Document Sample



FEBRUARY 23 - 28, 2009


                                          Harpreet Singh
                               [Type the company name]
Objective: ICMR Workshop on Clinical Data Management
ICMR has established nine biomedical informatics centers. These centers are established in institutes
which have access to patient and clinical data. One of the objectives of these centers is to develop and
support databases of specific clinical findings and transforming these databases into new methodologies
and solutions for the prevention and amelioration of diseases of national importance. In order to
achieve this objective there is a need to increase awareness and sensitize the staff of our biomedical
informatics centers about the patient and clinical data, how this data can be organized, interlinked and
converted to applications. In this context we have planned a series of workshops focusing on
development of clinical data repositories, integration of clinical data with biomedical data and probable
applications of clinical data. Some of the key targets that can be achieved through these workshops

    1. Creating next-generation electronic patient records, standards for patient-centric care, clinical
       practices, and public health
    2. Linking of databases for discovering associations between clinical evidence, genetic information,
       and environmental factors
    3. Improving biomedical knowledge representation

The first workshop in this series is intended to provide an overview of statistical procedures used in
analyzing clinical data, types of clinical data, how this data can be organized, what are standards and
issues associated with developing clinical data repositories, what is the impact of clinical databases on
public health and ethical issues associated with developing clinical databases

                                       February 23 - 28, 2009.
Day 1 (23-02-2009): Basic Statistics (SKDB and VVR)
Day 2 (24-02-2009): Hypothesis testing and predictive models (SKDB and VVR)
Day 3 (25-02-2009): Clinical Data Management – Planning and Design (SJ)
Day 4 (26-02-2009): Clinical Data Management – Quality and Security (SJ)
Day 5 (27-02-2009): Data management and Public Health (VS, VVR, ANB, EN and VM)
Day 6 (28-02-2009): Public Health, Clinical Data and Ethics (ANB, EN and VM)

ANB – Ajit N Babu, Associate Clinical Professor of Medicine, Saint Louis University, USA
EN - Engelbert Niehaus, Professor of Mathematics, University of Koblenz-Laundau, Germany
VS – Vikram Sridharan, National Sales Manager, SAS India, New Delhi
SKDB – Sushant Kumar Dey Biswas, Scientist – F, Indian Council of Medical Research (Hqrds.), New Delhi
SJ – Sanjay Jankar, Associate Director, Clinrx, Gurgaon.
VM – Vasntha Muthuswamy, Ex-Chief, Divison of Biomedical Sciences, ICMR (Hqrds), New Delhi
VVR – M.Vishnu Vardhana Rao, Scientist – F, National Institute of Nutrition, Hyderabad.


0930 – 0940hrs                          Welcome address               Dr. Vrinda Khole

0940 – 0950hrs                          About the workshop            Dr. Meera Singh

0950 – 1050hrs                          Inaugural lecture             Prof. Indira Ghosh

1050 – 1100hrs                          Vote of thanks                Dr. Smita Mahale

1100 – 1130hrs                          high tea

1130 onwards                            FIRST SESSION OF THE WORKSHOP ON BASIC STATISTICS*

Dr. Meera Singh, Scientist – F, Indian Council of Medical Research, New Delhi
Prof. Indira Ghosh, Dean, School of Information Science, Jawaharlal Nehru University, New Delhi
Dr. Vrinda Khole, Officer Incharge, National Institute for Research in Reproductive Health, Mumbai
Dr. Smita Mahale, Scientist – E, National Institute for Research in Reproductive Health, Mumbai

* Please see following pages for detailed course content
Day 1 (23-02-2009) : Basic Statistics                                                        SKDB and VVR
Focuses on the theoretical and practical aspects of statistical techniques used in Biomedical research.
The hands-on session is intended to introduce participants to the basic statistical analysis using SPSS.

    1130 – 1300                  Types of data
                                 Categorical, numerical, derived data etc., How type of data affects
                                 statistical procedures, conversion between different data types.
                                 Error checking and outliers
                                 Types of errors, Handling missing data, identifying and handling outliers
                                 Descriptive statistics
                                 Displaying data graphically – one variable as frequency distribution Bar,
                                 pie, histogram, dot-plot, stem-and-leaf, box plot etc and two variables
                                 as scatter plots, clustered bars etc.

    1300 – 1400                  LUNCH

    1400 – 1500                  Statistical distributions
                                 Probability and probability distributions (discrete and continuous),
                                 The normal distribution, standard distribution, t-distribution, F-
                                 distribution, Binomial, Poisson etc.
                                 Data transformation and fitting

    1500 – 1530                  TEA

    1530 – 1700                  Hands on session involving basic statistical analysis with SPSS

Day 2 (24-02-2008): Hypothesis testing and Predictive models                                 SKDB and VVR
This day will focuses on applied topics in statistics such as testing a hypothesis, concept of p-value and
predictive models

    0930 – 1100                  Hypothesis testing
                                 Defining the null and alternative hypothesis, P-statistics,
                                 Tests for 1,2,and more than two group numerical data such as one
                                 sampled t-test, paired t-test, unpaired t-test, Wilcoxon test, ANOVA,
                                 Kruskal-Wallis test etc.
                                 Tests for categorical data such as McNemar’s test, z-test, Chi-squared
                                 test, Fisher’s exact test etc.

    1100 – 1130                  TEA

    1130 – 1300                  Errors in hypothesis testing, multiple hypothesis testing

    1300 – 1400                  LUNCH

    1400 – 1500                  Data Analysis
                                 Regression methods, Correlation and regression, Longitudinal studies,
                                 Logistic, Poisson, survival analysis, Assessing evidence, Evidence-based
                                 medicine, systematic reviews and meta-analyses, Additional topics,
                                 Diagnostic tools – sensitivity, specificity, kappa and Bayesian methods

    1500 – 1530                   TEA

    1530 – 1700                   Hands on session involving basic statistical analysis with SPSS

Day 3 (25-02-2009): Clinical Data Management – (Planning and Design)                                  SJ
Focus on the introduction to clinical data management which includes terminology in clinical data
management, types of clinical data, clinical data management systems, standards for selecting variables
and design of database and forms

    0930 – 1100                  Clinical Data Management Systems (CDM)
                                 Types of clinical data, existing clinical data management systems, SOPs
                                 for a CDM

    1100 – 1130                   TEA

    1130 – 1300                  Designing a database for clinical data
                                 Standards for clinical database, quality assurance, SOPs for database

    1300 – 1400                   LUNCH

    1400 – 1500                  Data Management Plans (DMPs)
                                 What is DMP, Importance of DMPs and using DMPs

    1500 – 1530                   TEA

    1530 – 1700                  Case Record Forms (CRFs)
                                 Design, annotations, tracking, inventory, data cleaning, processing and
                                 quality assurance

Day 4 (26-02-2009): Clinical Data Management – (Quality and Security)                                    SJ
This day will focus on the issues related to quality of data and security of clinical database.

    0930 – 1100                  Coding
                                 Coding dictionaries, auto-coders, dictionary maintenance, quality
                                 assurance and quality control

    1100 – 1130                   TEA

    1130 – 1300                  Quality control
                                 Database quality control and quality assurance audits, GCDMP and CRF
                                 part 11: Clinical Data Interchange Standards Consortium (CDISC)
    1300 – 1400                  LUNCH

    1400 – 1500                  Access and Security
                                 Account management, Access control, Tracking CRF pages and

    1500 – 1530                  TEA

    1530 – 1700                  Access and Security
                                 Database lock procedures, guidelines

Day 5 (27-02-2009): Data Management and Public Health                         VS, EN, VVR, ANB and VM
This day will focus on issues related to SPSS. We have invited speakers who have practical knowledge of
SPSS and will be happy to share their experiences. Later half of the day will introduce participants to the
an exciting area called public health and public health informatics

    0930 – 1100                  Ethical issues in Clinical Data Management

    1100 – 1130                  TEA

    1130 – 1200                  SPSS in Biological Data Analysis

    1200 – 1300                  SAS in Biological Data Analysis

    1300 – 1400                  LUNCH

    1400 – 1500                   Evidence-based Medicine (EBM) Overview

    1500 – 1530                  TEA

    1530 – 1700                  EBM in Therapy and Prognosis

Day 6 (28-02-2009): Public Health, Clinical Database and Ethics                           ANB, EN and VM
The last day will focus on public health, public health informatics, impact of clinical data on public health
and often ignored but most important aspect of clinical data the Ethics including potential research
areas/activities in which Biomedical Informatics Centres of ICMR can contribute.

        0930 – 1100               Public Health Informatics Overview
                                  Structure, processes, outcomes, links to clinical data, data sources

    1100 – 1130                  TEA

    1130 – 1300                  Ethical issues and concepts in Public Health and clinical practice, Clinical
                                 Health and Clinical Data, Surveillance Systems, Role Geographical
               Information System (GIS) in public health, Developing
               predictive models – case study of EWARS project

1300 – 1400    LUNCH

1400 onwards   CLOSING SESSION – Brainstorming on Research activities that can be
               initiated at Biomedical Informatics Centres of ICMR, action plan on way