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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
Designed for those who desire an understanding of the drug/biologic approval process, the regulations that govern IND studies, and the CRA's role in monitoring these studies. The course provides a solid overview of the drug/biologic development process, presenting GCP obligations of the sponsor, investigator, and IRB together with a review of the regulatory documents, study documents, and drug accountability. A comprehensive review of the roles and responsibilities of the monitor and the types of site visits will be discussed, along with an example of FDA audit findings.

Daily Agenda / Course Topics

1 Overview of the Drug/Biologic approval Process
IND Submission and key content
Phases of Research
NDA Submission and Key Content
BLA Submission and Key Content

FDA GCP: Sponsor Obligations 21CFR312
ICH GCP (E6) Section 5: Sponsor
FDA GCP: Investigator Obligations 21CFR312
ICH GCP (E6) Section 4: Investigator
Financial Disclosure
Electronic Records and Signatures
FDA Form 1572 “Statement of the Investigator”
Essential Documents: TMF and the ISF
Study Drug Accountability
Protocol and the Investigator Brochure

3 Adverse Events
Serious Adverse Events vs. Non-Serious Adverse Events: Recognizing and Reporting
IND Safety Reports and SUSARS

4 Protection of Human Subjects
Data Safety Monitoring Board
Informed Consent
HIPAA: Research Authorization

5 Monitor Role and Responsibilities
Regulatory Obligation
Overview of Monitoring and Visit types
Defining the Monitoring Plan
Monitoring Responsibilities
Monitoring Documentation

6 FDA's Bioresearch Monitoring Program (BIMO)
BIMO program Objective and Function
What happens during an audit?
FDA audit finding classification
Recent Monitoring Warning letters
Recent Research Site Warning Letters

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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