The LICQual Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research) is a comprehensive qualification designed for professionals seeking to advance their careers in clinical research, pharmaceuticals, and drug development. This advanced programme equips learners with the knowledge, skills, and practical expertise required to manage and conduct clinical trials, evaluate drug efficacy and safety, and contribute to the development of innovative therapeutic solutions. By completing this diploma, learners enhance their professional credentials, broaden their career opportunities, and achieve recognized Continuing Professional Development (CPD) accreditation.
This Level 6 Diploma is particularly suitable for clinical research associates, trial coordinators, healthcare scientists, pharmaceutical researchers, and professionals involved in regulatory submissions or drug development strategy. Learners will develop the ability to design, implement, and analyse clinical trials, interpret research findings, and apply evidence-based approaches to drug development. The curriculum combines theoretical knowledge with practical application, preparing learners for complex decision-making, regulatory compliance, and leadership roles in clinical research and development.
To ensure high-quality learning, centres delivering this qualification must employ competent and qualified staff and provide all necessary learning resources, including access to clinical research databases, trial management tools, and up-to-date reference materials. Centres are expected to create a supportive learning environment, guiding learners through practical and theoretical components to ensure success.
With a focus on professional development, research excellence, and industry-relevant skills, the LICQual Level 6 Diploma in Clinical Research and Drug Development is ideal for learners who wish to enhance their expertise, contribute to innovative healthcare solutions, and progress confidently in the clinical research and pharmaceutical sectors.
Course Overview
Qualification Title
LICQual Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research)
Total Units
6
Total Credits
120
GLH
480
Qualification #
LICQ2201195
Qualification Specification
To enroll in the LICQual Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research) , applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201195-1 |
Introduction to Clinical Research |
20 |
80 |
|
LICQ2201195-2 |
Clinical Trial Design and Methodology |
20 |
80 |
|
LICQ2201195-3 |
Regulatory Compliance and Ethics in Clinical Research |
20 |
80 |
|
LICQ2201195-4 |
Data Management and Statistical Analysis |
20 |
80 |
|
LICQ2201195-5 |
Pharmacovigilance and Risk Management |
20 |
80 |
|
LICQ2201195-6 |
Advanced Clinical Research Project |
20 |
80 |
By the end of this course, learners will be able to:
Unit 1: Introduction to Clinical Research
By the end of this unit, learners will be able to:
- Explain the principles and objectives of clinical research in drug development
- Analyse the roles and responsibilities of clinical research professionals
- Evaluate different types of clinical studies and their applications
- Apply foundational knowledge to support clinical research activities
Unit 2: Clinical Trial Design and Methodology
By the end of this unit, learners will be able to:
- Demonstrate understanding of clinical trial phases and designs
- Analyse protocol development, randomisation, blinding, and control strategies
- Evaluate trial methodologies to ensure reliability and validity
- Apply trial design principles to plan and conduct clinical studies
Unit 3: Regulatory Compliance and Ethics in Clinical Research
By the end of this unit, learners will be able to:
- Explain national and international regulations governing clinical research
- Evaluate ethical considerations and Good Clinical Practice (GCP) requirements
- Apply informed consent procedures and patient safety protocols
- Ensure compliance with regulatory frameworks during clinical trials
Unit 4: Data Management and Statistical Analysis
By the end of this unit, learners will be able to:
- Demonstrate knowledge of clinical data collection, storage, and management
- Analyse trial data using appropriate statistical methods
- Evaluate the integrity and reliability of research data
- Apply data management and statistical techniques to support evidence-based conclusions
Unit 5: Pharmacovigilance and Risk Management
By the end of this unit, learners will be able to:
- Explain principles of pharmacovigilance and post-marketing surveillance
- Analyse adverse event data and implement risk mitigation strategies
- Evaluate regulatory requirements for safety reporting
- Apply risk management procedures to ensure patient safety and regulatory compliance
Unit 6: Advanced Clinical Research Project
By the end of this unit, learners will be able to:
- Plan and execute an independent clinical research project
- Critically review literature and existing data to support project objectives
- Develop solutions and strategies for clinical trial management challenges
- Present project findings professionally, demonstrating analytical and decision-making skills
The LICQual Level 6 Diploma in Clinical Research and Drug Development is designed for learners who wish to advance their careers in clinical research, pharmaceuticals, and healthcare innovation. This course is ideal for:
- Clinical research associates and coordinators seeking advanced knowledge in trial management and drug development
- Pharmaceutical researchers and scientists involved in drug discovery and development processes
- Healthcare professionals participating in clinical trials, patient safety monitoring, or regulatory compliance
- Regulatory affairs specialists aiming to enhance understanding of clinical trial approvals and compliance requirements
- Project managers and team leaders responsible for planning, conducting, and reporting clinical research studies
- Learners committed to Continuing Professional Development (CPD) and professional growth in clinical research and drug development
- International professionals seeking a UK-recognised qualification aligned with global clinical research standards
This course equips learners with practical, analytical, and research skills, enabling them to conduct clinical trials effectively, ensure regulatory compliance, and contribute to innovative healthcare solutions.
To deliver the LICQual Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research), centres must adhere to high standards to ensure learners receive a quality learning experience. Centres are expected to:
- Employ competent and qualified staff with relevant academic qualifications and professional experience in clinical research, drug development, or pharmaceutical sciences.
- Provide access to up-to-date learning resources, including clinical research databases, trial management software, scientific journals, regulatory guidelines, and reference materials.
- Maintain suitable facilities, such as classrooms, seminar rooms, or online learning platforms, to support both theoretical instruction and practical activities.
- Implement robust assessment and feedback processes to monitor learner progress and ensure achievement of learning outcomes.
- Support learners with practical tools and simulations, enabling them to apply clinical trial management, data analysis, and regulatory compliance skills effectively.
- Promote a culture of Continuing Professional Development (CPD), encouraging staff and learners to stay updated with the latest developments, regulations, and best practices in clinical research.
- Comply with national and international quality standards, ensuring all teaching, learning, and assessment practices meet recognised industry and educational benchmarks.
By meeting these requirements, centres provide a professional and supportive learning environment, enabling learners to develop the skills, knowledge, and confidence required to succeed in clinical research, drug development, and healthcare innovation.
Assessment and Verification
All units within this qualification are subject to internal assessment by the approved centre and external verification by LICQual. The qualification follows a criterion-referenced assessment approach, ensuring that learners meet all specified learning outcomes.
To achieve a ‘Pass’ in any unit, learners must provide valid, sufficient, and authentic evidence demonstrating their attainment of all learning outcomes and compliance with the prescribed assessment criteria. The Assessor is responsible for evaluating the evidence and determining whether the learner has successfully met the required standards.
Assessors must maintain a clear and comprehensive audit trail, documenting the basis for their assessment decisions to ensure transparency, consistency, and compliance with quality assurance requirements.
