. "0"^^ . . "2014-03-25+01:00"^^ . "clinical trials; investigator-initiated trials; pharmacovigilance; data management"@en . "2015-02-16+01:00"^^ . " investigator-initiated trials" . "1"^^ . . "1"^^ . "1"^^ . . "1"^^ . . "Vybudov\u00E1n\u00ED infrastruktury podporuj\u00EDc\u00ED nastaven\u00ED, prov\u00E1d\u011Bn\u00ED a anal\u00FDzu mezin\u00E1rodn\u00EDch akademick\u00FDch klinick\u00FDch hodnocen\u00ED a klinick\u00FDch studi\u00ED v\u00A0r\u00E1mci \u010Cesk\u00E9 republiky vytvo\u0159en\u00EDm koordina\u010Dn\u00EDch center na univerzit\u00E1ch a jejich propojen\u00EDm s\u00A0klinicko-v\u00FDzkumn\u00FDmi jednotkami v\u00A0jednotliv\u00FDch zdravotnick\u00FDch za\u0159\u00EDzen\u00EDch cestou n\u00E1rodn\u00EDho koordina\u010Dn\u00EDho centra a t\u00EDmto zapojen\u00ED do evropsk\u00E9 v\u00FDzkumn\u00E9 infrastruktury ECRIN. Zejm\u00E9na se jedn\u00E1 o podporu vytvo\u0159en\u00ED prost\u0159ed\u00ED pro systematick\u00E9 a spr\u00E1vn\u00E9 veden\u00ED IIT projekt\u016F v\u00A0souladu s\u00A0po\u017Eadavky legislativy a relevantn\u00EDch guidelines, vytvo\u0159en\u00ED s\u00EDt\u011B konzultant\u016F a profesion\u00E1l\u016F schopn\u00FDch zajistit kompletn\u011B nebo se pod\u00EDlet na vytvo\u0159en\u00ED dokument\u016F nutn\u00FDch k\u00A0zah\u00E1jen\u00ED, pr\u016Fb\u011Bhu a \u0159\u00E1dn\u00E9mu ukon\u010Den\u00ED IIT projekt\u016F. Aktivn\u00ED pomoc s\u00A0p\u0159\u00EDpravou kompletace dokumentace pro pod\u00E1n\u00ED \u017E\u00E1dosti o povolen\u00ED projektu IIT na regula\u010Dn\u00ED autority a EK. Vytvo\u0159en\u00ED systematick\u00E9ho vzd\u011Bl\u00E1vac\u00EDho programu pokr\u00FDvaj\u00EDc\u00EDho co nejkomplexn\u011Bji problematiku IIT projekt\u016F dostupn\u00E9ho \u0161irok\u00E9mu spektru \u00FA\u010Dastn\u00EDk\u016F. Konzulta\u010Dn\u00ED \u201Epr\u00E1vn\u00ED servis\u201C v\u00A0oblasti IIT projekt\u016F v\u010Detn\u011B problematiky poji\u0161t\u011Bn\u00ED odpov\u011Bdnosti, etick\u00FDch aspekt\u016F, Konzultace nastaven\u00ED proces\u016F pro spr\u00E1vn\u00E9 zaji\u0161t\u011Bn\u00ED reportingu a sledov\u00E1n\u00ED AEs/SAEs, podpora aktivn\u00EDho zapojen\u00ED do proces\u016F farmakovigilance." . " pharmacovigilance" . "Set up of the infrastructure supporting the setting, implementation and analysis of international academic clinical trials and clinical studies in the Czech Republic by creating coordination centers at universities and linking them to clinical research units in various health care facilities through the National Coordinating Center and active involvement in European research infrastructure ECRIN. In particular, support to create an environment for systematic and proper management of IIT projects in accordance with the requirements of relevant legislation and guidelines, creating a network of consultants and professionals who can provide a complete or participate in the creation of documents necessary to initiate, conduct and proper completion of projects IIT, active assistance with the preparation of documentation for the completion of the application for approval of the project to IIT by regulatory authorities and the European Commission. Create a systematic training program covering the most complex issues IIT projects available to a wide range of participants, consulting %22legal services%22 in IIT projects including the issue of insurance, ethical aspects consultation, process set up to ensure proper reporting and monitoring of AEs / SAEs, promoting active involvement in the processes of pharmacovigilance."@en . . . "LM2013034" . . . "clinical trials" . . . . "2014-01-01+01:00"^^ . . . "Projekt CZECRIN v r\u00E1mci budov\u00E1n\u00ED \u010Desk\u00E9 \u010D\u00E1sti v\u00FDzkumn\u00E9 infrastruktury pan-evropsk\u00E9ho v\u00FDznamu v r\u00E1mci Evropsk\u00E9ho konsorcia pro v\u00FDzkumnou infrastrukturu (ERIC)" . . "http://www.isvav.cz/projectDetail.do?rowId=LM2013034"^^ . "2017-12-31+01:00"^^ . "Project CZECRIN within the building of the Czech part of research infrastructure of pan-European importance within the European Research Infrastructure Consortium (ERIC)"@en .