Home PG Diploma in Clinical Research 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 Clinical Data Repository Clinical trial performance 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 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 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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