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PGDCR in Clinical Research
Master of Science Program in Clinical Research Design and Statistical Analysis
Coordinating a Clinical Trial
Drug/Biologic Approval Process, Good Clinical Practices and an Overview of Monitoring/FDA BIMO Inspections
Advanced Quality Monitoring
Writing Professional and Effective Monitoring Report, Post Visit Letters, and Memo-to-Files
 
Course Description

This course is designed to provide a brief overview of clinical research with a comprehensive review of FDA GCP and ICH GCP (E6) and the fundamental elements involved in coordinating a clinical trial. It provides practical tips and suggestions that can be applied to promote a GCP and HIPAA compliant clinical trial, including preventative measures and problem solving techniques of some of the most common GCP non-compliance issues.

1 Discuss the drug/biologic development process
2 Define GCP and identify its application in clinical research
3 List the key components of a clinical trial
4 Determine the GCP requirements for the informed consent, adverse and serious adverse events, source documentation and study drug accountability


Daily Agenda / Course Topics

Overview of Clinical Research
Phases of Research
Terminology
Roles and Responsibilities of the Clinical Research Team

FDA GCP & ICH GCP - The Investigator's Perspective
ICH GCP (E6) Section 4: Investigator
FDA GCP: Investigator Obligations 21 CFR312
FDA Form 1572 "Statement of the Investigator"
Electronic Records and Signatures
Financial Disclosure
Protection of Human Subjects

Clinical Trial Fundamentals
FDA Form 1572 and Protocol/Protocol Amendments and Investigator Brochure
Investigational Medicinal Product Storage, Documentation, and Problem Solving
Consenting Subjects
Source Documentation Strategies
Case Report Form and Data Clarification Records
HIPAA compliant Subject Recruitment and Retention
Interactions with the Monitor
Budget Issues and tracking payments
SAEs and Non-SAEs Recognizing and Reporting

 
Clinical Research
CDM – Data Management System for Clinical Research
PGDCR / MS in Clinical Research
LIMS - Laboratory Information Management Systems
Batch III PGDCR starting on 19th January 2009.
 
 
 
 
We have landed at our new CRO facility, for a sparkling start
 
 
 
 
Autoscribe UK has appointed Mithas Labs to further expand its network of business partners offering pre-sales and post-sales services for its successful LIMS, scientific and business software solutions and implementation across India.
 
 
 
 
Mithas Labs has chosen Oracle Clinical for CDM License.
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