Designed For Experienced Clinical Research Professionals
Advanced Certificate Program in Clinical Trials Monitoring
Eligibility - Clinical Research Professionals
Designed For Experienced Clinical Research Professionals
Advanced Certificate Program in
Clinical Trials Monitoring
Clinical Trials Monitoring
Eligibility - Clinical Research Professionals.
Certifications
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1Life Sciences Sector Skill Development Council.
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2Advanced PG Diploma – Cliniminds - Program Accredited by Accreditation Council for Clinical Research Education, United States of America.
- Investigator Responsibilities
- Sponsor Responsibilities
- Monitor Responsibilities
- EC Responsibilities
- eTMF - Essential Documents Recording and Archiving
- Investigator and Site Selection
- Potential Investigative Sites
- Investigator Selection Factors
- Site Selection Visits (Physical / Remote)
- Study Initiation Activities (Physical / Remote)
- Purpose
- Preparation
- Site Monitoring (Physical / Remote)
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CAPA Management
- Why debriefing with PI and team is important?
- Visit Report and Follow-up Correspondence
- Expecting the Unexpected
- Addressing Specific Challenges
- Improving Performance
- Audits & Inspections Preparedness
Cliniminds – A well-trained CRA plays a crucial part in the success of a clinical trial, which is why there is a need to invest heavily in a comprehensive and rigorous internal training program for CRA. Your performance as a successful CRA would also ensure your rapid career growth in the clinical trials industry. This specialized certification program provides each CRA with a hands-on training curriculum covering their job functions and all facets of clinical research for both drug/biologic and medical device clinical trials.
Broad Training Curriculum with Case Studies
- Who is a SMART CRA?
- Responsibilities of a CRA
- ICH GCP
- USFDA, EMA and New Drugs and Clinical Trials Rules, 2019
- Overview of Protocols and Amendments
- Monitoring A Study (Physical & Remote)
- Monitoring the Informed Consent
- Monitoring and Safety Reporting
- Effective Investigator Handling
- eTMF Management
- Remote Source Data Verification and Quality Review
- Managing CAPA: CRA’s Role in Preventing Inspection Finding
- Rules for Quality Documentation of Monitoring Activities
- Audit and Inspection Readiness
- Necessary Soft Skills for a CRA
