The Association of Clinical Research Professionals

Advanced GCP: Assessing Compliance Risk

Contact Hours: This course is approved for 7.0 ACRP contact hours. Accreditation Details

NOTE: This course is not available for individual registration.   

Upcoming Courses

This course is available for organizations only. If you are interested in this course for your organization, Contact Us >>

GCP compliance is all about avoiding or resolving issues related to risks that could potentially jeopardize patient safety, quality of data, and regulatory compliance. This highly interactive one-day classroom course allows you to put risk assessment into practice through collaborative instructor-led group exercises such as scenarios and quizzes.

This course is free from lecture; instead you will assess for yourself in a group setting whether the presented scenarios are a GCP compliance risk, while assigning a level of risk (low, medium, or high) for each to the sponsor, site, and IRB/IEC. Once the risk and its severity has been identified, you will learn to define the actions required to resolve the problem as presented in the scenario and to prevent it in the future, as well as how to prioritize each. In order to reduce the risk of non-compliance and to increase the likelihood of GCP compliance, a clinical researcher needs to exhibit, both individually and in a team, certain qualifications and characteristics which will become clear to you during your course interactions.

This course will leave you much better equipped to tackle GCP-related issues and risks immediately and independently in the field.

Learning Objectives

  • Assess overall compliance risk to sponsors, sites, and IRB/IECs, plus specifically to data integrity.
  • Re-assess compliance risk and the necessary corrective action as new information is gathered.
  • List success factors of all parties to support compliance in specific categories, such as adhering to the protocol, IP accountability, and evidence of oversight.
  • List the qualities of compliant individuals.

Audience

Site and sponsor staff looking for advanced-level GCP training.

Bring this Program to Your Team — Minimize out-of-office time and travel expenses while providing your team with programs that will improve job performance and build competency. This in-person classroom course is ready to deliver at your facility.
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We’re ready to help you achieve your organization’s staff development goals.