Monitoring Clinical Trials for GCP Compliance
Training Overview
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Comply with the FDA's expectations for monitoring of clinical trials
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Understand similarities and differences among various clinical trial designs
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Clarify the roles and responsibilities of all stakeholders involved in clinical trials
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Write and update SOPs and ensure they are followed properly by SOP users
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Meet HIPAA privacy requirements and additional human subject protection requirements
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Form and maintain successful working relationships with investigators and IRBs
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Implement effective data and safety monitoring measures
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Manage a study site and conduct monitoring visits
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Avoid common contract and budget pitfalls
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Recruit and retain study subjects and improve patient compliance
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-03-014-L04. Initial release: 03/2003.
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.