Monitoring is a crucial element of any clinical trial, with The National Statement on Ethical Conduct in Human Research 2007 (updated in 2018) stating that Sponsors, Investigators, institutions and Human Research Ethics Committees (HRECs) have a responsibility to monitor clinical trials.
Virtual Clinical Trials (also known as Decentralised Trials and Siteless Trials) bring clinical trials directly into the participant’s home via a central and virtual coordinating site. Vital equipment like the Investigational Product, and wearables are delivered to the participant while support by study physicians and pharmacists is offered via video conferencing. Mobile health applications and telehealth technologies are used to collect medical data from participants and transmit it to the central study centre.
An Investigator Site File (ISF) contains essential documents which shows that the clinical trial site and Investigator are following the regulatory requirements set out by the ICH GCP guidelines. According to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, essential documents are defined as “documents which individually and collectively permit evaluation of the conduct of the trial and the quality of the data produced.” The ICH GCP 4.9.4 guideline states that
CAPA (Corrective and Preventive Action) is a quality system plan which aims to resolve compliance issues and to prevent any further recurrences. A CAPA plan is crucial to a clinical trial as it helps keep trial participants safe and protects their rights. It also prevents the study data from being compromised.
CAPA processes include:
Josh Knowles: Good morning, good afternoon, everyone, depending on where you're joining us from, and welcome to today's webinar. My name is Josh from Business Review Webinars, and I will be your host. It is our pleasure to have Novotech with us today who will be presenting the webinar entitled Accelerating Clinical Trials in Rare Disease.
A ‘Serious Breach’ is defined as being a breach of Good Clinical Practice or clinical trial protocol which has an impact on the safety or rights of a clinical trial participant, and the reliability or efficacy of the data generated in the clinical trial. The term ‘Serious Breach’ was established by the European Union’s (EU’s) Clinical Trials Regulation (536).
An Investigator’s Brochure is a collection of clinical and non-clinical data about the investigational products that are the focus of the study. The brochure should provide an ongoing insight into the clinical trial study participants during the duration of the trial.
Randomisation Controlled Trials (RCT) is the process of randomly assigning participants to groups that receive different treatments, which ensures that each individual has an equal chance of receiving any of the treatments used in the clinical trial. It allows the trial staff to make unbiased and informed decisions about new treatments, and is usually considered the best way to evaluate the efficacy of a new treatment and the effectiveness of interventions.