• What is randomization and non randomization?
  • Prepare SAS analysis datasets, tables, listings and figures as per specifications.
  • Map and migrate legacy datasets into CDISC SDTM and ADaM standard datasets.
  • Co-ordinate with the client and US-team for clarity of specifications, data issues ,outlier etc
  • Preferably from the Clinical trials domain in the pharmaceutical or biotechnology industry
  • Knowledge/experience in CDISC-SDTM and Adam
Which is playing main role in Clinical Research?
  • What is SOP (Standard Operating Procedure)
  • Role of DBMS team in Clinical Research
  • What is CDM (Clinical Data Management)?
  • Importance of CDM systems for data loading
  • What is SAP (Statistical Analysis Plan)?
  • Role of SAP in Clinical Research
  • SAS Work Flow in Clinical Research
  • Relation between SAS and DBMS
  • Interaction between SAS with CDMs for data access
  • Various report generation in Clinical Research

Clinical Research

  • Introduction on Clinical Trials
  • Drug Discovery & Development Process
  • Evolution of Ethics
  • Institutional Review Board
  • ICH-GCP, Regulatory Authorities of different Countries
  • Clinical Trail Team (with more emphasis on CRA & CRC responsibilities)

Clinical Research Associate:

  • What is CRA
  • Preparing for the Study
  • Study Initiation
  • Study Monitoring
  • Adverse Events and Safety Monitoring
  • Recruitment, Retention and Compliance
  • Study Closeout
  • Audits
  • Errors, Misconduct and Frauds
  • Clinical Research Coordinator:
  • Planning Stages and Commencements of the study
  • Interaction with Sponsor
  • Interactions within the Institution
  • Role of Study Subjects
  • Data Management
  • Adverse Event

Investigational Agent Management

  • Informed Consent
  • Protocol
  • Investigators Broacher
  • Investigational Product
  • Case Report Forms
  • SOP’s
  • Essential Trail Documents
  • Audit
  • Clinical Research Terminology

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