Postgraduate Course: Data Enabled Clinical Trials (MCLM11097)
Course Outline
| 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 |
| SCQF Credits | 20 |
ECTS Credits | 10 |
| Summary | Data Enabled Clinical Trials (DECT) use data that is routinely collected by healthcare or other service providers. This course encompasses data communication, EHR utilization, ethical considerations, public trust, current limitations, future trends, and innovations to advance clinical research methodologies. |
| Course description |
This course provides students with insight into the evolving field that is data enabled clinical trials (DECT). Students will develop practical skills that can be applied in their current role or that they can take forward into their future careers. Namely, they will develop the ability to design and manage DECT, ensuring data integrity and regulatory compliance, while effectively collaborating with multidisciplinary teams.
We will start by introducing DECT and why they are used before moving on to cover topics including:
- Future trends and innovations in DECT
- Ethical considerations
- Legal and regulatory frameworks
- Data sources, data linkage, data quality
- Limitations and problem solving
- Communicating with a non-technical audience
- Equality, diversity and inclusivity of data
- Public involvement and trust
DECT Case Studies will be introduced at the beginning of the course and then referred back to when relevant topics are covered to give context throughout the 10 weeks.
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
Information for Visiting Students
| Pre-requisites | None |
Course Delivery Information
|
| Academic year 2025/26, Available to all students (SV1)
|
Quota: None |
| Course Start |
Flexible |
Timetable |
Timetable |
| Learning and Teaching activities (Further Info) |
Total Hours:
200
(
Lecture Hours 10,
Seminar/Tutorial Hours 2,
Online Activities 70,
Feedback/Feedforward Hours 10,
Formative Assessment Hours 10,
Revision Session Hours 2,
Programme Level Learning and Teaching Hours 4,
Directed Learning and Independent Learning Hours
92 )
|
| Assessment (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
|
| Additional Information (Assessment) |
Written exam 0%, Coursework 100%, Practical exam 0%
Includes final written assignment and incorporates other activities |
| Feedback |
Feedback will be provided in accordance with the University's assessment and feedback principles and priorities.
For the individual project of the overall grade there will be an associated formative assessment. Group feedback for this formative assessment will be given via a live Collaborate session to help students with their summative submission.
Similarly, for the second individual project there is an associated formative assessment. Again, group feedback for this formative assessment will be given via a live Collaborate session to help students with their summative submission.
Feedback for the graded discussion boards and summative assessments will be given in the usual way and will be broken down into relevant sections to provide clarity.
As well as tutor feedback there will be opportunity for peer-to-peer feedback via the discussion boards. |
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
- Identify key sources of data in clinical trials and describe the benefits, opportunities and limitations of DECTs
- Assess and ensure compliance with ethical principles, regulatory standards, and legal requirements in the design and conduct of data-enabled clinical trials
- Critically appraise published literature in DECTs and evaluate suitability of data for different stages of a trial
- Communicate and interpret data for technical and non-technical stakeholders
- Develop the ability to design and manage data-enabled clinical trials, ensuring data integrity and regulatory compliance, while effectively collaborating with multidisciplinary teams
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Additional Information
| Graduate Attributes and Skills |
Not entered |
| Keywords | Data,Electronic Health Records,decentralised trials,clinical trials,data quality,data sources |
Contacts
| Course organiser | Miss Laura Stewart
Tel: (01316) 503237
Email: lstewa17@ed.ac.uk |
Course secretary | Ms Rebecca Sewell
Tel: (0131 6)51 7112
Email: Rebecca.Sewell@ed.ac.uk |
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