New Supervisory Responsibilities of Investigators: Proactive Solutions for Sponsors and CROs

Held Oct. 14, 2008

Clinical trial investigators, CROs and sponsors could have a lot of changes to look forward to.

Two new sets of rules are in the works. The OHRP has issued a request for public comments as to whether it should issue further guidance on requiring additional training for personnel involved in clinical research and human subject protections.

The second is the FDA’s draft guidance “Protecting the Rights, Safety and Welfare of Study Subjects — Supervisory Responsibilities of Investigators” that was created to help clinical trial investigators meet their responsibilities to protect human subjects.

And although, in the FDA’s draft guidance, it may sound as though the burden to comply is on investigators, it’s not.

Re-evaluating current policies in relation to the draft guidance … improving site monitoring … working more closely with trainers on SOPs are just a few of the areas in which the FDA’s draft guidance will affect sponsors and CROs. And this means big changes for how operations are run.

Whether you’re an investigator, sponsor or CRO, you need a thorough understanding of what this guidance is all about. How will these new training requirements affect your clinical trials?
Clinical research expert Liz Wool will outline the impact this guidance will have on business standards, practices, processes and standing operating procedures (SOPs). Discover the best methods to use to inform, educate and train staff to meet the guidance standards and what proactive steps sponsors and CROs can take.

Order now to listen in and discover:

  • Four key elements of the draft guidance 
    • Are study-related tasks appropriately delegated
    • Does clinical study staff receive sufficient training
    • Is there adequate supervision and involvement in ongoing studies
    • Is there enough supervision and oversight of third-party involvement in studies
  • Definitions of the standards of the investigators, sponsors, CROs, SOPs, business practices and procedures impacted by the draft guidance
  • A discussion of why a gap analysis is required for certain study conduct and site monitoring practices to be in compliance with the draft guidance
  • Methods to use to inform, educate and train staff for the draft guidance
This audio CD/Transcript is a must fo:
  • CROs
  • Sponsors
  • Investigators
  • Study managers

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Liz Wool, RN, BSN, CCRA, CMT, has been active for 18 years in clinical research positions in sponsor companies, investigational sites, CROs and academia. She is president of the ACRP Northern California Chapter, an ACRP faculty member, teaches the CRA Certification Exam Review Course and president and CEO of QD-Quality and Training Solutions, Inc., which offers SOPs, standards and training services to investigational site staff, sponsors and CROs.

Liz is a faculty member in the clinical research programs at University of California Berkeley, University of California Santa Cruz and San Francisco State University. She is a program advisory board member for UC-Berkeley’s program, and a member of the Society of Quality Assurance’s GCP speaker’s bureau. She is a published author in the ACRP Monitor, June 2008 and “Good Training Practice 101: A Primer for Employee Training Plans.”

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