This course is intended to introduce principles of Clinical Data Management (CDM) and associated international standards for the conduct of clinical research. The course is targeted towards lead clinical researchers and other members who are involved in clinical research.

After the course the attendees will understand principles of CDM, GCP and other guidelines, Data Management Plan (DMP), SOPs, creating Case Report Forms (CRFs), data management systems, data entry methods, data validation, query management and database lock.

The "OpenClinica" database system will be used in practical session during the workshop.

Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, (Adjacent to College Chapel), Christian Medical College, Bagayam, Vellore 632 002.

Course Fee: Rs.5,000/-

Accommodation: Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation in the college campus on request (CHTC guest house). The accommodation arranged in CHTC is available from evening of August 15, 2010.

Course Fee should be paid in full by August 10, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.

Note: After Registration if cancelled the course fee will not be refunded. The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Course Content:

• Overview of Clinical Trial
• GCP and other regulatory guidelines
• Overview of Clinical Data Management
• Standard Operating Procedures (SOPs)
• Case Report Forms (CRFs) generation and management.
• Elements of Data Management systems
• Computer systems and validation
• Data Entry methods
• Validation Check Specification and Data Validation (QC)
• Query Management
• Audit Trail
• Quality Assurance (QA)
• Data Lock
• Data Extraction for analysis.
• Archival

Clinical Data Management Software:

• OpenClinica

This course is intended to introduce principles of Biostatistics, in a simpler manner to researchers who are in need of statistical application. This course is also intended to introduce principles, illustrate some of the basic methods of epidemiologic research, to improve the participant’s ability to understand and use appropriate statistical procedures.

The course is targeted towards researchers of varied profession such as biostatistics, medicine, public health, life science, social science, nursing, epidemiology etc.

Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, (Adjacent to College Chapel), Christian Medical College, Bagayam, Vellore 632 002.

Course Fee: Rs.4,000/-

Accommodation: Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation in the college campus on request (CHTC guest house). The accommodation arranged in CHTC is available from evening of August 15, 2010.

Course Fee should be paid in full by August 10, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.

Note: After Registration if cancelled the course fee will not be refunded. The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Course Content:

Fundamentals of Biostatistics:

• Descriptive statistics
• Probability and Distributions
• Test of Significance
• Analysis of Variance
• Non-parametric Methods
• Correlation and Regression
• Sampling techniques
• Sample Size

Basic Epidemiology:

• Measures of diseases frequency
• Cohort study
• Cross-sectional Study
• Case control study
• Qualitative research
• Diagnostic tests
• Clinical Trial

Statistical Software:

• SPSS (Analyses)

This course is intended to train people to Calculate Sample Size required in different research areas, in a simpler manner to researchers who are in need. The idea of this training program is to introduce a number of basic concepts and techniques that should allow the participants to get started with Sample Size.

This course is also planned to introduce the software nmaster1.0 which has been self developed by us. This software has been developed with all necessary formulae. The Sample size Practicals will be carried out using this software. The course is targeted towards researchers of varied profession such as biostatistics, medicine, public health, life science, social science, nursing, epidemiology etc., The participants should have basic knowledge in computers.

Those who wants to buy nMaster can buy with concession fee of Rs 1500/-(Full amount Rs 2500/-)

Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, (Adjacent to College Chapel), Christian Medical College, Bagayam, Vellore 632 002.

Course Fee: Rs.2,000/-

Accommodation: Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation in the college campus on request (CHTC guest house). The accommodation arranged in CHTC is available from evening of August 15, 2010.

Course Fee should be paid in full by August 10, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.

Note: After Registration if cancelled the course fee will not be refunded. The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Course Content:

Introduction:

Necessity for Sample Size, Basics concepts like alpha error, beta error, Power, Effect size, Confidence Intervals, One sided or two sided test, Equivalence or Non inferiority Margin, Dropouts will be introduced.

Means:

Estimating single mean, hypothesis testing of 2 & >2 means (paired and unpaired samples, repeated measurements, ANCOVA)

Proportions:

Estimating a single proportion, hypothesis testing of two proportions (equal & unequal) match paired designs

Agreement:

Kappa, Intra-class correlation coefficient (ICC)

Diagnostic test:

Sensitivity, Specificity, Positive Predictive Value, Positive & Negative likelihood ratios

Regression methods:

Simple correlation & regression, simple & multiple logistic regressions

Survival analysis:

Log-rank test, Cox regression, Exponential survival curves

Cluster design:

Estimation (continuous and binary), comparison of means, proportions and incidence rates (matched & unmatched)

Clinical Trials: Equivalence/Non Inferiority trials:

Paired & unpaired tests for means and proportions

Epidemiology methods:

Cohort, unmatched and matched case-control studies

This course is intended to introduce R for statistical computing, in a simpler manner to researchers who are in need. The idea of this training program is to introduce a number of basic concepts and techniques that should allow the participants to get started with practical statistics using R.

This course is also planned to furnish some advanced statistical analyses and techniques with real time datasets so as to improve the participant’s ability to understand and interpret the findings and produce R graphs. The course is targeted towards researchers of varied profession such as biostatistics, medicine, public health, life science, social science, nursing, epidemiology etc.,

Each statistical topics will have introduction about assumption, when and where to be used. Advanced statistical lecture will be provided before computing. The participants should have basic knowledge in computers.

Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, (Adjacent to College Chapel), Christian Medical College, Bagayam, Vellore 632 002.

Course Fee: Rs.3,000/-

Accommodation: Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation in the college campus on request (CHTC guest house). The accommodation arranged in CHTC is available from evening of August 15, 2010.

Course Fee should be paid in full by August 10, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.

Note: After Registration if cancelled the course fee will not be refunded. The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Course Content:

Introduction and Data manipulation using R:

Installation, libraries & packages, online help. Using R : basic arithmetic operations, creating variables, value labeling, functions, vectors, matrices & arrays, factors, data frame, indexing, conditional selection, subset & transform, sorting.

Importing data from difference software, Exporting, data entry in R, looping, merging and reshaping.

Probability and Distribution:

Random sampling, probability calculation, discrete distributions, continuous distributions, build in distributions in R.

Descriptive Statistics:

Calculating Mean, standard deviation, displaying Normal curve, generating tables.

Testing Hypothesis:

Parametric tests: – independent t test, paired t test. Non – parametric tests: - Mann Whitney U test (independent observations), Wilicoxon signed rank test (paired observations) and calculating the correlation coefficient.

Advanced Statistical Techniques:

Linear Regression:- Simple linear regression, its Interpretation, model building strategies and diagnostics.

Logistic Regression:- Performing logistic regression, Interpretation of the output, model building methods and diagnostics.

Survival Analysis:- Estimating the survival probabilities, comparison of survival curves, obtaining regression estimates using Cox proportional hazards model, Interpretation, model building and diagnostics.

R Graphs:

Histogram, Vertical bar chart, Pie Chart, Box plot, Scatter plot, Combining Charts.

Samarth is commencing its workshops on social science on “ Qualitative Research Methods and Analysis" and "Instrument Development” scheduled to be held from, 15th – 20th November 2010 at the Biostatistics Resource and Training Centre (BRTC), Department of Biostatistics, Christian Medical College, Adjacent to College Chapel, Bagayam, Vellore 632 002. Those interested in participating can contact us through e-mail (admin@samarthngo.org) or call us at +91 44-45010070. Attached are the registration form and details regarding the workshops. To confirm your participation in the workshops, please send your fees with the registration form.

Workshop materials, lunch and refreshments will be provided. The fee excludes travel, boarding and lodging costs. The workshop fee should be paid in full by 25th October 2010. Payment can be made by Demand Draft in favour of “Samarth”, payable at Chennai. The number of participants for each of these workshops is restricted to 35. No on-campus accommodation facility is possible. However, details of hotels in Vellore and their contact numbers is attached with this mail. Interested participants are requested to kindly contact the hotel of their choice from this list and make their own hotel bookings. Please note that no refund of course fee will be possible after 30th October 2010.

Qualitative Research Methods and Analysis (November 15-17, 2010 )

• Introduction to Qualitative Research - theories & concepts.
• Uses of qualitative research
• Contrasting qualitative and quantitative research methods.
• Types of qualitative research methods

-- In-depth interviews
-- Focus Group Discussion
-- Participant Observation
• Analysis of Qualitative Data

-- Data Management
-- Techniques in analysis
-- Use of software in qualitative data analysis

Instrument Development (November 18-20, 2010)

• Use of questionnaires in research
• Devising Items
• Developing Response scales
• Scaling techniques
• Translation
• Biases in responding
• Questionnaire standardization: Reliability, validity and factor analysis

Course content UNDER CONSTRUCTION. PLEASE CONTACT US FOR FURTHER DETAILS ON THIS COURSE.

This course is intended to introduce principles of Biostatistics, in a simpler manner to researchers who are in need of statistical application. This course is also intended to introduce principles and illustrate some of the basic methods of epidemiologic research and to improve the participant’s ability to understand and use appropriate statistical procedures.

The course is targeted towards researchers of varied profession such as medicine, public health, life science, social science, nursing, epidemiology, biostatistics etc.

Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, (Adjacent to College Chapel), Christian Medical College, Bagayam, Vellore 632 002.

Course Fee: Nominally fixed at Rs 4,000/- per course. If more than one course is opted then Rs. 3,500/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.

Accommodation:Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. No on-campus accommodation facility is possible. However, details of hotels in Vellore and their contact numbers is attached with this mail. Interested participants are requested to kindly contact the hotel of their choice from this list and make their own hotel bookings.

Course Fee should be paid in full by November 20, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.

Note: After Registration if cancelled the course fee will not be refunded. The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Course Content:

Fundamentals of Biostatistics:

• Descriptive statistics
• Probability and Distributions
• Test of Significance
• Analysis of Variance
• Non-parametric Methods
• Correlation and Regression
• Sampling techniques
• Sample Size

Basic Epidemiology:

• Measures of diseases frequency
• Cohort study
• Cross-sectional Study
• Case control study
• Qualitative research
• Diagnostic tests
• Clinical Trial

Statistical Software:

• SPSS (Analyses)

This course is intended to introduce the concept of multilevel theories and statistical treatment of clustered data. This course enables the statisticians to understand the concepts of Multilevel Modeling (MLM), Generalized Estimating Equations (GEE) and their applications. This course also provides real time examples that will be analyzed using SAS software.

Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, (Adjacent to College Chapel), Christian Medical College, Bagayam, Vellore 632 002.

Course Fee:Nominally fixed at Rs.4,000/- per course. If more than one course is opted then Rs. 3,500/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.

Accommodation: Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. No on-campus accommodation facility is possible. However, details of hotels in Vellore and their contact numbers is attached with this mail. Interested participants are requested to kindly contact the hotel of their choice from this list and make their own hotel bookings.

Course Fee should be paid in full by November 20, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.

Note: After Registration if cancelled the course fee will not be refunded. The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Course Content:

Multilevel Modeling (MLM):

Multi-stage sampling and multilevel theories Macro, micro level units and cross-level relations

Statistical treatment of clustered data Aggregation, disaggregation, Intra-cluster correlation coefficient (ICC), design effect in two stage sampling

The random intercept model Definition, within and between group regressions, simple and multiple regression models

The random slope model Introduction, analyses and interpretation, explanation of random intercept and slope

Generalized Estimating Equations (GEE):

Introduction to longitudinal dataTraditional methods: Repeated measures Analysis of Variance,summary measures and relationship with other variables

Generalized estimating equations-The best approach Introduction, working correlation structures, GEE for continuous and categorical outcome, interpretation and diagnostics (QIC)

MLM versus GEE Comparison between random coefficients and GEE

Statistical Software:

MLWin and STATA

This course is intended to introduce the basic concepts to use SAS, in a simpler manner to researchers who are in need. This course is also planned to furnish the basic and some advanced statistical analyses techniques with real time datasets so as to improve the participant’s ability to understand and interpret the findings.

The course is targeted towards researchers of varied profession such as medicine, public health, life science, social science, nursing, epidemiology, biostatistics etc.

Note: The participants should have basic knowledge in computers.

Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, (Adjacent to College Chapel), Christian Medical College, Bagayam, Vellore 632 002.

Course Fee:Nominally fixed at Rs 4,000/- per course. If more than one course is opted then Rs. 3,500/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.

Accommodation: Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. No on-campus accommodation facility is possible. However, details of hotels in Vellore and their contact numbers is attached with this mail. Interested participants are requested to kindly contact the hotel of their choice from this list and make their own hotel bookings.

Course Fee should be paid in full by November 20, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.

Note: After Registration if cancelled the course fee will not be refunded. The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Course Content:

Introduction to SAS:

Data Management Facility, Structure of SAS program, Data Analysis and reporting utilities.

Creating permanent libraries, using temporary and permanent data set within the libraries, Methods of importing data into SAS and saving datasets in SAS libraries.

Data Manipulation / Transformation:

Creating new variables, operating logical expressions, recoding, variable and value labeling, sorting.

Advanced Data manipulation techniques:

Renaming and retaining variables, Do Blocks & Do Loops, sub-setting datasets (select), working with arrays, generating multiple datasets, merging files, reshaping dataset.

Descriptive Statistics:

Calculating Mean, standard deviation, displaying Normal curve, reporting frequencies.

Testing Hypothesis:

Parametric tests – independent t test, paired t test.

Non – parametric tests - Mann Whitney U test (independent observations), Wilicoxon signed rank test (paired observations) and calculating the correlation coefficient.

Advanced Statistical Techniques:

Linear Regression - Simple linear regression, its interpretation, model building strategies and diagnostics.

Logistic Regression - Performing logistic regression, interpretation of the output, model building methods and diagnostics.

Survival Analysis - Estimating the survival probabilities, comparison of survival curves, obtaining regression estimates using Cox proportional hazards model, interpretation, model building and diagnostics.

SAS Report Writing and Macro Writing