1122 Investigation courses

A clinical investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects that investigators and clinical staff are fully trained in GCP. Duties and functions discussed in this short course include: provision of adequate resources; liaison with IRB/IEC; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.

Clinical trial protocols are an essential part of clinical trial design. Protocol documents are critical to conducting safe and cost-effective investigations. Protocol documents are large and complex, containing comprehensive information relating to purpose, design and conduct of a clinical trial. Aspects of a protocol include patient eligibility criteria, and treatment specifications. This short course provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.

The demands on quality from clinical trials are increasing. Quantitative aspects of clinical trials, such as the mass of study data to be collected, the multiple investigational sites, and the need to meet predetermined timelines, often supersede qualitative features. Therefore, addressing basic requirements for quality management is essential when preparing a clinical trial. This short course describes the core elements required for the establishment of a clinical trial and provides an overview of the role of the sponsor in supporting and improving trial quality.

The sponsor of a clinical trial takes responsibility for its initiation, management, and/or financing. A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a contract research organisation, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Duties and functions discussed in this short course include trial design, selection of investigators, QA and QC, data handling and record keeping, finance and compensation, regulatory submissions, management of investigational product(s), safety reporting, monitoring, audit, dealing with noncompliance, and clinical trial reports. ICH guideline E6 (revision 2) encourages sponsors to adopt a risk-based approach to managing the quality of trials. We discuss this approach in general, and aspects such as risk-based monitoring in particular.

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An Introduction to Medical Terminology short course delivered online via Teams, suitable for anyone wishing to learn the basics of terminology. Dates of courses can be seen when clicking ‘register’ below. Level One – Introduction to Medical Terminology. “It's like a light has just been switched on and I now understand more of what I'm doing!” – Feedback from attendee of Level one course. This course is aimed at anyone who requires a knowledge of medical terminology in their role. It is suitable for administrative staff, health care workers, medical secretaries, managers, Allied Health Professionals, essentially anyone who may encounter medical terminology and wishes to develop their medical terminology knowledge further. We also offer sessions to those requiring an overview of medical terminology to support applications to study medicine, veterinary medicine or dentistry.We can train between 1-30 learners from any organisation. If you have a specific training request, please speak to us and we can accommodate your needs. We recently trained a group of sign language interpreters who found the training invaluable when working in medical environments.The sessions are delivered via Teams (2x 2 hour meetings) so are highly accessible, a webcam and microphone are required although not essential.The aim of the course is for learners to develop an understanding of medical terminology in an enjoyable, interactive and informative way so that they are better able to decipher and unravel the mystery of long medical words.The course covers the following topics:- Basics of medical terminology – word building Common Roots, prefixes and suffixes Anatomy and physiology via a virtual tour of the body Major bones of the body Prescription writing and abbreviations Classification of drugs Common Abbreviations Instruments and investigations Medical Specialities and personnel Blood tests At the end of the course students will have a clear understanding of medical terminology and are encouraged to use their newly learned skills in a series of quizzes and interactive games. All attendees are given a Certificate of Attendance and a comprehensive handout. Many people who attend these courses are keen to develop their skills further and may wish to proceed to the Level Two Intermediate Award in Medical Terminology. Medical Terminology Training Courses Established in 2006 and the UK’s largest provider of medical terminology training, we offer a range of courses to suit your needs from beginner through to advanced level. Our bespoke courses have been designed to suit the needs of healthcare professionals incorporating relevant terminology and content to directly benefit the workplace. Click 'more course information' below to view further details of each of our courses. 

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.