LBIOL4276A Regulatory Environment In Clinical Trials Course Descriptor

Course Overview

This course is an eight-week course that includes an intensive two-week block of face-to-face teaching and project work that helps learners to delve into the regulatory landscape of clinical research. In particular, learners examine the purpose of Good Clinical Practice (GCP). The course covers the basic principles of GCP, the International Conference on Harmonisation (ICH) GCP guidelines, the responsibilities of key stakeholders such as sponsors, investigators and ethics committees. It also explores the role of regulatory authorities and how these are set-up across various regions (inside and outside the ICH area). The varied  roles within clinical trials, and how the skills developed in the workplace support the upholding of GCP and the safety and well being of participants at large, is also discussed. Finally, the course also explores methods of communication and the impact they have on professional practice.

Learning Outcomes

On successful completion of the course, learners will be able to:

Knowledge and Understanding

Subject Specific Skills

Transferable and Professional Skills

Teaching and Learning

This is an e-learning course, taught throughout the year. 

This course can be offered as a standalone short course.

Teaching and learning strategies for this course will include: 

• Online learning
• Online discussion groups
• Online assessment

Course information and supplementary materials will be available on the University’s Virtual Learning Environment (VLE).

Learners are required to attend and participate in all the formal and timetabled sessions for this course. Learners are also expected to manage their self-directed learning and independent study in support of the course.

The course learning and teaching hours will be structured as follows:

• Off-the-job learning and teaching (16 days x 7 hours) = 112 hours
• On-the-job learning (24 days x 7 hours) = 168 hours
• Private study = 20 hours

Total = 300 hours

Workplace assignments (see below) will be completed as part of on-the-job learning.

Assessment

Formative

Learners will be formatively assessed during the course by means of set assignments. These will not count towards the final degree but will provide students with developmental feedback. 

Summative

Feedback

Learners will receive formal feedback in a variety of ways: written (via email or VLE correspondence) and indirectly through online discussion groups. Learners will also attend a formal meeting with their Academic Advisor or Success Manager (and for apprentices, including their Line Manager). These bi or tri-partite reviews will monitor and evaluate the learner’s progress.  

Feedback is provided on summatively assessed assignments and through generic internal examiners’ reports, both of which are posted on the VLE.

Indicative Reading

Note: Comprehensive and current reading lists for courses are produced annually in the Course Syllabus or other documentation provided to learners; the indicative reading list provided below is used as part of the approval/modification process only.

Books

Kritikos, M. (2018). Governing Gene Editing in the European Union: Legal and Ethical Considerations. In Ethics and Integrity in Health and Life Sciences Research (Vol. 4, pp. 99–114). Emerald Publishing Limited.

Smyth, R. L. (2011). Regulation and governance of clinical research in the UK. BMJ (Online), 342, d238-.

Journals

Learners are encouraged to read material from relevant journals on chemistry for the life sciences as directed by their course leader.

Electronic Resources

Learners are encouraged to consult relevant websites on the history and general design of clinical trials.

Indicative Topics

Students will study the following topics:

• Good Clinical Practice
• Regulatory authorities
• Protection of clinical research subjects

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