Admission

RA/SRF/JRF Fellowships Increased by 56% | JRF – Rs 25000, SRF – Rs 28000 , RA Rs 36000

Finally, Government of India hiked the fellowships for RA/SRF/JRF around 50% increase.

Now JRF

Rs 25,0000

with 30 % HRA 

Rs. 32,500

JAWAHARLAL NEHRU TECHNOLOGICAL 

UNIVERSITY KAKINADA M.TECH ADMISSION

SCHOOL OF BIOTECHNOLOGY 
INSTITUTE OF SCIENCE AND TECHNOLOGY 
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY KAKINADA
KAKINADA, ANDHRA PRADESH.

JNTUK invites applications for admission to M.Tech Biotechnology for the year 2014-2015.

The Department of Biotechnology at Jawaharlal Nehru Technology University is dedicated to provide quality education that combines intense academic study with the excitement of discovery. The programme equips its graduates to meet challenges in biotech industries, while at the same time preparing them for research in frontier areas of Biotechnology.

Eligibility criteria

B.E./ B.Tech. / AMIE : Chemical Engg. / Bio-Technology / Biochemical Engg. / Bioinformatics/Industrial Biotechnology/ Agricultural Engg.

or

M.Sc. in Env. Sciences/ Chemistry / Biochemistry / Microbiology / Biotechnology /Life Sciences / B.V.Sc / M.B.B.S. / B.D.S. / B.Pharmacy / Food Technology are eligible to apply.

Candidates with a valid GATE, GPAT & PG-CET score are eligible to get scholarships.

For further information regarding counseling schedule and admission visit www.jntuk.edu.in or mail us at jntukdbt@gmail.com

JNCASR MS/PhD Mid Year Admissions 2014-15

RESEARCH ADMISSIONS 2014-15

Mid - year admissions

Importance notice for prospective applicants:

• Interviews for admitting students in respective Units will be held subject to the vacancies available then.
• Selection to the degree programmes of JNCASR are subject to excellent academic background score/percentile/rank obtained in national fellowship exams and performance in the interview. Merely satisfying the minimum eligibility criterion for applying does not guarantee a call for interview or selection to the degree programme.

JNCASR invites applications for admission to Ph.D/M.S programmes

• M.S(Engg.)/ M.S.(Research)
• Candidates with an M Sc., B E, B Tech, M E, M Tech or MBBS are eligible to apply. They should have at least 50% in their highest University examination, and should also have qualified in the GATE / UGC -/ CSIR - NET-JRF / ICMR - JRF / DBT-JRF/JEST / INSPIRE or any other equivalent national level examination. The certificate of such test should have the validity period for seeking admission to research programme as on 1 January 2015.

• Ph.D
• Candidates with an M Sc., B E, B Tech, M E, M Tech or MBBS are eligible to apply. They should have at least 50% in their highest University examination, and should also have qualified in the GATE / UGC -/ CSIR - NET-JRF/ ICMR - JRF / DBT-JRF/JEST / INSPIRE or any other equivalent national level examination. The certificate of such test should have the validity period for seeking admission to research programme as on 1 January 2015. Generally ME/M.Tech students are required to qualify one of the exams mentioned above, however exceptional candidates without these exams may also be considered.

• The online Application Form will be available from 13 October 2014 
• The online application form for M.S./Ph.D programme……(click here)
• The list of short listed candidates and other announcements regarding admission will be uploaded on www.jncasr.ac.in/admit website periodically.

Last date for submitting duly completed onlin application for M.S./Ph.D. programmes is 10 November 2014.

Advertisement: www.jncasr.ac.in/admit/

RESOLVE CLINICAL RESEARCH INSTITUTE PG Diploma Admissions in Pharmacovigilance, Clinical Research, Clinical Data Management, & SAS Clinical (Base SAS and Advance SAS) with Live Projects

Advanced Post Graduate Diploma in Pharmacovigilance, Clinical Research, Clinical Data Management, & SAS Clinical (Base SAS and Advance SAS) with Live Projects

RESOLVE CLINICAL RESEARCH INSTITUTE

Features:

• Job experience certificate will be provided till you are getting placement, because of availability of patients data with us from time to time
• Job experience certificate will be provided till you are going to abroad
• This is the only place in India where you can get job experience certificate because of availability of clinical records. This job experience certificate will be very much useful in shortlisting process by companies
• Certificate will be provided after successful completion of the course
• Relieving certificate will be provided after getting the job
• Resume preparation tips / Interview guidance
• Placement Support will be provided
• Printed material will be provided
• Practical Hands-on training on Databases
• Direct access will be provided to Argus Safety Database & Oracle Clinical Database

Resolve Clinical Research Institute is a leading Clinical Research Organization offering
trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.

We would like to inform you that the tentative schedule for the next batch is 10-12-2014. 

Duration is six weeks and the fee is Rs 25,000/-. To reserve the seat immediately, you need to pay Rs.5,000/-.

Please note that we also provide separate hostel facility assistance for ladies as well as gents.

Course Curriculum

Pharmacovigilance

• Clinical Development process
• Different phases of Clinical Trials
• History and overview of Pharmacovigilance
• Introduction and responsibilities of USFDA, EMA and CDSCO
• Pharmacovigilance in India
• Adverse Events and its types
• Drug Safety in clinical trials and post marketed drugs
• Different sources of Adverse Events reporting
• Different types of AE Reporting Forms
• Expedited reporting and its timelines
• Different departments working on Pharmacovigilance
• Roles and responsibilities of case receipt unit
• Roles and responsibilities of Triage unit
• Four factors for the reportable case
• Seriousness criteria of adverse event
• Expectedness or Listedness of adverse event
• Causality assessment of the adverse event
• Importance and procedure of duplicate check
• Data Entry
• Case booking or initiation
• Case processing
• MedDRA and WHODD coding
• SAE narrative writing
• Case quality check, Medical review and its submission

• PSUR and its submission timelines

Oracle Argus Safety Database (Optional)

Argus Console:

• PV Overview
• PV Business process
• Introduction to Oracle Argus Safety Database
• Family, Product and License creation
• Study creation
• Sites, users and Groups creation
• Workflow Configuration
• Expedited Report Configuration
• Case priority Configuration
• Case Numbering
• Field Validation
• Code list Configuration
• LAM (Local Affiliate Module) Configuration

Argus Safety:

• Different icons used during the case processing and their purpose.
• Different tabs used in case processing
• Minimum requirements for a case bookin
• Case Bookin and Data entry
• Case Processing
• Case Routing Based on workflow
• Case Quality check, Medical review
• Duplicate case check or verification
• Report Generation for Regulatory Submission
• Expedited Reports and Aggregate Reports
• Case Bookin in LAM and Routing to Central Safety database
• MedDRA coding and WHO DD coding
• Narrative Writing
• Different Case Studies

You will be extensively involved in:

• Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database
• Processing of all incoming cases in order to meet timelines
• Writing a detailed medically oriented description of the events in the form of safety narrative.
• Perform the duplicate search in Argus safety database
• Assessment of seriousness, expectedness/listedness of Adverse Events
• Evaluate the entered cases as per quality review checklist in terms of quality, accuracy, and completeness against the source documents provided
• Performing QC review of the cases to meet case processing timelines
• Coding of adverse events with the help of MedDRA and labeling the events
• Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries.
• Meeting the timelines and supporting global regulatory submissions in expedited reporting of ICSRs
• Preparation of PSURs for regulatory submissions
• Entry of Adverse events in Local Affiliate Module (LAM) and Routing Local events to
central Argus safety
• Codelist Configuration in Argus console
• Creating Sites, Users, User groups
1• Creating Products, Licenses, Studies and Expedited Reporting Rules
• Configuring Workflow States and rules
• Knowledge of Advanced conditions; Setting up of field validation to ensure consistency of data

Clinical Research

• Introduction to Clinical Research
• Pharma Research/Drug Development Process
• Pre-Clinical Research
• Clinical Trial Phases (I - IV)
• IND/NDA/ANDA
• Ethics in Clinical Research
• ICH-GCP Guidelines
• Regulatory Affairs
• US FDA Guidelines
• DCGI/Schedule Y
• EMA
• CRO Industry
• IRB / IEC
• Informed Consent Process
• Roles and Responsibilities of Clinical Trial Team
• Site Initiation Study
• CRF & e-CRF
• Standard Operating Procedures (SOPs)
• Investigator Brochure (IB)
• Protocol Design and Format
• Investigational Product (IP)
• Essential Documents for a Clinical Trial
• Submission & Publication of Clinical Study Report
• Audits & Inspections

Clinical Data Management

• Introduction to Clinical Research
• Introduction to Clinical Data Management
• Guidelines for CDM
• Roles and Responsibilities of CDM Team
• Clinical Data Management Process and Life cycle
• Data Management Plan
• 21 CFR Part 11
• CRF Designing
• CRF Annotation
• Data Capture Methods
• Data Entry
• Edit Checks
• Data Validation Procedures
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Database Locking and Freezing
• Data Storage & Archival
• Data Coding and Medical Dictionaries
• SAE Reconciliation
• Quality Assurance & Quality Control • Auditing • CDISC Standards

Oracle Clinical OC/RDC (Optional)

INTRODUCTION: • Introduction to OC window • Subsystems in OC
STUDY PLAN: • Defining Programs and Projects • Defining Organization Units • Defining Regions • Defining Planned Studies
STUDY DESIGN: • Easy Study Design • Creating Intervals • Creating Events • Creating treatment patterns • Creating Investigator, Site Records and Assignments • Creating Patient Positions and Assignments
GLIB: • Creating Questions • Creating Question Groups • Creating and Maintaining DVG's • Copy Groups
STUDY DEFINITION: • Creating DCM's, DCI's & DCI Books • Validation Procedures • Derivation Procedures • Test a Study • Test Data Entry
DATA ENTRY: • Initial Login • Key Changes • First Pass Entry • Second Pass Entry • Comparison Reconciliation • Update • Browse • Patient Enrollment • Missing DCMs
STUDY CONDUCT: • Data Validation(Batch validation) • Discrepancy Management • Data Clarification Forms (DCFs) • Data Extract and SAS Extract • Making Mass Changes • Locking and Freezing
LAB: • Labs • Lab Ranges
1• Lab Units
• Lab test questions
• Lab Assignment Criteria
RDC (Remote Data Capture):
• Data entry in RDC
• Discrepancy Management in RDC
• Study and Site Security

You will be extensively involved in:

• Designing of electronic Case Report Forms (eCRFs) in Oracle Clinical
• Creation and maintenance of global library objects like DVGs Questions, Question groups, DCMs and DCIs
• Creating Data Collection Modules and layouts corresponding to CRFs to allow for data entry
• Generating and Testing data entry screens and validate the range, format, date, missing fields
• Conduct study start up activities, like Study design and Defining Sites, investigators and
patients
• Creating, generating and testing Data Validation and Derivation procedures
• Writing edit checks or validation procedures using ranges provided or in accordance with the protocol
• Performing User Acceptance Testing (UAT)
• Data Entry like Initial Login, Key Changes, First Pass and Second Pass Data Entry, Comparison Reconciliation and Update
• Test and execute validation procedures (Both single and batch validation)
• Discrepancy management and Query management
• Generating queries based on validation checks to clarify and improve the quality of the data
• Creating DCFs and maintaining Discrepancies
• Resolving queries and updating the database.
• Review of un-resolved discrepancies, raise manual discrepancies wherever required and close
where appropriate.
• Improving the quality of the data to ensure an error free, accurate data with no open queries
• Establishing and coordinating the timely completion of the database lock procedures.
• Reviewing clinical data as per SOP, protocol, and study specific guidelines
• Knowledge of Data Extract and SAS extract views
• Maintaining Lab ranges, Lab units, Lab test questions
• Data entry in RDC and Discrepancy Management in RDC

SAS Clinical (Base SAS and Advance SAS)

SAS Modules:

SAS / BASE
SAS / STAT
SAS / REPORT
SAS / ODS
SAS / GRAPH
SAS / SQL
SAS / MACROS
SAS / ACCESS
SAS / CONNECT

LIVE SAS CLINICAL PROJECT

SAS / BASE

1• Introduction to SAS System & Architecture • SAS Windowing Environment • SAS Libraries • Variables & SAS Syntax Rules • Data Step and Proc Step • Titles & Footnotes • Proc Print Statement • Proc Print Options • Set Statement • Dataset Options • Options Statement • Types of Input Statements • Infile Statement With Options • Keep, Drop and Rename Statements • Update Statement • Modify Statement • Merging Concepts • Interleaving Concept • Logical Variables • Retain Statement • Formats and Informats • Conditional Statements • SAS Functions • Do Statement • Randomization

BASE SAS PROCEDURES

• Proc Sort • Proc Append • Proc Transpose • Proc Contents • Proc Format • Proc Import • Proc Export • Proc Compare • Proc Copy • Proc Options • Proc Forms • Proc Datasets • Proc Printto • Proc Calendar

BIOSTATISTICS

• Introduction To Biostatistics – Clinical Applications • Frequency Distribution Of Clinical data • Clinical Data Presentation • Measures Of Centering Constants • Measures Of Dispersion • Normal Distribution • Null Hypothesis / Alternate Hypothesis • p – Value Interpretation • Sampling Variation
1• Probability Concepts In Clinical Trials
• t-Test – Pharma Applications
• Chi Square test – Adverse Event Analysis
• Correlation & Regression – Estimation Analysis
• ANOVA – Efficacy Analysis

SAS / STAT (DATA ANALYSIS)

• Proc Means (mean, median, std, n, var, cv, range, q, q3, qrange, p50)
• Proc Univariate
• Proc Summary
• Proc TTest (Paired and Unpaired)
• Proc Anova (One Way, Two Way and Manova)
• Proc Glm
• Proc Freq
• Proc Chisq
• Proc Corr
• Proc Reg
SAS / GRAPH
• Proc Plot
• Proc Gplot
• Mutliple Plots & Overlay
• Symbol Statement
• Title and Footnote Statements
• Proc Chart
• Proc Gchart
• Vertical, Horizontal, Pie
• Group, Subgroups
• Proc G3D
• Proc Gprint
• Graph-N-Go

SAS / REPORT

• Proc Report
• Column Statements
• Break/Rbreak Statements
• Compute Statement
• Frequency Procedure
• Proc Tabulate
• One-Dimensional Tables
• Two-Dimensional Tables
• Summary Statistics
• Proc Summary
SAS / ODS
• ODS Statements
• ODS Options
• Using ODS to Create HTML, PDF, RTF
• Proc Template
• Proc Report with ODS

SAS / SQL

• Introduction to SAS/SQL
• Proc Sql Statements
• Proc Sql Options
• Set Clause
• Where Clause
• Order by Clause
• Group by Clause
• Having Clause
• Distinct Clause
• Formatting Output
• Case Expression and Conditional Logic
• Sql Set Operators
• Joins in Sql
• Creating ,Populating & Deleting Tables
• Alter Table Statement
• Renaming A Table & Columns
• Changing Column's Length
• Aggregate Functions
• Pass Through Facility

SAS / MACROS

• Macro Concepts
• Macros And Macro Variables
• Creating Macro Variables
• Using Macro Variables
• Invoking A Macro
• Passing Arguments to Macros
• Macro Quoting Functions
• Macro Options
• Macro Expressions
• Macro Character Functions
• Macro Interface Functions
SAS / ACCESS
• Import & Export Procedures
• Proc Access
• Worksheet Statement

SAS / CONNECT

• Cimport Procedure
• Cport Procedure
• Using Select Statement

LIVE SAS CLINICAL PROJECT

You will be extensively involved in:

1• Extracting the data from various internal and external databases (Oracle, MS Access, Excel spreadsheets) using SAS/ACCESS, SAS/INPUT
• Developing programs for converting the Oracle data into SAS datasets using SQL Pass
Through Facility • Clinical trial data analysis with different Statistical Procedures
• Using various statistical procedures to find out the efficiency of the drug as per 21 CFR
USFDA Guidelines
• Interpretation of p-value and drawing conclusions
• Assigning subjects to different treatment arms with SAS Randomization Programs
• Creating the reports using the SAS procedures and using ODS statements to generate different output formats like HTML, PDF, RTF and excel to view them in the web browser
• Creating the statistical reports using Proc Report, Proc Tabulate and SAS Macro
• Thorough understanding of Protocol, Statistical Analysis Plan (SAP)
• Analyzing the data and creating tables according to the Statistical Analysis Plan (SAP)
• Generating the demographic tables, adverse events and serious adverse events reports
• Using the SAS procedures (MEANS, FREQ, SUMMARY, TRANSPOSE, TABULATE,
REPORT etc) and SAS/STAT procedures (REG, CORR, GLM, ANOVA and UNIVARIATE
etc.) for summarization, cross-tabulations and statistical analysis
• Manipulation of SAS datasets using SET, MERGE, UPDATE, MODIFY and Conditional
statements
• Generating Graphs and Figures using PROC CHART, PROC GCHART, PROC PLOT,
PROC GPLOT and Graph-N-Go
• Validation and QC of the efficacy and safety tables
• Using PROC EXPORT and Export wizard to Transfer SAS data to external data sources
• Providing programming support for the creation and maintenance of programs used in Data Management, Data Validation, Data Cleaning and Statistical Report Generation
• Extensive Applications in SAS/SQL, SAS/ACCESS, SAS/CONNECT and SAS Macros
• Generating Tables, Listings, Figures/Graphs (TLFs or TLGs)
• Working with datasets such as DM (Demographics), LB (Laboratory), MH (Medical History), AE (Adverse Events), VS (Vital Signs), CM (Concomitant Medication)
• Manipulation and Reporting of clinical data using PROC SQL
• Extensive programming in writing and debugging the Macro routines and applying Macro variables in SAS program
• CDISC Standards (SDTM, ADaM, LAB, ODM)
• Live SAS Clinical Projects

FOR Admission contact:RESOLVE, 8148452460

http://www.resolveclinicalresearch.in/