Becoming a Clinical Research Investigator: Expectations and Responsibilities

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Course Description

Industry trends indicate that the majority of physicians who participate in a research study do not return to do another. This costs the industry time, money and frustration in trying to identify new investigators, ensure adequate training, and support compliance at inexperienced sites. Additionally, the cost to the physicians acting as an investigator for the first time are possible loss of income, more time spent than anticipated, frustration, and possible inspection findings that are publicly posted. In this course, the core requirements, regulatory expectations, and practical approaches to becoming an industry research investigator are covered. Included are the expectations for setting up a research site and staff, what questions investigators should ask before taking on a study, and ongoing regulatory requirements for investigator oversight and Good Clinical Practices (GCPs). FDA regulations and applicable guidance documents will be explored as well as ICH GCP E6 for application to international trials.

Learning Objectives

  • Review industry clinical research and regulatory requirements
  • Describe investigator responsibilities in the context of study protocol oversight and GCP compliance
  • Discuss basic requirements for setting up a research site including staffing and essential budget considerations
  • Discuss questions to ask a sponsor before taking on a research study
  • Recognize critical elements of human subject protection
  • Discuss the requirements for investigational product management and maintenance of adequate and accurate records for research trials
  • Recognize key requirements for patient safety management and regulatory reporting
  • Discuss mandatory critical interactions with Institutional Review Boards (IRBs) or Ethics Committees (ECs)
  • Explain the concepts of root cause analysis (RCA) and corrective and preventive action (CAPA) to improve compliance
  • Examine recent trends in non-compliance

Who Should Attend

  • Investigators
  • Study Coordinators
  • Site Managers
  • Project Managers
  • General Managers
  • Project and Department Leads
  • Clinical Research Associates
  • Personnel that want to learn more about the regulatory expectations for a Clinical Research Investigator, site selection, Investigator training, or site set-up


The course will be led by one of the following instructors:

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.

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Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • GCP and Investigator Responsibilities
  • New Developments and Emerging Trends in GCP  
  • Human Subject Protection  
  • Quality Systems and Investigational Product Management  
  • Adequate and Accurate Records and Safety Event Management  
  • Advanced Cases in GCP: Application of GCP, RCA and CAPA
  • Recent Non-Compliance Issues with Discussion  

Interactive Activities

  • Practical Applications of FDA Guidance Documents
  • Identification of Audit Preparation Best Practices
  • Informed Consent Process and Signature Group Discussion
  • Source Document to Case Report Form Issue Identification

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-17-058-L01-P. Released: 3/17.


Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.