The module focuses on the on-going monitoring of the data in a study in order that sufficient data are available to answer the trial’s question reliably without recruiting more patients than necessary, or exposing them to unacceptable risks. Statistical, ethical and conduct issues are considered.

The overall module aim is to equip students with knowledge and understanding of, and skills to address, issues relating to the on-going monitoring of the data in a study in order that sufficient data are available to answer the trial’s question reliably without recruiting more patients than necessary, or exposing them to unacceptable risks.

Intended learning outcomes

Upon successful completion of the module a student will be able to: 

1. Explain what is meant by data monitoring in the context of decisions about whether or not to continue to enter participants in a trial.
2. Describe the independent review role of a Data Monitoring Committee.
3. Evaluate the appropriateness of statistical, ethical and economic decisions about whether or not to continue to enter participants in a trial.
4. Apply a range of stopping guidelines using software provided.
5. Participate effectively in a Data Monitoring Committee.

Assessment

The assessment strategy for the Data Monitoring and Interim Analyses module includes:

• Groupwork (20%).
• A 1,500 words Assessed Assignment (30%).
• A 2,500 words Assessed Assignment (50%).

Mode of delivery

Our distance learning modules are delivered entirely online via directed self-study and online materials via the Virtual Learning Environment.

Module duration

Distance learning module studies begin at the start of October each year. Students may start their studies at any time once they gain access to Moodle (the virtual learning environment) and study materials, and work through the materials in line with the assessment schedules. The study year runs from the beginning of October through to June examinations. Some students also study between June and September with extended tutorial support (e.g. those undertaking projects, the Clinical Trials integrating report, or two of the Epidemiology modules). Deadlines for submission of coursework vary per programme but are usually in February, March, May, and September.

How you'll study

Our distance learning programmes are predominantly online and largely self-directed study to enable you to study independently and at times convenient to you. You'll have access to tutorial support and the ability to interact with other students and form study groups throughout the study year via the discussions in our Virtual Learning Environment, Moodle.

Credits

• CATS: 15
• ECTS: 7.5

Module specification

For full information regarding this module please see the module specification.

Please note: information based on the 2025-26 module specification subject to change for 2026-27 entry.