Monitoring Clinical Drug Studies: Advanced

EARLY REGISTRATION
Course #: SSAA0918
September 25-26, 2018 | Philadelphia, PA
8:30 AM - 5:00 PM Eastern
Convene Cira Centre
Take advantage of our $1675.00 price by registering early!
* After Friday, August 24, 2018, costs are $1875.00.
*
$1,675.00

Take advantage of our $1675.00 price by registering early!
* After Friday, August 24, 2018, costs are $1875.00.

Course Description

This course will focus on more complex and challenging issues affecting the Clinical Research Associate with management/leadership responsibilities. Current hot topics and trends will be discussed. Participants will analyze case studies to identify how monitors/study leaders could have identified, managed, and followed up on under performance or non-compliance issues. Corrective and preventive action plans (CAPA) will be developed as part of the course activities. Training and mentoring techniques will be included to assist training/mentoring sponsor/CRO and site staff.

Learning Objectives

  • Explain the most recent regulations and guidance documents that govern clinical research
  • Discuss current issues that affect clinical monitoring
  • Describe effective mentoring techniques
  • Discuss ways of assessing monitor skills
  • Develop techniques to manage stakeholders
  • Define techniques to promote successful site management
  • Identify, manage, and report study-related issues
  • Describe how to manage situations involving fraudulent data
  • Discuss FDA’s BIMO program for sponsor and investigator inspections

Who Should Attend

  • CRAs with management responsibilities that include mentoring and assessing monitoring skills and complex issues involving site management, study management, sponsor/ CRO challenges

Instructor

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

Gary B. Freeman, M.S.

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

Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • Regulatory Update: The latest FDA Guidances will be reviewed
  • Monitoring Visits Update: Risk-Based Monitoring Approach
  • Monitoring Plans: Writing, evaluating, implementing, and assessing effectiveness
  • Mentoring, Communication, and Negotiating Skills: Tips for making the most of “mentoring” opportunities
  • Co-Monitoring/Assessing Monitoring Skills: Techniques for assessing monitors in the Sponsor/CRO environment

Day Two: 8:30 a.m. – 5:00 p.m. 

  • Managing Stakeholders: Developing and communicating realistic expectations; reaching stakeholder agreement
  • Site Management (Performance) Regular Copy
  • Identifying, Reporting and Managing Study-Specific Issues/Corrective and Preventive Action Plans Regular Copy
  • Managing Situations Involving Fraudulent Data Regular Copy
  • Regulatory Compliance: Discussion of sponsor and investigational site inspections by FDA; current information regarding FDA and regulatory authority inspections/audits; practical tips for preparing your site for an audit

Interactive Activities

  • Reviewing Reports and Study Documentation
  • Case Studies/Scenarios: Assessing Monitoring Skills, Site Issues, Stakeholder Relations
  • Detecting Fraudulent Data

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.  

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 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#: 0778-0000-18-007-L01-P. Released: 1/18.

 

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