LBIOL52103A Trial Master File And E-Systems Course Descriptor

Course Overview

This course provides an overview of clinical data management and processes such as data coding, transfer and validation, involved in the generation of high quality clinical trials data. It also examines how the Trial Master File, and careful planning of the essential documents that go into it allows the conduct of the clinical trial to be reconstructed and evaluated. Finally, it highlights the importance of trial data management standardisation, through the implementation of computerised document management systems. This is to provide the assurance that the rights, safety and wellbeing of patients are protected, regardless of where the study takes place.

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 (6 days x 7 hours) = 42 hours
• On-the-job learning (12 days x 7 hours) = 84 hours (e.g. 2 days per week for 6 weeks)
• Private study (4 hours per week) = 24 hours

Total = 150 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 Guide or other documentation provided to learners; the indicative reading list provided below is used as part of the approval/modification process only.

Books

Piantadosi, S., & Meinert, C. L. (Eds.). (2022). Principles and practice of clinical trials. Springer.

Journals

Learners are encouraged to read material from relevant journals on oncology as directed by their course leader.

Andersen, J. R., Byrjalsen, I., Bihlet, A., Kalakou, F., Hoeck, H. C., Hansen, G., Hansen, H. B., Karsdal, M. A., & Riis, B. J. (2015). Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials. British Journal of Clinical Pharmacology, 79(4), 660–668.

CROs can use eTMF to their competitive advantage. (2015). Applied Clinical Trials, 24 (2–3), 6-.

Husovich, M. E., Zadro, R., Zoller-Neuner, L. L., Vangheel, G., Anyangwe, O., Ryan, D. P., & Rygiel-Zbikowska, B. (2019). Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development. Therapeutic Innovation & Regulatory Science, 53(1), 25–35.

Suprin, M., Chow, A., Pillwein, M., Rowe, J., Ryan, M., Rygiel-Zbikowska, B., Wilson, K. J., & Tomlin, I. (2019). Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development. Therapeutic Innovation & Regulatory Science, 53(1), 36–44.

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:

• Trial Master File and Essential documents
• Quality Assurance and audits
• Clinical Trial Management Systems

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