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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

The starting point in creating a quality monitoring process is using a systematic approach. This course trains the CRA on MRM's three step monitoring method to facilitate consistency and standardization in performing the monitoring responsibilities. Another important aspect of monitoring is learning how to bring a non-compliant investigator into compliance using Corrective Action and Preventative Action (CAPA) plans and documenting such plans in a professional and effective monitoring report and follow-up visit correspondence. This 3 day course is enhanced by the hands-on training that utilizes simulated case studies, an investigator study file, and report writing exercises. These techniques can be applied to all studies whether they are drug, device, or biologic.


Daily Agenda / Course Topics

1 Overview of Monitoring and Preparation for the Case Studies
Monitoring Obligation and Purpose
Monitoring Activities
General Monitoring Plan Content
Three-Step Monitoring Method/Technique, Tools, and Organization
Developing Corrective and Preventative Action Plans (CAPA) for GCP ICH non-compliance
Monitor preparation prior to a site visit
Setting up the Monitoring file system
Protocol and CRF Review for Case Study Exercises on Day 2 and Day 3

2 Case Study #1
Applying Monitoring Technique and Tools
Monitor SV1, SV2, V1, AEs, and CC meds
Case Study # 1 – Review and Discussion of Deficiencies, Remedies, and Prevention (CAPA)

3 Case Study #2
Applying Monitoring Technique and Tools
Monitor SV1, SV2, V1, AEs, and CC meds
Case Study #2 – Review and Discussion of Deficiencies, Remedies, and Prevention (CAPA)
Potential Issue/Problem Exercise

4 Investigator Study File Review including the Regulatory reason and different SOP requirements
ISF Case Study – Monitoring
ISF Case Study – Review and Discussion of Deficiencies, Remedies, and Prevention

5 Monitor Report and Follow-up Letter
Content “What goes in a report” and Writing Style
Writing Reports using the CAPA style (Corrective Action and Preventative Action) to document the securing of compliance

 
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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