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PG Diploma in Clinical Research

PG Diploma in Clinical Research which consists of clinical research, clinical data management, SAS and Pharmacovigilance training for 4 months, followed by a 3-month internship in one of the above fields.

#Course content for PGDCR (Course code: GAC006)

Clinical Research

  • Pharmacokinetics and Pharmacodynamics
  • Drug discovery
  • Toxicology
  • Special toxicology
  • Predictions [beneficial & harmful]
  • Study design
  • Regulatory authorities (RA) & ethics committee (EC)
  • RA & EC submission
  • Essential Documents
  • Site selection
  • Site set up
  • CRC & CRA responsibilities
  • GCP
  • Schedule Y
  • Patient recruitment
  • Informed consent process
  • Monitoring visits
  • Documentation and study logs
  • Accountability, Interactive voice responsive systems, central lab
  • SAE reporting
  • Trial Master File
  • Data entry in the case report form(CRF)
  • ICF documentation
  • Source data verification
  • Consistency of the CRFs/eCRFs
  • IP storage
  • IP accountability
  • Patient recruitment and retention
  • Query management
  • Data alerts to CDM
  • All the visit reports
  • Audit ready stage
  • Completion of CRF’s/e-CRF
  • Archival of study documents
  • Resolution of query and database lock
  • Serious Adverse Event and DCFs within a specific timeline
  • Shipment or Destruction of IPs as per the sponsor requirements
  • Introduction to Pharmacovigilance
  • Role of WHO in Drug safety monitoring
  • EU perspective
  • US perspective
  • ICH Guidelines
  • Safety monitoring in pre-approval stages
  • Post-marketing surveillance methods
  • ICSR(Individual Case Safety Reports)
  • Aggregate reports
  • Coding Dictionaries
  • Case processing in-class assignments
  • Narrative writing
  • Real time project

CLINICAL DATA MANAGEMENT

  • Data management plan
  • Study set up
  • Tracking CRF Data
  • Entering data
  • Managing lab data
  • Identifying and Managing discrepancies
  • Collecting adverse Event Data
  • Where systems come from?
  • Choosing vendor products
  • Implementing New Systems
  • System Validation
  • Test plans
  • Migrating legacy Data
  • Change control
  • Creating hierarchies
  • Sops and guidelines
  • Working with CROS
  • CRF Design Consideration
  • Remote Data Entry
  • Auto coder Algorithms
  • Fundamentals of clinical trials
  • Basic statistics for clinical trials
  • Clinical trials in practice
  • Reporting and reviewing clinical trials
  • Protocol development
  • Trial designs
  • Project management and research co-ordination
  • Regulatory affairs, good clinical practice and ethics
  • Data management
  • Data monitoring and interim analyses

SAS

  • Introduction SAS
  • Log File
  • Output File
  • Work File
  • Permanent SAS datasets
  • Environments where SAS runs
  • SAS System Options
  • Step boundaries and run-group processing
  • Where is my raw data?
  • INFILE
  • DATALINES
  • Input statement
  • Column INPUT
  • Formatted INPUT
  • List INPUT
  • MISSOVER, DLM
  • Informats with list INPUT
  • :
  • &
  • Advanced input pointers
  • Formatted lists with pointers
  • Reading multiple line input
  • Multiple INPUT statements
  • / and # pointers
  • The trailing @
  • The double trailing @@
  • Character functions (Left, Tranwrd, Index,Find,Trim,catx,Compress, Put, Input, Scan, Substr, Upcase, Lowcase Etc.)
  • Numaric functions (Int, ceil, floor, Round, Min, Max, sum,mean).
  • Date Function (Todat, Datetime, Date, Time, Timepart, Day,Month, Year, Qtr).
  • Arrays
  • Input and output
  • DATA step overview
  • Compile processing
  • DATA
  • LENGTH
  • FORMATS, INFORMATS, LABELS
  • RENAME
  • RETAIN
  • DROP and KEEP
  • If, If- then, Else-if, If then Do.
  • Reading existing SAS datasets with SET
  • Assignment statements
  • Numeric-character conversion
  • Character concatenation
  • Accumulating totals
  • RETAIN and SUM
  • SUM statement
  • SELECT statement
  • Subsetting observations
  • Deleting observations
  • Subsetting IF statement
  • WHERE statement
  • OUTPUT
  • PUT
  • Proc Print
  • Proc Contents
  • Proc Sort
  • Proc Means
  • Proc Freq
  • Proc Report
  • Proc Tabulate
  • Proc Printto
  • Proc Transpose
  • Proc Format
  • Proc Import
  • Proc Export
  • Proc Append
  • Proc Summary
  • Syntax
  • One to one merges
  • Match merging
  • Multiple OBS with the same BY variable
  • Merging with identical variable names
  • Merging without a common variable
  • Update statement
  • ODS /Trace/Select/Exclude
  • ODS /HTML FILE
  • ODS/PDF FILE
  • ODS/RTF FILE
  • ODS REPORT WITH STYLE OPTION
  • Proc PLOT
  • Proc GPLOT
  • Proc CHART
  • Proc GCHART
  • SQL/CREATE TABLE
  • SQL/ALTER
  • SQL/DROP
  • SQL/INSERT
  • SQL/UPDATE
  • SQL/SELECT
  • SQL/DELETE
  • SQL/WHERE
  • SQL/OPERATORS
  • SQL/JOIN
  • SQL/UNION
  • SQL/ORDER BY
  • SQL/GROUP BY
  • Functions of the SAS macro processor
  • Defining and using a macro
  • Macro processor flow
  • Macro and macro variable
  • Local and global macro
  • Avoid macro errors
  • Positional macro parameters
  • Automatic macro variables
  • Call Symput
  • System options for debugging macro
  • Proc UNIVARIATE
  • Proc MEANS
  • Proc FREQ
  • Proc GLM
  • Proc RANK
  • Proc ANOVA
  • Proc REG
  • Proc TTEST (Paired)
  • Proc CORR (correlation)
  • How to connect with data server
  • Libname Code
  • Sql Code
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