“Meeting Competence, Training and Awareness Rules for Medical Devices”

Description: Management systems expert Dan O’Leary explains how to comply with U. S. and International standards for personnel training. He discusses:

  • The four elements of competency and how to include them in job descriptions
  • The concept and qualifications of a “designated individual”
  • Implementing a training program using the ISO 10015:1999 model
  • Competence gap analysis and how to close identified gaps

Date:  Thursday, June 21, 2018

Time: 11:30 AM-1:00 PM

Location: RAHN 2/280

1.5 CRS Elective Credit


“Paying Clinical Trial Subjects”

Description:  Research ethics specialist Luke Gelinas discusses the ethical and regulatory issues involved with paying research subjects and proposes a practical framework that can guide the design and evaluation of payment offers. He covers:

  • Reasons to pay research participants and the role the payment plays in facilitating recruitment
  • Risk of undue influence and the possibility that payment might motivate deception about eligibility
  • Current practices regarding payment of research participants, such as payment rates and frequency of payment amounts, including distinguishing different reasons for offering payment, such as reimbursement, compensation for time, or recruitment incentive

Date :Thursday, June 28, 2018

Time: 11:30 AM-1:00 PM

Location: RAHN G230

1.5 Elective Credit


“Clinical Trial Agreements: Words (and Phrases) Matter”

Description: Attorney Eric Babineaux explains the importance of precise wording in clinical trial agreements.  He discusses:

  • Understanding nuanced and specific contract language
  • Importance of debarment provisions and how to respond to contract qualifiers on debarment certification
  • Interpreting important indemnification provisions and understanding the differences between “indemnify” and “hold harmless”

Date: Wednesday, July 11, 2018

Time: 11:30 AM- 1:00 PM

Location: TBA

1.5 CRS Elective Credit