The LICQual Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research) is a specialised qualification designed for professionals seeking to enhance their knowledge and skills in the planning, execution, and management of clinical research and drug development processes. This course provides learners with a comprehensive understanding of clinical trial design, regulatory compliance, ethical considerations, data analysis, and the drug development lifecycle, enabling them to contribute effectively to the advancement of healthcare and pharmaceutical innovation. It is ideal for individuals aiming to advance their careers, broaden their professional expertise, and strengthen their Continuing Professional Development (CPD).
Learners will explore essential topics such as clinical research methodologies, patient recruitment, trial monitoring, safety reporting, and the application of good clinical practice (GCP) standards. The programme combines theoretical knowledge with practical applications, allowing learners to develop the skills needed to manage research studies, interpret clinical data, and ensure regulatory compliance throughout the drug development process.
LICQual emphasises the importance of high-quality training delivery. Centres offering this qualification must have competent and qualified staff, along with access to all necessary materials and resources, to provide a structured, supportive, and engaging learning environment. This ensures learners gain the knowledge, practical skills, and professional confidence required to succeed in their studies and careers.
By completing the LICQual Level 3 Certificate in Clinical Research and Drug Development, learners enhance their professional expertise and open doors to career opportunities in clinical research, pharmaceutical development, regulatory affairs, and healthcare project management. This qualification is an essential step for committed professionals aspiring to excel in the dynamic field of clinical research and make meaningful contributions to healthcare innovation.
Course Overview
Qualification Title
LICQual Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research)
Total Units
6
Total Credits
60
GLH
240
Qualification #
LICQ2201131
Qualification Specification
To enroll in theLICQual Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research) , applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201131-1 |
Introduction to Clinical Research |
10 |
40 |
|
LICQ2201131-2 |
Drug Development and Clinical Trials |
10 |
40 |
|
LICQ2201131-3 |
Regulatory Compliance and Ethical Considerations |
10 |
40 |
|
LICQ2201131-4 |
Patient Recruitment and Data Management |
10 |
40 |
|
LICQ2201131-5 |
Monitoring, Reporting, and Risk Management |
10 |
40 |
|
LICQ2201131-6 |
Professional Development and CPD in Clinical Research |
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 principles and objectives of clinical research in healthcare and drug development
- Describe different types of clinical studies and research methodologies
- Analyse the role of clinical research in advancing medical knowledge and patient care
Unit 2: Drug Development and Clinical Trials
By the end of this unit, learners will be able to:
- Demonstrate knowledge of the phases of drug development from preclinical to post-marketing
- Develop and interpret clinical trial protocols and study designs
- Apply practical skills to support the planning and execution of clinical trials
Unit 3: Regulatory Compliance and Ethical Considerations
By the end of this unit, learners will be able to:
- Explain regulatory frameworks and Good Clinical Practice (GCP) requirements in clinical research
- Apply ethical principles in research, including informed consent and patient protection
- Analyse the role of ethics committees and regulatory authorities in overseeing clinical studies
Unit 4: Patient Recruitment and Data Management
By the end of this unit, learners will be able to:
- Plan and implement effective patient recruitment strategies for clinical studies
- Apply data collection, management, and quality control procedures
- Evaluate the importance of accurate data management for research integrity and compliance
Unit 5: Monitoring, Reporting, and Risk Management
By the end of this unit, learners will be able to:
- Monitor clinical trial activities to ensure adherence to protocols and regulations
- Document and report adverse events and safety information accurately
- Identify potential risks in clinical research and implement mitigation strategies
Unit 6: Professional Development and CPD in Clinical Research
By the end of this unit, learners will be able to:
- Reflect on personal practice and identify areas for professional growth in clinical research
- Develop a plan for continuous professional development (CPD)
- Apply ethical and professional standards in decision-making and clinical research practice
This course is designed for professionals and learners who wish to enhance their knowledge and skills in clinical research, drug development, and regulatory compliance. It is particularly suitable for:
- Pharmacists, Pharmacy Technicians, and Healthcare Professionals seeking to gain expertise in clinical research and drug development processes
- Clinical Research Coordinators and Associates aiming to strengthen their understanding of clinical trial management and regulatory compliance
- Healthcare Scientists and Analysts involved in drug development, clinical trials, or research studies
- Learners pursuing Continuing Professional Development (CPD) to improve professional skills and career progression in clinical research
- Professionals working in pharmaceutical companies or research organisations who require practical knowledge of clinical trial protocols, patient recruitment, and data management
- Learners committed to ethical and compliant research practices to ensure patient safety and high-quality research outcomes
This course is ideal for motivated learners who wish to combine theoretical knowledge with practical skills, preparing them for success in a wide range of clinical research, drug development, and healthcare research roles.
To ensure high-quality delivery and successful learner outcomes, centres offering the LICQual Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research) must meet the following requirements:
- Qualified and Competent Staff: Centres must have instructors and assessors with relevant qualifications and professional experience in clinical research, drug development, or healthcare research management.
- Comprehensive Learning Resources: Centres should provide access to up-to-date textbooks, research guidelines, digital learning platforms, and practical tools to support effective teaching and learning.
- Safe and Adequate Facilities: Learning environments must be well-equipped, safe, and suitable for classroom instruction, research simulations, and practical exercises.
- Assessment and Monitoring Systems: Centres must implement robust processes to assess learners’ theoretical knowledge, practical skills, and competency in accordance with LICQual standards.
- Access to Practical Learning Opportunities: Learners should have opportunities to apply research methodologies, data management techniques, and trial monitoring processes in simulated or real-world scenarios.
- Commitment to Quality and CPD: Centres must support continuous professional development for staff and maintain ongoing quality assurance processes to ensure learners achieve high-standard outcomes.
Meeting these requirements ensures learners benefit from a structured, engaging, and professional learning experience, equipping them with the knowledge and skills necessary for career advancement in clinical research and drug development.
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.
