CLINICAL DATA-MANAGEMENT OR MANAGEMENT OF CLINICAL DATA
The Clinical Data Management is the research activity to ensure data quality and thus make it usable for the purpose of statistical analysis.
The hospital management data includes all means to design databases of clinical studies creating an environment for consistency, control, security and integrity of patient data.
Its main objective is the creation of an Electronic Case Report Form (e-CRF): an electronic observation notebook for collecting biological and medical knowledge whose purpose is to improve health in humans.
The purpose of the data manager (= Data-Manager) is to computerize the information “papers” of clinical research, structuring them in a database, to verify whether they are consistent and to prepare them for analysis statistical.
Throughout his mission, the data manager works with the Promoter (Director Legal and Administrative) of the study, with the coordinating investigator (physician), the Research Associates Clinic (CRAs), study Technicians clinic, Biostatistician the pharmacovigilant.
Integration of the Data Manager in GIRCI-GO Network
In May 2005, the Ministry of Health launched a tender with a view to creating interregional structures of clinical research, which leads to the creation of seven Dirc (Interregional Delegation for Clinical Research) on French territory.
At the end of 2012 the Dirc becomes GIRCI (Interregional Group of Clinical Research and Innovation) which aims organizing continuing education for professionals involved in research, support for achieving certain missions specific promoter and assessment of institutional research programs and accompanying certification teams and hospital clinical research facilities.
In 2006, the network Biostatistics – Data Manager – Methodological advice is implemented and coordinated by the University Hospital of Tours, this network aims to contribute to the planning and analysis of prospective studies, to professionalize the activity of data management and ensure quality outcomes databases of clinical trials.
In 2012, the integration of cancer structures in data management network has to have a common information system for all the institutional structures of the Great West.
Management uses the data in the life of every day, of patient data subject to regulation. Thus the data are protected and no one can have access except those involved in the clinical study.
The e-CRF must comply with the regulations of the CNIL (Commission Nationale Informatique et Libertés), created by the law No. 78-17 of 6 January 1978 and amended on 6 August 2004. this commission is responsible for ensuring that information technology is at the service and it does not affect in the human identity, human rights or privacy or individual or public liberties.
The American agency FDA (Food and Drug Administration), founded in 1906, is responsible for pharmacovigilance is to say, it controls and regulates drugs before marketing. The FDA notes that the use of computer technology would become widespread, to minimize the risks associated with the use of new technologies and prevent the risk of fraud. Thus in 1997, it issues regulations 21 CFR Part 11, which states that electronic records and signatures will be considered equivalent to records in paper form and handwritten signatures. This regulation therefore applies to all electronic records are created, modified, maintained, archived, retrieved or transmitted under cover of any rule issued by the FDA (Pharmaceuticals, Medical Devices, Cosmetics). 21 CFR Part 11 therefore seeks to ensure the authenticity, integrity, confidentiality and data continuity, as well as the authenticity of signatures. In order to allow both the equivalence of the electronic regulatory registration with the regulatory paper record.
Finally, throughout its mission, the data manager must ensure to always respect the CNIL guidelines on the management of personal data and regulations on medical research projects.
The data management software environment
The software CLINSIGHT
CLINSIGHT is a complete data management software that includes all stages of the implementation of a clinical trial.
The software has 12 different applications that enable the capture, randomization, study design, consistency tests, medical coding and import / export data. It also allows CRAs to monitor the conduct of the study through a remotely accessible Web site. To meet the regulations, CLINSIGHT respects the recommendations of the FDA regarding the Computerized Systems for the management of clinical trials.
The steps for setting up an Electronic Case Report Form (e-CRF)
A Clinical study is an applied medical research project whose aim is to improve the health of patients. Conducting a study requires a significant collection of data to be able to capture, monitor and validate.
The e-CRF will then allow to meet its needs and questions: the drug he improves patient health? Is the diagnostic method considered more effective? Is this new medical equipment performance …?
Transfer all data CRF paper to e-CRF provides better data quality through automatic consistency checks when entering a verification of input data formats and immediate verification at the onset side effects. The e-CRF also optimizes traceability information via the Audit Trail. Indeed, an electronic signature is required at each action on the data, any connection is recorded and accompanied by the details of action taken.
In the end, the FIU-improving the availability, accessibility and traceability of information from the clinical study.
First, the coordinating investigator transmits the data manager on the clinical study protocol, CRF and a paper designed previously by CRA coordinator. This will allow the database manager to create an e-CRF to collect all medical information necessary for research. Then it will check the data entered into the database by setting the controls to test the presence and consistency of the data, this will prevent some input errors clinical data. Finally, he made a review of actions to check the database and provides a quality assessment of this database before sending the statistician for analysis.
CNIL and Medical Research
Presentation of the MR-001
The reference methodology MR-001 is a procedure used to facilitate reporting of data processing, in clinical trials, with the CNIL (Commission Nationale Informatique et Libertés). It precisely defines the type of data collected and terms of conduct and analysis of the studies.
The sole purpose of processing personal data is the achievement of medical research:
Biomedical research on drugs.
Therapeutic studies, drug or not.
Pharmacogenetic / pharmacogenomic studies.
Retrospective or prospective studies of genomics and proteomics fitting into the context of biomedical research.
The document consists of two parts: one devoted to data of patients participating in biomedical research, and the second to integrate data from investigators and other professionals involved in the implementation of biomedical research.
Non biomedical or biomedical research does not meet the criteria of the MR-001 should follow other declarative approaches:
request for an opinion.
request for authorization in medical research.
request for authorization evaluation of care practices.
Then take contact with the Computing and Liberties Correspondent CHU Poitiers
The Research Information System is a national decision-making system implemented
in all CHU, the PBC and some CH (78 schools to date).
The application of the CRS used to provide indicators for the allocation of
Modular MERRI share of financing (Missions Education, Research,
Reference and Innovation) up to 67.5% for 2010 (57.5% for SIGAPS
and 10% for SIGREC)
You can go to step 2 “Validation of Publications.”
(nb: Lost your password / you want to create a SIGAPS account, log r to http: // sigaps on the host interface in the blue square in the upper right click on “request an account / password lost”.)
VALIDATION AND EXPORT
VALIDATION AND EXPORT
After managing your connection, you get on your configuration interface, the number of publications to validate indicated. Click “View.” Your list appears to validate it only remains to confirm the publication by checking “yes” or refute the publication by checking “no”.
Do not forget to check the box “Accept” at the end of your validation so that it is taken into account.
(Note: If you mess up and check one by mistake and you commit this error, contact the administrator with the exact reference of the publication in order to initialize your account.)
Export is defined as a return of data CHU Poitiers to the national server of the department that requests it. The final export took place in October 2015
Therefore, it is important that everyone can check his publication list before each export.
MAKE AN ANALYSIS
KNOW THE SIGAPS CLASSIFICATION REVIEW (A-B-C-D-E-NC)
Log into your account SIGAPS
In the horizontal menu, click “SIGAPS” and “Documentation”, the following interface appears:
Click “Access to the classification of the journals” and search for the desired magazine (search by title or discipline)
T2A mission and DGOS set up, in addition to three indicators (publications, patents, students) currently used in the endowment of the modular part of MERRI, a specific indicator for clinical trials managed by the SIGREC software.
SIGREC “System Information and Research Management and Clinical Trials” is set up at Poitiers University Hospital since 2009 and accessible via the SIGAPS interface with the same usernames and passwords.
Each promoter must reference its trials. The system is interconnected to the national level, the exhaustive survey of all clinical trials is conducted; each school can then check their participation.
This software allows to identify clinical trials in 3 types of promotion:
Eligible institutional developers to MERRI (CHU-CHU, PBC, FEHAP institutions)
Private industrial developers (pharmaceutical laboratory, medical device manufacturers)
In 2009, the seizure of records and information inclusions were a load of DRC. The 2009 export resulted in the birth of three indicators: a Clinical Trial Score, a score of Inclusion Promoter Score and Inclusion investigator. respective point values are 1816 and 363 263 euros for the 2008 allocation.
This year, like the SIGAPS software, data validation by a write access will be given to investigators to ensure their participation in studies reported by hospitals. In addition, it will allow them to declare their inclusions, add speakers and modify aspects of the project progress. Rights will also be open to Clinical Research Associates (CRAs) but to TECs and Nursing Research that will regularly update the national database for the investigators concerned. These entries will be those that will be taken into account in calculating SIGREC score and that will determine the MERRI envelope.
Regarding academic studies “cooperative groups, scholarly society” will be gradual insertion of SIGREC, we await the directives of the Ministry about it.
An operational unit was set up within the Directorate of Research and Innovation to help investigators, Arcs, technicians and research nurses. Beforehand, a census information will be requested at the research staff by individual interviews concerning studies, this will also provide initial training in the use of the software and regular and imperative entry.
The software is SIGREC quantify and map all biomedical research, conducted in the care of establishements engaged in research axis. The general principle is to compile the common data centers (in red) and specific data (blue).
The developer is in charge of administrative and regulatory information.
The entry of inclusions is made by the investigators, CRA / TEC / FDI as and inclusions.
The graphic data inclusions are visible for all stakeholders related to a study.
Connect to SIGREC
The portal site is safe for now in local mode subjected to identification (username / password).
These passwords are common to applications SIGAPS / SIGREC
SIGREC rights are awarded to professionals of the University Hospital of the time they are identified as interveners (principal investigator, coordinator, TEC-TRC, IDE) on a study, based on the rights they can access SIGAPS or SIGREC .
Entering SIGREC inclusions
N³Lab and clinical research
The unit “Neuromodulation and Neural Networks Lab” (N³Lab) is located at the University Hospital of Poitiers. The N³Lab is a clinical research laboratory to study and promote research neuromodulation nerve networks.
We have developed a software acquisition pains function paraesthesia and dermatomes in patients suffering from LRPO.
3 patents were filed jointly on behalf of the Poitiers University Hospital by Professor Farid GUETARNI and Rigoard:
Patent-1 device and method of evaluation and monitoring of physical pain
Patent-2 device and method for evaluating neurostimulation devices for analgesic
Patent-3 process and mapping system, method and system for evaluating the effectiveness of spinal cord stimulation
This tool allows viewing and collecting stimulus data “live” in the operating room, through the use of integrated room block and a technique of minimally invasive surgery being published.
Study EMVOLS : Pr Christophe JAYLE
: Evaluation Médico-économique de la prise en charge des VOLets thoraciques entre traitement médical et traitement chirurgical par raccords 3D Stracos®
Mis en en place d’un circuit de gestion des données intégrant des auto-questionnaires développés sur support mobile indépendant (Pascal BLOUIN)
During Data-Management / Biostatistics / medico-economy
VIRTUAL BUSINESS 2015-2016- Master 2 “Physiological Engineering and Informatics”
Mission Team Project : Propose an ergonomic and intuitive solution for automating the integration of CRFs and optimize the development time of Data-Managers of the establishment.
This solution will be developed by the virtual company ICE.
From left to right : Maeva FERRIER-William BRI-Juliette VERNAULT-Margaux HERVOUET-Sarah GARNIER-JUlien BRAULT
TRAINEES 2015 :
Anne-Sophie FOURNIER: Master 2 “Physiological and Computer Engineering”
Title of course: “standardization of clinical trial management process: the implementation of a centralized software the practice”