BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//AGAH - ECPv5.16.4//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:AGAH
X-ORIGINAL-URL:https://dev.agah.eu
X-WR-CALDESC:Events for AGAH
BEGIN:VTIMEZONE
TZID:Europe/Berlin
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20170326T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20171029T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;VALUE=DATE:20171205
DTEND;VALUE=DATE:20171206
DTSTAMP:20260929T022900
CREATED:20190510T113738Z
LAST-MODIFIED:20190617T064226Z
UID:3086-1512432000-1512518399@dev.agah.eu
SUMMARY:Clinical Data Management in Early Phase Trials
DESCRIPTION:An introduction into the principles and strategies for PK/PD and BA/BE studies in healthy subjects and patients.\nAlso in early phase trials the ultimate goal of Clinical Data Management is to assure that data structure\, data collection and quality as well as data analysis adequately support conclusions to be drawn from clinical research. In the end high-quality data should be accurate\, suitable for statistical analysis and the structure should follow internationally accepted standards. \nQuality by design in clinical data management means a structured interplay of all relevant core documents including the trial protocol\, CRF\, DMP\, DVP\, SAP as well as the data base itself. \nHow to ensure this already in early clinical development? Our workshop wants to give an introduction into the basic principles of clinical data management starting from the trial protocol and ending with the completed data base. The workshop will offer a first insight into CDASH principles and how this helps to systematically reach a high-quality data structure. \nWho should attend? The workshop has been specifically developed for clinical investigators\, project leaders and project managers\, monitors and also for phase-I/II experienced study nurses with a certain IT-enthusiasm who want to better understand the principles of a good-quality data management and how they can contribute already in the planning phase to set-up a data structure following international principles. It covers questions relevant for industry-sponsored studies as well as IITs. \nWe are looking forward to your registration. \n\n\n\n	CONTENT \n\nContent\n\nAlso in early phase trials the ultimate goal of Clinical Data Management is to assure that data structure\, data collection and quality as well as data analysis adequately support conclusions to be drawn from clinical research. In the end high-quality data should be accurate\, suitable for statistical analysis and the structure should follow internationally accepted standards. \nQuality by design in clinical data management means a structured interplay of all relevant core documents including the trial protocol\, CRF\, DMP/DVP/SAP as well as the data base itself. How to ensure this already in early clinical development? This workshop gives an introduction into the basic principles of clinical data management starting from the trial protocol and ending with the completed data base. Participants will train the knowledge communicated in a practical example together with an experienced team of data managers. \nFurthermore\, the workshop will offer a first insight into CDISC principles\, how this helps to systematically reach a high-quality data structure and in how far this is of relevance for submission procedures. The workshop has been developed for clinical investigators\, project leaders and project managers\, monitors and also for phase-I/II experienced study nurses with a certain IT-enthusiasm who want to better understand the principles of a good-quality data management and how they can contribute already in the planning phase to set-up a data structure following international principles. It covers questions relevant for industry-sponsored studies as well as IITs. \nBarbara Schug\nPresident of AGAH e. V. \n\n\n\n\n	Programme \n\nProgramme\n\n\n\n\n08:30\n Registration\n\n\n09:00\n Welcome \nBarbara Schug\, Oberursel/Germany \n\n\n\n09:05\n Introduction into the workshop: from protocol writing to data management – how to bridge the gap? \nRelevance of study type; Interplay of persons involved from design development to practical performance and evaluation; \nspecificities of early phase trials; relevance of adequate overarching processes and quality control procedures \nBarbara Schug\, Oberursel/Germany \n\n\n\n09:30\n Interaction between trial protocol and CRF – how to specify precisely the data to be assessed? \nWhat do you have to consider while writing the clinical trial protocol with regard to CRF design? \nHow to translate the clinical trial protocol into the CRF; Different types of CRF structures; Points to consider during \nCRF set-up: accurate questions\, clearly specified CRF entry fields\, logical data collection; how to realize “ease for use” \nJuliana Brudel\, Erfurt/Germany \n\n\n\n10:30\n Structured interplay of all relevant core documents including the trial protocol\, DMP and DVP \nDescription of responsibilities and tasks in DMP with regard to information flow between involved parties (e. g. for PK analysis\, SAE reconciliation) and data transfers from different sources to the target data base\, including the medical coding process. Data cleaning (CRF related) and validation (electronic data transfers) processes based on DVP. \nManfred Wargenau\, Düsseldorf/Germany \n\n\n\n11:30\n Break\n\n\n11:45\n Introduction into CDISC standards \nAn introduction into basic principles \nDagmar Kottig-Roth\, Darmstadt/Germany \n\n\n\n12:45\n Break\n\n\n14:00\n Practical Exercise \nDevelopment of CRF module for different data types; consideration of data standards for data base structure; \ndevelopment of mock tables for statistical evaluation \nJuliana Brudel\, Stephan Herrmann\, Erfurt/Germany \n\n\n\n15:45\n Break\n\n\n16:00\n Data Standards for clinical data: preparation of CDISC data for submissions to regulatory authorities \nUnderstanding regulatory review processes of CDISC data depending on regulatory authorities and kind of trials; \nRegulatory review environment: How are CDISC data processed at the agencies and what are standard review processes for CDISC data; Relevance of traceability from data collection to analysis; What can we learn from the regulatory review process for the data standards collection \nDagmar Kottig-Roth\, Darmstadt/Germany \n\n\n\n17:00\n Summarising discussion\n\n\n17:15\n End of Workshop\n\n\n\n\n\n\n\n	Programme Committee / Speaker \n\nJuliana Brudel\nHead Data Management at SocraMetrics GmbH\, Erfurt\, Germany\nStephan Herrmann\nHead Electronic Data Capture at SocraMetrics GmbH\, Erfurt\nDagmar Kottig-Roth\nPrincipal Data Standards and Governance Manager\, Global Clinical Data Sciences at Merck KGaA\, Darmstadt\, Germany\nBarbara Schug\nManaging Director at SocraTec R&D GmbH\, Oberursel and at SocraMetrics GmbH\, Erfurt\, Germany\nManfred Wargenau\nCEO\, Principal Statistician and Pharmacokineticist at M.A.R.C.O. GmbH & Co. KG\, Düsseldorf\, Germany\n\n\nTorsten Petsching\nTeam Leader Clinical Data Standards Group at Boehringer Ingelheim Pharma GmbH & Co. KG\, Biberach\, Germany\n\n\n\n\n\n	Organisation \nAttendance Fee\n\n\n\n450€\nNon Member\n\n\n320€\nMember of AGAH or of DGKliPha or Junior Scientist up to the age of 30\n\n\n\nThe participation fee is per person. Please note\, according to §4 para 22 German turnover tax law\, registration and workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e. V. All bookings are subject to change \nRegistration Deadline: November 28\, 2017 \nA certification (CME – continuing medical education points) of the medical association Hessen is requested. \n\n\n\n\n	Workshop Venue \nDas Spenerhaus\nHotel und Tagungszentrum am Dominikanerkloster\nDominikanergasse 5\n60311 Frankfurt am Main/Germany\nWeb: www.spenerhaus.de \n\n\n\n\n	Contact & Registration  \nCSi Hamburg GmbH\nGoernestraße 30\n20249 Hamburg/Germany\nPhone: +49 40 30770300\nFax: +49 40 30770301\nEmail: agah-meetings ( a t ) csihamburg.de \nRegistration_Form_AGAH_Workshop_05_12_17 \n\n\n\n\n	Contact \nArbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH) e. V.\nSekretariat / Mitgliederverwaltung: Goernestraße 30\n20249 Hamburg/Germany\nPhone: +49 170 7844438\nEmail: info ( a t ) agah.eu\nWeb: www.agah.eu · www.studynurse.de
URL:https://dev.agah.eu/event/clinical-data-management-in-early-phase-trials-2/
LOCATION:AGAH Workshop\, Frankfurt\, Deutschland
CATEGORIES:Training
END:VEVENT
END:VCALENDAR