| Fundamentals of Clinical Research & GCP - (Short Course) |
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| This 1-day course is a plain language guide to product development, clinical trial methodology and terminology and essentials of GCP. No prior knowledge or experience is required. This course is ideal for new personnel, those in non-technical roles requiring basic knowledge of clinical trials and GCP responsibilities, administrators, members of non-clinical departments in commercial companies and members of ethics committees. The course is the first day of our Foundation in Clinical Research course. | | Future dates | 16 November 2010 | | Funding/Fees | £450 (ex VAT) | | Date(s) | 14/09/2010 |
| Introduction to Clinical Trials & Clinical Trials Practice - (Short Course) |
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This course is designed to educate delegates in the role of clinical research in drug development and in clinical trials methodology and instruct them in the principles of Good Clinical Practice.
An introduction to:
• Drug development
• Statistics for CRAs
• Protocol design
• Clinical trial design and theory workshop
• Case report form design
• Pre-trial organisation
• Ethics committees and informed consent
• Introduction to GCP and investigator selection and motivation
• Source data verification and clinical trial monitoring
• Quality assurance
• Phase I studies
• Adverse effects and adverse drug reactions
• Regulatory affairs | | Funding/fees | Member £1100
Non-member £1320
Member Health Service / Academic £899 | | Date(s) | 27/09/2010 to 29/09/2010 |
| Introduction to Good Clinical Practice (GCP) - (Short Course) |
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This course will provide a practical insight to the history and application of regulations within clinical research.
Course Outline:
* History and purpose of GCP
* Development of ICH GCP
* Roles and responsibilities in clinical research according to ICH GCP
- Sponsor
- Monitor
- Investigator
- Ethics Committees
* Essential documentation
* The EU Directives 2001/20/EC and 2005/28/EC
- Purpose
- How the introduction affects clinical research in the EU
- Clinical trial authorisations
* GCP in action
- Informed consent
- Safety reporting
- Maintaining data integrity
By the end of this course participants will be able to:
* Describe the purpose of Good Clinical Practice (GCP)
* Outline the significant milestones in the history of GCP development
* Review the respective responsibilities of Sponsors, Investigators and Ethics Committees in the context of GCP
* State the purpose of the EU Clinical Trial Directive
* Outline the scope of the Directive
* Discuss the major implications of the Directive for clinical researchers
* Describe some practical applications of GCP. | | Requirements | This course will benefit all new clinical personnel | | Date(s) | 06/10/2010 |
| Introduction to Good Clincal Practice (GCP) - (Short Course) |
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Understand the significance of Good Clinical Practice (GCP) and it’s ever increasing importance within clinical research, and also the impact of the EU Clinical Trials Directive.
| | Requirements | This course is suitable for everyone who is new to the industry or is working in a support role. It has particular relevance to CTAs and support staff working alongside CRAs or Project Managers. | | Funding/fees | £599.00 | | Date(s) | 13/10/2010 |
| Foundation Course in Clinical Research (BASIC COURSE) - (Short Course) |
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A 2-day certification course covering the basics of clinical research & GCP. Ideal for the new or inexperienced and essential for those wishing to attain certification. This course incorporates the Fundamentals of Clinical Research & GCP course (Day 1)
Faculty of Pharmaceutical Medicine (Royal Colleges of Physicians of the United Kingdom) has awarded 13 CPD credits to this course
We use visual, auditory and kinaesthetic learning methods to make the course fun and enjoyable.
Objectives and Course Content
Participants of courses learn in different ways. Our foundation course has been designed to ensure that all the visual, auditory and kinaesthetic methods of learning are incorporated. We have drastically reduced the use of PowerPoint presentations and included non-threatening activities. These both enhance learning and make the course far more enjoyable for the participants.
No prior experience is required but participants will gain most benefit if they have worked in the field of clinical research for at least six months prior to attendance.
At the end of the course participants should have a thorough basic knowledge of the clinical trial process, be aware of the need to comply with GCP and be aware of the most important GCP responsibilities.
Our last course in Copenhagen attracted a vast number of enthusiastic comments about our new teaching style, including ....
"Finally a course where you don't just sit down and listen for hours all the time. Excellent with interactive sessions — it certainly kept my attention".
"Thank you very much — I never thought learning GCP could be so interesting"
"A fantastic course with extremely competent teachers who know how to explain the topics in an easy to understand way"
This course covers and participants will be made aware of:
* the process of the development of a new medicinal product through the various phases of clinical research (Phases I to IV and PMS)
* the types of study undertaken (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use)
* plain language explanations of abbreviations, methodology and terminology including study designs (parallel group/crossover), blinding methods, use of placebo
* introduction of GCP and its implementation by standard operating procedures. | | Funding/fees | New two-day course, price reduced to £950 (ex VAT)
Clinical Research Club: £875 (ex VAT) | | Date(s) | 14/09/2010 to 15/09/2010 |
| Advanced Course in Clinical Research (& Cert CRGCP Part 2) - (Short Course) |
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| This 1-day course covers advanced and practical topics not covered in Part 1. It gives participants the chance to develop their project management and problem solving skills. General awareness information is provided about the new European requirements for interventional trials in humans. Participants who have passed the basic course examination and have attended this course are eligible to sit the optional examination for the “Certificate in Clinical Research & GCP”. The course is also open to participants who do not wish to take the examinations or attain certification. | | Future dates | 18 November 2010 ** | | Requirements | This is an advanced course ideal for those who have already attended the Fundamentals course or have experience in the clinical trial process | | Funding/Fees | Next 1-day course, £450 (ex VAT) - Pay online
| | Date(s) | 16/09/2010 |
| Good Practice in Clinical Research - (Short Course) |
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A five day course covering Good Practice in Clinical Research has been designed by experienced researchers from UBHT and the University of Bristol.
The course has been structured to take participants through from initial study design, to regulatory approvals, recruitment, conduct of the study, analysis and closure and is a MUST for both new and experienced staff from all disciplines working in clinical research. The course has been approved for 25 CPD points.
| | Funding/fees | Delegates from the Trust and the University of Bristol are asked to complete a registration form and submit this with a personal cheque for £100 as deposit to the R&E Department. Cheques are returned at the end of the course provided delegates attend the training for which they have booked.
Whilst this course is intended mainly for staff of the Trust or University of Bristol, a limited number of places are available for staff from other organisations at a cost of £450 for the five day course. Such delegates will be required to make their own travel and subsistence arrangements. Phone the R&D office first to check whether external places are available. | | Date(s) | 04/11/2010 to 08/11/2010 |
| One day ICH - Good Clinical Practice (GCP) Training Courses - (Workshop/Seminar) |
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One-day training course outlining the principles of Good Clinical Practice.
| | Future dates | 13 October 2010
17 November 2010
15 December 2010 | | Additional Information | By the end of the day delegates will:
•Understand the main difference between research and audit.
•Be familiar with the regulatory aspects of conducting clinical research.
•Be familiar with the approvals systems for R&D, Ethics and the MHRA.
•Be able to identify adverse events and the reporting procedures.
•Understand the importance of maintaining a good site file.
•Be able to identify ‘essential documents’ and know what to do with them.
•Be familiar with processes for monitoring, audits and inspections.
Learning methods:
A combination of lectures and interactive workshops. | | Requirements | This course is aimed at personnel new to clinical research and experienced staff who require GCP training. | | Funding/Fees | These courses are free to staff from UBHT and partner organisations, but it has been agreed that in future all delegates will be asked to submit a personal cheque for £25 at the time of booking.
Spaces on the courses are limited and course tutors are keen to ensure that delegates are committed to attending the session booked. The cheques will be returned to delegates at the end of each session. Delegates who cancel their place within 48 hours of the course will be refunded, but the department reserves the right to retain cheques from delegates who fail to attend on the day. | | Date(s) | 16/09/2010 |
| Good Clinical Practice (GCP) Auditing - Principles and Practice - (Workshop/Seminar) |
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This two and a half day course offers the ideal external training opportunity for those new to the auditing of clinical research and those moving into the area from monitoring or from auditing in other disciplines. It is directed principally towards the requirements of Good Clinical Practice and the methods for assuring that these requirements have been met.
The first afternoon of the course provides an introduction to Good Clinical Practice and is optional. The remaining two days concentrate on the practicalities of clinical audit. | | Future dates | 7th-9th March 2011 | | Funding/fees | COURSE FEES
including optional first day
Association Members £785 inc VAT
Non Members £940 inc VAT
COURSE FEES
excluding optional first day
Association Members £725 inc VAT
Non Members £880 inc VAT | | Date(s) | 20/09/2010 to 22/09/2010 |
| Implementing Good Clinical Laboratory Practice (GCLP) - (Workshop/Seminar) |
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This course is designed to provide comprehensive guidance and practical help for those who are implementing Good Clinical Laboratory Practice in laboratories which undertake the analysis of samples from clinical trials.
The course will address the current regulatory framework for laboratory work in support of clinical trials with reference to the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive and related regulations and guidance. The course will also draw on the BARQA guidance document on Good Clinical Laboratory Practice (GCLP).
The course is structured to encourage delegates to:
* discuss and develop ideas
* solve specific problems
* examine particular aspects of GCP and GCLP
Benefits include:
* guidance on the interpretation and application of GCLP within the framework of Good Clinical Practice (GCP)
* understand how GCLP fits within a clinical (GCP) programme
* practical help on how to implement GCLP within a clinical research laboratory
* an opportunity to update your knowledge of GCLP with the current interpretation of requirements including guidance on clinical laboratories published by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). | | Requirements | Who should attend:
Laboratory Managers, analysts, investigators, trial coordinators, monitors and auditors working in:
* pharmaceutical company laboratories
* central laboratories
* contract research organisations
* hospital laboratories
* clinics
* investigator sites. | | Funding/Fees | Association Members £750 inc VAT
Non Members £910 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service. | | Date(s) | 22/03/2011 to 24/03/2011 |
| EU Directive on Good Clinical Practice Clinical Trials - (Workshop/Seminar) |
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GCP training is an essential legal requirement for all researchers involved in clinical trials of investigational medicinal products. These one day events provide a comprehensive and practical introduction to GCP for new and current researchers.
Next Event:
18th November 2010 - (9 am – 3.30 pm) Full day for all clinical trials staff new to GCP - Venue: UCLH Education Centre, Room 3, 1st Floor, 250 Euston Road, London NW1 2PG
| | Future dates | 2 December 2010 - (9 am – 3.30 pm) - Full day for all clinical trials staff new to GCP - Venue: UCLH Education Centre, Room 3, 1st Floor, 250 Euston Road, London NW1 2PG | | Requirements | For all staff involved in clinical trials of investigational medicinal products. | | Funding/fees | All courses are FREE to UCL/UCLH/Royal Free employees
(Please note that £50 will be charged if you cancel in less then 14 days or do not turn up on the day)
External - £200 (by invoice) | | Date(s) | 18/11/2010 |
| EU Clinical Trials Directive - (Workshop/Seminar) |
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| The practical effects of the Clinical Trial Directive 2001/20/EC regulations are widespread and on-going. What impact is the Directive having on your clinical trials? Are you losing valuable time seeking clarification? This intensive 2-day interactive training course has been designed to help you meet the challenges of the EU Clinical Trials Directive head-on. Practical sessions, step-by-step guidance and group discussions will help you to perform your responsibilities in line with Directive and reach your targets with a timely and compliant strategy. | | Requirements | Who should attend? Clinical Trials Manager' Regulatory Affairs Manager, GMP Inspector, Clinical Development Manager, Clinical Process Manager Medical Advisor, International/Global Regulatory Affairs Manager, Quality Control/Assurance Manager, Clinical Research Manager, Scientific Affairs Manager, GCP manager, QC Associate Drug Safety Manager, Clinical Operations Manager Clinical Project Leader, Pharmacovigilance Statistician, Biostatistician, Data Manager Clinical Pharmacologist, Clinical Pharmacology, Drug Evaluation Manager, Medical Director.
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| Writing and Managing SOPs for Clinical Quality Assurance - (Workshop/Seminar) |
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SOPs play a crucial role in clinical quality assurance and it is therefore essential that they are understood and followed by all end-users in a clinical trial. If SOPs are not followed correctly, the validity of data generated is compromised, leading to warning letters being issued and delays in the trial process. Auditors and inspectors see SOPs as essential and following them is crucial.
In this highly interactive course you will develop the skills and practical experience required to write and review SOPs for GCP compliance. Participants will review GCP fundamentals and also relevant regulations. This knowledge will then be used to examine considerations of style, length and content. | | Requirements | This course is beneficial to all involved in writing or managing SOPs for clinical trials, particularly those working in the following departments:
* Quality Assurance
* Clinical Trials
* Clinical Development
* Clinical Operations
* Clinical Research
* Clinical R&D
* Clinical Project Management | | Date(s) | 29/11/2010 to 30/11/2010 |
| Planning and Managing Clinical Trials - (Short Course) |
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This course comprises a single M level module, designed for those whose work involves them in clinical trials or who wish to become involved in such work. It provides training in line with the European directives on Clinical Trials and Good Clinical Practice (GCP). It offers an opportunity for students to gain an understanding the principles of planning and managing clinical trials on human volunteers. Students will be able to explore and apply relevant knowledge and skills to your own working environment. The module uses a blended learning approach which includes a detailed workbook supplemented by electronic learning materials. This Interactive learning is supported by Brookes’ virtual campus facility.
Unit description
1. Introduction to the module and literature skills
Includes general information about the module; an introduction to Brookes Virtual (contents, quizzes, electronic activities, assessments and discussion board); assessment criteria; literature searching and critical appraisal skills; databases.
2. Legislation and good clinical practice
Offers an overview of the European directives and legislation governing clinical trials in the 21st century; international perspectives; principles of the International Committee on Harmonisation (ICH)-GCP.
3. Drug development and trial planning
Explores drug development; pre-study requirements for clinical trials; regulatory approvals for clinical trials; Consort statement.
4. Trial responsibilities and protocols
Addresses the roles and responsibilities of investigators, sponsors and others; requirements of clinical trials protocols; legislative requirements for investigational medicinal products.
5. Project management in clinical trials
Introduces principles of project management; application in clinical trial management, risk assessment.
6. Research ethics and clinical trials
Examines the principles of research ethics, historical perspectives and current statutory requirements; ethical issues in clinical trials.
7. Consent and data protection
Explores the principles of informed consent; consent processes; data protection legislation and its application.
8. Data management
Introduces trial master files and essential documents; data management.
9. Quality assurance and governance
Addresses quality control in clinical trials; monitoring and audit; inspections; pharmacovigilance; research governance.
10. Trial closure and pitfalls
Examines trial closure, reporting and legal requirements; common pitfalls in clinical trial management. | | Additional Information | Level M 20 CATS points (equivalent to 10 ECTS credits). | | Requirements | Applicants need to meet the module’s minimum criteria in order to demonstrate that they will be able to study at an appropriate level. Applicants offered a place on the module must have reliable access to the Internet and email.
Note: Applicants whose home language is not English must demonstrate that their level of English is appropriate for study at postgraduate level with fluent writing skills. English language requirements are: IELTS level 6.5 or above, TOEFL 600/250 or above, WELT (BBC or above), or equivalent. | | Funding/fees | The cost of the module is £1,160 for UK/EU students (£1,210 for international students). |
| Clinical Trial Administration; an Introduction - (Short Course) |
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| This course aims to provide an introductory training for the CTA to help make sense of the background to clinical research and trial management. | | Additional Information | CPD Points: 10 | | Date(s) | 09/11/2010 |
| Update on Current Issues in Clinical Research - (Short Course) |
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This course is designed to keep the clinical research professional up-to-date with the current issues in clinical research. It will cover the rationale for the changes and most importantly how they impact you!
Course outline
• Latest developments in ICH GCP
• Update on the EU Directives (Clinical Trial & GCP) and their impact on clinical research
• Ethics committees
• Informed consent
• Regulatory inspections
• Declaration of Helsinki
• Data protection
• Paediatric studies
The course outline may vary depending on current developments. | | Funding/Fees | Member £425
Non-Member £510
Member Health Service / Academic £335 | | Date(s) | 10/11/2010 |
| Introduction to Clinical Research - (Workshop/Seminar) |
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The drug development process is complex, expensive, high risk and on average can take 12 years to complete. Clinical research has a pivotal role in the process and through the first three phases the efficacy and safety profile will be determined. However, both need to be explored in more detail after approval for marketing and during this phase a more complete picture of safety and efficacy emerges. This course will cover the full range of clinical research activities, bringing together the important features of this process and including how the complementary activities conducted in various departments result in a successful clinical project.
• The evolution of the pharmaceutical industry
• The phases of drug development
• Some common abbreviations
• History of GCP
• EU GCP Directive
• EU Clinical Trials Directive
• Roles and responsibilities in clinical research
• Life cycle of a clinical trial
• The protocol and case report form
• Informed consent
• Safety reporting
• Data flow
• Marketing Authority Applications
• The marketing and selling of medicinal products | | Funding/Fees | Member £425
Non-Member £510
Member Health Service / Academic £335 | | Date(s) | 01/12/2010 |
| Effective Monitoring Visits - (Workshop/Seminar) |
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| What every monitor should know to be able to comply with the regulatory requirements for carrying out effective monitoring visits. | | Funding/fees | £1,290.00 | | Date(s) | 15/11/2010 to 16/11/2010 |
| Good Clinical Practice Online - (Short Course) |
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The Medicines for Human Use (Clinical Trials) Regulations 2004 requires that Clinical Trials are conducted in accordance with the ICH Guideline for Good Clinical Practice (GCP). To assist our researchers in meeting this requirement, the College has Introduced an online Good Clinical Practice course, free of charge for all staff working on College sponsored projects.
This course is designed for Imperial College and their associated Trust staff undertaking or who are planning to take part on clinical trials. The aim of the course is to provide an overview of Good Clinical Practice and the requirements for regulatory affairs and pharmacovigilance.
Please note, this online course is only available to Imperial College academic staff. NHS Staff from our associated Trusts should check with their local R&D offices for access to a GCP course. |
| Online Good Clinical Practice Course - (Workshop/Seminar) |
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| The course will give individuals an up-to-date and comprehensive guide to the basic principles of ICH Good Clinical Practice and covers all the new changes/amendments proposed in the EU Directive 2005/28/EC and the UK Regulations. The Summary of Proposed Changes to current Regulations is attached for ready reference and these changes are also included in all relevant chapters of the course. | | Funding/fees | An individual can take this course by registering and paying a fee of £35 plus VAT. |
| Certificate in Good Clinical Practice - (Short Course) |
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Almost every aspect of pharmaceutical medicine is subject to regulation and for many years it has been a requirement of regulatory authorities that clinical trials performed to support licensing of new medicines be conducted in compliance with a set of standards known as Good Clinical Practice (GCP). Therefore pharmaceutical physicians, clinical research scientists, research nurses and others employed within the industry are required to have a good working knowledge of GCP. Most pharmaceutical companies provide training courses for their personnel either in-house or externally. However, for the most part training has not extended to clinicians, research nurses, technicians and other personnel serving as investigators and support staff involved in the conduct of clinical trials. Furthermore, there has been no qualification in GCP widely recognised as evidence of attaining a satisfactory standard of knowledge. The importance of attaining adequate knowledge of GCP extends beyond the investigation of potential new pharmaceuticals since an EU Clinical Trial Directive stipulates that from 2004 all clinical trials on human subjects involving medicinal products in the European Union, irrespective of their purpose, must be conducted in compliance with GCP. In the UK the EU Clinical Trial Directive was implemented from 1st May 2004.
The examination will be held in the UK but candidates may be from any country. Successful candidates will be awarded the Certificate of GCP. To gain the required standard in the examination, candidates will need to prepare themselves. The next examination will be held on 15th June 2009 at the Royal College of Physicians, London. | | Requirements | There are no specific eligibility criteria to register for the Certificate examination. It is open to all personnel involved in the conduct of clinical trials including research nurses, clinical research scientists and technicians as well as physicians. The examination will be held in the UK but candidates may be from any country. |
| Monitoring for Non-Commercial Clinical Trials - (Short Course) |
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The requirements of the new EU directives for clinical research mean that there is now a requirement for monitoring of non-commercial clinical trials. This course provides non-commercial monitors with the knowledge and skills to monitor effectively.
Background and history of Good Clinical Practice
* Declaration of Helsinki
* ICH GCP
* EU Clinical Trials Directive
* EU GCP Directive
* UK Statutory Instrument 1301
Role of the monitor
* ICH GCP chapter 5.18
* Qualifications for monitors
* Purposes of monitoring
* Monitor responsibilities
Data Review
* CRF review
* Source Data Verification
* Data Query processes
Adverse Event reporting
* Definitions
* Reporting requirements
IMP
* Storage and handling
* Drug accountability | | Requirements | This course is suitable for those involved in clinical research at site and who have responsibilities connected with monitoring. This would include:
* Study Site Co-ordinators
* Investigators
* Sub-investigators
* R&D office staff
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| E-learning 1: Introduction to the EU Clinical Trials Directive - (Short Course) |
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The Institute of Clinical Research's e-learning programme breaks up the directive into easy bite size modules in simple English.
* The modules highlight the key areas of the directive and the differences between current ICH GCP practice.
* There are simple questions to answer as you work through the modules to let you gauge your understanding.
* In conclusion, there is a test comprising 20 multiple-choice questions that provides the evidence that you have a thorough knowledge of the directive and its requirements.
* At the end of the programme you can print off a progress sheet to add to your training record. | | Funding/fees | £57.50 to purchase access to the e-learning course. |
| ICH GCP for Investigators - (Short Course) |
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By the end of this module you will know what the requirements of the Investigator are under ICH/GCP. Its aim is to explain what the the ICH GCP guidelines are, and to explore the meaning of the requirements.
The programme is clear and simple in design and gives full instructions for use. | | Funding/Fees | Non-member - £78 per licence
ICR Member - £65 per licence
Non-member NHS/Academic - £62 per licence
ICR Member NHS/Academic - £52 per licence. |
| E-learning 3: Principles of ICH GCP - (Short Course) |
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| The objective of ICH GCP is to provide a unified standard for the EU, Japan and the US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these regions. | | Funding/Fees | Non-member - £78 per licence
ICR Member - £65 per licence
Non-member NHS/Academic - £62 per licence
ICR Member NHS/Academic - £52 per licence. |
| E-learning 4: ICH GCP for Sponsors - (Short Course) |
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| The objective is to increace subject knowledge for Sponsors and especially for Sponsors of non-commercial studies | | Funding/Fees | Non-member - £78 per licence
ICR Member - £65 per licence
Non-member NHS/Academic - £62 per licence
ICR Member NHS/Academic - £52 per licence. |
| Online Good Clinical Practice Training - (Short Course) |
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The online course provided by Infonetica was written by Dr Isaac John, Assistant Director of Research & Development at Ashford & St Peter’s Hospital NHS Trust, and will lead you through the key areas critical to GCP, including:
• The principles of GCP
• Informed consent
• Ethics
• Responsibilities of the investigator
• Responsibilities of the sponsor
• Clinical Trial Protocol
• Investigator Brochure
• Essential Documents
• Safety Reporting
| | Additional Information | 9 CPD points. | | Funding/fees | The Course is free of charge to Leeds Teaching Hospital Trust researchers and University of Leeds researchers who hold honorary Trust contracts. The training course is available to those without a Trust honorary contract at a cost of £30. |
| Good Clinical Practice (GCP) Training - (Short Course) |
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| To ensure that our researchers are equipped with the latest knowledge of Good Clinical Practice and Research Governance, the Research Office will require that all researchers seeking approval of research projects show evidence of having undertaken GCP training within the last two years. The Research Office will be providing half-day GCP training sessions on a monthly basis to help researchers comply with this requirement. | | Future dates | * Monday 18th October 2010 9.00am to 1.00pm Seminar Room 1, Postgraduate Centre, MRI
* Tuesday 16th November 2010 1.00pm to 5.00pm Seminar Room 2, Postgraduate Centre, MRI
* Wednesday 8th December 2010 9.00am to 1.00pm Seminar Room 1, Postgraduate Centre, MRI | | Date(s) | 15/09/2010 |
| Introduction to Clinical Research Regulations - (Workshop/Seminar) |
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This workshop will introduce researchers to the national regulations governing clinical research, specifically the Research Governance Framework for Health and Social Care and the Medicines for Human Use (Clinical Trial) Regulations 2004, as well as addressing some of the over-riding principles of good clinical practice. The primary focus will be on explaining the internal and external processes necessary for obtaining approval for projects which involve NHS patients, staff and facilities.
By the end of the workshop participants should have an understanding of:
• the background to Research Governance in the NHS;
• how to get a sponsor;
• the Trust R&D Project registration and Review;
• getting ethical approval in Wales; and
• the Clinical Trials Directive. | | Requirements | The workshop is suitable for all those who manage or undertake research involving NHS patients, staff or facilities or clinical trials of a medicinal product. |
| Good Clinical Practice Compliance in Document Management - (Workshop/Seminar) |
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Clinical Research has to be carried out to both ethical and scientific standards so the rights and welfare of the subjects are upheld and that the data collected can be verified. As well as carrying out the activities that support these fundamental issues, clinical researchers also have to document both what they intend and what actually happened during a study. This audit trail of documents must be transparent and robust. This one day course deals with how to
set up, maintain and preserve a manageable document system that meets regulatory requirements. An overview of the regulatory background and deals with specific requirements in documentation management and archiving is also covered.
Course Outline
• EU CT Directive, Declaration of Helsinki, Data Protection Act
• GCP Issues – Consent, Ethics and Essential
• Documents Archiving – The Why/What and When?
• Electronic Records Management
• Investigator Archiving
• Audits/Inspections
• Archiving and Retention Requirements by GCP/EUCTD and Regulatory Authorities
• Preparation of Documents for Archiving
• Tracking of Archived Documents
• Requirements of Archives for Long-Term Storage
• How to select a suitable off-site storage Company
• What the Inspectors expect
• Alternative Long-term Storage Media
• Electronic Archiving | | Future dates | 8 December 2010 | | Requirements | This is an essential course for CRAs, CTAs, Archivists and anyone involved in the Management of Clinical Trial Documentation. | | Funding/fees | Member £425
Non-Member £510
Member Health Service / Academic £335 | | Date(s) | 08/12/2010 |
| GCP Refresher - (Workshop/Seminar) |
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This concise course is aimed at those who have been working to Good Clinical Practice in research for at least two years and have completed the Advanced level GCP and/or the GCP for Investigators courses.
The training aims to provide an update on the latest information on the UK regulations and framework guidelines and changes in research approval and inspection processes.
The day comprises a series of presentations with the opportunity for questions and discussions throughout the day.
9th November (PM) - Angel Hotel, Cardiff
10th November (AM) - Angel Hotel, Cardiff | | Future dates |
24th January 2011 (PM) - Oriel House, North Wales
25th January 2011 (AM) - Oriel House, North Wales
9th March 2011 (PM) - South West Wales
10th March 2011 (AM) - South West Wales | | Funding/fees | This course is offered free of charge. | | Date(s) | 09/11/2010 |
| GCP Compliance in Document Management - (Short Course) |
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This is the essential course for CRAs, CTAs, Archivists and anyone involved in the Management of Clinical Trial Documentation. The course runs for one-day and can be customised to suit your own specific archiving and document management needs addressing the following subjects-
* EU CT Directive, Declaration of Helsinki, Data Protection Act
* GCP Issues – Consent, Ethics and Essential
* Documents Archiving – The Why/What and When?
* Electronic Records Management
* Investigator Archiving
* Audits/Inspections
* Archiving and Retention Requirements by GCP/EUCTD and Regulatory Authorities
* Preparation of Documents for Archiving
* Tracking of Archived Documents
* Requirements of Archives for Long-Term Storage
* How to select a suitable off-site storage Company
* What the Inspectors expect
* Alternative Long-term Storage Media
* Electronic Archiving. | | Funding/fees | Fee- £385 per delegate + VAT. | | Date(s) | 08/12/2010 |
| Good Clinical Practice Training - (Workshop/Seminar) |
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Good Clinical Practice [GCP] is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that involve human subjects. Compliance with GCP provides assurance that the clinical trial data are credible and accurate and that the rights, safety confidentiality and well-being of trial subjects are protected.
It is a requirement that all researchers and sites conducting research show GCP compliance and evidence of appropriate training. |
| GCP Directive 2005/28/EC - (Short Course) |
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This module allows the learner to get insight into the important requirements of the GCP Directive on the conduct of clinical trials. It also shares the views of various clinical trial personnel on the impact of this Directive on their role.
The module includes information on the UK specific requirements as a result of the incorporation of this Directive into UK law under SI 1928, the module also includes the European view by including the Notice to Applicants, volume 10 on Good Clinical Practice. | | Funding/fees | Non-member - £78 per licence
ICR Member - £65 per licence
Non-member NHS/Academic - £62 per licence
ICR Member NHS/Academic - £52 per licence. |
| Introduction to Good Clinical Practice (GCP) - (Short Course) |
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This course is relevant to individuals who have no previous GCP training and those whose previous GCP training was more than two years ago.
The course is appropriate for anyone conducting or supporting clinical research. It is particularly suitable for those who are conducting or supporting Clinical Trials of an Investigational Medicinal Product (CTIMPs) and, as such, are required to provide evidence of GCP training.
Topics include:
* History of clinical trials and the development of GCP.
* Deciding what is a clinical trial
* Informed consent
* Responsibilities of research personnel
* Pharmacovigilance
* Monitoring. | | Future dates | 22/09/10 - GCP Half Day
14/10/10 - Royal Alexandra Hospital, Paisley
22/11/10 - Learning & Development Centre, Atlas Industrial Estate, 12 Edgefauld Street, Glasgow
24/11/10 - GCP Half Day, Beatson Gartnavel Hospital
08/12/10
09/12/10 - GCP Half Day | | Funding/fees | The course is free to all NHS and University staff.
External Applicants - Full Day fee £150. | | Date(s) | 23/09/2010 |
| Good Clinical Practice (GCP) Refresher Course - (Short Course) |
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These sessions are appropriate for all staff who are involved in any context with clinical research, in particular for those conducting a Clinical Trial of an Investigational Medicinal Product it is a regulatory requirement.
Topics include:
*Regulation Amendments
*MHRA Inspections
*Pharmacovigilance
*Standard Operating Procedures
*Trials master files
*Clinical Trials in Glasgow | | Requirements | This session is relevant to individuals who have had previous GCP training. |
| Good Clinical Practice (GCP) - (Short Course) |
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The Sheffield Children's Hospital Clinical Research Group (CRG) in collaboration with the Clinical Research Facility (CRF) are organising a number of seminars for novice and experienced researchers to help individuals and teams gain an understanding of the research process and offer practical help to research issues.
This programme is essential for all researchers planning to start or already involved in research. GCP is mandatory for researchers conducting clinical trials, and evidence of GCP training is increasingly becoming a requirement for non-clinical trials by Ethics Committees. This online programme will ensure that you are able to provide proof that you understand these principles and a certificate of attendance will be issued on completion. |
| GCP Awareness Workshop - (Workshop/Seminar) |
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How good is your GCP awareness?
Perhaps you or your staff have taken part in basic GCP training?
QED Partnership can now offer a workshop giving YOU the opportunity to test your awareness and hone your GCP skills in a "real life" situation.
Have fun checking the conduct of our dummy study by reviewing study site documentation, completed CRF data and sponsor's visit reports. Can you identify all the issues and problems?
The workshop is tailored to present a challenge at all levels and is suitable for those relatively new to clinical research as well as more experienced personnel.
Workshop overview:
Review Clinical Trial Documentation including:
- Study Site File
- CRF
- Reports
Details of study design – setting the scene, meet Dr Mainman and hear about his study.
Identify errors and omissions errors in both Site File and CRF
Discussion of errors in both Site File and CRF – How good an auditor are you. What have you learned? | | Funding/fees | Academic/NHS Employee £120 per person
Industry £150 per person
The cost includes full supporting documentation for each delegate and details of useful sources of reference. A certificate of attendance will also be provided for your training records. |
| On-Line GCP Courses - (Short Course) |
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| The on-line course is for staff that require GCP training but are unable to attend a face-to-face course before study commencement or for staff that have attended a course over 2 years ago and require an update. |
| GCP Update - Review of the latest requirements in Europe & the US - (Short Course) |
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This intense one day workshop provides the latest developments in GCP to ensure that you are up-to-date and able to meet the requirements for GCP inspection.
To ensure clinical trials meet the requirements of the regulatory authorities it is essential that trials are carried out to the latest GCP regulatory requirements. It is particularly important to keep up to date and be familiar with the recent developments in GCP, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. Regulatory inspectors expect those involved in clinical trials to be updated with recent developments in GCP - this workshop will be ideal for this.
By the end of this course, you will:
* be familiar with the most important recent developments which are having an impact on clinical trials.
* understand the requirements of the recently issued new CT Directive guidelines and hear feedback from the recent EMEA conference on the problems with the CT Directive.
* review changes in Europe and the US GCP requirements having an impact in Europe
* understand the key recent GCP developments both in Europe and the US
* be prepared for GCP inspection
* have had an opportunity to discuss your issues in order to help you develop your strategies for managing these GCP changes. | | Funding/fees | The full fee for this course is £650 +vat and includes full course materials, lunch and refreshments. | | Date(s) | 01/11/2010 |
| Introduction to GCP - (Short Course) |
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| Customised In-house Courses are designed for organisations wishing to train a group of your employees at a location of your choice. This course is aimed at those new to clinical research. The content can be tailored to the function of the audience, for example, CRAs, CTAs, support staff, staff from service providers. |
| GCP Update - (Short Course) |
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| This course provides an update on recent changes in GCP. The course assumes a working knowledge of GCP and focuses on changes in the last 12-24 months. This course is therefore most suitable for those with clinical research experience. | | Date(s) | 10/11/2010 |
| Ethics & GCP Forum - (Short Course) |
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ICR forums provide an excellent opportunity to
*Learn about new industry initiatives
*Keep up to date with current clinical research issues
*Hear key industry figures speak about their specialist fields
*Network with fellow clinical research professionals | | Date(s) | 19/10/2010 |
| Monitoring Safety in Clinical Trials and Drug Development - (Short Course) |
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Outline
Objectives of pharmacovigilance planning and monitoring in drug development programmes
Pharmacovigilance in clinical trials - a regulatory perspective
Pre-registration pharmacovigilance planning
Assessing safety issues in the Common Technical Document
Planning for pharmacovigilance in the new ICH programme
Implementation of the Clinical Trials Directive and the detailed guidance
Eudravigilance and proposed DRA tracking of investigational adverse events under the Clinical Trial Directive
CIOMS VI issues
Communication for the protection of the trial population
Monitoring safety with an investigational agent in co-development
Development of labelling from Development Core Safety Information through to CCSI and the SPC
SAEs in high mortality conditions
Unravelling the unexpected | | Funding/fees | £1,050.00 + VAT or £685.00 + VAT (academic units, public sector organisations, registered charities) | | Date(s) | 01/02/2011 |
| Essential GCP - (Short Course) |
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This course provides a detailed understanding of the latest developments and requirements of ICH GCP, and gives practical advice and guidelines for monitoring.
This course will help everyone responsible for working within the GCP guidelines, to include CRAs and clinical trial administrators. It will also be of interest to anyone who requires a good understanding of the requirements of ICH/GCP.
By the end of this course, you will:
* Understand the history and origins of ICH GCP and the impact this has had on modern clinical trials.
* Understand how to work with the regulations
* Understand how the regulations affect you and your role within the industry
* Comply with GCP and the requirements of ethics committees
* Prepare for and respond to audit inspections. | | Funding/fees | £1,095.00 + VAT | | Date(s) | 08/12/2010 to 09/12/2010 |
| Regulatory Affairs for Clinical Trials - (Short Course) |
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To ensure clinical trials meet the requirements of the regulatory authorities, it is essential that trials are carried out to the latest regulatory requirements. It is particularly important to keep up to date and be familiar with the recent developments in regulations for running clinical trials, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. This course will also highlight the most important of these key changes, including:
- Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials
- Develop effective processes for obtaining Clinical Trials Authorisation:
- Regulatory Approval and Ethical Approval
- Understand the requirements for running clinical trials in Children
- Understand the most important legal aspects of clinical trials
- Ensure compliance in regulatory requirements for investigational medicinal product, pharmacovigilance, Clinical Trial Data Management including EDC and e-source
- Explore recent developments in clinical trial regulations including FDA requirements
- Achieve successful regulatory inspection | | Requirements | The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO –companies, or study sites including investigator initiated studies.
The workshop will also be of interest to those departments who liaise with clinical trial personnel (such as regulatory affairs, clinical trial supply, quality assurance, document management, legal) and all other professionals who want to know more about regulations covering clinical trials. | | Date(s) | 27/09/2010 to 28/09/2010 |
| Clinical Research & GCP for Data Management - Certificate in Clinical Research Data Management (Cert CRDM) - (Short Course) |
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The Academy holds a two-day course for data management personnel. A list of those interested is now being compiled and a date/venue will be arranged according to demand.
The aim of the first day of this course is to provide a core awareness of clinical research and GCP basics.
Day 2 will then specialise on issues of relevance to data management. The course aims to provide a practical insight into the development of a computerised system, having due regard for compliance with PIC/S and FDA guidance. In addition the course will developing problem solving skills. The course will also consider preparation for data management audits.
At the end of the workshop the participants will have
• a good general awareness of the requirements affecting clinical trials, including GCP
• a specialised knowledge of the essentials of validation of computerised systems and evaluation of data management systems in preparation for audit. | | Requirements | This course is designed for personnel working in the data management departments of pharmaceutical companies and contract research organisations.
Although no experience is required, participants will derive most benefit if they have an awareness of how data is collected and managed in clinical trials.
The focus of the course will be on commercial clinical trials in humans. | | Funding/fees | £950 per place (ex VAT): discounts for group bookings |
| Good Manufacturing Practice for Investigational Medicinal Products - (Workshop/Seminar) |
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This course is intended for those contributing to quality in the manufacture, testing, distribution and use of investigational medicinal products and will build on your knowledge of the principles and interpretation of current Good Manufacturing Practice.
This course is structured to encourage delegates to:
* discuss and develop ideas
* solve specific problems
* examine particular aspects of Good Manufacturing Practice.
By the end of the course delegates will have:
* a clear understanding of the history and current status of Good Manufacturing Practice and its application to the manufacture, testing and distribution of investigational medicinal products
* an understanding of the variety of clinical trial designs and their impact on the investigational product manufacturing process
* an understanding of the interface between Good Manufacturing and Good Clinical Practice
* an understanding of the roles and responsibilities of the Qualified Person and Quality Assurance
* gained an insight into the activities of the United Kingdom Medicines and Healthcare Products Regulatory Agency and other regulatory agencies. | | Requirements | Who should attend:
GMP and GCP quality assurance personnel
Aspiring Qualified Persons
Operational personnel in pharmaceutical operations
Manufacturing
Packaging
Laboratories
Operational personnel in the clinical environment including clinical research associates hospital pharmacists | | Funding/fees | Association Members £734
Non Members £891
(all prices are in GB Pounds and include VAT at the standard rate).
The member rate is available as a concession to those working in relevant charities and academic institutions or for the NHS. Concessions cannot be booked online. | | Date(s) | 11/01/2011 to 12/01/2011 |
| Good Clinical Practice (GCP) - (Short Course) |
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The Medicines for Human Use (Clinical Trials) Regulations 2004 requires that clinical trials are conducted in accordance with the ICH Guideline for Good Clinical Practice (GCP).
This course is now used by most of top UK medical schools and NHS Research units. More than 500 researchers have enrolled on the course in first year.
This programme consists of 5 courses with 7.5 hours of content:
Course list
GCP 01. Protocol & Associated Documents - 1 CPD point
GCP 02. Applications, Agreements, Approvals - 2 CPD points
GCP 03. Trial Master Files - 1 CPD point
GCP 04. Conducting the Trial - 2 CPD points
GCP 05. Safety Reporting - 1 CPD point. | | Additional Information | Approved by: the Royal College of Physicians of the UK for 7 distance-learning CPD credits. | | Funding/fees | Epigeum training programmes are available on an annual licence. |
| Clinical Trials - Roles and Responsibilities of Health Care Professionals - (Short Course) |
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This course will enable research nurses and other health care professionals working in this area to explore the multifaceted role and responsibilities of the practitioner in relation to clinical trials. It will enable participants to develop the knowledge and skills required to ensure that these are conducted safely and effectively whilst maintaining scientific integrity. The course will include research methodology, good clinical practice (GCP and EU Directives), ethical considerations, Research Governance, monitoring/management of adverse effects, and the impact of clinical trials on patients, professionals, and others involved in the clinical trials process.
| | Additional Information | 15 Credits | | Requirements | Students undertaking this module should be working in clinical trials and should ideally take the module within 18 months of commencing in post |
| Introduction to Good Clinical Practice - (Short Course) |
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| The EU Clinical Trials Directive came into force on May 1st 2004 and impacts on both commercial and non-commercial drug trials alike. This course is designed to give a particular insight into the challenges facing non-commercial research organisations conducting and/or sponsoring trials within the scope of the EU Clinical Trials Directive (drug trials). In addition, this course will give a thorough overview of the informed consent process, responsibilities of research personnel, pharmacovigilance, monitoring and Good Clinical Practice (GCP) applicable to all research on human subjects conducted in the NHS | | Funding/fees | No fees have been specified for this course. | | Date(s) | 18/11/2010 |
| CT201 Protocol development [9160CT201] - (Short Course) |
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| Material in this compulsory module will build on the work of the core modules*, but will go further into the steps to be taken for preparing the protocol for a trial. It is recommended that this module is taken in the same year that students attempt the last of the written papers. Working in small groups, students will critically appraise a systematic review and start drafting the background section for a trial protocol. Students can then use this as a basis for developing a draft protocol for assessment. | | Additional Information | Assessment: one two-hour unseen written paper and written assignment(s). | | Requirements | [*Advanced CT modules may also be useful but are not prerequisites] | | Funding/fees | http://www.londonexternal.ac.uk/prospective_stu
dents/postgraduate/lshtm/clin_trials/fees.shtml |
| CT203 Project management and research co-ordination [9160CT203] - (Short Course) |
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| This module will provide students with a full understanding of project and business management theory in the context of a clinical trial. Students will learn how to develop a project management plan, identify key milestones and develop delivery plans. The module will explore implementation and co-ordination of the project plan with an emphasiseon communication and project promotion and monitoring. It will also consider the major challenge of identifying barriers to implementation and creating deliverable solutions. | | Additional Information | Assessment: one two-hour unseen written paper and written assignment(s). | | Funding/Fees | http://www.londonexternal.ac.uk/prospective_stu
dents/postgraduate/lshtm/clin_trials/fees.shtml |
| CT204 Regulatory affairs, good clinical practice and ethics [9160CT204] - (Short Course) |
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| The module will cover issues relating to the regulatory legislation and associated approvals and permissions required to conduct high-quality single-centre, national and international clinical trials. Integral to the legislation is Good Clinical Practice (GCP). Students will gain a solid understanding of GCP and will explore ways of implementing GCP, including risk assessment and trial monitoring. A variety of clinical and geographical settings will be examined. Ethical issues will be considered throughout the module. | | Additional Information | Assessment: one two-hour unseen written paper and written assignment(s). | | Funding/Fees | http://www.londonexternal.ac.uk/prospective_stu
dents/postgraduate/lshtm/clin_trials/fees.shtml |
| CT206 Data monitoring and interim analyses [9160CT206] - (Short Course) |
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| This module will cover issues relating to the on-going monitoring of the data in a study in order that sufficient data are available to answer the trial’s question reliably without recruiting more patients than necessary, or exposing them to unnacceptable risks. The module will therefore focus on the ethical context of decisions about whether or not to continue entering patients into trials. A number of different statistical approaches will be explored, and the role and conduct of data monitoring committees in this process will be examined. | | Additional Information | Assessment: one two-hour unseen written paper and written assignment(s). | | Funding/Fees | http://www.londonexternal.ac.uk/prospective_stu
dents/postgraduate/lshtm/clin_trials/fees.shtml |
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