The Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research) is an advanced qualification designed for professionals seeking to deepen their expertise in clinical research, pharmaceutical development, and drug evaluation. This programme is not intended for fresh entrants; it is specifically tailored for experienced healthcare and pharmaceutical professionals who wish to enhance their career prospects, expand their knowledge, and actively contribute to their Continuing Professional Development (CPD).
Learners on this programme will gain comprehensive knowledge of the clinical research process, including trial design, ethical considerations, regulatory compliance, and data analysis. The course emphasises evidence-based approaches to drug development, equipping learners with the skills to manage clinical trials, evaluate therapeutic interventions, and ensure adherence to international regulatory standards.
Delivered in line with international standards, the programme combines theoretical understanding with practical application. Learners engage with real-world case studies, research projects, and interactive learning activities, enabling them to make informed decisions that positively impact patient safety, trial integrity, and organisational performance.
Centres delivering this qualification are required to uphold the highest standards of teaching. They must employ competent and qualified staff with expertise in clinical research and drug development, while providing learners with access to all necessary materials, resources, and facilities. This ensures a high-quality learning experience, fostering learner success and professional growth.
By completing this Level 7 Postgraduate Diploma, learners position themselves as leaders in clinical research and drug development, equipped to navigate complex research environments, influence strategic decision-making, and contribute effectively to the advancement of healthcare and pharmaceutical innovation.
Course Overview
Qualification Title
LICQual Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research)
Total Units
6
Total Credits
120
GLH
600
Qualification #
LICQ2201227
Qualification Specification
To enroll in the Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research) , applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201227-1 |
Principles of Clinical Research |
20 |
100 |
|
LICQ2201227-2 |
Clinical Trial Design and Methodology |
20 |
100 |
|
LICQ2201227-3 |
Regulatory Affairs and Compliance in Drug Development |
20 |
100 |
|
LICQ2201227-4 |
Pharmacovigilance and Drug Safety |
20 |
100 |
|
LICQ2201227-5 |
Biostatistics and Data Analysis in Clinical Research |
20 |
100 |
|
LICQ2201227-6 |
Clinical Research Leadership Project |
20 |
100 |
By the end of this course, learners will be able to:
Unit 1: Principles of Clinical Research
Learning Outcomes:
- Critically evaluate the principles and frameworks underpinning clinical research.
- Analyse ethical considerations, regulatory requirements, and governance in clinical studies.
- Apply evidence-based approaches to plan and assess clinical research activities.
- Demonstrate advanced understanding of trial phases, study designs, and research methodologies.
Unit 2: Clinical Trial Design and Methodology
Learning Outcomes:
- Critically assess the design and methodology of clinical trials, including randomisation, blinding, and control strategies.
- Evaluate the selection of appropriate study populations, endpoints, and trial protocols.
- Apply methodological principles to ensure data integrity, reliability, and validity.
- Develop strategies to address challenges and optimise clinical trial outcomes.
Unit 3: Regulatory Affairs and Compliance in Drug Development
Learning Outcomes:
- Analyse national and international regulatory frameworks for drug development and clinical trials.
- Apply compliance strategies to ensure adherence to Good Clinical Practice (GCP) and ethical guidelines.
- Evaluate regulatory submission processes and documentation requirements for approvals.
- Develop approaches to mitigate risks and maintain regulatory compliance throughout drug development.
Unit 4: Pharmacovigilance and Drug Safety
Learning Outcomes:
- Critically assess pharmacovigilance systems and safety reporting standards.
- Monitor and evaluate adverse drug reactions, signal detection, and risk management practices.
- Apply strategies to improve patient safety and ensure regulatory compliance.
- Analyse safety data to support evidence-based decision-making in clinical research.
Unit 5: Biostatistics and Data Analysis in Clinical Research
Learning Outcomes:
- Apply quantitative and qualitative statistical methods to analyse clinical trial data.
- Critically interpret research outcomes to inform evidence-based clinical decisions.
- Evaluate data validity, reliability, and potential sources of bias.
- Develop advanced skills in statistical reporting and data presentation for regulatory submissions.
Unit 6: Clinical Research Leadership Project
Learning Outcomes:
- Design and implement a clinical research project addressing a real-world challenge.
- Demonstrate project management, leadership, and problem-solving skills in clinical research settings.
- Critically evaluate project outcomes using appropriate performance and research indicators.
- Reflect on professional practice and propose evidence-based recommendations for clinical research improvement.
This programme is designed for experienced professionals seeking to advance their careers in clinical research and drug development. It is ideal for:
- Clinical research professionals aiming to enhance their expertise in trial design, regulatory compliance, and data analysis.
- Pharmacists, medical graduates, and life sciences professionals seeking leadership roles within clinical research or pharmaceutical development.
- Healthcare and pharmaceutical managers who wish to develop strategic, operational, and regulatory knowledge in drug development.
- Quality assurance and safety officers looking to deepen their understanding of pharmacovigilance, risk management, and regulatory frameworks.
- Professionals pursuing senior or leadership roles in pharmaceutical companies, contract research organisations (CROs), or regulatory agencies.
- Learners committed to Continuing Professional Development (CPD) and evidence-based practice in clinical research and drug development.
- International professionals seeking a globally recognised Level 7 qualification aligned with international clinical research standards.
This course equips learners with the advanced knowledge, practical skills, and leadership capabilities required to manage complex clinical trials, ensure regulatory compliance, and drive innovation in drug development.
To deliver the Level 7 Postgraduate Diploma in Clinical Research and Drug Development effectively, centres must meet the following requirements:
- Accreditation and Recognition: Centres must be accredited by recognised national or international educational authorities and approved to deliver postgraduate-level programmes in clinical research, pharmaceuticals, or healthcare.
- Qualified Academic Staff: Centres should employ competent and experienced teaching staff with expertise in clinical research, drug development, regulatory affairs, and pharmacovigilance at Level 7 or equivalent.
- Learning Resources: Centres must provide access to comprehensive learning materials, including textbooks, regulatory guidelines, research journals, case studies, and digital learning platforms.
- ICT and Online Learning Infrastructure: Reliable internet access, computers or laptops, and secure online platforms are required to facilitate interactive learning, research, and assessments.
- Practical and Research Facilities: Centres must provide facilities for project work, simulations, and research activities relevant to clinical trials and drug development.
- Assessment and Quality Assurance Systems: Centres should maintain robust assessment processes, including formative and summative evaluations, with quality assurance procedures aligned with international standards.
- Learner Support Services: Centres must provide academic guidance, career advice, and access to professional networks to support learner progression and success.
These requirements ensure that centres deliver a high-quality, internationally recognised programme, providing learners with the knowledge, skills, and practical experience needed to excel in clinical research and drug development roles.
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.
