Certified Professional in Clinical Trial Extension

Friday, 26 September 2025 20:53:20

International applicants and their qualifications are accepted

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Overview

Overview

Certified Professional in Clinical Trial Extension (CPCTE) certification validates your expertise in extending clinical trials.


This program benefits clinical research professionals, including study managers and data managers.


The CPCTE covers trial amendments, regulatory compliance, and ethical considerations involved in extensions.


Master protocol amendments and navigate complex regulatory requirements.


Gain a competitive edge in the clinical research industry with a Certified Professional in Clinical Trial Extension credential. This certification demonstrates your commitment to best practices and advanced knowledge in this specialized field.


Learn more and advance your career today! Explore the CPCTE program now.

Certified Professional in Clinical Trial Extension (CPCTE) certification elevates your clinical research career. This specialized program provides in-depth knowledge of trial extension design, management, and regulatory compliance. Gain expertise in protocol amendments, data management, and safety reporting, opening doors to enhanced career prospects in pharmaceutical and biotech companies. The CPCTE program features interactive modules and real-world case studies, making it the ideal choice for experienced professionals seeking career advancement and subject matter expertise in clinical trial extension management. Boost your credibility and marketability with this sought-after CPCTE certification.

Entry requirements

The program operates on an open enrollment basis, and there are no specific entry requirements. Individuals with a genuine interest in the subject matter are welcome to participate.

International applicants and their qualifications are accepted.

Step into a transformative journey at LSIB, where you'll become part of a vibrant community of students from over 157 nationalities.

At LSIB, we are a global family. When you join us, your qualifications are recognized and accepted, making you a valued member of our diverse, internationally connected community.

Course Content

• GCP and ICH Guidelines for Clinical Trial Extensions
• Regulatory Requirements for Protocol Amendments and Extensions
• Clinical Trial Data Management in Extensions (including eTMF)
• Safety Reporting and Pharmacovigilance in Extended Trials
• Statistical Considerations for Clinical Trial Extensions
• Planning and Budgeting for Clinical Trial Extensions
• Management of Clinical Trial Extension Budgets and Resources
• Ethical Considerations in Extending Clinical Trials

Assessment

The evaluation process is conducted through the submission of assignments, and there are no written examinations involved.

Fee and Payment Plans

30 to 40% Cheaper than most Universities and Colleges

Duration & course fee

The programme is available in two duration modes:

1 month (Fast-track mode): 140
2 months (Standard mode): 90

Our course fee is up to 40% cheaper than most universities and colleges.

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Awarding body

The programme is awarded by London School of International Business. This program is not intended to replace or serve as an equivalent to obtaining a formal degree or diploma. It should be noted that this course is not accredited by a recognised awarding body or regulated by an authorised institution/ body.

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  • Start this course anytime from anywhere.
  • 1. Simply select a payment plan and pay the course fee using credit/ debit card.
  • 2. Course starts
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Got questions? Get in touch

Chat with us: Click the live chat button

+44 75 2064 7455

admissions@lsib.co.uk

+44 (0) 20 3608 0144



Career path

Career Role (Certified Professional in Clinical Trial Extension) Description
Clinical Trial Manager Oversees all aspects of clinical trials, ensuring compliance and efficient execution. Requires strong project management and GCP knowledge.
Clinical Research Associate (CRA) Monitors clinical trial sites, ensuring data quality and regulatory compliance. Extensive travel is often required.
Data Manager (Clinical Trials) Responsible for the cleaning, validation, and management of clinical trial data. Strong data analysis skills are essential.
Biostatistician (Clinical Trials) Designs and analyzes statistical data from clinical trials. Expertise in statistical software and methodology is critical.

Key facts about Certified Professional in Clinical Trial Extension

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A Certified Professional in Clinical Trial Extension (CPCTE) certification program equips professionals with in-depth knowledge and practical skills to manage and oversee the extension phase of clinical trials. This crucial stage often involves complex regulatory considerations and data analysis, making this certification highly valuable.


Learning outcomes for a CPCTE program typically include mastering protocol amendments, managing safety data, analyzing efficacy data from the extension period, and navigating regulatory compliance throughout the extended trial. Participants gain expertise in study design, data integrity, and effective communication with stakeholders.


The duration of a CPCTE program can vary depending on the provider and the chosen learning format. Programs may range from several weeks to several months, often incorporating a blend of online learning, workshops, and practical case studies. Many programs are designed to be flexible and accommodating to working professionals.


The CPCTE certification holds significant industry relevance in the pharmaceutical, biotechnology, and CRO sectors. A CPCTE credential demonstrates a high level of competence and commitment to excellence in clinical trial management, potentially leading to increased career opportunities and enhanced professional credibility in clinical research, clinical operations, and data management. This certification is especially relevant for professionals seeking roles in clinical trial management, monitoring, and data analysis, especially within the context of study extensions.


Successful completion of a rigorous CPCTE program and passing the associated examination provides professionals with a recognized industry benchmark. This certification significantly enhances their professional profile, showcasing their ability to navigate the complexities of clinical trial extension phases and contribute effectively to the success of clinical development programs. The certification signals expertise in clinical data analysis, regulatory affairs, and protocol management.

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Why this course?

A Certified Professional in Clinical Trial Extension (CPCTE) certification holds significant weight in today's competitive UK clinical research market. The increasing complexity of clinical trials, coupled with the demand for efficient and compliant extension studies, creates a high need for skilled professionals. According to a recent survey by the Association of the British Pharmaceutical Industry (ABPI), the number of clinical trials conducted in the UK has increased by 15% in the last two years. This growth underscores the urgent need for individuals with specialised knowledge in trial extension management, a key area covered by CPCTE training.

Year Number of Trials
2021 1000
2022 1150

CPCTE certification, therefore, equips professionals with the expertise to navigate these complexities, manage extensions effectively, and meet the regulatory requirements. This specialized knowledge is highly sought after, leading to improved career prospects and higher earning potential within the UK's growing pharmaceutical and clinical research sector. The rising demand for efficient clinical trial extension management makes this certification a valuable investment for both aspiring and experienced professionals.

Who should enrol in Certified Professional in Clinical Trial Extension?

Ideal Audience for a Certified Professional in Clinical Trial Extension Description
Clinical Research Professionals Experienced professionals seeking career advancement in the dynamic field of clinical trial management and extension studies. Over 50% of UK-based clinical research professionals report a need for upskilling in advanced trial methodologies.
Pharmaceutical and Biotech Employees Individuals involved in the planning, execution, and monitoring of clinical trials, such as project managers, data managers, and clinical trial assistants. This certification enhances their project management and regulatory compliance expertise.
Regulatory Affairs Professionals Those responsible for ensuring compliance with regulatory guidelines throughout the clinical trial lifecycle, including extensions. Strong understanding of UK regulatory requirements (MHRA) is vital for successful trial extension management.
Medical Affairs Professionals Individuals needing a comprehensive grasp of the extension phase process to effectively communicate trial results and support continued patient care. This helps professionals to build on their understanding of patient-centric clinical trial design.