
project, funded by the European Union Public Health Program 2007, from April
2008 to March 2011.
nEUroped aims at improving diagnosis, management and dissemination of
information for rare neurological disorders in children characterized by
The Steering Board of the project (represented by HCL) wishes to develop the
nEUroped registry to collect the clinical information of the European patients
affected by three categories of disorders: Alternating Hemiplegia of Childhood
(AHC), Narcolepsy (NAR) and a subgroup of disorders with epilepsy that may be
treated surgically (*) that will be referred in this document as RSTES (Rare
Surgically Treatable Epileptic Syndromes). The major common characteristic of
all the above rare disorders is the presence of paroxysmal attacks.
The Registry Template defines the list of the items to collect in the nEUroped
Registry for each disease and how they are organized.
The nEUroped registry is the basic IT infrastructure supporting the nEUroped
Network, established by the nEUroped project. The Network brings together
patient organizations, clinical centres, research groups, and other interested
parties across Europe.
Thus the nEUroped registry will expected to become an IT model for the
information processing and sharing in the healthcare and research area for
several rare paediatric neurological diseases: as such it should be designed to
eventually easily include in the future the clinical information on similar
In this framework, HCL (the Customer) launch the following call for tender,
whose subject is the development of the nEUroped Registry, under the nEUroped
project, and its management and maintenance for three years.
* Landau-Kleffner Syndrome, Sturge-Weber syndrome, Rasmussen’s
encephalitis, Hypothalamic Hamartomas, Cerebelar hamartomas
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POSITION 1 : The nEUroped Registry Provider
The nEUroped Registry Provider (the Provider) will develop the nEUroped registry
application and provide the hosting and maintenance services for three further
A1 – Introduction
The nEUroped registry will be developed according to the Technical
Specifications and Requirements detailed in this document.
The nEUroped registry consists of a set of interconnected Registries for the
following initial group of three rare child neurological diseases:
• Alternating Hemiplegia of Childhood
• Rare Surgically Treatable Epileptic Syndromes (RSTES), which is a sub-
group of homogeneous diseases (Landau-Kleffner syndrome, Sturge-
Weber syndrome, Rasmussen’s encephalitis, Hypothalamic Hamartomas,
The nEUroped regsitry shall be designed in such a way that a new interconnected
Registry can be easily developed in the future, for any new rare neurological
disease that will be integrated in the nEUroped Network.
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A2 - General Description
The nEUroped registry consists of a set of relational databases to be accessed,
managed and maintained by means of a suitably developed website (application
website). Registered users, identified by username and password, will access the
registry by means of a secured system in order to perform the following
operations, according to their specific authorization:
• Definition, modification and deletion of user profiles.
• Input, retrieval, modification, deletion, validation and sharing of the
data of the patients affected by one of the abovementioned diseases.
• Search and simple statistical analysis of the shared data, whose results
can be extracted, displayed, printed and saved on file in the specified
A3 - Privacy Protection Requirements
The characteristics of the data contained in the nEUroped data base require the
fulfilment of the current EU legislation concerning the treatment of personal
data (specifically, the information about health condition), with special attention
to the contents of the directive 95/46/EC of the European Parliament and of
the Council of 24 October 1995 on the protection of individuals regarding the
storage and movement of personal data, enclosed to this Call for Tender.
Should the current EU legislation on the treatment of personal data, even
anonymous, require the possession of specific permissions or authorizations, the
Provider is required to have such permissions or authorizations obtained at its
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A4 - Technical Specifications of the Website
• The website shall be developed in English only.
• The domain name is www.registry.neuroped.eu, created inside the
neuroped.eu domain, which already exists and is the property of the
• The characteristics of the data contained in the nEUroped registry require a
secure (https) Internet connection and a valid protection certificate.
Users shall access the nEUroped registry by means of secured systems, whose
supply is part of this Call for Tender.
The website structure shall include the following areas:
o User identification.
o Administration and management.
o Disease-specific home pages.
o Data consultation, search and reporting.
o Data entry, updating, validation and sharing.
• The website shall be organized in such a way as to easily add new disease-
specific home pages and the related data entry, updating and validation
The website graphics will be designed by the Provider and proposed to the
Steering Board for validation. Each page shall however include the nEUroped
project logo, the European flag and statements: "This registry arises from the
nEUroped project which has received funding from the European Union, in the
framework of the Public Health Program 2008-2013".
• The customer will provide the logo file and the text and formatting
directions of the project statements.
• The website shall be designed for a screen resolution of 800 x 600 pixels or
• The latest versions of the most popular Web browsers currently available for
Microsoft®, Linux® and MacIntosh® operating systems shall be supported.
Installation of client-side additional software modules should be avoided.
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A5 - Technical Specifications of the Databases
The relational databases which make the core of the nEUroped registry shall be
developed according to the following specifications.
A5.1 – Database Organization
A set of 3 databases shall be developed, one for each rare disorder (or group of
disorders) listed in Section A1. A fourth database shall accommodate user data
and profiles and any other non disease-specific information required by the
structure of the nEUroped registry.
Each disease database consists of a set of common items (i.e., data common to
all diseases) and a set of disease-specific items.
In order to achieve a common structure, all items are labelled according to a
scheme that the Customer will supply to the Provider.
In other words, the same labels identify items common to all diseases, while
different labels identify disease-specific items. This approach allows for a
straightforward extension of the nEUroped registry to other rare diseases as well
as for easy modification of each item.
A5.2 – User Data and Profiles
Each user shall access the nEUroped registry through a common login page, by
entering a username and a password.
Any additional security system for the user authentication (smart card, etc) will
be considered an important enhancement.
Different user profiles may be created with different access rights
(read/consult; write/edit; search/report) to the patient data.
When a new user account is created, it will be assigned the following attributes:
• User profile(s): default user profiles to be implemented are (1) data
entry; (2) search/analysis; (3) administration/management.
• The beginning and expiry dates.
Each user may have several associated user profiles.
Only the administration/management users can create new user profiles and
accounts and are always entitled to all access rights.
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A5.3 – Patient Data
The Registry Template defines the list of the data items to collect in the
nEUroped data base for each disease and how they are organized.
The corresponding entered data are the actual values of the instances of the
items in the database.
The Items in the Template
Each item is defined by the following information:
2. Descriptions: a short description and a long description to be displayed as an
3. Data type
- Boolean (true/false)
- Predefined (to be selected from drop-down lists allowing single or
4. Attributes (common/disease-specific; required/optional; automatic/manual)
5. Default value (when applicable)
6. Check rules (to be activated when applicable on data entry, either by the
user or automatically)
The Template will be provided by the Customer, as well as all the information
related to each item.
The Customer will provide also the check rules and the rules to calculate the
value of a data according to the values of one or more related data.
The structure of the Template
The items in the template are grouped into a number of data categories: (1)
general/anamnestic, (2) genetic, (3) neurological, (4) cognitive and
neuropsychological, (5) social and quality of life.
Under this Call for Tender only the items of the first four categories, for all the
three diseases, will be completely defined and the corresponding data collected
in the nEUroped registry.
However the nEUroped registry must be designed so that new categories, as well
as new items in a category, can be easily added (and the corresponding data
entered, validated and searched), as a maintenance activity.
A category is composed of a number of sections and a section is composed by a
number of sets of items.
The sections in the neurological category are: neurological symptoms;
treatments; investigations; misc.
The sections in the genetic category (when applicable) are: family data; genetic
information; family tree (to be built graphically and described by a suitable set
The data for all the items related to a single patient are collected in a patient
Patient records include a general section and zero or more follow-ups.
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Updating of data in the follow-up sections should be possible in a way to preserve
pre-existing data and allow follow-up of evolution.
Each set of items will therefore be labelled with a time stamp, corresponding to
the date of the follow-up observation.
A5.4 - Coding schemes
As required by the current EU legislation concerning the treatment of personal
data and the ethics recommendations about the privacy of patients whose health
data are used for research, patient records must be referenced in the nEUroped
registry only by an anonymous alphanumeric code.
The logical link to the personal data of the patients (kept in a repository
separate from the nEUroped data base) is achieved by a specific user-defined
Therefore both the internal and the user-defined coding systems must be
Both coding systems shall protect the anonymity of patients, yet allow the
authorized users to univocally identify each patient and perform the following
• Enter the data of new patients.
• Retrieve the data of registered patients, using the patient code as search
• Add, modify and delete all or part of the data of registered patients.
• Delete a whole patient record.
A6 - Workflow management
The basic workflow for a patient record shall include the following
activities/states, for all the diseases:
• Create: creation and coding of a new patient record
• Edit: insertion, modification and deletion in the private workspace
• Share : moving from the private to the public workspace (record
available for search and export )
More complex, predefined workflows (review, validate, ..) will be evaluated by
the nEUroped Steering Board according to their actual adherence to the specific
needs for the nEUroped Registry.
In general, the possibility, for a management/administration user, to customize
the basic workflow adding any further states, linear or conditional, will be
considered a plus.
Also the possibility to define a different, specific workflow for each disease, will
be positively evaluated.
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A7 - Search and Statistical Analysis
Authorized users/user groups will search the nEUroped Registry by means of
suitably designed web pages, according to the following steps:
• Selection of one or more diseases
• Selection of one or more categories
• Selection of items among the selected diseases/categories, both common
• Definition of relational (AND, OR, NOT, IN, etc.), comparison (equal to,
different from, greater than, etc.), and aggregation (sum, maximum,
count, etc.) criteria. The Customer will provide the lists of relational,
comparison and aggregation criteria.
• Definition of comparison values if required (e.g., the number of years a
given drug has been taken, etc.).
Since search criteria may include both common and disease-specific fields and
may be performed on one or more diseases, search results must be properly
extracted and presented.
Suppose a search is defined to select “all patients where common field C.21 = 10
and all patients of disease B where specific field B.12 > 20”.
The results shall include all patients from all diseases whose records satisfy the
first criteria and the patients of disease B whose records satisfy the second
criteria (discarding duplicates if any). Each row of the resulting record set shall
always indicate the disease.
Search results shall be:
• Displayed in suitably designed web pages
• Printed, if required by the user
• Saved on a file to be downloaded, if required by the user.
The Customer will provide the required data and file formats (default formats:
MS Excel and CSV).
Simple statistical analysis (e.g., calculating the percentage of patients who have
taken a given drug for a number of years) is considered a plus. The Customer will
in case provide a list of statistical analyses.
Both for search and statistical analysis no logical check is required. Any non-
logical requests shall yield a result such as “No data satisfies the defined search
criteria.” or “The requested statistical analysis cannot be executed.”
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A8 - Data Security and Back-Up
The Provider shall adopt all the technical means available to guarantee the
maximum level of security of the data and the continuity of the service.
Periodical full and incremental back up shall be provided.
A9 - Further Specifications and Requirements
A log utility shall keep track of the history of patient records (creation,
modification, validation, etc.).
The following reports shall be provided:
• Standard reports, for management and administration purposes: number
of accesses per user/per record; number of records, per user/per state;
• User-defined reports, for data analysis and statistics purposes.
The Customer will specify the structure of both kinds of reports.
Periodic exports of the full content of the nEUroped data base will be performed
and the result made available in the nEUroped Registry to authorized users only,
in CSV format.
The data representation format will be provided by the Customer so that this
full-export file will be importable into specific tools for the data analysis (SAS,
The possibility to create a library of predefined searches to be accessed by
means of suitably designed web pages is optional but greatly appreciated.
An internal communication system (e.g., trouble ticketing, etc) between the
nEUroped data base users is considered an important plus.
A specific tool for automatic generation of templates is also considered a plus.
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A10 - Terms of Reply and Required Activities
The Call for Tender for this Position of nEUroped Registry Provider is to be
replied in English according to the terms of the “Réglement de la consultation”
and “Cahier des clauses administratives particulières”.
Applications arriving after the closing of the call will not be considered.
The reply shall display the costs and the estimated time to accomplish the
• Detailed technical analysis of the customer requirements, in
collaboration with the selected Program Manager (Position P2, see
• Development of the nEUroped Registry (databases and website) according
to the abovementioned technical specifications.
• Training course to end-users.
• Registration of the domain name and purchase of the certificate.
• Security system for access: please, give the detailed description and
costs of any provided security system in addition to username and
• Website hosting for a period of two years, beginning from a date to be
agreed upon. Please specify your general conditions for this service, with
special emphasis on service continuity, security, data protection issues,
hosting time, price.
• Maintenance of the databases for the same period defined above.
Please display also the costs of website hosting and databases maintenance for a
period of 2 more years, beginning from the expiry of the first two-year period.
Also the costs for the adding of a new disease, of a new category for an already
existing disease, and a new item for an already existing category should be
included in the maintenance costs and considered as a maintenance activity.
The availability of an on-line demo version of the Provider’s product is also
A11 – Selection criteria
The candidate to the position 1 is a well-established IT company, with a proven
experience in the development of web-based information applications and
services in the healthcare and research area.
The use of a standard middleware and application software development tools
will be considered a plus, as well as a specific experience in the development of
Extraction of data for analysis is another key point for evaluation.
An administrative and a technical contact will be always clearly identified by the
Provider during all the development process and the following regular
functioning of the Registry.
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POSITION 2 : The nEUroped Registry Program and Data Manager (The Manager)
The nEUroped Registry Program Manager
The nEUroped Registry Program Manager (the Manager) will be in charge of the
technical management of the development process for the nEUroped registry, on
behalf of the nEUroped Steering Board.
He/she will be the technical contact towards the selected nEUroped Registry
Provider (Position P1) since the very first phase of negotiation of the contract
regarding the development of the nEUroped Registry (the Contract).
The tasks of the Program Manager, to be carried out in collaboration with the
Registry Provider, are:
T1.1Normalization of the Registry Template provided by the nEUroped Steering
T1.2Detailed technical analysis of the Functionalities and Features (workflow,
user profiles, user and administration tools) to implement in the Registry;
T1.3Definition of all the technical aspects of the contract, included the schedule
for the building of the Registry;
T1.4Monitoring, testing and validation of each phase defined in the schedule for
the building of the Registry;
T1.5Regular reporting about the progress of the development work to the
nEUroped Steering Board;
T1.6Opening of the Registry for the start of its regular use.
The nEUroped Registry Data Manager
The nEUroped Registry Data Manager (The Manager) will be in charge of the
coordination and management of all the regular activities in the developed
nEUroped data base, on behalf of the nEUroped Steering Board.
He/she will be the contact for all the Registry end-users both for technical and
The Registry Data Manager will be in charge of the following tasks:
T3.1Organization of the training of the end-users, in collaboration with the
T3.2Preparation of the user documentation (Glossary, User Manual, etc..);
T3.3Technical support to the end-users, in collaboration with the Provider;
T3.4Registry Coordination and Data Management (coordination of the data
collection, workflow management and data check and integration);
T3.5User Data management;
T3.6Reporting about the activities and the content of the Registry to the
nEUroped Steering Board;
T3.7Fault analysis and reporting to the Provider;
T3.8Analysis and definition of new functionalities to be developed by the
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The candidate to Position P2 is:
CP2.1an English speaking consultant with a graduation degree in Computer
Science, or equivalent, or an English speaking clinician with a graduation
degree in medical science or equivalent,
CP2.2with a well proven experience in the development and management of
large cooperative IT systems,
CP2.3with a specific know-how in the use and management of IT clinical
CP2.4with a basic know-how in the collection and management of clinical data
A specific experience in the development of Clinical Registries for Rare Diseases
will be considered as a plus.
A specific experience in the coordination of large and distributed clinical data
collection and processing is considered a plus
Either an independent worker or an IT Consulting company, or an IT or medical
organization located in a EU country and selecting the candidate among its
personnel, can apply for P2.
In both cases, a CV of the candidate is required. In case of an applying company,
also a list of references is requested.
An estimation of the total needed hours per month, and a cost per hour is
A company applying for P1 cannot apply also for Position P2.
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