Bibliometrics unit and data management

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.

Etapes du data management

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.

Regulation

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.

Organizational chart

OrganigrammeDRC

 

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