Comprehensive Training Program on Pharmacovigilance, Medical Writing, Clinical Data Management and Clinical SAS.

Module 1: SAS Programming 1: Essentials

• Navigate the SAS windowing environment
• Navigate the SAS Enterprise Guide programming environment
• Read various types of data into SAS data sets
• Create SAS variables and subset data
• Combine SAS data sets
• Create and enhance listing and summary reports
• Validate SAS data sets.

SAS Programming 2: Data Manipulation Techniques

• Control SAS data set input and output
• Combine SAS data sets
• Summarize, read, and write different types of data
• Perform DO loop and SAS array processing
• Transform character, numeric, and date variables.

Module 2: Pharmacovigilance

• Introduction to Pharmacovigilance
• Clinical Development process
• Responsibilities :USFDA, CDSCO
• Pharmacovigilance in India
• Drug Safety in clinical trials and post marketed drugs
• Different sources of Adverse events reporting
• Different types of AE reporting Forms
• Adverse events and its types
• Expedited reporting and its timelines
• Four minimum information for a reportable case
• Seriousness criteria of adverse event
• Expectedness ( Listedness) of adverse event
• Causality assessment of the adverse event
• Case Narrative writing
• Case processing
• Periodic Safety Update Report (PSUR) and its submission timelines
• Development Safety Update Report (DSUR)
• Roles & Responsibilities in a CROs & Sponsor in Pharmacovigilance.
• Medical Dictionary for Drug Regulatory Activities – MedDRA
• Overview of Oracle Argus

Module 3: Medical writing

• General introduction
• epidemiology and ebm
• pharmaceutical medicine
• basics of good medical writing
• computer skills
• overview of the regulatory, marketing and drug promotion processes
• common technical document
• protocol, investigator’s brochure & case report forms
• clinical study report
• sentence control
• writing flow and cohesiveness
• publication writing
• documents in medico-marketing
• managing the review process

Module 4: Clinical Data Management

• Introduction to CDM
• Data collection instruments
• CRF designing elements
• Paper based CRF designing
• Data Entry, remote data entry
• Electronic data Capture
• e-CRF designing
• Data quality management plan
• Data Validation
• Query management
• Open Clinica – Role based access as Monitor
• Open Clinica- Role based access as Data manager
• Open Clinica – Study creation and designing
• Open Clinica CRF designing
• Open Clinica metadata
• MedDRA
• Annotated CRFs
• Overview Oracle clinica