Mapi Research Trust and CDISC collaborate on data and metadata standards for eCOA migrations

Lyon, France — 18 Oct 2016 – The non-profit Mapi Research Trust (MRT) and the Clinical Data Interchange Standards Consortium (CDISC©) join their efforts towards the improvement of medical research and related areas of healthcare.
Through the Collaboration Agreement established between MRT and CDISC, both organizations  provide mutual assistance to each other with the update of information and extension of their services, thus achieving their common objective to deliver unique, reliable and comprehensive information to  the entire scientific community in the field of medical research.

With the access to MRT’s PROQOLID database and facilitated contacts with questionnaires’ developers through MRT, CDISC benefits from unique, quick and streamlined information on questionnaires, ratings, and scales (QRS) and an invaluable help in the development of standards for QRS. In addition, CDISC provides MRT with expert advice on the content of the PROQOLID database which will also highlight the questionnaires for which CDISC standards are available.  “This is a natural relationship for the Mapi Research Trust as we continue to promote the integration of COAs both in Clinical Research and in Therapeutic Care.” Commented Katrin Conway, Managing Director of the Mapi Research Trust. “We believe that patients must be the heart of Health Research and Healthcare. That the lives of patients can be improved through the application of Clinical Outcomes Assessments (COAs). Working with CDISC enables the further adoption of these measures by simplifying the integration into data collection systems such as eCOA solutions and Electronic Medical Records.”

The mission of Mapi Research Trust is to promote the use of Clinical Outcomes Assessments (COAs), and encourage exchanges in the Patient-Centered Outcomes field between academics, pharmaceutical companies, and international organizations around the world. For over 25 years, Mapi has facilitated access for researchers and clinicians to nearly 4000 COAs and their derivatives (e.g. translations and e-versions) as well as to unique information on thousands of COAs through online databases of questionnaires, COA labeling claims granted by health authorities and clinical guidelines including COA recommendations (ePROVIDE platform available at https://eprovide.mapi-trust.org/).

CDISC (http://www.cdisc.org/) is a global, open, multidisciplinary organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. CDISC standards for questionnaires, ratings, and scales (QRS) include controlled terminology for test codes, test names, standard timing values, standard results for database values, an annotated CRF with the Study Data Tabulation Model (SDTM) domain variable names and SDTM and Analysis Data Model (ADaM) Supplements that describe how to organize the data in the relevant CDISC domain and standard.