Postgraduate taught 

Clinical Trials MSc/PgDip/PgCert

Clinical Trials Management BIOL5451

Clinical Trials Management BIOL5451

  • 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

Personnel working in the clinical trial sector should have knowledge of and practical skills in managing the project accordingly. This course provides trial management skills, from participant recruitment through to trial closure.

Timetable

This course runs for 6 weeks in Semester 2 and will be delivered face to face on campus.

Excluded Courses

None

Co-requisites

None

Assessment

Assessment will consist of:

  1. Group Presentation (20 minutes, 50%) (25% of the grade will be based on individual performance and 25% will be based on overall group performance)) [ILO1, ILO2].
  2. Individual written assignment (1500-2000 words, 50%) [ILO3, ILO4].

Course Aims

  • To provide students with knowledge on trial monitoring and, the process for reporting issues and amendments.
  • To provide knowledge of the role of audits and inspections in ensuring compliance with good clinical practice.
  • To provide training and knowledge on how to close trials centrally and at each active site, and the potential implications of trials being terminated prematurely (including misconduct).
  • To familiarise students with the considerations around general data protection regulation and trial misconduct.
  • To familiarise students with the reporting procedures to all stakeholders.

Intended Learning Outcomes of Course

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

  1. Design management elements, such as planning, coordination, regulatory compliance, team leadership, quality assurance, budget and resource management, data management and reporting, risk management, patient safety and documentation in clinical trials.
  2. Critically evaluate project plans for clinical trials, including scope, timelines, budgets, and risk management strategies.
  3. Identify regulatory and ethical standards relevant to the management of clinical trials.
  4. Examine quality assurance and quality control processes to ensure the integrity and reliability of clinical trial data. 

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.