CLINICAL RESEARCH TRAINING

• 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