The LICQual Level 3 Diploma in Drug Development (Dip Clinical Research) is a specialised qualification designed to equip learners with comprehensive knowledge and practical skills in the clinical research and drug development process. This programme focuses on providing an in-depth understanding of clinical trial design, regulatory requirements, ethical considerations, and the stages of drug development from pre-clinical research to market approval.
Learners undertaking this diploma will explore critical aspects of clinical research, including trial management, patient recruitment, data collection and analysis, pharmacovigilance, and adherence to Good Clinical Practice (GCP) guidelines. The course emphasises practical application, enabling learners to contribute effectively to clinical research projects, ensure compliance with regulatory standards, and support the safe and ethical development of new medicines.
This qualification is aimed at professionals who wish to enhance their career prospects, expand their expertise, and strengthen their commitment to Continuing Professional Development (CPD). By completing the programme, learners gain the skills required to pursue roles in clinical research, drug development, regulatory affairs, or pharmaceutical project management, while contributing to high-quality, compliant, and ethically conducted clinical trials.
Centres delivering this qualification must uphold high standards of training by employing competent and qualified staff with relevant expertise in clinical research and drug development. They are also required to provide all necessary learning materials, facilities, and resources to ensure learners have a structured and high-quality learning experience.
By undertaking the LICQual Level 3 Diploma in Drug Development, learners take an important step towards advancing their professional careers, gaining specialised expertise, and supporting the development of safe, effective, and regulatory-compliant pharmaceutical products.
Course Overview
Qualification Title
LICQual Level 3 Diploma in Clinical Research and Drug Development (Dip Clinical Research)
Total Units
6
Total Credits
60
GLH
240
Qualification #
LICQ2201163
Qualification Specification
To enroll in the LICQual Level 3 Diploma in Clinical Research and Drug Development (Dip Clinical Research) , applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201163-1 |
Introduction to Clinical Research |
10 |
40 |
|
LICQ2201163-2 |
Clinical Trial Design and Methodology |
10 |
40 |
|
LICQ2201163-3 |
Regulatory and Ethical Requirements |
10 |
40 |
|
LICQ2201163-4 |
Data Management and Analysis |
10 |
40 |
|
LICQ2201163-5 |
Pharmacovigilance and Safety Monitoring |
10 |
40 |
|
LICQ2201163-6 |
Applied Clinical Research Project |
10 |
40 |
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 fundamentals of clinical research and the drug development process
- Identify and describe the phases of clinical trials and their objectives
- Analyse the roles and responsibilities of stakeholders in clinical research
- Demonstrate understanding of professional standards in clinical research practice
Unit 2: Clinical Trial Design and Methodology
By the end of this unit, learners will be able to
- Explain different clinical trial designs and methodologies
- Develop protocols incorporating randomisation, blinding, and control measures
- Analyse statistical considerations and methods for clinical research
- Apply trial design principles to ensure valid and reliable study outcomes
Unit 3: Regulatory and Ethical Requirements
By the end of this unit, learners will be able to
- Explain Good Clinical Practice (GCP) and ethical guidelines in clinical research
- Apply regulatory requirements and procedures to ensure compliance in trials
- Analyse the importance of informed consent and patient safety
- Demonstrate understanding of legal and ethical responsibilities in clinical research
Unit 4: Data Management and Analysis
By the end of this unit, learners will be able to
- Apply techniques for data collection, validation, and database management
- Analyse clinical trial data using appropriate statistical methods
- Interpret study results to support decision-making in drug development
- Demonstrate accurate documentation and reporting of trial outcomes
Unit 5: Pharmacovigilance and Safety Monitoring
By the end of this unit, learners will be able to
- Explain the principles of pharmacovigilance and post-marketing surveillance
- Apply procedures for adverse event reporting and safety monitoring
- Analyse risk management strategies to ensure patient safety
- Demonstrate understanding of regulatory and ethical obligations in pharmacovigilance
Unit 6: Applied Clinical Research Project
By the end of this unit, learners will be able to
- Plan and execute a clinical research project addressing real-world scenarios
- Apply trial management, regulatory, and ethical principles in practice
- Analyse project data and provide evidence-based recommendations
- Present findings professionally, demonstrating applied knowledge of clinical research and drug development
The LICQual Level 3 Diploma in Clinical Research and Drug Development is ideal for
- Healthcare professionals seeking to develop expertise in clinical research and drug development
- Pharmacy professionals and pharmaceutical scientists aiming to work in clinical trial management, regulatory affairs, or drug safety
- Graduates in pharmacy, pharmaceutical sciences, life sciences, or healthcare disciplines who wish to specialise in clinical research
- Professionals involved in patient recruitment, trial monitoring, data management, or pharmacovigilance seeking to enhance their skills
- Individuals committed to Continuing Professional Development (CPD) and career progression in the pharmaceutical and clinical research sectors
- Learners aspiring to manage, monitor, and contribute to high-quality, ethically conducted clinical trials
- Professionals seeking practical skills to implement regulatory, ethical, and safety standards in clinical research
Centres delivering the LICQual Level 3 Diploma in Clinical Research and Drug Development must meet high standards to ensure effective learning and successful outcomes for all learners. The following requirements should be in place:
- Qualified and Competent Staff
Centres must employ trainers, assessors, and internal quality assurers with relevant academic qualifications and professional experience in clinical research, drug development, and pharmaceutical sciences. - Access to Learning Resources
Centres must provide up-to-date study materials, textbooks, digital resources, and case studies covering clinical trial management, regulatory compliance, pharmacovigilance, and data analysis. - Practical Training and Applied Learning Facilities
Centres should provide facilities and tools to support practical exercises, simulations, project work, and applied clinical research scenarios. - Assessment and Quality Assurance Systems
Centres must implement robust assessment strategies and internal quality assurance processes to ensure reliability, consistency, and compliance with international standards. - Learner Support Services
Centres must offer academic guidance, mentorship, and access to Continuing Professional Development (CPD) resources to support learner engagement and success. - Technology and Digital Access
Centres should provide access to e-learning platforms, data management tools, and digital resources to facilitate flexible and blended learning. - Commitment to Compliance and Continuous Improvement
Staff must engage in ongoing CPD, maintain up-to-date knowledge of clinical research and drug development standards, and follow ethical and regulatory best practices in education and training.
By meeting these centre requirements, providers can deliver a high-quality, learner-focused programme that equips professionals with the knowledge, skills, and confidence to excel in clinical research, drug development, and pharmaceutical practice.
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.
