Programme Specification Postgraduate

(1)

Programme Specification

Postgraduate

Applicable to postgraduate programmes

Please click here for guidance on completing this specification template. Part A: Programme Summary Information 1. Title of programme: MSc Clinical Research

2. Programme Code: MSC/CR/DST

3. Entry Award(s): Credit: Level:

☐ MA ☒ MSc 180 7 ☒ PGDip 120 7 ☒ PGCert 60 7 ☐ PG Award ☐ DPS ☐ CPS ☐ Other (please specify below:

4. Exit Awards: Credit: Level:

☒ PGDip 120 7

☒ PGCert 60 7

☒ PG Award 30 7

☐ CPS

Exit awards will automatically bear the name of the entry award. If an exit award is to be unnamed (i.e. it will show only the qualification achieved) or if it is to have a different name from the entry qualification you must indicate this below:

(2)

6. Frequency of intake: Continuous:approx.6 entry points per year 7. Duration and mode of

study:

MSc: Part-time, 1-6 years, on-line distance learning PGDip: Part-time, 1-5 years, on-line distance learning

PGCert: Part-time, 1-3 years, on-line distance learning

8. Applicable framework: University Framework for Full-time and Part-time modular Postgraduate Programmes

Framework exemption required:

Please indicate the applicable boxes:

☒ No (please go to section 9)

☐ Yes (please provide a brief summary below)

Date exemption approved by AQSC:

9. Applicable Ordinance: Ordinance 42 New/revised Ordinance

required:

☒ No (please go to section 10) Please indicate the applicable

boxes: ☐ Yes (please provide a brief summary _below)

Date new/revised Ordinance approved by Council:

10. Faculty: Health & Life Sciences

11: Level 2

School/Institute:

Institute of Translational Medicine

12. Level 1 unit: Department of Biostatistics

13. Campus: On-line

14. Other contributors from UoL:

N/A

15: Teaching other than at UoL:

Programme is delivered in partnership with Laureate Online Education

16: Director of Studies: Dr Catrin Tudur Smith

17: Board of Studies: Faculty Board of Studies for On-Line Programmes

18: Board of Examiners: Faculty Board of Examiners for On-Line Programmes

(3)

Name Institution Position

Musculoskeletal Trials Unit, Keele University

Professor Jane Nixon, Clinical Trials Research Unit, Leeds University

20. Professional, Statutory

or Regulatory body: None

21: QAA Subject benchmark

Statements(s): N/A

22. Other reference points: QAA:The UK Quality Code for Higher Education QAA Frameworks for HE Qualifications of UK Degree-Awarding Bodies (2014)

23. Fees: Fees charged by Laureate Online Education, within

the terms of the institutional agreement between Laureate Online Education and the University. 24. Additional costs to the

student: None

25: AQSC approval:

Part B: Programme Aims & Objectives 26. Aims of the Programme

The programme aims to meet the needs of healthcare professionals who wish to obtain the specialized theoretical and practical skills required to plan, coordinate and conduct clinical trials research. The pharmaceutical industry and research institutions both need highly trained professionals to manage clinical trials for new drugs, medical products and devices.

No. Aim:

1 To provide graduates with the specialized skills and knowledge they need to pursue career opportunities in a variety of settings within the field of conducting clinical research

27. Learning Outcomes

No. Learning outcomes – Master’s degree 1

2

3

4

Demonstrate an in-depth knowledge and understanding of the stages of drug and device development. Apply this knowledge to the decision making processes to progress from pre-clinical testing through to registration and post-marketing surveillance in both resource rich and resource poor settings.

Critique the advantages and disadvantages of various study designs as related to the hierarchy of evidence. Review and appraise critically published clinical research and interpretation of new research in the context of existing knowledge.

Evaluate critically the roles and responsibilities of various individuals who participate in the clinical research enterprise and use this expertise to develop a project management plan.) Show an in-depth knowledge and a systematic understanding of the ethical, legal, and regulatory frameworks that impact on the conduct of the clinical trial and use this knowledge to identify challenges to the conduct of international clinical trials.

(4)

5 6 7 8 9 10 11

Demonstrate in-depth knowledge of the required conduct of a clinical trial according to the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP).

Show an in-depth knowledge and a systematic understanding of the requirements in the planning, implementing, monitoring and managing of a clinical trial from pre-study activities to study close-out including the full costs involved.

Critically evaluate the risks associated with a clinical trial and instigate a risk management plan for clinical trial monitoring, including reporting of adverse events.

Demonstrate in-depth knowledge, understanding and skills related to accessing and managing data for clinical research utilising and evaluating the strengths of appropriate information technology. Assess new modalities of information technology as applied to clinical research.

Demonstrate in-depth knowledge and understanding of key statistical methods required for presentation, analysis, and interpretation of clinical research data.

Demonstrate in-depth knowledge and understanding of economic issues in relation to health care and the importance of cost effectiveness evaluation in clinical research. Use this knowledge to recognise appropriate aims and objectives in the clinical trial protocol. Demonstrate the ability to identify and define a research question of relevance and importance to clinical research. Critically evaluate current research in this area and apply appropriate research methods to address the question of interest, presenting and

discussing findings in an appropriate professional manner to draw reasoned conclusions

Learning Outcomes

No. Learning outcomes – Postgraduate Diploma 12 13 14 15 16 17 18

Demonstrate an in-depth knowledge and understanding of the stages of drug and device development. Apply this knowledge to the decision making processes to progress from pre-clinical testing through to registration and post-marketing surveillance in both resource rich and resource poor settings.

(5)

19

20

21

Demonstrate in-depth knowledge, understanding and skills related to accessing and managing data for clinical research utilising and evaluating the strengths of appropriate information technology. Assess new modalities of information technology as applied to clinical research.

Demonstrate in-depth knowledge and understanding of key statistical methods required for presentation, analysis, and interpretation of clinical research data.

Demonstrate in-depth knowledge and understanding of economic issues in relation to health care and the importance of cost effectiveness evaluation in clinical research. Use this knowledge to recognise appropriate aims and objectives in the clinical trial protocol Learning Outcomes

No. Learning outcomes – Postgraduate Certificate 22 23 24 25 26 27

Learning Outcomes

No. Learning outcomes – Postgraduate Award

The learning outcomes for the Postgraduate Award are variable, depending on the modules to the value of 30 credits that have been successful passed

27a. Mapping of subject-based learning outcomes: Learning outcome

No. Module(s) in which this will be delivered Mode of assessing achievement of learning outcome PSRB/Subject benchmark statement (if applicable) 1&12 CLRA101 CLRA107 Discussion group input and written assignments

2, 13 & 22 CLRA103 Discussion group

(6)

assignments

3,14 & 23 CLRA101

CLRA104

Discussion group input and written assignments

input and written assignments

5, 16 & 25 CLRA102

CLRA104

7, 18 & 27 CLRA104

CLRA107

8 & 19 CLRA106 Discussion group

11 CLRA109 Dissertation

28. Skills and Other Attributes No. Skills and attributes:

1 2 3 4 5 6 7 Information gathering Problem solving

Written and oral communication Working with numbers

Information and communication technology Time management

Improving own learning & performance

28a. Mapping of skills and other attributes: Skills and other

attributes No. Module(s) in which this will be delivered and assessed Learning skills, research skills, employability skills Mode of assessing achievement of the skill or other attribute

1 All modules Learning skills Research skills

Discussion group input and written assignments 2 CLRA103 CLRA104 CLRA109 Learning skills Research skills

Discussion group input and written

assignments 3 All modules Learning skills

Research skills Employability skills

assignments, presentations with voiceovers

(7)

4 CLRA105 CLRA108

Learning skills Employability skills

Written assignments 5 CLRA106 Employability skils Written assignments 6 All modules Research skills

Employability skills Completion of assignments within set timeframes

7 All modules Learning skills Research skills Employability skills

assignments

29. Career opportunities:

The PGCert/PGDip/MSc in Clinical Research will provide a strong basis for

healthcare professionals to undertake a leading role in the administrative conduct of clinical trials either within the pharmaceutical industry or within academic and institution clinical trials units.

Part C: Entrance Requirements

30. Academic Requirements:

The programme is available to any University graduate in a health or health-related profession, and also to non-health graduates and others approved by the University. This will normally include:

 Graduates in medicine of an approved University who have not less than one year (and preferably longer) post-registration professional experience  Other health-related graduates of an approved University or other institution

who have not less than two years of professional experience;

 Non-health-related graduates of an approved University or other institution who have not less than two years of health related professional experience.  Others who have satisfied the requirements of approved exam boards, or

have satisfied the University that they are suitably qualified to undertake a postgraduate course. They must have at least three years approved health related professional experience.

Applicants from outside the UK will also normally be required to have passed the IELTS (International English Language Testing System) examination or the TOEFL (Test of English as a Foreign Language) before commencing the programme. The following standard is required:

 IELTS

o an overall score of at least 6.5 for IELTS

o a score of at least 6.0 on each of the four elements of IELTS

o the IELTS reading and writing tests taken by candidates must be the Academic Reading and Academic Writing tests

 TOEFL

o a score of 571 on the paper based test

o a score of 91 on the internet based test

(8)

See Academic requirements 32. Other requirements:

None

Part D: Programme Structure

33. Programme Structure:

The PGCert in clinical research comprises 4 required modules: CLRA101, CLRA102, CLRA103 and CLRA104 (60 credits).

The PGDip in clinical research comprises 4 required modules CLRA101, CLRA102, CLRA103 and CLRA104 (60 credits) plus further 60 credit points from 4 required modules CLRA105, CLRA106, CLRA107, CLRA108.

The MSc in clinical research comprises the 9 required modules CLRA101, CLRA102, CLRA103, CLRA104, CLRA105, CLRA106, CLRA107, CLRA108 and CLRA109 (Dissertation).

Module Code

Module Title Credit level

Credit value

Assessment Status Exit awards CLRA101 Introduction to Clinical Research 7 15 Discussion questions 40% Hand in assignments 25% Individual project 35% R PGCert in Clinical Research

CLRA102 Ethical, legal &

regulatory considerations in clinical investigations 7 15 Discussion Questions 40% Hand in assignments 25% Individual project 35% R

CLRA103 Design &

conduct of the clinical protocol 7 15 Discussion Questions 30% Hand in assignments 40% Individual project 30% R

CLRA104 Good clinical

practice in managing and monitoring clinical trials 7 15 Discussion Questions 30% Hand in assignments 40% Individual project 30% R

CLRA105 Biostatistics 7 15 Discussion

Questions 30% Hand in assignments 40% Individual project 30% R

CLRA106 Information &

Data management 7 15 Discussion Questions 30% Hand in assignments 35% Individual project 35% R CLRA107 Product development in 7 15 Discussion Questions 30% R

(9)

the pharmaceutical, biotech and medical device industries Hand in assignments 35% Individual project 35% PGDip in Clinical Research1 CLRA108 Health Economics & Financial management in clinical research 7 15 Discussion Questions 35% Hand in assignments 35% Individual project 30% R

CLRA109 Dissertation 7 60 100% written

assignment (guide: 10,000 words) R MSc in Clinical Research2 R – Required,

1 Unnamed PGCert awarded if credits from modules other than CLRA101-CLRA104 are used within the 60 credits required for PGCert

2 Unnamed PGDip awarded if credits from dissertation are used within the 120 credits required for PGDip

A sequence diagram of this is given below. CLRA101:

Order of these modules is interchangeable CLRA 102 CLRA 103 CLRA 104

Order of these modules is interchangeable CLRA 106 CLRA 107 CLRA 108 CLRA109: Dissertation

Exit point for PGCert in Clinical Research. Minimum 60 credits required from modules CLRA101-CLRA104.

Exit point for PGDip in Clinical Research.

Minimum 120 credits required from modules CLRA101-CLRA108.

Exit point for MSc in Clinical Research. Minimum 180 credits required from modules CLRA101-CLRA109.

(10)

34. Industrial placement/work placement/year abroad: None

35. Liaison between the Level 2 Schools/Institutes involved: Delivery of the programme involves a partnership between the University and Laureate Online Education. Academic staff in the Programme Team, notionally attached to the e-Learning Unit, liaise on a regular basis with colleagues at Laureate Online Education who are responsible for the day-to-day management of the programme. Through this organisation the University retains authority over all academic aspects of the programme and its delivery. Appropriate Laureate Online Education personnel are represented on the Board of Studies and Board of

Examiners, together with representatives of the parent Department and the Faculty of Health & Life Sciences.

Part E: Learning, Teaching and Assessment Strategies 36. Learning, Teaching and Assessment Strategies:

The mode of delivery of taught modules is by distance learning over the Internet. This mode of study enables students to pursue modules via home study while continuing in employment.

Module delivery involves the establishment of a virtual classroom in which a relatively small group of students (usually 15-20) work under the direction of the module instructor, using an internet-based distance learning package. Module delivery proceeds via a series of one-week online seminars, each of which typically includes:

i. An online lecture, and other learning materials, posted electronically to a public folder in the virtual classroom.

ii. Coursework assignments, which may include both reading assignments and practical work, results from which are posted to closed folders in the virtual classroom.

iii. Class discussions and group assignments, facilitated and moderated by the class instructor, carried out within open folders.

Communication within the virtual classroom is asynchronous, preserving the

requirement that students are able to pursue the module in their own time, within the weekly time-frame of each seminar.

Two broad principles inform the teaching and learning strategy: constructivism, and collaborative enquiry. Constructivism describes a view of learning in which students construct their own unique understanding of a subject, through a process which includes social interaction so that the learner can explain understandings, receive feedback from teachers and other students, clarify meanings, and reach a group consensus. Collaborative enquiry via Internet-mediated communication provides a framework for this mode of learning. The aim is to use the medium to foster the creation of a learning community which will enable dialogue between participants, sharing of information, and collaborative project work. This mode of learning is particularly appropriate when, as in this case, the students themselves will often bring to the class knowledge and expertise that is outside the experience of the module teacher, and which can be shared with the group.

A key feature of the approach is the use of moderated discussions of material introduced in the virtual classroom. Every taught module includes, each week, a discussion of topics specified by the instructor. Participation in these discussions is a requirement for students attending, and forms part of the basis for assessment. This

(11)

requirement ensures a continuing commitment from the students to the learning process.

Assessment is entirely based on work carried out in the virtual classroom, including contribution to discussions, weekly assignments, and longer individual or group-based projects. The weighting assigned to each component is prescribed separately for each module. The main aim of the assessment strategy is to verify the achievement of learning outcomes within the broad framework of the degree classification, i.e. at Pass (threshold) and Distinction levels, rather than to produce a fine-grained classification. Project-based modules, including in particular the concluding major dissertation project, are also carried out online, normally via individual supervision. All communications that take place within the virtual classroom, including all assignments carried out by students and assessments by instructors, are recorded and are available for scrutiny by staff with appropriate access permissions. This enables two aspects of quality control:

i. Module delivery is monitored by staff of the University's e-Learning Unit (i.e. Academic staff of the parent Department) to ensure that defined syllabuses, procedures, and assessment processes are followed, appropriate standards are maintained, and to check for plagiarism.

ii. All assessment is subject to moderation both by the e-Learning Unit and by the external examiners.

All students, at the start of the programme, complete a (non-assessed) online

induction module to gain familiarity with the learning system and software being used. This serves an additional purpose of verifying the English-Language skills of any students for whom this is not their first language, before the start of the programme proper. Students who fail the online induction module will be required to leave the programme but will be entitled to a refund of fees.

36a. Learning, Teaching and Assessment methods: Online virtual classroom

 Lectures  Discussions  Seminars Written assignments Discussion questions Project work Dissertation

37. Assessment information for students: Code of Practice on Assessment

The University has a Code of Practice on Assessment which brings together the main institutional policies and rules on assessment. The Code is an

authoritative statement of the philosophy and principles underlying all assessment activities and of the University's expectations in relation to how academic subjects design, implement and review assessment strategies for all taught programmes of study.

The Code of Practice includes a number of Appendices which provide more detail on the regulations and rules that govern assessment activity; these include:

The University marks scale, marking descriptors and qualification descriptors; The framework for modular, postgraduate programmes;

(12)

Information about students’ progress, including guidance for students; The procedure for assessment appeals;

Regulations for the conduct of exams;

The University’s policy on making adjustments to exam arrangements for disabled students.

The code of practice relating to external examining (see also below)

The Academic Integrity Policy, which covers matters such as plagiarism and collusion and includes guidance for students;

The policy relating to mitigating circumstances which explains what you should do if you have mitigating circumstances that have affected assessment; and The policy on providing students with feedback on assessment.

Please click here to access the Code of Practice on Assessment and its

appendices; this link will also give you access to assessment information that is specific to your cohort:

A summary of key assessment information is also available in the ‘Your University’ handbook.

Marking criteria:

Grade Description Key features

Outstanding (A*) 80%+

Outstanding work. Factually almost faultless; clearly directed; logical;

comprehensive coverage of topic; strong evidence of reading/research outside the material presented in the programme; substantial elements of originality and independent thought; very well written.

Distinction: Originality; Well-directed independent thought Excellent (A) 70-79%

Excellent work. Logical; enlightening; originality of thought or approach; good coverage of topic; clear, in-depth

understanding of material; good evidence of outside reading/research; very well written and directed.

Very Good (B) 60-69%

Very Good work. Logical; thorough; factually sound (no serious errors); good understanding of material; evidence of outside reading/research; exercise of critical judgement; some originality of thought or approach; well written and directed. Merit: & Pass: Essentially correct and complete; Competence; Critical judgement Good (C) 50-59%

Good work. Worthy effort, but undistinguished outcome. Essentially correct, but possibly missing important points. Largely derived from material delivered in the programme, but with some evidence of outside

reading/research; some evidence of critical judgement; some weaknesses in expression/ presentation.

Marginal Fail (D) 40-49%

Inadequate work. Incomplete coverage of topic; evidence of poor understanding of material; Poor presentation; lack of coherent argument. Compensatable Fail: Significant weaknesses, but serious effort. Fail (F) <40%

Unsatisfactory work. Serious omissions; significant errors/ misconceptions; poorly

Fail: Little or no

(13)

directed at targets; evidence of inadequate effort.

achievement of learning

outcomes 38. Student representation and feedback:

Because of the nature of delivery of the programme, a Liverpool-based staff-student committee is not appropriate, and the world-wide distribution of the student body makes physical participation in programme meetings impracticable. The principal channel for students to communicate with their colleagues and with staff will be, in keeping with the medium for programme delivery, the Internet. Each module delivered establishes a virtual classroom within which the module instructor will communicate with students to deliver module materials, receive coursework assignments, and facilitate class discussions. This mechanism automatically provides a framework for students to share concerns with their colleagues and with staff, either privately or publicly within the class. Other concerns can be raised privately via the student’s Programme Manager. Each student is assigned for the duration of his/her studies to a Programme Manager at Laureate Online Education, whose role includes that of acting as a personal tutor.

Additionally, there has been established a staff-student forum within the programme delivery software framework, i.e. in the form of email folders. Approximately one month before each meeting of the Board of Studies, this forum is opened for a period of one week. During this time, a group of student volunteers engage in a discussion with representatives of Laureate Online Education and the e-Learning Unit. The debate is viewable by all students, who can contribute comments and suggestions in a separate folder. At the end of the week, a summary of conclusions reached is drawn up for presentation to the Board of Studies. Outcomes from the Board of Studies or otherwise, are posted in an online announcements folder, which may also be used by staff to make other announcements of a general nature.

Feedback on the delivery of individual modules is provided by the issue of a questionnaire to all students attending. A summary of the questionnaire returns is given to the module instructor, who is asked to comment on this and any other issues arising in the delivery of the module, in the form of a report with prescribed headings. This report is further augmented by comments from a member of staff at the

e-Learning Unit (the module monitor). Each module delivery is reviewed by the Board of Studies, which is provided with the composite module report, including the

questionnaire summary. An overall summary of student feedback is also presented for consideration at each meeting of the Board of Studies. These reports are also made available to the Board of Examiners.

Online students may also be represented at Laureate Programmes Co-ordinators Group by a non-Laureate student or Guild representative.

Part F: Status of Professional, Statutory or Regulatory Body Accreditation 39. Status of Professional, Statutory or Regulatory Body Accreditation:

N/A

Part G: Diversity & Equality of Opportunity and Widening Participation 40. Diversity & Equality of Opportunity and Widening Participation:

(14)

University’s Diversity and Equality of Opportunity Policy.

ANNEX 1

Annex Of Modifications Made To The Programme

Please complete the table below to record modifications made to the programme. Description of

modification (please include details of any student consultation

undertaken or confirm that students’ consent was obtained where this was required) Minor or major modifications Date approved by FAQSC Date approved by AQSC (if applicable) Cohort affected

Programme name change from Clinical Research

Administration to Clinical Research

Major 2011

Two entry awards: PGCert and PGDip

Major April 2012

Merge module 1 with two week introductory course

Major April 2012

Modification to assessment weight for modules 1 to 8

Minor April 2013

Modification to assessment structure of dissertation module 9

Minor April 2013

Modification to assessment structure of dissertation module 9 (previous modification not implemented)