1. 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

2. 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 visit
PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA
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3. 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
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4. 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
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5. ……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
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6. 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 design
PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 6

7. 7
PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA

8. 8
PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA

9. 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 deviation
PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA
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10. ……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 clarification
PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA 10

11. …..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
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12. THANK YOU!
PGDCRRA 2011-2012 / JADAVPUR UNIVERSITY / ARKA MOITRA
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