London School of Hygiene & Tropical Medicine

Clinical Data Management is an indispensable part of clinical research. Clinical Data Managementactivities should lead to the collection of reliable, high quality and statistically sound data. This module will enable students to gain a solid understanding of the best practices for developing a data management project while abiding by and applying the regulatory requirements. Throughout the sessions, we focus on practical examples, short quizzes and hands-on exercises as we explore together the best practices in data management. Students will also gain a solid understanding of the regulatory framework governing all data management activities in addition to data quality control and quality assurance activities that should ideally be implemented to ensure that the ICH Good Clinical Practice and the applicable regulatory requirements with respect to data quality and integrity are met.

The overall module aim is to present the critical concepts and practical methods related to a data management project and to understand the role of the data management function within a clinical trial setting in addition to the regulatory environment governing the data management processes.

Intended learning outcomes

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

1. Demonstrate knowledge and understanding of the role of data management within the framework of a clinical trial.
2. Apply fundamental practices in designing, implementing, managing and closing out a data management project.
3. Demonstrate knowledge and understanding of the key principles which should be implemented to deliver high quality data for statistical analysis.
4. Demonstrate knowledge and understanding of the regulatory framework governing the data management process.
5. Critically evaluate the quality control/assurance activities governing the data management process.

Assessment

The assessment strategy for the Data Management module includes a 4,000 words Assessed Assignment.

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.