CAS Clinical Research II (Advanced Clinical Trial Management)
Certificate of Advanced Studies

The goal of this program is to impart information and skills necessary for the variety of management and leadership positions in different clinical research settings such as academia, pharmaceutical, medical device or biotech industry, as well as clinical research organisations and regulatory agencies. The program extensively covers the ethical challenges of performing research involving human participants, it teaches project management skills and covers efficiency strategies and the latest technology options, all specifically applied to clinical trial planning and conduct. Further topics are regulatory and legal requirements in international research settings and enhanced communication and conflict management skills.

This continuing education program has been designed to meet the needs of experienced clinical research professionals from industry and academia (study/trial coordinators, study /trial managers, study physicians, clinical trial/research associates, clinical monitors, study nurses, etc.), as well as experienced members of ethics committees or regulatory agencies. It provides an opportunity for advancing experience, knowledge and skills and for professional networking in the environment of clinical trial practice and management.

Students interested in a higher level of postgraduate education in this field may consider completion of the program Diploma of Advanced Studies DAS Clinical Trial Practice and Management. The DAS program requires successful completion of the CAS Clinical Research I or an equivalent training program from other universities, successful completion of the CAS Clinical Research II, composition of a diploma thesis and passing of an oral final exam.

This program consists of 4 teaching modules. Teaching modules comprise online courses for self-study and individual completion and classroom training sessions (2-3 days with practical exercises and group discussions). Acquired competencies will be checked by a multiple choice test and completed by homework assignments.

To gain insights into the daily work life in a clinical research profession, a one-week internships (work-shadowings) at a host site within the field of clinical research have to be completed. The host’s main field of activity should be different from the student’s main expertise. It is the responsibility of the student to find a suitable host for the internship.

Completion of the CAS Clinical Research I, CAS Study Nurse/Coordinator or equivalent qualification

People with minimum 5 years of experience in clinical research working either in academia or in industry (study nurses, study coordinators, clinical research associates, study physicians, assistant physicians, etc.) may apply to be directly admitted to the CAS Clinical Research II program. A certificate in CAS Clinical Research I, CAS Study Nurse/Coordinator or equivalent qualification/experience is recommended.

Continuing in the DAS Clinical Trial Practice and Management program requires documented completion of training equivalent to the CAS Clinical Research I and CAS Clinical Research II programs.

Very good command of oral and written English is a pre-requisite for admission to the program.

  • PhD Marie Mi Bonde Hansen, PhD
  • Dr Daniel Hammes, PhD

This program is conducted in partnership with the European Center of Pharmaceutical Medicine (ECPM). The multidisciplinary teaching faculty consists of national and international experts in clinical research ethics, regulatory sciences and the different fields of operational clinical research.

Marie Mi Bonde Hansen, PhD
University of Basel, Department of Clinical Research, Clinical Trial Unit
c/o University Hospital Basel
Schanzenstrasse 55
CH-4031 Basel
Tel. +41 61 328 51 47
MarieMiBonde.Hansen@usb.ch

CHF 6’000

Fees include course materials, provisions during coffee/tea breaks and overhead fees. The course fee will be collected in two equal tranches approximately 6 months apart.

The Department of Clinical Research (DKF) offers training grants of CHF 1’000 for members of the DKF clinical research groups. A list of DKF clinical research groups can be found here. Applications for training grants can be submitted when registering for the program.

Cancellation and withdrawal
Cancellations made prior to the closing date for enrolment will not be subject to any charge. If a cancellation is made after the closing date for enrolment, the full applicable fee will be charged. Course fees already paid will not be refunded. Should participants withdraw from the program or discontinue participation no discount from the course fee will be granted and any share of the course fee will not be refunded.

Medical Faculty of the University of Basel

Course language
Course materials, language of instruction and module tests are in English. Homework and reports may be submitted in English or German.

Course certificates will be issued after successful completion of the module tests, submission of all homework assignments and submission of the work-shadowing report.
Credit points: 11 ECTS

Next round of the course will begin in November 2020. Classroom training dates will be communicated in due time.
Online training material will be available approximately one month prior the respective classroom training.

Location

University Hospital Basel Schanzenstrasse 55, 4031 Basel

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