Real World Data in Clinical Trials BIOL5457

• Academic Session: 2024-25
• School: MVLS College Services
• Credits: 20
• Level: Level 5 (SCQF level 11)
• Typically Offered: Semester 2
• Available to Visiting Students: No

Short Description

This course will cover the use of real-world patient data in clinical trials. It will also encompass data and statistics management in a clinical study, the concepts and process of pseudoanonymisation and anonymisation of data and building shareable trial datasets.

Timetable

This course runs in Semester 2 and will be delivered online live.

Excluded Courses

None

Co-requisites

None

Assessment

Assessment will consist of:

1. Individual written assignment (50%, 1500-2000 words) [ILO1, ILO2, ILO3].
2. Individual project output (50%, 2000 words) [ILO1 - ILO4].

Course Aims

The specific aims of this taught course are:

• To provide students with a comprehensive knowledge of Real-World data and how to use it for clinical trials.
• To allow students to develop a comprehensive knowledge of the regulations governing trial-based data.
• To facilitate students depth of understanding of using the correct data management plans and statistical methodology in clinical research.
• To equip students with the necessary skills to build and utilise shareable clinical datasets

Intended Learning Outcomes of Course

By the end of this course students will be able to:

1. Critically evaluate the use of Real-World data in clinical trials.
2. Justify appropriate data governance and regulations in clinical trials.
3. Evaluate data-based methods in clinical trials.
4. Critically appraise the statistical methods and data management plans used in various clinical research.

Minimum Requirement for Award of Credits

Students must submit at least 75% by weight of the components (including examinations) of the course’s summative assessment.