Postgraduate Course: Monitoring and Audit (20 credit) (MCLM11021)
|School||Deanery of Molecular, Genetic and Population Health Sciences
||College||College of Medicine and Veterinary Medicine
|Credit level (Normal year taken)||SCQF Level 11 (Postgraduate)
|Course type||Online Distance Learning
||Availability||Available to all students
|Summary||This 20-credit elective will run for 10 weeks and builds on the foundation of knowledge and skills acquired in Year 1 courses, Introduction to Clinical Trials and Good Clinical Practice, Ethics and Regulatory Issues.
As we know, Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. Quality should be in built and on a continuum, which begins during the planning and design phase, is critical during the conducting and recording period, and persists throughout reporting and publication of the trial results.
Two quality assessment activities well known to the clinical research team are monitoring and audit. While both are normally discussed collectively in relation to clinical trial oversight, they have individual functions with inter-dependencies set within compliance regulation.
This course will introduce quality assurance systems and quality control activities used for audit and monitoring purposes to ensure the quality of all aspects of the clinical trials, as well as presenting opportunities to develop hands on risk assessment and monitoring skills.
Additionally, participants will examine, identify and problem-solve specific challenges presented by the increasing complexity of clinical research involving for example, globalisation, third party vendors, electronic data and trial management systems.
This elective offers practical opportunities to develop processes, skills and critical appraisal abilities to employ quality within participants' current and future roles as investigator, trial manager or researcher as presented in the following 5 units:
Unit 1 - Introduction to Monitoring and Audit
Unit 2 - Safety Reporting, Protocol Violations and Breaches
Unit 3 - Monitoring 101
Unit 4 - Data Management
Unit 5 - Trial Close and When an Inspector Calls
Entry Requirements (not applicable to Visiting Students)
||Other requirements|| None
|Additional Costs|| 0
Information for Visiting Students
|High Demand Course?
Course Delivery Information
|Academic year 2022/23, Available to all students (SV1)
|Course Start Date
|Learning and Teaching activities (Further Info)
Seminar/Tutorial Hours 5,
Online Activities 100,
Feedback/Feedforward Hours 40,
Formative Assessment Hours 12,
Summative Assessment Hours 10,
Revision Session Hours 8,
Programme Level Learning and Teaching Hours 4,
Directed Learning and Independent Learning Hours
|Assessment (Further Info)
|Additional Information (Assessment)
||Assessment is undertaken throughout the course with each element structured to provide opportunities for formative feedback at key points. Assessment is designed to be integral to the learning process and triangulates between learning outcomes, learning content and graduate attributes.
Reflective patchwork text: 25%
Individual project I: 30%
Individual project II: 45%
|No Exam Information
On completion of this course, the student will be able to:
- Evaluate the differences between quality control and quality assurance activities in clinical trials
- Critically appraise techniques employed for auditing and monitoring electronic medical records, informed consent, case report form (eCRFs) and clinical trial databases
- Appraise, prepare and implement a quality management plan that meets the needs of GCP regulatory standards.
- Critically assess and conceptualise the practicalities of quality management systems in various clinical research settings and populations.
- Critically appraise the QMS tools to ensure, control, maintain and improve quality
|International Conference on Harmonisation of Technical Requirements for Registration of |
Pharmaceuticals for Human Use: Guideline for Good Clinical Practice E6.
|Graduate Attributes and Skills
||With the work to be undertaken this course will provide course participants with the opportunity to develop or further develop key attributes:
- In-depth knowledge of specialist discipline
- Develop new understanding by exercising critical judgement and challenging knowledge
- Be a self-directed and curious learner
- Solve problems effectively taking ethical, professional and environmental issues into account
- Use information responsibly in a range of contexts
- Engage in reflective practice and self-development
- Collaborate with others, capitalising on their different thinking, experience and skills
- Communicate (written, oral, online) effectively, respectful of social and cultural diversity
- Application of numeracy
- Application of IT
|Keywords||Clinical trials,quality assurance,GCP,MHRA,inspections,sponsors
|Course organiser||Ms Judith Syson
|Course secretary||Ms Rebecca Sewell
Tel: (0131 6)51 7112