Departement Klinische Forschung Clinical Trial Unit Study Handbook Diploma of Advanced Studies (DAS) in Clinical Trial Practice and Management 2014-2016 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) and the European Center of Pharmaceutical Medicine (ECPM)
Index 1. General Description... 3 2. Target Audience... 4 3. Course Structure... 4 4. Course Language... 6 5. Performance Records... 6 6. Institutions... 8 7. Teaching Faculty... 9 8. Program logistics... 10 9. Scientific Advisory Board... 10 10. Quality Assurance... 11 11. Finances... 11 Attachment I Curriculum and Learning Outcomes... 12 Page 2 of 17
1. General Description The goal of the program Diploma of Advanced Studies (DAS) in Clinical Trial Practice and Management is to prepare trainees for the variety of management and leadership roles of different clinical research settings such as academia, pharmaceutical, medical device or biotech industry, clinical research organizations and regulatory agencies. Successful clinical research requires clinical experience, but also extensive knowledge about all phases of the clinical research process, awareness of regulatory requirements as well as project management and leadership skills. The complex and highly competitive nature of clinical research demonstrates a growing need for well-trained clinical research professionals, especially those working as study coordinators, study managers, clinical monitors or clinical research assistants. Clinical research professionals usually start their careers with background knowledge from diverse graduate trainings but mostly lack structured training in clinical research. Still, they are facing highly demanding responsibilities in a complex, ever-evolving, interdisciplinary and often multinational environment. Fortunately, training at the postgraduate level is more and more being recognized as being essential to developing scientific, technical and interpersonal competences to ultimately enhance the quality in clinical research performance in general. Therefore, the Clinical Trial Unit at the University Hospital Basel (CTU Basel) has developed this study program successfully in 2009 and is now implementing structural changes to specifically meet the needs of interested students. The new structure comprises two constitutive Certificate of Advanced Studies (CAS) programs (CAS in Clinical Research I and CAS in Clinical Research II) followed by a diploma thesis and a final examination (for details see below). 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). Page 3 of 17
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.) with a minimum of 2 years of work experience. People holding a science or medical degree (minimum Bachelor s) with an interest in pursuing continuing education in clinical research practices. 3. Course Structure Overall this program is scheduled for two years. It consists of two Certificate of Advanced Studies (CAS) programs (CAS in Clinical Research I and CAS in Clinical Research II) comprising a total of 9 face-to-face teaching modules (all 3-days in length except for the last one which is 2- days). Each module comprises lectures, practical exercises, group discussions and self-directed learning with homework assignments. Students have to pass a multiple choice test at the end of each module. To gain insight into practical aspects of the daily work life in a clinical research profession two one-week internships (work-shadowing) at a chosen host site have 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. After successful completion of the 9 modules and the 2 work-shadowings, students will be required to prepare a diploma thesis related to their personal work environment or special interest within the scope of clinical research. A final oral examination will be conducted by members Page 4 of 17
from the teaching faculty for each individual student (for more Information see section 6. Performance Records). For a detailed Curriculum and Learning Outcomes please see Attachment I. 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 4: Clinical Study Conduct and Data Management September 01-03, 2014 Work-shadowing I 5 days, planned individually 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 5: Communication Skills and Conflict Management 2 days, 2015 Work-shadowing II 5 days, planned individually Diploma Thesis To be composed individually Final Examination Anticipated February 2016 Page 5 of 17
4. Course Language Course materials, language of instruction and module tests are in English. Homework assignments, reports and diploma thesis may be submitted in English or German. The final examination may be taken in German or English. 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 Page 6 of 17
lessons learned during the work-shadowing week has to be submitted within one month after the 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. Diploma Thesis The diploma thesis has to be formulated individually and preferably with a defined mentorship. Generally, the diploma thesis has to comply with the principles of scientific writing like: Clearly defined rational Detailed description of methods Clearly defined conclusions/recommendations Clear structure and form Declaration of references As a first step of theses preparation, a thesis proposal (short summary of planned topic(s), rational and methods, appropriate length 2 pages) has to be approved by the directors of studies. Topics related to the personal work environment and development of materials/structures that might contribute to an improvement of work processes will be preferred. Templates outlining the preferred structure of a thesis proposal will be provided on demand. The directors of studies will give general advice to students regarding ideas for topics, the methods and structuring of the thesis at any time but will not take over the full task of mentorship. It is therefore highly recommended to seek mentorship from a person related to the student s personal work environment or a person with expert knowledge in the chosen topic. Templates outlining the preferred structure of a diploma thesis will be provided on demand. Theses will be reviewed for sufficiency in quality (e.g. content, methods, structure, clarity in language) by the directors of studies and the respective expert reviewers/examiners. If the Page 7 of 17
quality of the thesis is concurrently considered insufficient, the student will be asked to improve his/her work according to the detailed feedback within a given timeline. If the resubmitted thesis is still not meeting the minimum requirements it will not be regarded as of sufficient quality. Timelines for submission of thesis proposal and final thesis will be communicated duly and have to be met by all students without exception. Final Examination Following elements of qualification are required for admission to the final examination: Minimum of 80% presence in face-to-face teaching modules Minimum of 80% homework assignments delivered in sufficient quality and within the given timeline Minimum of 60% correct answers in module tests 2 work-shadowing reports of sufficient quality Preparation of a diploma theses of sufficient quality Final examinations will be hold orally by an examination committee consisting of a minimum of two lecturers from the teaching faculty. The examiners will have read and reviewed the diploma thesis of the respective student. All examinations will be scheduled for 30 minutes. The first part of the examination will be dedicated to questions regarding the respective diploma thesis. The second part will comprise general questions from topics covered during the face-to-face teaching modules. The achievement of a student during the final oral examination will be evaluated as sufficient or insufficient. If a student fails the examination he/she may apply for taking the examination a second time after an appropriate period for preparation. Unexcused absence at a scheduled examination will result in failing of the examination. 6. Institutions The program is operated by the CTU Basel, in partnership with the Department of Medicines Research from the SwissTPH and the ECPM. The SwissTPH covers approximately 45% of Page 8 of 17
the teaching responsibility in CAS in Clinical Research I, approximately 15% of the teaching responsibility in CAS in Clinical Research II. The ECPM is responsible for development and operation of the module Bioethics. 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 Faiz Kermani, PhD; SLF Scientific Communications, Basel Ingrid Klingmann, MD, PhD, FFPM, FBCPM; Pharmaplex BVBA, Belguim Nina Labhart, MPharm; PFC Pharma Focus, Switzerland Kai Langel; eclinicalhealth, UK Annette Magnin, MPharm.; SCTO, Basel Christiane Pauli-Magnus, MD, Prof.; Director CTU Basel Peter Philipp, PhD; Beyer AG and GCP Consulting, Basel Gabriele Pohlig, PhD, SwissTPH, Basel Alexandra Rätz Bravo, DPharm; Pharmacovigilance Center, University Hospital Basel Page 9 of 17
Holger Maria Rohde, MD; Teva Pharma GmbH, Germany Patrick Simon, MSc; CTU Basel Sandra van de Cauter; Roche 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: melanie.wicki@usb.ch 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 Page 10 of 17
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 8,500.- for employees from the University Hospital Basel and the University Basel CHF 11,500.- for regular participants Fees include course documentation and provision during coffee/tea breaks. The course fees will be collected in 3 tranches. Page 11 of 17
Attachment I Curriculum and Learning Outcomes Diploma of Advanced Studies (DAS) in Clinical Trial Practice and Management 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) and the European Center of Pharmaceutical Medicine (ECPM) DAS in Clinical Trial Practice and Management Topics Learning outcomes Duration Contact hours (h) Workload (h) ECTS credit points CAS in Clinical Research I -Clinical Trial Planning and Conduct See below See below 17 days assignments 150 250 10 CAS in Clinical Research II -Advanced Clinical Trial Management See below See below 19 days assignments 168 275 11 Diploma thesis To be determined individually Individually 175 7 Final examination All topics covered in modules 1-9 (see below) Approx. 30 min 50 2 Total 318 750 30 Page 12 of 17
CAS in Clinical Research I 2014 Module 1 Basics of Clinical Research Module 2 GCP, Ethics and Regulations Topics Learning Objectives Duration Contact 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 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 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. 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. 3 days assignments 3 days assignments hours (h) Work- load (h) ECTS credit points 27 50 2 27 50 2 Page 13 of 17
Module 3 Clinical Study Planning Module 4 Clinical Study Conduct and Data Management Work-shadowing I Total CAS in Clinical Research I 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 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 One-week internship, organized individually 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. 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 assignments 3 days assignments 5 days + report 17 days assignments 27 50 2 27 50 2 42 50 2 150 250 10 Page 14 of 17
CAS in Clinical Research II 2014/2015 Module 1 Bioethics Module 2 Clinical Study Project Management Topics Learning Outcomes Duration Contact The evolution of biomedical research ethics Inducement in clinical research Risk-benefit of research interventions Advertisement for patient s participation in trials Scientific integrity Performing clinical research in developing countries Vulnerable patients Confidentiality and personal data protection Ethical issues of accelerated drug development Insurance protection in multinational studies Sequencing and Scheduling Time management Resource management Budgeting Risk management Managing collaborations Stakeholder analysis Outline and critically appraise the evolution of biomedical research ethics and its basic principles. Explain the role of ethics committees and regulatory authorities in patient protection and reviewing safety information. Assess the issues related to confidentiality, personal data protection and intellectual property issues. Critically discuss special issues related to research involving vulnerable populations. Review and interpret ethical considerations of performing clinical research in low-income countries. Apply basic principles of project management to the overall and detailed planning and preparation of a clinical study. Demonstrate competency in planning necessary study infrastructures and resources. Assess and select adequate study sites. Successfully conduct stakeholder analyses. Successfully conduct risk analyses and implement risk control strategies. Develop and implement communication standards and effectively manage collaborations within your study team. 3 days assignments 3 days assignments hours (h) Work- load (h) ECTS credit points 27 50 2 27 50 2 Page 15 of 17
Module 3 Efficiency Strategies for Clinical Studies Module 4 Clinical Studies in International Settings Module 5 Communication Skills and Conflict Management Quality risk management Streamlining feasibility Risk-adapted monitoring Electronic Quality Management Systems Electronic Communication Tools Electronic communication with patients New electronic technologies for data management The role of patient organization Publication strategies of study results International regulatory bodies (EAM, FDA, European ethics committee systems) European legal framework (CTD) European clinical trial authorization (CTA) process and documentation Eudra CT application International registries Paediatric regulations Challenges of multinational studies Research in low income countries The process of marketing authorization Communication challenges Communication techniques Working in a team Types of conflicts Conflict handling Public speaking Presentation of study results Impromptu speaking Perform risk analyses of the quality management system in place and implement improvements. Perform all necessary feasibility assessments and implement resulting actions. Critically review and compare methods of riskadapted monitoring. Appraise and compare different technology options developed for clinical research applications. Embrace study patients as active partners in a clinical trial and adopt efficient standards of patient management (recruitment and compliance control). Explain the responsibilities related to sharing study results with the medical community and review the principles and tools of scientific publishing. Review all elements of the European legal framework for performing clinical research. Outline roles, responsibilities and processes related to relevant international regulatory bodies. Review and compare the different Ethics Committee Systems in Europe. Appraise the function of international study registries. Demonstrate competency in the process of European Clinical Trial Authorization including Eudra CT application. Explain and discuss issues and challenges of running multinational trials. Review specificities of performing clinical studies in the paediatric population. Explain the process of international market authorization. Outline challenges of working in a team with special focus on communication. Assess your personal values of collaboration with others and review tools to communicate these values efficiently. Review types of potential interpersonal conflicts within your work environment and discuss strategies to handle these conflicts. Explain principles and strategies for successful public speaking. Demonstrate competency in clear an structured presentation of work related contents to different audiences. 3 days assignments 27 50 2 3 days 27 50 2 assignment 2 days 18 25 1 Page 16 of 17
Work-shadowing II One-week internship, organized individually Total CAS in Clinical Research II ECTS European Credit and Accumulation Transfer System 5 days + report 42 50 2 19 days assignments 168 275 11 Page 17 of 17