in Clinical Research I

Departement Klinische Forschung
Clinical Trial Unit
Study Handbook
Certificate of Advanced Studies (CAS) in Clinical Research I Clinical Trial Planning and Conduct
2014
A postgraduate educational program at the
Developed by the Clinical Trial Unit at the University Hospital Basel (CTU Basel)
Operated by the CTU Basel, in partnership with the Swiss Tropical and Public Health Institute
(SwissTPH)
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Index
1. General Description ............................................................................................................. 3
2. Target Audience ................................................................................................................... 3
3. Course Structure .................................................................................................................. 4
4. Course Language ................................................................................................................. 6
5. Performance Records .......................................................................................................... 6
6. Institutions ............................................................................................................................ 7
7. Teaching Faculty .................................................................................................................. 7
8. Program logistics ................................................................................................................. 8
9. Scientific Advisory Board .................................................................................................... 8
10. Quality Assurance .............................................................................................................. 9
11. Finances.............................................................................................................................. 9
Attachment I– Curriculum and Learning Outcomes ............................................................ 10
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Page 2 of 12
1.
General Description
Clinical research is a manifold and multidisciplinary business with a growing need for welltrained professionals who guarantee efficient planning and smooth conduct of all sorts of clinical trials.
The goal of this program is to impart information and skills necessary to successfully start or
enhance a new career as clinical research professional. The program provides profound
background on the development of new therapies with a focus on drug development, covers
major ethical aspects of conducting research in humans, teaches the regulatory and legal
requirements of performing clinical studies and finally broadens on planning and performance
competences of conducting clinical trials.
This continuing education program has been designed to meet the needs of young clinical
research professionals from industry and academia (study nurses, study coordinators, study
physicians, clinical trial/research associates, clinical monitors), as well as for new members of
ethics committees. Furthermore it provides an opportunity for graduates from life sciences
and medical schools to gain a comprehensive understanding of the phases of clinical research and the practical aspects of clinical trial planning and conduct.
The DAS in Clinical Trial Practice and Management is operated by the CTU Basel, in partnership with the Swiss Tropical and Public Health Institute (SwissTPH) and the European
Center of Pharmaceutical Medicine (ECPM).
2.
Target Audience
People working in any area of clinical research either in academia or in industry (study nurses, study coordinators, clinical research associates, study physicians, assistant physicians,
etc.).
People holding a science degree (minimum Bachelor’s) or medical students with an interest
in pursuing continuing education in clinical research practices.
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Page 3 of 12
3.
Course Structure
This program consists of 4 face-to-face teaching modules (3 days each). Each module comprises lectures, practical exercises, group discussions and self-directed learning. Acquired competencies will be checked by a multiple choice test and completed by homework assignments.
To gain insight into practical aspects of the daily work life in a clinical research profession a oneweek internship (work-shadowing) at a chosen host site has to be completed. Following national
or international institutions in Switzerland or abroad may serve as a work-shadowing host: academic clinical research sites (located mostly at University Hospitals), pharmaceutical or biotech
companies, consulting companies (Clinical Research Organizations, Regulatory Affairs Agencies, etc.) or regulatory agencies. The host may be involved in any field of clinical research like
On-site Management, Data Management, Clinical Project Management, Regulatory Affairs,
Methodological Planning etc. The host’s main field of activity should be different from the student’s main expertise. It will be the student’s responsibility to find a suitable host and to apply
for the internship. Each student has to prepare a detailed report to document the experiences
and learnings during the work-shadowing week.
Students who are interested in a broader training on operational aspects of clinical trials including management and leadership skills may be interested in either following the Diploma
of Advanced Studies (DAS) in Clinical Trial Practice and Management directly or complementing their knowledge through an additional CAS in Clinical Research II (Advanced Clinical
Trial Management) after completion of CAS in Clinical Research I (see figure below).
For a detailed Curriculum and Learning Outcomes please see Attachment I.
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
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DAS in Clinical Trial Practice and Management
CAS in Clinical Research I
CAS in Clinical Research II
Module 1: Basics of Clinical Research
January 20-22, 2014
Module 1: Bioethics
3 days, fall 2014, date tbd
Module 2: GCP, Ethics and Regulations
June 02-04, 2014
Module 3: Clinical Study Planning
July 08-10, 2014
Module 2: Clinical Study Project Management
3 days, 2015
Module 3: Efficiency Strategies for Clinical
Studies
3 days, 2015
Module 4: Clinical Studies in International Settings
3 days, 2015
Module 4: Clinical Study Conduct
and Data Management
September 01-03, 2014
Module 5: Communication Skills and Conflict
Management
2 days, 2015
Work-shadowing II
5 days, planned individually
Work-shadowing I
5 days, planned individually
Diploma Thesis
To be composed individually
Final Examination
Anticipated February 2016
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Page 5 of 12
4.
Course Language
Course materials, language of instruction and module tests are in English. Homework assignments and work-shadowing reports may be submitted in English or German.
5.
Performance Records
Presence
A minimum of 80% presence and active participation in the face-to-face teaching days is required (20.5 days out of 26 days total).
In exceptional cases (documented existing knowledge/experience, documented case of illness) additional days absent may be granted by the directors of studies. Permission for additional days absent has to be obtained in advance whenever possible. The directors of studies
will decide whether the homework assignments related to the missed face-to-face teaching
days will have to be delivered.
Module Tests
After each module a multiple-choice-test comprising approximately 30-50 questions has to be
passed. A minimum of 60% correct answers is needed for passing the test. Students who fail
the test may resit the test once.
Homework Assignments
A minimum of 80% of homework assignments has to be prepared in sufficient quality and
submitted to the directors of studies within the given timeline. If a homework assignment is
considered insufficient in quality (e.g. content, structure, clarity), the student will be asked to
improve his/her work within a given timeframe. If the re-submitted homework assignment is
still not meeting the minimum requirements it will not be regarded as sufficient.
Work-shadowing Reports
A report describing the main business of the work-shadowing host, the main motivation of
visiting this host and a detailed description of all relevant experiences, observations and lessons learned during the work-shadowing week has to be submitted within one month after the
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Page 6 of 12
work-shadowing week. A report between 2 and 5 pages is considered appropriate. A report
template outlining the preferred structure of such a report will be provided on demand.
The directors of studies according to prior agreement with the responsible person at the host
site will decide upon the sufficiency in quality of the report. If a report is considered insufficient in quality (e.g. content, structure, clarity) the student will be asked to improve the report
within a given timeframe. If the re-submitted report is still not meeting the minimum requirements it will not be regarded as of sufficient quality.
6.
Institutions
The program is operated by the CTU Basel, in partnership with the Department of Medicines
Research from the SwissTPH.
7.
Teaching Faculty
The multidisciplinary teaching faculty consists of national and international experts in clinical
research ethics, regulatory sciences and the different fields of operational clinical research.
The following list provides an overview of currently established lecturers and may be subject
to changes:
Michael Hamann, PhD; AMGEN International Scientific Affairs, Germany
Maura Power, MSc, Covidien, Ireland
Peter Brauchli, PhD; Swiss Group for Clinical Cancer Research (SAKK), Berne
Patricia Blank, PhD; ECPM, University of Basel & ISPMZ, University of Zurich
Christian Burri, MPharm, PhD; SwissTPH, Basel
Stefanie Deuster, DPharm; Hospital Pharmacy, University Hospital Basel
Thomas Fabbro, PhD; CTU Basel
Julian Gray, MD PhD MBA FFPM; Gray’s Academy, UK
Manuel Haschke, MD, PD; University Hospital Basel
Jennifer A. Kealy, BSc MPH; Cascade Clinical Consulting, France
Ingrid Klingmann, MD, PhD, FFPM, FBCPM; Pharmaplex BVBA, Belguim
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Page 7 of 12
Annette Magnin, MPharm.; SCTO, Basel
Christiane Pauli-Magnus, MD, Prof.; Director CTU Basel
Gabriele Pohlig, PhD, SwissTPH, Basel
Patrick Simon, MSc; CTU Basel
Pierre Vankan, PhD; Vankan Consulting, Riehen, Switzerland
8.
Program logistics
The CTU Basel holds all responsibilities related to organization, administration and student
support.
Directors of Studies
Christiane Pauli-Magnus, MD, Prof., Director, CTU Basel
Barbara C. Peters, PhD, Head of Teaching and Training, CTU Basel
Melanie Wicki, PhD, Teaching and Training, CTU Basel
Contact
Melanie Wicki, PhD, Teaching and Training, CTU Basel
Schanzenstrasse 55, CH-4031 Basel, Tel.: +41-61-556 5976, Email: [email protected]
Location
The face-to-face teaching modules will be accommodated mostly within the University Hospital Basel or otherwise in alternative venues in the Basel area. Work-shadowings will be organized individually by the students and are independent of the geographic location.
9.
Scientific Advisory Board
Current members
Jasper Dingemanse, MD; Vice President, Actelion Pharmaceuticals Ltd., Basel
Theodor W. Guentert, MD Prof.; Senior Advisor, Hoffmann La-Roche Ltd., Basel
Annette Magnin, MPharm, Managing Director, SCTO, Basel
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Page 8 of 12
Detlev Niese, MD; Head Global Development External Affaires; Novartis Pharma AG, Basel
Andre Perruchoud, MD Prof. President Ethikkommission beider Basel
Alan Tyndall, MD Prof., Head Department of Rheumatology, Felix Platter Spital, Basel
Jan-Willem van der Velden, MD; CEO, Mesama Consulting, Schnitznach Bad
10. Quality Assurance
Following quality assurance measures are in place:
Systematic evaluation of each module
o
Standardized feedback form at the end of each module
o
Anonymously filled out by each student
o
Collection of feedback on content, quality of instructors, time management etc.
Individual feedback and discussion with instructors according to content of systematic
module evaluation
Debriefing and feedback round on homework assignments at the beginning of the following module
Yearly meetings with Scientific Advisory Board
11. Finances
Course fees
CHF 4,000.- for employees from the University Hospital Basel and the University Basel
CHF 5,000.- for regular participants
Fees include course documentation and provision during coffee/tea breaks.
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Page 9 of 12
Attachment I– Curriculum and Learning Outcomes
Certificate of Advanced Studies (CAS) in Clinical Research IClinical Trial Planning and Conduct
A postgraduate educational program at the
Developed by the Clinical Trial Unit at the University Hospital Basel (CTU Basel)
Operated by the CTU Basel, in partnership with the Swiss Tropical and Public Health Institute (SwissTPH)
CAS in
Topics
Learning Objectives
Duration
Clinical Research I
2014
Module 1
Basics of Clinical Research
The drug development process
Drug discovery
Manufacturing issues
Pre-clinical studies
Phases of clinical development
Study types and designs
Specificities of Investigator-initiated
trials
Studies with medical devices
Biologics and Advanced Therapies
Basics of health economics
Basic statistic concepts
Outline and critically appraise the different phases
and landmarks in drug development from target identification to market license.
Explain the general purpose and concept of each
phase in clinical development.
Describe the specificities of investigator-initiated
trials, of studies with medical devices and the development of advanced therapies.
Explain the basic principles of health economics
Critically appraise different types of study designs
and assess their pros and cons.
Describe the process of (random) sampling and
sample size estimation and apply basic principles of
the probability theory and hypothesis testing.
Explain the differences between non-inferiority, superiority and equivalence testing.
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
3 days
Contact
Work-
ECTS
hours
load
credit
(h)
(h)
points
27
50
2
+ home
assignments
Page 10 of 12
Module 2
GCP, Ethics and Regulations
Module 3
Clinical Study Planning
The evolution of regulatory guidelines
ICH guideline E6 on Good Clinical
Practice
Swiss legal framework
Ethics committees (EC) – principles
and roles
Submission dossiers
Reporting requirements to EC and
regulatory bodies
The informed consent process
Special patient populations
Data protection issues
Registration of clinical studies
Patient safety management
Elements of a Quality Management
System (QMS) in clinical research
Standard Operating Procedures
(SOPs): Purpose, structure & content, training
Study protocol: purpose and content
Feasibility assessments
Time and resource management
Advertisements and patient recruitment
Patient data anonymization and data
blinding
Investigator site file and Trial master
file
Outline the structure and contents of the ICH-GCP E6
guideline and explain its influence on the national legislation.
Critically appraise the guiding principles of ICH-GCP
E6 and the roles and responsibilities of different parties involved in the planning and conduct of clinical
studies.
Assess and compare the obligations and timelines in
the clinical trial application process.
Demonstrate competence in the compilation of submission dossiers and relate essential documents according to the definitions of ICH-GCP E6.
Appraise and compare the principles of the informed
consent process in regular and special populations.
Critically review and interpret the ethical issues involved in data protection.
Understand the responsibilities for patient safety and
manage and report Adverse Events.
Outline the essential elements of a quality management system in clinical research and explain the concepts of quality assurance and quality control.
Assess and compare Standard Operating Procedures
(SOPs), standard forms and work instructions.
Explain the purpose and structure of a study protocol
and critically evaluate its contents for feasibility.
Apply time and resource management to the overall
planning and preparation of a clinical study.
Demonstrate competency in planning necessary
study infrastructure and resources.
Efficiently set-up collaboration standards and communication tools with all necessary partners.
Review and prepare different measures for efficient
patient recruitment and management.
Prepare necessary trial documentation and filing
systems.
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
3 days
27
50
2
27
50
2
+ home
assignments
3 days
+ home
assignments
Page 11 of 12
Basics of data management
Medical coding
Source data
Case report forms
Queries and data validation
Databases
Purpose and process of monitoring
Types of study reports
Data safety monitoring board (DSMB)
Audits and inspections
Archiving of study data and documents
Module 4
Clinical Study Conduct and
Data Management
Work-shadowing I
Outline and critically appraise all aspects of data
management.
Explain technical terms like source documents, essential documents and case report forms.
Demonstrate competency in query management.
Outline the purpose of monitoring and critically interpret the contents of a monitoring plan.
Interpret monitoring reports
Review all documentation and reporting obligations
according to Good Clinical Practice during and after
running a clinical study.
Arrange for proper archiving of study documents.
Prepare for an audit or inspection and demonstrate
competency in handling audit/inspection findings.
3 days
27
50
2
42
50
2
150
250
10
+ home
assignments
One-week internship, organized individu-
5 days
ally
+ report
Total CAS in Clinical
17 days
Research I
+ home
assignments
ECTS …European Credit and Accumulation Transfer System
Clinical Trial Unit, Schanzenstrasse 55, CH-4031 Basel, Tel +41 61 328 77 17, www.clinicaltrialunit.ch
Page 12 of 12

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