BSc (Hons) Applied Biomedical Sciences with Clinical Trials Programme Specification

Programme Overview

The BSc (Hons) Applied Biomedical Sciences with Clinical Trials is a work-related learning programme that integrates academic learning at degree level with on-the-job practical training to provide a holistic programme of education and training to meet the bioscience skills needs of employers now and in the future. The programme adheres to the Level 6 Clinical Trials Specialist (ST0609) apprenticeship standards.

Learners may study the programme as an apprenticeship or non-apprenticeship. The programme is identical for both streams, only differing in that the apprenticeship stream will receive an additional apprenticeship completion certificate. For both streams, the learner must be in employment, or be sponsored by an employer, with duties aligned to the level 6 Clinical Trials Specialist apprenticeship standard. Learners whose job role aligns to the level 6 Clinical Trials (degree) apprenticeship will study for a full Bachelor’s degree (Stage 1 – 3).

This work-related learning programme will develop professional practice, contextualised in the workplace using industry standard approaches and technologies that are shaped by modern organisations. Learners studying on this programme are employed, or sponsored by an Employer.

The learner will study with Northeastern University London (University) for approximately 60 days a year (or Stage) – i.e. one day per week for 42 weeks each year, and up to three five-day ‘bootcamps’ in any given year; for the duration of the three-year programme.

Additionally, the learner and employer will commit to a further two days per week, for 42 weeks each year, for University-guided work-related training. Learners will study 120 credits per year and will be considered part-time learners by the University. Each course, typically 15 credits, is assessed by a range of activities aligned to industry norms, i.e. almost all assessments relate to workplace activities that are expected in a bioscience-related occupation. The content, and consequently the learning outcomes and methods of assessment, vary between courses. Where possible, assessments will be undertaken in the workplace.

The programme begins with a Welcome Week (non-credit bearing) to the programme covering essential study skills and fostering collegiality. The first course is ‘Introduction to Clinical Trials’, acquainting the learners with the lifecycle and types of clinical trials, followed by ‘Applied Cell Biology’, which looks at the structure and function of eukaryotic and prokaryotic cells. Next, the programme introduces ‘Biochemistry and Molecular Biology’ and ‘Drug Discovery and Development (Including Pharmacology)’. ‘Human Physiology and Pathophysiology’ explores the normal functions and mechanisms of the human organism. ‘The Project Lifecycle’ examines the roles of the project manager and management tools and techniques. Year one, or Stage one, concludes with a 30-credit, eight week course called ‘The Regulatory Environment in Clinical Trials’ where learners will gain hands-on experience on informed consent and the protection of clinical trials participants and will develop their communication skills. This course includes an intensive week of teaching in person.

Year two, or Stage two, starts by introducing the project management lifecycle in ‘IT Project Management’ before examining processes of infection and the human immune response in ‘Infection and Allergy (Including Microbiology)’. This is followed by ‘Oncology’ and advances in ‘Cell and Gene Therapy’. Learners examine demand and supply in the healthcare system and the healthcare markets in ‘Industrialisation, Manufacturing and Health Economics’. Then they study how raw data is collected, stored, cleansed and interrogated in ‘Trial Master File and esystems’. Proceeding with ‘Biological Samples’ which reviews the types and the management of biological samples. Year two, or Stage two finishes with ‘Statistical Principles Applied to Clinical Trials’ is an intensive two-week bootcamp where learners will gain insight into the principles of statistics and how they help to make decisions on the outcome of clinical trials.

Year three, or Stage three starts with reflective practice in ‘Critical Thinking and Ethics’. Learners examine advances in digital science in ‘Digital Health and AI’, followed by ‘Frontier Topics in Bioscience’, taught through the lens of global case study analysis. ‘Business and Change Management’ examines digital transformation and change. Year three, or Stage three culminates with an extensive 24-week clinical trials research project.

Dedicated Success Managers will undertake regular tripartite reviews with learners and their employers (every eight weeks or less) and provide supplementary support for apprentices.

Structure and Requirements

The degree requires that students take courses to the value of 360 credits across three years.

Stage 1 (Level 4)

Required Courses

Welcome Week

LBIOL4274A Introduction to Clinical Trials (15 credits)

LBIOL4283A Applied Cell Biology (15 credits)

LBIOL4284A Biochemistry and Molecular Biology (15 credits)

LBUSI4282A The Project Lifecycle

LBIOL4285A Drug Discovery and Development (Including Pharmacology) (15 credits)

LBIOL4286A Human Physiology and Pathophysiology (15 credits)

LBIOL4276A Regulatory Environment in Clinical Trials (30 credits)

Stage 2 (Level 5)

Required Courses

NCHNAP555 IT Project Management (15 credits)

LBIOL52110A Infection and Allergy (Including Applied Microbiology) (15 credits) 

LBIOL52102A Oncology (15 credits) 

LBIOL52108A Cell and Gene Therapy (15 credits)

LBIOL52109A Industrialisation, Manufacturing and Health Economics (15 credits)

LBIOL52103A Trial Master File and eSystems (15 credits)

LBIOL52104A  Biological Samples (15 credits) 

LBIOL52105A Statistical Principles Applied to Clinical Trials (15 credits)

Stage 3 (Level 6)

Required Course

End point assessment and project induction

LBIOL62125A Critical Thinking and Ethics (15 credits)

LBIOL62126A Digital Health and Artificial Intelligence (15 credits) 

LBIOL62127A Frontier Topics in Bioscience (15 credits)

LISYS62112A Business and Change Management (15 credits)

LBIOL62121AClinical Trials Research Project (60 credits)

Entrance Requirements

Age

The University requires applicants to be at least 18 years old on 1 September in the year of entry.

General Entrance Requirements

The learner will need to be in employment with, or sponsored by, a hiring business, with responsibilities to be aligned to the level 6 Clinical Trials Specialist (ST0609) apprenticeship standards.

Entry requirements are agreed based on numerous factors including availability of additional on-the-job support, by both the employer or sponsor and University As such, entrance requirements may vary. Learners are selected based on their application and an assessment process which is tailored to the learner’s employment/sponsored employment position.

Typically, employers require:

• English and Maths Level 2
• Three A levels (or equivalent at BBB or above) including Biology 
• At least Grade 4/C GCSE Maths, English and IT

Some applicants may not have traditional qualifications as listed above, and have prior learning and skills developed from the workplace, these will be considered on a case-by- case basis.

Where a learner will be studying the programme as an apprentice, they will also need to meet the government’s eligibility criteria:

• Have been a UK/EU/ESS resident for the past three years or more prior to starting the programme.
• Have left full-time education prior to the start date of the apprenticeship.
• Be aged at least 16 years old to meet government funding criteria.

Recognition of Prior Learning

Where a student wishes to apply for the recognition of prior learning on the basis of certificated or experiential learning, they should follow the University’s Recognition of Prior Learning Policy. 

Learning Outcomes

By completion of the programme:

Knowledge and Understanding

A student will be able to: 

Subject Specific Skills

A student will be able to: 

Transferable and Employability Skills

A student will be able to: 

All of the above learning outcomes are mapped to the relevant QAA Subject Benchmark threshold statements and Clinical Trials Specialist Apprenticeship Standard.

Teaching and Learning 

Teaching and Learning Activities

The program is delivered through distance blended learning using aVirtual Learning Environment (VLE). This style of delivery combines the benefits of distant and “traditional” or physical place-based learning. The blended-learning work related programme ensures that learners have the opportunity to explore their subject in an incrementally structured, well-managed and appropriate manner. It develops the knowledge, core and subject-specific skills, and transferable skills, required by learners and enhances their confidence. The combination of academic study and work-based learning is a key feature of the programme. Practical and theoretical experiences in the workplace, in tandem with their academic studies, develop and enhance the learner’s specialist knowledge, skills and behaviours.

Assessment

A dedicated Assessment Strategy supports authentic, inclusive, and experiential assessment. This includes offering students a broad range of assessment types, which support active learning. The assessment types available to students are listed in the University Assessment Strategy. Whilst it is not expected that all programmes should offer all of these different assessment types, and choice of assessment should be based on the most effective and appropriate way to test student learning, there will be a range available which empowers students to demonstrate their discipline knowledge via diverse means.

Courses at the University are assessed formatively and summatively in a variety of ways, including:

• Written Assignment (e.g. long-form coursework essay; study report; literature review; reflective essay; dissertation)
• Examination (e.g. open book scheduled exam; closed book; 24-/48-hour exam)
• Presentation (e.g. oral presentation with accompanying slides; Viva voce)
• Role Play (e.g Moot; consultancy simulation)
• Practical ( e.g. lab skills assessments)
• Artefact (e.g. piece of code or poem with an accompanying report)
• Portfolio (students only have one final, formal deadline, but what they submit includes a series of shorter pieces created and reflected upon and revised across the course)
• Set Exercises (e.g a series of short set exercises distributed across the course)

Feedback on formative and summative assessment tasks is provided in verbal or written forms.

Appendix C contains the programme structure and assessment summary. 

The University’s Assessment Strategy can be found here. 

The University’s Assessment Regulations for Taught Awards can be found here.

Teaching and Learning Environment

The teaching and learning environment includes:

The University’s campus has state-of-the-art teaching rooms and independent and group study spaces.

A Virtual Learning Environment (VLE) for each course with a syllabus and range of additional resources (e.g. readings, question prompts, tasks, assessment briefs, slides or handouts, discussion boards, and sample examination papers and examiners’ reports) to orientate and engage students in their studies. 

Northeastern University’s online library digital resources, and other online academic resources, such as JSTOR and the OED. Students are inducted on their use at the start of the programme, and wider digital literacy is reinforced and developed across their studies.

Learners can also apply for a reader’s card to use the British Library membership and apply for membership of any of the City of London libraries. Students at the University can apply for Senate House Library membership. 

As part of the wider teaching and learning environment, the University hosts a range of academic and social events in which students, faculty, alumni and interlocutors from outside the academy are brought together.

Research

The University is an active research and knowledge exchange community. Its programmes are designed by faculty with relevant research expertise and teaching is allocated to faculty as far as possible to align with their research expertise and interests.

All learners have the opportunity to develop their research skills as they progress through the programme, culminating with the written assignment in their final year, when their supervisor will be on hand to provide bespoke support.

Learners are invited to a range of faculty research events and, where possible and from time to time. 

Student Support and Development

Disabilities and/or Specific Learning Difficulties (SpLDs)

Learners are strongly encouraged to inform the University of any medical conditions, disabilities, specific learning difficulties (SpLD) or neurological differences as soon as is practical. Learners will be asked to submit supporting documentation from a doctor, clinical or educational psychologist detailing the nature of their disability and the impact it is likely to have on their studies in order to help us put in place appropriate support and accommodations. More information can be found in the Student Disability Policy. This data is managed and securely stored by Student Support and Development (SSD). At the start of the academic year, a number of talks and events are held which are designed to support and inform students with regard to mental health, disabilities, safety and learning support.

SSD meet with students as soon as possible, and preferably before the start of the academic year, to discuss their needs and draft a Learning Support Plan (LSP) which outlines the support to be provided both within the University (if appropriate) and externally. If requested by the student, the SDD will then arrange to inform relevant faculty of the student’s needs and any reasonable adjustments required. 

If a student is undiagnosed but believes they may have a SpLDS (e.g. Dyslexia) the SDD will help them to access diagnostic services. If the assessment confirms a SpLDS, the SDD will work the student in preparing a LSP and will provide advice about accessing additional funding and support through the Disabled Students Allowance, where a student may be eligible

For more information, please click here.

Quality Assurance and Enhancement

Award Standards

Every programme of study is developed by the faculty, utilising their subject specialists and approved by the University’s Academic Board.

Review and Evaluation Mechanisms

The University has robust procedures, as described in AQF4 Programme and Course Approval and Modifications and AQF5 Annual Monitoring and Reporting, in place to assure the quality of the programme development, delivery, and management, alongside systematic monitoring, ongoing review and enhancement of all University programmes. Enhancements are made as necessary to ensure that systems remain effective and rigorous.

The University utilises constructive feedback from a variety of sources, internal and external, to inform its decision-making process to enhance the programme and the student experience. These feedback sources are:

• Annual Course Reviews, written by the Course Leader, are prepared to enable the Course Leader to reflect on the course, using a variety of data and student/faculty feedback to enhance the course and support the writing of the Annual Programme Review.
• Annual Programme Reviews, written at the end of each academic year, are prepared in order to enhance individual programmes and to plan ahead.
• Annual External Examiner Reports are prepared by the External Examiners, as appointed by the University, to confirm that a programme has been assessed in accordance with the approved documentation and that the student performance meets the appropriate academic standards.
• Formal student feedback mechanisms consist of course questionnaires and Learner Voice Committee meetings at least once each quarter, as well as annual student satisfaction surveys, including external independent surveys, such the National Student Survey. 
• Informal student feedback is also valued by the University and this can take the form of students talking or corresponding with faculty or professional staff.   

In addition to academic progress monitoring, progression also includes checking that the learner is achieving planned levels of off-the-job learning required by the apprenticeship as set out in the Commitment Statement. This six/eight-weekly discussion between the Success Manager, line manager and learner will also confirm whether the learner is keeping pace with their plan of learning at work, and is meeting the competency progression points as part of their apprenticeship.

Learner attendance at scheduled learning opportunities, as well as monitoring periods of off-the-job training, is monitored through the use of an online Learner Management System.

Version History

Disclaimer 

The University has checked the information provided in this Programme Specification and will aim to deliver this programme in keeping with this Programme Specification. However, changes to the programme may sometimes be required arising from annual monitoring, student feedback, and the review and update of courses and programmes. Where this activity leads to significant changes to courses and programmes there will be prior consultation with students and others, wherever possible, and the University will take all reasonable steps to minimise disruption to students. It is also possible that the University may not be able to offer a course or programme for reasons outside of its control, for example, due to the absence of a member of staff or low student registration numbers. Where this is the case, the University will aim to inform applicants and students as soon as possible, and where appropriate, will facilitate the transfer of affected students to another suitable programme. 

Copyright 

The contents of this Programme Specification are the copyright of the University and all rights are reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, such as electronic, mechanical, photocopied, recorded or otherwise, without the prior consent of the University.

Appendix A – Map to QAA Subject Benchmark

* This is intended to mean that all students (taken over all years) graduating with an honours degree in this discipline will have achieved this.

QAA benchmark statement can be found here.

Appendix B – Map of Courses to Learning Outcomes

Appendix C – Map to Apprenticeship Standard

Appendix D – Programme Structure and Summative Assessment Summary

Course Type:   

R = Required or O = Optional

Course Mode: 

CD = Campus Delivery; BK = Block Delivery; DL = Distance Learning and Self-Directed Learning; OL = Online Learning; WB = Work Based Learning

Assessment Weighting:

AE1 = Assessment Element 1; AE2 = Assessment Element 2; AE3 = Assessment Element 3

Assessment Activity Type                                                          Code  

Written assignment                                                                          WA

Examination                                                                                      Exam

Presentation                                                                                     Pres

Role play                                                                                           RP

Portfolio                                                                                             P

Set exercise                                                                                      Set

Practical                                                                                             Pract

Artefact                                                                                            Arte

Appendix E – Exit Awards

Certificate in Higher Education

In order for a student to be awarded a Certificate in Higher Education (Cert HE), they are required to have achieved 120 credits at the University in any combination across Level 4 and Level 5.

Learning Outcomes

By completion of the programme:

Knowledge and Understanding

A student will be able to:

Subject Specific Skills

A student will be able to:

Transferable and Employability Skills

A student will be able to:

Diploma in Higher Education

In order for a student to be awarded a Diploma in Higher Education (Dip HE), they are required to have achieved 240 credits in any combination across Level 4, Level 5 and Level 6, with a minimum of 120 credits at the University.

Learning Outcomes

By completion of the programme:

Knowledge and Understanding

A student will be able to:

Subject Specific Skills

A student will be able to:

Transferable and Employability Skills

A student will be able to: