Essentials of Clinical Trials

    Certificate in Essentials of Clinical Trials at London School of Hygiene & Tropical Medicine, University of London

    Certificate in Essentials of Clinical Trials at London School of Hygiene & Tropical Medicine, University of London

    London School of Hygiene & Tropical Medicine, University of London offers the Certificate of Essentials of Clinical Trials as a full-time degree delivered hybrid at its main campus in Camden, United Kingdom. Taught in English and completed over 1 year, the program equips students with the theoretical knowledge and practical skills required for essentials of clinical trials and related professional fields. The next available intake begins on July 3, 2027.

    About Certificate in Essentials of Clinical Trials

    Overview
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    Course dates: 3 - 7 July 2023

    The course will have a hybrid format and students can choose to attend in person in London or online.  Offer holders will be required to confirm before the course start date whether they are planning to attend online or in person.

    LSHTM understands this is an uncertain time and rules around international travel could change at very short notice. We strongly advise candidates that choose to attend the course in person in London to only book refundable tickets and accommodation, and to ensure you have checked and comply with all UK entry requirements.

    Overview - Clinical Trials
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    This course gives attendees a clear understanding of the fundamental principles of Randomised Clinical Trials (RCTs).

    Video lectures and live online Q&A and practical sessions will cover the key issues in design, conduct, analysis and reporting, with a focus on major clinical trials that directly influence clinical practice. Topics are addressed with perspectives from both public sector research and the pharmaceutical industry.

    Who should attend?

    The course is relevant to anyone who'd like to get an understanding of the rigorous evaluation of interventions in health care, including clinical research professionals, research managers, statisticians and other scientists with an interest in clinical trials.

    Teaching

    The course is coordinated by Jennifer Nicholas, Tim Collier, and Ruth Canter and taught by members of the Department of Medical Statistics who have extensive experience in the design, conduct and analysis of trials in a variety of clinical specialities.

    Course fee

    The course fee for 2023 is £1,750.  

    Fees cover participation in the course and access to the course materials, including videos and downloadable course notes.

    Accreditation

    The course has been approved by the Federation of the Royal Colleges of Physicians of the United Kingdom for 28 category 1 (external) CPD credit(s).

    Course objectives
    Course objectives - Clinical Trials
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    Course content

    The topics to be covered will include:

    • Design of RCT: randomisation, blinding, trial size
    • Ethical conduct: participant consent, data monitoring and when to stop early
    • Certified Good Clinical Practice (GCP) training
    • Introduction to statistical methods for design and analysis
    • Alternative designs for clinical trials
    • Reporting: how to write, and critique, a clinical trial report
    • Clinical trials in practice
    • Practical experience in development of a clinical trial protocol.
      (Participants will work in small groups to develop and present trial protocols.)
    • Guest lecture

    In addition to the formal teaching sessions, we will run two optional drop-in sessions on Wednesday and Thursday afternoon. Participants will be able to discuss specific questions about their own research with a member of staff from the Medical Statistics Department or the Clinical Trials Unit. We will provide forms for you to submit your questions ahead of the drop-in sessions.

    Teaching format

    Teaching will take place through a blend of pre-recorded video lectures and live Q&A and practical sessions.

    Video lectures on each topic will be available to watch from one week before, and until 3 weeks after, the course. Participants will be expected to have watched the video lecture before the related live Q&A and practical. All participants are asked to please watch the video for the first lecture before the course begins on 4 July.

    Live online Q&A and practical sessions will run each day of the course. These live sessions will take place from approximately 9.00am to 3.00pm British Summer Time (BST) with comfort breaks. The live sessions will take place online using Zoom and therefore participants will need to have a reliable internet service and a PC or laptop with microphone and speakers.

    A Guest Lecture will be given by an invited speaker.

    Course materials

    The course materials include lecture videos which will be available to watch for 5 weeks as described above. Lecture notes and slides and practical handouts will be available to download and keep. All materials required for the course will be provided in advance. Practical solutions will be provided at the end of each practical.

    The following are recommended as optional additional background materials:

    • Evans I, Thornton H, Chalmers I and Glasziou P. Testing Treatments: Better Research for Better Healthcare.  Pinter and Martin, 2011.
    • Friedman LM, Furberg CD, DeMets D, Reboussin DM, and Granger CB. Fundamentals of Clinical Trials. Springer, 2015
    • Pocock SJ. Clinical Trials: A Practical Approach. Wiley, 1983

    Assessment

    There is no formal assessment.

    Testimonials
    Testimonials - Clinical Trials
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    Comments by course participants

    'Having the lectures online so you can watch (and re-watch) is really helpful and keeping the content available for a couple of weeks is great.'

    'In my opinion it was very well structured and nicely tailored to its wide range of professionals attending the course'.

    'The knowledge of the speakers was very good. You could see that most of them had real experience in the areas of these topics, which is good from a learning perspective'.

    'There were opportunities to discuss ideas with peers'.

    'GCP was enjoyable and useful and good to get certificate'.

    ‘The organisation was perfect and the interaction with the lecturers was fantastic’.

    ‘Practical sessions were very helpful and allowed the theory to become more understandable’.

    ‘Broad range of topics were covered – case studies are brilliant tools to consolidate knowledge'.

    ‘I enjoyed study design, data monitoring and the designing protocol and practical sessions. I do like data monitoring a lot and also liked the randomisation session’.

    How to apply
    How to apply - Clinical Trials
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    Applying for the course

    Applications for 2023 are now open and can be made via our online application form. 

    Please read LSHTM's Admissions policies prior to submitting your application.

    Short courses - visas, accommodation, disclaimer
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    Visas

    The student is responsible for obtaining any visa or other permissions to attend the course, and is encouraged to start the application process as early as possible as obtaining a visa for the UK can sometimes take a long time. The Short Courses team can provide supporting documentation if requested.

    Accommodation

    A list of hotels located in the vicinity of LSHTM, along with further resources for short term accommodation, can be found on our accommodation pages. 

    Important information

    Please note:

    • If you have been offered a place on the course you will not be able to register without bringing formal ID (Passport) and without having obtained the correct visa if required.
    • It is essential that you read the current visa requirements for short course students.
    • LSHTM may cancel courses two weeks before the first day of the course if numbers prove insufficient.  In those circumstances, course fees will be refunded.
    • LSHTM cannot accept responsibility for accommodation, travel and other losses incurred as a result of the course being cancelled.

    Course content

    The topics to be covered will include:

    • Design of RCT: randomisation, blinding, trial size
    • Ethical conduct: participant consent, data monitoring and when to stop early
    • Certified Good Clinical Practice (GCP) training
    • Introduction to statistical methods for design and analysis
    • Alternative designs for clinical trials
    • Reporting: how to write, and critique, a clinical trial report
    • Clinical trials in practice
    • Practical experience in development of a clinical trial protocol.
      (Participants will work in small groups to develop and present trial protocols.)
    • Guest lecture

    In addition to the formal teaching sessions, we will run two optional drop-in sessions on Wednesday and Thursday afternoon. Participants will be able to discuss specific questions about their own research with a member of staff from the Medical Statistics Department or the Clinical Trials Unit. We will provide forms for you to submit your questions ahead of the drop-in sessions.

    Teaching format

    Teaching will take place through a blend of pre-recorded video lectures and live Q&A and practical sessions.

    Video lectures on each topic will be available to watch from one week before, and until 3 weeks after, the course. Participants will be expected to have watched the video lecture before the related live Q&A and practical. All participants are asked to please watch the video for the first lecture before the course begins on 4 July.

    Live online Q&A and practical sessions will run each day of the course. These live sessions will take place from approximately 9.00am to 3.00pm British Summer Time (BST) with comfort breaks. The live sessions will take place online using Zoom and therefore participants will need to have a reliable internet service and a PC or laptop with microphone and speakers.

    A Guest Lecture will be given by an invited speaker.

    Course materials

    The course materials include lecture videos which will be available to watch for 5 weeks as described above. Lecture notes and slides and practical handouts will be available to download and keep. All materials required for the course will be provided in advance. Practical solutions will be provided at the end of each practical.

    The following are recommended as optional additional background materials:

    • Evans I, Thornton H, Chalmers I and Glasziou P. Testing Treatments: Better Research for Better Healthcare.  Pinter and Martin, 2011.
    • Friedman LM, Furberg CD, DeMets D, Reboussin DM, and Granger CB. Fundamentals of Clinical Trials. Springer, 2015
    • Pocock SJ. Clinical Trials: A Practical Approach. Wiley, 1983

    Assessment

    There is no formal assessment.

    Requirements and Admission Criteria for Certificate in Essentials of Clinical Trials at London School of Hygiene & Tropical Medicine, University of London

    English Requirements

    • IELTSMin 7.5

    English Program Requirements

    English Language requirements

    As part of the application process, applicants are required to demonstrate how they meet LSHTM's minimum English Language requirements. This is particularly important for applicants requiring a Student Visa, as the UK Home Office requires that every student from outside the UK and Republic of Ireland shows evidence of a minimum level of English language ability (called CEFR B2 level) in order to be granted a Student visa and study in the UK.

    Additionally, LSHTM asks for English language proficiency levels that are necessary for our academic programmes, which is slightly higher than the Common European Framework for languages (CEFR) B2 level.

    English language requirements policy (pdf)

    Accepted English language tests

    The academic English language requirements for each of LSHTM’s programmes are categorised into one of three profiles:

    • Band A (highest requirement)
    • Band B (mid-range/’standard’ requirement)
    • Band C (lowest requirement)

    Please refer to the appropriate Programme Specification for the English language requirement Band of your preferred programme.

    • IELTS (Academic)
    • Pearson PTE Academic

    These tests are only valid for entry for 2 years. As a result the qualification must have been completed no more than 2 years prior to enrolment.

    LSHTM requires the following minimum proficiency test scores. Please refer to the appropriate Programme Specification for the Band of your preferred programme.

     Band ABand BBand C
    IELTS (Academic)

    7.5 overall with 7.0 in each component

    7.0 overall with 6.5 in each component

    6.5 overall with 6.0 in each component

    Pearson PTE Academic

    80 overall with 80 in each component

    76 overall with 76 in each component

    59 overall with 59 in each component

    Majority English-speaking countries

    Last updated: 26 October 2022

    The UK Government recognises the following countries as majority English-speaking countries:

    • Antigua and Barbuda
    • Australia
    • The Bahamas
    • Barbados
    • Belize
    • Dominica
    • Grenada
    • Guyana
    • Ireland
    • Jamaica
    • Malta
    • New Zealand
    • St Kitts and Nevis
    • St Lucia
    • St Vincent and the Grenadines
    • Trinidad and Tobago
    • United Kingdom
    • United States of America

    These countries have been classified as majority English-speaking countries by the UK Government. Further information on Student Visa requirements, including Knowledge of English, can be found on the government website. In the interest of compliance, LSHTM is not able to consider other countries as majority English-speaking countries.

    If you are a national of one of these countries, you are not required to submit evidence of English language proficiency.

    If you have undertaken a full degree in one of the above countries, you will not be required to submit further evidence of your English Language if the degree certificate is successfully verified with the issuing body on receipt. Any applicant found to have submitted fraudulent documentation will have their application withdrawn.

    Canadian nationals are also exempt from English Language requirements but non-Canadian nationals who have studied in Canada are required to meet standard English Language requirements due to Home Office policy.

    Conditions

    If you request to defer your entry to LSHTM, we may ask you to re-take your test if your original offer was based on a test which will be out of date at the point of registration. Our English language programme requirements and other accepted tests provide details of how long your qualification is deemed valid.

    All test scores are verified with the issuing body on receipt. Any applicant found to have submitted a fraudulent score will have their application withdrawn.

    LSHTM reserves the right to change minimum English Language requirements during an application cycle in-line with any compliance guidance released by the Home Office. In the event of a change in Home Office policy which affects entry requirements, the University will notify affected applicants in writing.

    Exemptions

    Applicants who are a national of a majority English-speaking country or who have successfully completed an appropriate academic qualification (at least equivalent to a UK Bachelor's degree), which was taught in a majority English speaking country from the UKVI approved country list automatically meet our English Language requirements.

    • UKVI’s approved country list

    *Please note, Canadian nationals are exempt from English Language requirements but non-Canadian nationals who have studied in Canada are required to meet LSHTM’s standard English Language requirements due to Home Office regulations.


    Academic entry requirements

    LSHTM's minimum entry requirements for each of its degrees are listed below. Applicants who do not meet the minimum entry requirement for the programme of their choice but who have relevant professional experience may still be eligible for admission.

    Master's programmes (intensive)

    In order to be admitted to an LSHTM master's degree programme, an applicant must:

    • hold either a first degree at Second Class Honours (2:2) standard in a relevant discipline, or a degree in medicine recognised by the UK General Medical Council (GMC) for the purposes of practising medicine in the UK, or another degree of equivalent standard awarded by an overseas institution recognised by UK ENIC or the GMC).

    or

    • hold a professional qualification appropriate to the programme of study to be followed obtained by written examinations and judged by LSHTM to be equivalent to a Second Class Honours (2:2) degree or above.

    or

    • have relevant professional experience or training which is judged by LSHTM to be equivalent to a Second Class Honours (2:2) degree or above.

    and

    • satisfy any additional requirements where prescribed for admission to a specific programme.

    If you have not previously studied in the UK, you can check our guide to international equivalent qualifications for our master's degrees.

    Some degree programmes may have a higher entry requirement than specified above. Please be sure to check the individual programme for any additional entry requirements.

    MPhil and PhD

    Academic requirements

    The normal minimum entrance qualification for registration at the School on a MPhil/PhD programme is evidence of an aptitude for research and at least one of the following:

    • a master’s degree in a subject appropriate to the course of study to be followed (recommended)
    • a qualification appropriate to the course of study to be followed, in medicine, dentistry or veterinary studies
    • an Upper Second Class Honours (2:1) degree from a UK university, or an overseas qualification of an equivalent standard, in a relevant subject.

    English language requirements

    If English is not your first language, you will need to meet these requirements: Band B.

    DrPH

    Academic requirements

    The normal minimum entrance qualification for registration at the School on a Doctoral programme is evidence of an aptitude for research and at least one of the following:

    • a master’s degree in a subject appropriate to the course of study to be followed (recommended)
    • a qualification appropriate to the course of study to be followed, in medicine, dentistry or veterinary studies
    • an Upper Second Class Honours (2:1) degree from a UK university, or an overseas qualification of an equivalent standard, in a relevant subject.

    Applicants for the DrPH study are also required to have a minimum of two year's appropriate experience.

    English language requirements

    If English is not your first language, you will need to meet these requirements: Band B.


    Essential digital skills

    Digital skills and using computers are an everyday part of modern life – and you'll need both during your time at LSHTM.

    You'll need to be able to use standard software (such as Word), a web browser and email. You'll also need to be able to type at a reasonable speed in order to perform to the best of your ability during any online assessments – for reference, the average person types around 40 words per minute – there are a number of free typing speed tests available online.

    It'll benefit your studies if you know how to:

    • use digital technologies to find, evaluate and create information
    • communicate effectively with online technologies
    • select the correct tools to complete online and offline tasks
    • perform tasks efficiently in a variety of digital environments

    Whatever you're studying you'll need to know how to work with digital technologies, stay safe online and build a positive online presence.

    Reasonable adjustments and support are available for students who have additional accessibility or learning needs, and LSHTM recognises the use of voice to text or alternative software being available for those students with disabilities.

    Career Opportunities after Completing Certificate in Essentials of Clinical Trials

    Course content

    The topics to be covered will include:

    • Design of RCT: randomisation, blinding, trial size
    • Ethical conduct: participant consent, data monitoring and when to stop early
    • Certified Good Clinical Practice (GCP) training
    • Introduction to statistical methods for design and analysis
    • Alternative designs for clinical trials
    • Reporting: how to write, and critique, a clinical trial report
    • Clinical trials in practice
    • Practical experience in development of a clinical trial protocol.
      (Participants will work in small groups to develop and present trial protocols.)
    • Guest lecture

    In addition to the formal teaching sessions, we will run two optional drop-in sessions on Wednesday and Thursday afternoon. Participants will be able to discuss specific questions about their own research with a member of staff from the Medical Statistics Department or the Clinical Trials Unit. We will provide forms for you to submit your questions ahead of the drop-in sessions.

    Teaching format

    Teaching will take place through a blend of pre-recorded video lectures and live Q&A and practical sessions.

    Video lectures on each topic will be available to watch from one week before, and until 3 weeks after, the course. Participants will be expected to have watched the video lecture before the related live Q&A and practical. All participants are asked to please watch the video for the first lecture before the course begins on 4 July.

    Live online Q&A and practical sessions will run each day of the course. These live sessions will take place from approximately 9.00am to 3.00pm British Summer Time (BST) with comfort breaks. The live sessions will take place online using Zoom and therefore participants will need to have a reliable internet service and a PC or laptop with microphone and speakers.

    A Guest Lecture will be given by an invited speaker.

    Course materials

    The course materials include lecture videos which will be available to watch for 5 weeks as described above. Lecture notes and slides and practical handouts will be available to download and keep. All materials required for the course will be provided in advance. Practical solutions will be provided at the end of each practical.

    The following are recommended as optional additional background materials:

    • Evans I, Thornton H, Chalmers I and Glasziou P. Testing Treatments: Better Research for Better Healthcare.  Pinter and Martin, 2011.
    • Friedman LM, Furberg CD, DeMets D, Reboussin DM, and Granger CB. Fundamentals of Clinical Trials. Springer, 2015
    • Pocock SJ. Clinical Trials: A Practical Approach. Wiley, 1983

    Assessment

    There is no formal assessment.

    Fee Information

    How to Apply

    Applying for CPD and short courses

    All of our short courses can be applied for online. Details on how to apply including fees and payment deadline can be found the page of the course you are interested in. A link to the online application form will be found on the tab of the chosen course. For a full details of what is on offer, please visit our short courses section.

    Please also read our Continuing Professional Development (CPD) and short courses admissions policy before applying for a course.

    Applying for London-based modules

    Details on how to apply including fees and payment deadline can be found on the London-based module section of the website. Applicants for individual modules should complete the MSc module application form and email it to [email protected].

    Please note that the School gives priority to the needs of students registering for masters and research degrees, and so places on any module may be limited.

    Applying for distance learning modules

    Applications should be made online to the University of London international programmes. Applicants should go to the relevant programme webpage and click on the corresponding ‘Apply online’ tab. Please see below for the list of available modules per programme and to apply:

    • Clinical Trials modules
    • Demography & Health modules
    • Epidemiology modules
    • Global Health Policy modules
    • Infectious Diseases modules
    • Public Health modules

    Further information on the application process for the distance learning programmes can be found on the University of London website.

    Certificate in Essentials of Clinical Trials at London School of Hygiene & Tropical Medicine, University of London
    London School of Hygiene & Tropical Medicine, University of London
    London School of Hygiene & Tropical Medicine, University of London
    United Kingdom

    United Kingdom, Camden

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