Job oriented training on Clinical research, SAS, Pharmacovigilence, Medical writing

Six Sigma Academy of Clinical Research
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Important information

  • Training
  • Duration:
    2 Months
Description

Suitable for pharmacy, biotechnology, doctors

Important information

Course programme

MODULE I:CLINICAL RESEARCH
DRUG DISCOVERY AND DEVELOPMENT
PRECLINICAL STUDIES
BASICS OF CLINICAL TRIALS & CLINICAL RESEARCH
TERMINOLOGY & DEFINITIONS IN CLINICAL TRIALS
TYPES AND PHASES OF CLINICAL TRIALS
GOOD CLINICAL PRACTICES (GCP)
CLINICAL TRIAL STATISTICS (BIOSTATS)
BA/BE STUDIES
RESEARCH METHODOLOGY&CLINICAL TRIAL DESIGN
CLINICAL TRIAL REGULATORY AFFAIRS
BIOETHICS
PREPARATIONS & PLANNING FOR CLINICAL TRIALS
ESSENTIAL DOCUMENTATION IN CLINICAL TRIALS & REGULATORY SUBMISSIONS
CLINICAL TRIAL OPERATIONS AND MONITORING
RESPONSIBILITIES OF CLINICAL RESEARCH PROFESSIONALS
21 CFR 11
INTRODUCTION TO CDISC
INFORMED CONSENT FORM
SCHEDULE Y
PROTOCOL DEVELOPMENT
INTELLECTUAL PROPERTY RIGHTS (IPR) AND PATENT LAWS

MODULE II: CLINICAL DATA MANAGEMENT
INTRODUCTION TO DATABASE
DATA MANAGEMENT PLAN
EDC (ELECTRONIC DATA CAPTURE)
CRF DESIGN (PAPER)
E-CRF DEVELOPMENT
REPORT CREATION AND DATA TRANSFER
DATA CLEANING
STUDY LOCKING
OPEN CLINICA (COMPREHENSIVE THEORY AND PRACTICAL)
ORACLE CLINICAL , RAVE,INFORM,MEDRIO (OVERVIEW)
SYSTEM VALIDATION

MODULE III: SAS
SAS 9.1.3 / SAS 9.2
SAS/BASE
SAS/STAT
SAS/PROCEDURES
SAS/ACCESS
SAS/SQL
SAS/GRAPH
SAS/MACROS
SAS ENTERPRISE GUIDE 4.1MODULE IV: PHARMACOVIGILANCE
OVERVIEW OF PHARMACOVIGILANCE
REGULATORY ASPECTS IN PHARMACOVIGILANCE
PERIODIC SAFETY UPDATE REPORTS (PSUR'S)
SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS
CASE REPORT PROCESSING
EUDRA VIGILANCE
SIGNAL DETECTION PROCESS AND TOOLS
SAFETY INTELLIGENCE
OVERVIEW OF PHARMACOVIGILANCE S/W

MODULE V: MEDICAL, SCIENTIFIC AND REGULATORY WRITING
INTRODUCTION TO MEDICAL WRITING
MANUSCRIPT WRITING
SCIENTIFIC SLIDES
BRANDING AND COMMERCIAL WRITING
GRANT WRITING
PATIENT NARRATIVES
INTRODUCTION TO REGULATORY WRITING
INVESTIGATOR BROCHURE (IB) PREPARATION
CLINICAL STUDY REPORTS (CSR)
PROTOCOL WRITING
COMMON TECHNICAL DOCUMENT (CTD/ ECTD PREPARATION
DOSSIER SUBMISSIONS (IND/NDA/ANDA)
ICF TRANSLATIONS

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