Welcome on DIVAT website The Immunology and nephrology department of the Nantes University hospital constituted a database with the monitoring of medical records for kidney and/or pancreas transplant recipients. The associated software is called DIVAT (Données Informatisées et VAlidées en Transplantation).
After Nantes University hospital, the transplantation centers of Nancy, Montpellier, Toulouse, Necker (Paris) and Lyon were included in this cohort with the software extension via Internet, allowing the homogeneity of the multicentre network in the collection of data. The six centers established between them collaboration in order to be able :- To collect and exchange information
- To conduct clinical and epidemiological studies all together (increasing of the statistical power and better representative population)
- To communicate and exchange data and results with other academic researchers (not included in the DIVAT network)
- To construct partnership with pharmaceutical industries
The six centers decided the creation of a centralized database with a web-network :
- A central database is carried out in Nantes with an Oracle server.
- Each center created a local database.
- The data are collected by Clinical Research Assistants.
- The system is validated by an annual audit between centers: the original information on paper is compared to the information in the database.
- The queries on the centralized database can be carried out by the centers directly via internet.
=> Data are collected since 1990
ParticipantsOther centers will be able to enter in the DIVAT network. Their candidature has to receive the full agreement of the original centers. The definitive decision could be considered only after the first quality audit.
Conformity of Network DIVAT to the legal requirementsThe Commission Nationale de l’Informatique et des Libertés (CNIL) had offered a favorable opinion (09-17-2004, number n°891735, Réseau DIVAT: 10.16.618). The Network has to respect the requirements and procedures of this commission. A preliminary writing assent of the patients needs to be collected before the access to the medical record, the collection and the processing of the data. The clinical research assistant will ensure the reality of this assent before recording the patients in the database. The data of the medical record of the patient will be anonymous. A primary key preserves the anonymity of patients. The data circulates via network with encrypted mode. Each participant has coded access to DIVAT. Creation of the database on each siteThe centers have to respect the following methods : - A clinical research assistant or a nurse collects the data in real time independently from the medical team. It concerns the immunological baseline information, baseline recipient characteristics, induction treatments and parameters of the donors.
- The follow-up parameters are then collected at 3 months, 6 months, 1 year and then every year.
- All information is validated by the ARC.
- All the items must be collected according to the reference procedure in agreement with the six centers (Thesaurus). All the items are obligatory.
- Each modification is associated with a date of last modification of the base.
- The percentage of missing data can be computerized every year or on the entire database.
- Every year, 20 patients are randomized and an audit is performed between centers. A maximum of 2% is tolerated for the error rate. If this error rate is higher, the data of the last 6 months have to be recollected by the clinical research assistant.
- A delay in the collection of more than one year leads to the exclusion from the network.
Organization of DIVAT networkEach center supports its own costs of creation, follow-up and development. Property of the databasesEach center is owner of its data (free use). The database of each center is accessible on the central server by the concerned center. The direct access of the other centers is forbidden without their accordance. Each center is responsible for the quality of its data and must agree to be subjected to audits. The database is coupled with a simple statistical module which makes it possible to analyze in real time the recorded data : - Creation of a sample
- Extraction of the files
- Kaplan Meier curve
- Calculation of mean
- Calculation of Chi-square
- Comparison of means
Collaboration between centersA center can use the data for publication only after the first audit. This collaboration will have to be formalized by writing. If collaboration does not relate to the whole of the members of the Network, the collaborator centers will have to inform the other centers ( Form). Studies and PublicationsScientific work could be initiated only after the first audit of quality. - Studies and works between centers :
When work uses the totality of the database, all the centers must be informed before and give their written agreement. Moreover, the common studies have to be written and the protocols have to be addressed to all the centers ( Form). The publications will be done under the signature of the initiating center, followed by those according to the proportion of patients included in the study by decreasing order. The mention of the DIVAT quality label is obligatory is the publication. The agreement of all the centers has to collect before the publication. The property right of the results will follow the same rules. In the case of patent, a written agreement will be written in order to specify the rights of each partner.
- Studies and work by center :
- The centers can freely use their own database for studies and work. Preliminary information of the network members is obligatory. Without this information, the possibility is given to the other centers to be opposed for any publication.
- The publications will be done under the signature of the initiating center of the study.
- The property right on the results of work will belong to the initiating center.
Financial provisions and administrativeThe network members will meet at least once a year. The members can be represented by the scientific leader. The exchanges can use all the communications tools. However, a written report will be written for collaborators. These documents will be saved in Nantes hospital, which is in charge of the secretary. Withdrawal - Cancellation - End of the NetworkThe participating centers can leave the Network by observing a delay of six months. The data of this center will be removed. The members will keep the right of use of DIVAT software but will not have access to the updates. |
