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
24
GLH
120
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 |
4 |
20 |
|
LICQ2201131-2 |
Drug Development and Clinical Trials |
4 |
20 |
|
LICQ2201131-3 |
Regulatory Compliance and Ethical Considerations |
4 |
20 |
|
LICQ2201131-4 |
Patient Recruitment and Data Management |
4 |
20 |
|
LICQ2201131-5 |
Monitoring, Reporting, and Risk Management |
4 |
20 |
|
LICQ2201131-6 |
Professional Development and CPD in Clinical Research |
4 |
20 |
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
The LICQual Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research) is ideal for healthcare professionals, pharmacists, researchers, and students seeking to gain practical and theoretical expertise in clinical trials, drug development, and research management. This course is perfect for those who want to advance their career, enhance professional credibility, and develop skills in regulatory compliance, ethical practices, and data analysis within the pharmaceutical and healthcare sectors.
Healthcare Professionals
- Gain knowledge of clinical research principles and trial procedures
- Understand patient safety and ethical considerations
- Apply research skills in healthcare settings
- Learn to interpret and analyze clinical data
- Contribute to evidence-based healthcare decisions
- Enhance career opportunities in healthcare research
Pharmacists and Pharmacy Technicians
- Learn drug development and clinical trial processes
- Ensure regulatory compliance in pharmaceutical practice
- Monitor medication safety and efficacy in studies
- Support clinical research teams effectively
- Apply evidence-based practices in patient care
- Strengthen professional credentials with a UK-recognized certificate
Clinical Researchers and Scientists
- Design and manage clinical trials efficiently
- Analyze research data with accuracy and precision
- Ensure adherence to ethical and legal guidelines
- Conduct pharmacovigilance and safety monitoring
- Develop expertise in research documentation and reporting
- Advance career opportunities in clinical and pharmaceutical research
Students and Graduates in Health Sciences
- Build foundational knowledge in clinical research and drug development
- Prepare for careers in pharmaceuticals, healthcare, or research
- Gain practical skills for clinical trial participation
- Learn regulatory compliance and ethical standards
- Understand clinical study evaluation and reporting
- Enhance employability in healthcare and research sectors
Pharmaceutical Industry Professionals
- Understand drug lifecycle and approval processes
- Monitor clinical trials for compliance and quality assurance
- Apply best practices in pharmaceutical research
- Manage regulatory submissions and documentation
- Contribute to safe distribution and marketing of medicines
- Expand career prospects in pharmaceutical operations
Research Coordinators and Trial Managers
- Oversee clinical trial activities efficiently
- Ensure adherence to study protocols and timelines
- Coordinate with investigators and stakeholders
- Monitor participant recruitment and retention
- Implement quality assurance procedures
- Develop leadership and project management skills
International Healthcare and Research Practitioners
- Gain a UK-recognized qualification for global recognition
- Apply clinical research knowledge in international settings
- Ensure ethical compliance across diverse healthcare systems
- Access flexible online or blended learning options
- Connect with a global network of healthcare professionals
- Expand career opportunities in clinical research and drug development
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.
