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Process Involved in Planning and Conduct of Diabetes Clinical Trial
 

Process Involved in Planning and Conduct of Diabetes Clinical Trial

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    Process Involved in Planning and Conduct of Diabetes Clinical Trial Process Involved in Planning and Conduct of Diabetes Clinical Trial Presentation Transcript

    • A PRESENTATION ON INTERNSHIP PROJECT REPORT ENTITLED AS“PROCESS INVOLVED IN PLANNING& CONDUCT OF DIABETES CLINICAL TRIAL” BY Mr. ARKA MOITRA P G DIPLOMA IN CLINICAL RESEARCH & REGULATORY AFFAIRS BATCH – 2011-12 ROLL NO: PD2CRR 12-11 JADAVPUR UNIVERSITY INTERNSHIP FROM – NOVO NORDISK INDIA PVT LTD, BANGALORE
    • HIGHLIGHTS OF THE PRESENTATION• Background of selecting the topic• Activity performed during the project• Unique characteristics in conduct of diabetes clinical trial• Schematic presentation of whole conduct and progress of a clinical trial• Features of site monitoring visitPGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 2
    • BACKGROUND OF SELECTING THE TOPIC• Sponsor level project• Sponsor responsible for planning and conduct of a clinical trial• Novo Nordisk perform only diabetes clinical trial since they deals with insulin or insulin related product PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 3
    • ACTIVITY PERFORMED DURING THE PROJECT• Involved in two new trial at initial phase of conduct• Customization of ICD as per Indian regulation• Translation process for ICD and other document which meant to be submitted to the subjects• Collecting and compilation of essential documents required before initiation of clinical phases through communicating with site coordinators PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 4
    • ……CONTINUED• Preparation of EC submission dossier for EC approval• Site monitoring for ongoing trial• Preparation of monitoring visit report PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 5
    • UNIQUE CHARACTERISTICS IN CONDUCT OF DIABETES CLINICAL TRIAL• Indentifying potential investigators based on their prescribing pattern and choice of insulin or insulin related product• Tracking of SMPG value through subject diary• Special protocol defined guideline for intention to treat study designPGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 6
    • 7PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA
    • 8PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA
    • FEATURES OF SITE MONITORING VISIT• Preparation monitoring visit o Freezing of resolved query of last monitoring o Generation of drug accountability sheet o Reviewing last monitoring visit findings• Activity during monitoring o Temperature monitoring of trial product, generation of query if deviation o Source data verification, tallying eCRF data with original source document and laboratory findings, generation of query if deviationPGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 9
    • ……Continued o Drug accountability of used, returned and unused trial product after randomization as per system generated sheet o Stock checking of fresh trial product o Reviewing the investigator trial master file for all the essential documents as consistent with the course of the study o Debriefing meeting with investigator to highlight the monitoring activity, to discus the issues and raised queries and ask for clarificationPGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 10
    • …..Continued• Post monitoring activity o Preparation of monitoring visit report o Forwarding a follow up letter to the site stating the findings and mentioning the timeline to resolve the queries PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 11
    • THANK YOU!PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 12