Effective Monitoring Visits
Categories: Pharmaceutical
What every monitor should know to be able to comply with the regulatory requirements for carrying out effective monitoring visits.

What Is The Course About?
Monitoring clinical trials to comply with ICH GCP, FDA, ISO 14155 the Clinical Trial and the new GCP Directives is vitally important to meet regulatory requirements and sponsor SOPs. This interactive course will cover all the key aspects of how to carry out the different monitoring visits effectively and also to ensure compliance with the latest requirements. This will include planning and preparation for carrying out different types of monitoring visits such as site
selection, initiation, routine monitoring, and close out. This course will enable you to gain an understanding of the responsibilities at both the study site and the sponsor site, and how to carry out the crucial study site visits. You will also cover how to prepare for a monitoring visit when you are audited and/or regulatory inspection. This highly enjoyable course will help ensure you will meet the stringent audit and inspection requirements that we now have in Europe. This course has been specifically designed for monitors, CRAs, medical research associates and other clinical research professionals wanting to learn about how to carry out effective and compliant monitoring visits including study site professionals who have responsibility for monitoring.

The full fee for this course is £1,090 +vat and includes full course materials, lunch and refreshments.

Course Programme:
DAY ONE
What is the role and responsibilities of the monitor?
- How the monitor’s role is essential for carrying out clinical trials to meet GCP requirements
- Responsibilities of the monitor, sponsor team and study site: working to GCP
- Common monitoring visit problems and identifying solutions
Develop effective monitoring visits to the study site
Preparing for study set up visits: planning and preparation so as to comply with all key GCP requirements
- Ensuring that Informed Consent procedures are properly implemented
- Working effectively with Ethics Committees (ECs) and Institutional Review Boards (IRBs)
- Obtaining ethical approval compliant with GCP
- Preparation of study documentation and the trial master files
How to select Investigators and study site personnel able to comply with GCP and the CT Directive
- Selecting investigators and carrying out site selection visits
- Understanding the importance of investigator selection for laying the foundation to the trial
- Discussing patient recruitment strategies with the study site
- Confirming study sites have sufficient patients for the study
Conducting initiation visits
DAY TWO
Review of Day One
Conducting initiation visits (continued)
- What documents are needed to initiate a site?
- Carrying out an initiation visit
- Visiting the laboratories and pharmacy
- Developing preventative approaches to managing the study site
Conducting monitoring visits
- Ensure the monitor and the investigator site understand the GCP requirements
- Source Data Verification: how much, how to document?
- Ensuring effective subject/patient recruitment
- How to motivate the investigator site team - what approaches work well?
- Effective communication with the site
- Managing difficult situations at the study site
- Handling amendments and non-substantial amendments
- Clinical trial supply issues, drug accountability
- Safety reporting
- CRF tracking and query resolution
- Ensuring study documentation is kept up-to-date
- Preparing monitoring reports and follow-up actions
- E-clinical: approaches for collecting data electronically and how the monitor can successfully
monitor EDC trials.
Close-out visits
- End of study reports
- Documents to collect
- Archiving and storage of documents
- Close out visit checklist items
How to manage Inspection and Audit visits of your sites
- How to prepare effectively for a study site audit and/or regulatory inspection (role play)
- The Do’s and Don’ts to a successful site inspection and audit
- What do QA departments and inspectors look for?
- What are the commonly occurring monitoring visit audit and inspection findings?
 
Course Dates
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LocationDistance (approx)Course Start DateNo. DaysWeb price ex.VATCourse Status 
London3 miles Mon 08 Dec 08 2£1,090      CLICK TO ENQUIRE
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Tools
 
Key Details
Duration2 days
 
£1,090
per delegate