Advanced Course in Clinical Research & GCP

A New course combining six of our online training courses and webinars to give comprehensive advanced knowledge in Clinical Research & GCP
 

Risk Management in Clinical Trials -  In this 60-min course, we look at the general principles relating to risk management in clinical trials. We utilize relevant regulatory guidance as well as the principles in ICH GCP to help you to understand the risk management process and how this is done. 

Content includes:
• The principles of risk-based management of clinical trials
• Who should be involved in a risk assessment?
• Why might risks change as the trial progresses?
• Identification of ‘Critical to Quality Factors’
• The steps involved in a risk-based approach to clinical trials
• Setting Quality Tolerance Levels
• Risks at the system and trial level
• Risk mitigation
• Risk-based monitoring
• Case studies
• Quick quiz to test knowledge
• Glossary of terms.

A Guide to European Data Protection (GDPR) - This 30 min online on demand training with a quiz and certification is an ideal way for those processing personal data to learn about the latest requirements for data protection. 
Content includes:
• Key roles
• Definitions of personal data
• Applicability of the GDPR and exemptions
• Consent and rights of Data Subjects
• Legal basis for processing
• Obligations towards Data Subjects
• Risk assessment
• Data transfer outside EEA
• Record keeping
• Data security and storage
• The Data Protection Officer
• Data protection ‘by design and default’
• Audits
• Managing breaches, compensation and penalties
• Data protection checklist
• Specific content on the impact of GDPR on pharmacovigilance and clinical trials.

Essential Guide to the EU CTR - This online, on-demand course covers in more depth the main content and requirements of the EU Clinical Trial Regulation. The course is interactive and takes around 1-hour to complete. It also contains questions as an integral part of the course to check knowledge gained. 
Content includes:
• Structure of the CTR and supporting guidelines.
• The Clinical Trial Information System (CTIS) – what is it? Functionality of the CTIS
•  Interventional, non-interventional and low interventional trials.
•  Authorization of a clinical trial – a single application.
•  Notifications and templates.
•  Substantial and non-substantial modifications.
•  Conditions for conducting a clinical trial.
•  Site suitability statement.
•  Additional informed consent requirements.
•  Consent for vulnerable patients.
•  Safety reporting.
•  Serious breach reporting.
•  Urgent safety measures.
•  Summary of trial results.
•  Trial Master File and document retention.

The Clinical Trial Master File Essentials

The Trial Master File (TMF) is one of the most common areas for critical and major inspection findings.This online course covers the key requirements of the TMF.
It is suitable for all those involved with clinical trials who are generating and maintaining trial documents.

The course is based on known inspection findings and the European Medicines Agency guideline on the Trial Master File and takes around 1-hour to complete
It has both read-only and narrated tracks.

The course is packed with interactions to maintain interest and to enhance the learning experience.
It is based on a series of questions that may be posed by an inspector or auditor and this forms the basis of a ‘health-check’ for those working with trial documents.

Topics include:

• Inspection metrics and critical TMF issues.
• ICH basics relating to TMF.
• Definition of the TMF and its content, the TMF index.
• TMF and trial reconstruction.
• Documents common to several trials.
• Segregation: sponsor, vendor and investigator documents.
• Drafts and superseded documents.
• Dealing with correspondence and emails.
• Scanning and certified copies.
• Destruction of trial documents.
• Vendors and CRO involvement in the TMF.
• Access and security.
• Retention and archiving.
• Quality management , QC, TMF oversight.
• Impact of the pandemic on TMF.
• Filing rules and inspection readiness.

Overview and impact of ICH E8(R1) on clinical trials - A recording of the webinar held  on Tuesday 28 June, 1 pm BST, 2pm CEST, 8 am EST. Approx  90 mins.
The ICH guideline on General Considerations for Clinical Studies (E8) has recently undergone revision. It is now implemented at Step 5 in many countries.
Indeed the impact of E8(R1) has grown and it’s requirements are likely to be mirrored in the E6 GCP guidelines revision. This document has a significant impact on the way you need to undertake clinical trial risk assessment, development and management.Find out about critical to quality factors, patient involvement in trial development, practical considerations and much more.

 

Essential PV - This 60 min* ‘Step 2’ online training covers essential PV in more depth. It is ideal for those who need a more detailed knowledge of PV. 
Content includes:
• What is and what governs PV
• Roles and responsibilities
• Key PV process steps; safety information and its capture
• Product safety oversight
• ADRs – basic facts, solicited v unsolicited reports
• Expedited individual case safety reporting
• MedDRA coding
• Periodic safety reporting, PSURs, PBRERs, DSURs
• Risk management planning
• Safety signals
• Reference safety information
• PV system master file
• Inspections.