Regulatory authorities tend to abide by the maxim that ‘If it isn’t documented, it didn’t happen’. Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of GCP and compliance with regulatory requirements, as well as enabling effective management of the trial. In this short course we describe important examples of the documents designated by ICH GCP as essential to the conduct of a clinical trial.
Clinical trial design establishes the framework upon which the clinical trial process will be conducted, and sets the objectives of the trial. The application for marketing approval, submitted to the regulatory authorities, will provide clinical data reflecting the trial design. Since trial design impacts the whole drug development process and lifecycle, particular care and due diligence is essential. This short course provides an overview of the main types of study design.
Level 5 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 150 CPD Points | Lifetime Access
Level 5 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 150 CPD Points | Lifetime Access
Level 5 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 150 CPD Points | Lifetime Access
If you are a newbie in the field of ethical hacking or want to become an ethical hacker, this course is just what will get you started. This is a comprehensive course with real-world examples to help you understand the fundamentals of hacking and cyber security.
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