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Oversight of Clinical Monitoring: Trends and Strategies

May 13 2014 12:00PM - May 16 2014 2:00PM | Online

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Overview 

This online training will be broadcast in Eastern Time (ET)


DIA is pleased to present a three-part online training series focusing on clinical monitor oversight.  Hear from experienced faculty on the trends impacting monitors, requirements, approaches, selection, and how to manage a site monitor’s performance. This intermediate course also focuses on the elements of risk-based monitoring.

Course Level: Intermediate

Featured Topics 

  • Trends in the clinical development landscape driving change
  • ICH and FDA requirements for site monitoring
  • Current approaches to risk-based monitoring
  • Warning signs and problems with site monitors
  • Managing site monitors and their performance
  • Common errors made in site monitoring
  • Metrics used to measure site monitor performance

Who Should Attend 

  • Professionals who work with or manage site monitors
  • Sponsors from small-to-mid-size pharmaceutical, biotechnology, and device companies who have clinical operations responsibilities including interaction with sourcing site monitors

Learning Objectives 

At the conclusion of this activity, participants should be able to:

  • Describe the current factors impacting clinical development necessitating change
  • Recognize the impact on approaches to risk-based monitoring from FDA Guidance and TranCelerate viewpoints
  • Identify audit trends and inspection findings relative to site monitoring
  • Discuss how to develop measurable expectations and objectives for site monitors
  • Identify best practices in managing site monitors

Special Offers 

Register More than One Group Site and Save 15%!

Contact Information 

Registration Questions and
Technical Support Day of Event

Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details and Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Faculty 

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Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102, (703) 506-3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .6 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 4 Core Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Oversight of Clinical Monitoring: Trends and Strat IACET 6.00 0.600

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

Continuing education credits are available to learners who participate in the live online training course. To request credit, complete the on-line credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests two weeks after the last day of the activity.

Continuing education credits are available to learners who participate in the live online training course. Continuing education credits are not available for participation in the archived version of the online training course.

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE

Agenda  

Day 1 Tuesday, May 13, 2014

  • 12:00PM - 2:00PM

    Part 1: Current Trends in Pharmaceutical/Medical Device Development Impacting Monitoring

Day 2 Wednesday, May 14, 2014

  • 12:00PM - 2:00PM

    Part 2: The Details of Site Monitoring

Day 3 Friday, May 16, 2014

  • 12:00PM - 2:00PM

    Part 3: Managing Site Monitor Performance

Registration Fees 

Other Fees

Group Site
$1750.00

Member

Charitable Nonprofit/Academia Member Individual
$350.00
Member Government Individual
$350.00
Member Standard Individual
$695.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$435.00
NonMember Government Individual
$435.00
NonMember Standard Individual
$785.00
Group Discounts

GROUP SITE:
Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.

*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.

This online training offering is sold as one complete series and cannot be purchased in parts.


Cancellation Policy: No refunds will be provided in the event of a participant’s cancellation since all costs for this online training course have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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