Online Advanced Course in Clinical Research

Advanced Course in Clinical Research & GCP

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

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.

 

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.

 

How to avoid Trial Master File-related inspection findings - TMF guidance explained - A Recording of the 2hr webinar held in April 2022, plus additional to answer participant’s questions. The course highlights key inspection findings relating to TMF and then goes on to use the EU TMF guideline as a template for good TMF structure and management. A number of questions are addressed, as if being challenged by an inspector
Content Includes:

Why is getting the TMF right so important?

What makes up your entire Trial Master File?

Where are all of your TMF documents located?

What documents are not filed in the TMF?

Do you have documentation that ranks the importance of your e-systems?

Does your documentation allow me to reconstruct the trial conduct and show compliance with the protocol and GCP?

Which documents do you segregate in your TMF and how do you do that?

Are your documents filed chronologically?

How do you deal with documents common to several trials?

Do you have a standard TMF checklist? – highlights that a standard checklist is not feasible and needs to be trial specific

How do you handle draft documents?

How do you handle superseded documents?

How do you manage correspondence in the TMF?

Tell me how you deal with emails? – brings in need for metadata

How do you deal with copies of TMF documents? – brings in certified copies

Do you ensure metadata are retained when transferring documents?

How do you document management and oversight of your vendors?

How and when do you file documents to your TMF?

How and where do you store your TMF? Have you documented a risk assessment for this?

What controls do you have in place for your e-systems and e-TMF?

How do you QC your TMF?

Do you have a policy for destroying documents after scanning?

What arrangements are in place for the retention of your TMF?

What impact has the pandemic had on TMF management and documentation?

What are the requirements for getting remote approval of documentation?

What processes are in place for the oversight of the TMF?

Is your TMF always inspection ready?

Protocol deviations and the TMF.

Case study on document data integrity.
 

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