ICTQual AB Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research)

The ICTQual AB Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research) is designed to provide learners with a comprehensive understanding of the processes, principles, and practices that underpin clinical research and pharmaceutical drug development. This qualification equips learners with the essential knowledge to contribute effectively to clinical trials, research studies, and the regulatory compliance required throughout the drug development lifecycle.

Learners will explore key concepts including clinical trial design, research methodology, drug discovery, development processes, and ethical considerations in human research. The programme also emphasises the importance of regulatory compliance, patient safety, and data integrity, ensuring learners understand the rigorous standards necessary to bring safe and effective medicines to market.

Ideal for individuals aspiring to build a career in clinical research, pharmaceutical development, or healthcare science, this qualification also supports Continuing Professional Development (CPD) for professionals already working in related sectors. Learners will gain practical insights into clinical protocols, trial management, monitoring, and reporting, enabling them to contribute confidently to research teams and pharmaceutical projects.

By completing the ICTQual AB Level 3 Certificate in Clinical Research and Drug Development, learners will develop the expertise to support clinical research operations, contribute to evidence-based medicine, and understand the scientific, regulatory, and ethical frameworks that govern the development of new treatments. This internationally relevant qualification provides a strong foundation for career progression, advanced study, or specialised roles within clinical research, pharmaceutical companies, and healthcare organisations, making it a valuable asset for anyone seeking to advance in the pharmaceutical and clinical research sector.

Course overview

Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research)

To enrol in ICTQual AB Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research), learner must meet the following entry requirements:

  • Age Requirement: Learners must be at least 16 years old at the time of registration.
  • Educational Background: A basic secondary school qualification or equivalent is expected. While prior knowledge of science, healthcare, or pharmaceutical studies is beneficial, it is not mandatory. Learners with an interest in clinical research, drug development, or healthcare science will gain the most from this course.
  • Professional Experience: As the qualification is delivered in English, learners must demonstrate sufficient proficiency in reading, writing, and communication to engage effectively with course materials and complete assessments. Centres may require evidence of English language skills, particularly for learners whose first language is not English.
  • English Proficiency: Since the medium of instruction is English, learners must demonstrate a reasonable standard of English proficiency. This may be shown through prior education in English or recognised language qualifications. Centres may also conduct their own internal assessments to confirm suitability.
  • Additional Requirement:Learners may need access to a computer and a reliable internet connection for research, assignments, and participation in online or blended learning formats. Commitment, analytical skills, and an interest in clinical research and drug development are essential to ensure successful completion of the programme.
  • Centre Requirements: Centres offering this qualification must have qualified and competent staff, along with adequate learning resources, study materials, and assessment facilities to ensure high-quality learning experiences and learner success.

This qualification, the ICTQual AB Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research), consists of 6 mandatory units.

  1. Introduction to Clinical Research
  2. Drug Discovery and Development Processes
  3. Clinical Trial Design and Methodology
  4. Regulatory Compliance and Good Clinical Practice (GCP)
  5. Data Management and Reporting in Clinical Research
  6. Ethics and Patient Safety in Clinical Trials

Learning Outcomes for the Study Units:

Introduction to Clinical Research

  • Understand the fundamentals of clinical research, including its purpose, scope, and role in advancing medical science and patient care.
  • Demonstrate knowledge of different types of clinical studies and research designs used in healthcare and pharmaceutical development.
  • Apply foundational principles to support the planning and management of clinical research activities.

Drug Discovery and Development Processes

  • Gain insight into the stages of drug discovery, preclinical research, and clinical development.
  • Understand the processes involved in bringing new medicines from laboratory research to patient use.
  • Apply knowledge of drug development pathways to support research teams and regulatory submissions.

Clinical Trial Design and Methodology

  • Understand the principles of designing and conducting clinical trials, including control groups, randomisation, and blinding.
  • Demonstrate knowledge of sampling, data collection, and statistical considerations in research methodology.
  • Apply trial design concepts to evaluate the validity, reliability, and ethical soundness of research studies.

Regulatory Compliance and Good Clinical Practice (GCP)

  • Understand national and international regulatory requirements governing clinical research, including GCP guidelines.
  • Recognise the responsibilities of researchers, sponsors, and regulatory authorities in maintaining compliance.
  • Apply regulatory principles to support ethical and legally compliant research practices.

Data Management and Reporting in Clinical Research

  • Demonstrate knowledge of data collection, management, and analysis methods used in clinical trials.
  • Understand the importance of accurate record-keeping, reporting, and data integrity.
  • Apply data management techniques to ensure transparency, reproducibility, and compliance with regulatory standards.

Ethics and Patient Safety in Clinical Trials

  • Understand the ethical principles underpinning clinical research, including informed consent, confidentiality, and risk minimisation.
  • Demonstrate awareness of patient safety considerations and monitoring during trials.
  • Apply ethical and safety frameworks to support responsible conduct in clinical research and drug development.

The ICTQual AB Level 3 Certificate in Clinical Research and Drug Development equips learners with essential knowledge and skills in clinical trials, drug development, and regulatory compliance. This qualification also contributes to Continuing Professional Development (CPD), supporting learners in enhancing professional competence and career advancement.

Academic Progression

Learners who successfully complete this qualification may progress to higher-level study, including:

  • Level 4 Diplomas in Clinical Research, Pharmaceutical Sciences, or Healthcare Management, providing advanced knowledge in trial management, regulatory affairs, and research methodology.
  • Level 5 and Level 6 Diplomas in clinical trials, drug development, or healthcare research, preparing learners for specialist or leadership roles.
  • Specialised Professional Courses in pharmacovigilance, clinical data management, regulatory affairs, or advanced drug development, enhancing skills and employability.

Career Progression

This qualification provides learners with opportunities to pursue roles such as:

  • Clinical Research Assistant or Coordinator, supporting trial planning, data collection, and reporting.
  • Pharmaceutical or Biotechnology Industry Roles, including drug development support, regulatory compliance, and quality assurance.
  • Healthcare Research Positions, contributing to evidence-based medicine and clinical study implementation.
  • Policy and Governance Roles, assisting organisations in adhering to ethical, legal, and regulatory standards.
  • Professional Development Pathways, preparing learners for senior or specialist roles within clinical research, pharmaceutical companies, and healthcare organisations.

Continuing Professional Development (CPD)

For professionals already working in healthcare or pharmaceutical research, this qualification contributes significantly to CPD by:

  • Enhancing knowledge of clinical research methodology, regulatory compliance, and drug development processes.
  • Developing skills in trial management, data integrity, and patient safety.
  • Supporting professional credibility and demonstrating commitment to industry standards.
  • Equipping learners to contribute effectively to clinical research teams and regulatory submissions.

The ICTQual AB Level 3 Certificate in Clinical Research and Drug Development therefore serves as both an academic and professional development pathway, enabling learners to progress confidently within clinical research, pharmaceutical development, and healthcare innovation.

FAQs

This course is designed for learners seeking to develop expertise in clinical research, drug development, and regulatory compliance. It is suitable for individuals aspiring to work in pharmaceutical research, clinical trials, or healthcare research, as well as professionals seeking Continuing Professional Development (CPD).

Learners must be at least 16 years old and hold a basic secondary school qualification or equivalent. While prior experience in healthcare, pharmacy, or research is beneficial, it is not mandatory. Learners must demonstrate sufficient English proficiency to engage with course materials and complete assessments.

ICTQual AB Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research) is 15 days training program. As this Training program have mandatory assessment which will be conducted through Approved Training Centers.

ICTQual AB allows to offer Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research) in various formats, including online, in-person, or a combination of both. Participants can choose the format that best fits their schedule and learning preferences. But final decision is made by ATC.

Yes, ICTQual AB Level 3 Certificate in Clinical Research and Drug Development (Cert Clinical Research) consist of 6 mandatory assessments . These assessments are designed to evaluate participants’ comprehension of course material and their capacity to apply concepts in practical situations. It is mandatory to pass assessments with a minimum score of 75%