* Sponsor company clinical trial team members of industry-sponsored drug trials

** Clinical research associates (CRA) monitors

** Data managers

* Study site team members

** New Investigators/Sub-Investigators (physicians)

** Clinical research coordinators (CRCs)

** Regulatory administrators

* Clinical research organizations (CROs) team members

* Hospital Staff and Medical University employees

** Transitioning employees

** Operation staff of clinical research units

* Institutional Review Board/Ethics Committee Members * Preparation for the SoCRA and ACRP Certification Examinations

* Discuss the ethical situations unique to clinical trials

* Describe effective investigator selection and patient recruitment strategies

* Describe data considerations for clinical trials

* Explain protocol and statistical considerations for trial design

* Outline the responsibilities of the sponsor, investigator, and IRB for clinical drug trial conduct according to GCPs

* Compare and contrast the project management flow using paper versus an e-Clinical Trial (EDC) process

* Explain the team responsibilities for human safety protection during the conduct of clinical trial research

* Complete a clinical trial site standard operating procedure template

* Demonstrate an understanding of the informed consent process historical timeline, current regulations, and guidelines

* Recognize the phases of clinical research and the drug application & approval process under the FDA regulations and guidelines

(1) The introductory session is an energizing, highly-interactive, and fast-paced in preparation for the group to complete the post-course CCRP self-study course and to interact successfully during the one-month on-line ethics course. This comprehensive course structure will provide participants with an intense review of the process of drug development regulations and guidelines, good clinical practices (GCPs), human safety protection, project management, clinical trial design and implementation, study conduct, data management, and ethics training related to human safety protection. The critical roles of the sponsor, principal investigator and study site staff, institutional review board (IRB)/Ethics Committee and FDA (and other regulatory agencies) will be covered.

(2) The CCRP Foundations of Clinical Research one-month self-study program (workbook, manuals, and exam to be completed following the cruise) includes:

* TEXTBOOK - Covers key issues and regulations affecting the day-to-day conduct of clinical research, a glossary of terms, bibliography, and section tests (see below for a complete table of contents).

* WORKBOOK - Includes 10 exercises using a sample Protocol, Investigator Brochure and Case Study. Apply the fundamentals learned in the Textbook to practical application in the daily conduct of a clinical trial.

* WORKBOOK ANSWER KEY - Provides a discussion of responses addressed in each exercise of the Workbook.

MEDICAL RECORD AND SOURCE DOCUMENTATION - Includes samples of medical history and physical exam, lab and radiographic test results, progress notes etc. Using the data contained in the source documents, the learner completes an abbreviated case report form.

* SAMPLE PROTOCOL AND SAMPLE INVESTIGATOR'S BROCHURE

(3) The on-line ethics course, The Least of My Brothers, is offered in the springtime following the cruise and after completing the CCRP materials so that participants can apply their knowledge. During the on-line course they will read in greater depth, discuss more intelligently, and evaluate ethical conduct and responsible professional decision-making strategies during clinical trial research.

Notes:

An intensive ethics training workshop on human safety protection during clinical trial conduct.