Postgraduate Course: Monitoring and Audit (20 credit) (MCLM11021)
Course Outline
| School | School 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 |
| SCQF Credits | 20 |
ECTS Credits | 10 |
| Summary | This course will build on the robust foundation of knowledge and skills attained in the previous courses encompassing Good Clinical Practice (GCP), trial management, and monitoring.
Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials1. Quality is on a continuum, which begins during the planning and design phase, is critical during conducting and recording, and persists through the reporting stage.
Two quality assessment activities well known to the clinical research team are monitoring and audit. While both are discussed collectively in relation to clinical trial oversight, they have individual functions with interdependencies set within compliance regulation.
This course will cover quality control (QC) and the quality assurance (QA) activities used to build quality management systems (QMS) in single and multi-site international clinical research involving 3rd party vendors and clinical laboratories.
Participants will discuss the role of the sponsor in relation to regulatory compliance and clinical trial delivery through implementation of quality management systems. Additionally, this will allow participates to critically appraise specific challenges to quality such as: globalization, trial complexity, and electronic trial management.
When developing a QMS for clinical trials a key component is an effective Corrective and Preventive Action (CAPA) program. CAPA requirements are not specifically stated in Good Clinical Practice (GCP) regulations; however, requirements for a QMS and a subsequent CAPA process in clinical trials are guided by GCP (5.1.1) and International Organization for Standardization (ISO). An overview of the Medicines and Healthcare Products Regulatory Agency (MHRA) and Food and Drug Administration (FDA) common inspection findings will present case studies to allow participants to implement a CAPA program.
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| Course description |
Not entered
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
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Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | 0 |
Information for Visiting Students
| Pre-requisites | None |
Course Delivery Information
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| Academic year 2014/15, Available to all students (SV1)
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Quota: None |
| Course Start |
Semester 1 |
Timetable |
Timetable |
| Learning and Teaching activities (Further Info) |
Total Hours:
200
(
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
21 )
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| Assessment (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
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| Additional Information (Assessment) |
Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20% |
| Feedback |
Not entered |
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
- Examine and evaluate the differences between quality control and quality assurance activities in clinical trials and recommend the activities essential to achieve the goals of high quality data and participant well-being.
- Critically appraise techniques employed for auditing and monitoring electronic medical records, informed consent, case report forms (eCRFS) and clinical trial databases.
Critically appraise the QMS tools to ensure, control, maintain and improve quality. - 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.
- Create a plan for a regulatory authority inspection (FDA/MHRA) and critically assess their recommendations and implement a corrective and preventative actions (CAPA) process.
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Reading List
International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use: Guideline for Good Clinical Practice E6.
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Additional Information
| Graduate Attributes and Skills |
Not entered |
| Keywords | Clinical trials, quality assurance, GCP, MHRA, inspections, sponsors |
Contacts
| Course organiser | Prof Stuart Ralston
Tel: 72 791 31108
Email: Stuart.Ralston@ed.ac.uk |
Course secretary | Mrs Danielle Marlow
Tel: 0131 537 3798
Email: Danielle.Wilson@ed.ac.uk |
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