Foreign Clinical Trials not conducted under an IND (21 CFR 312.120)
Thursday, September 12, 2013 from 10:00 AM to 11:30 AM (PDT)
This webinar will discuss requirements for acceptance of foreign clinical studies, the guidance for foreign investigator qualification, foreign research facility requirements and study monitoring documentation.
Why Should You Attend:
FDA will not accept as support for an IND or application for marketing approval any study that does not meet the conditions of 21 CFR 312.120. Even so, sponsors must submit all studies and other information as required under the applicable regulations for drugs, including those studies that do not comply with the requirements because they will be examined for safety issues.
In this webinar we will review the guidance for investigator qualification, foreign research facility documentation, requirements for FDA review of foreign source documents, and access to original medical records and full CSRs. We will discuss required contents of waiver requests for unavoidable noncompliance situations and when these might be necessary, incentives, study monitoring and documentation of GCP training and compliance at the foreign site.
Areas Covered in the Webinar:
- Overview of 21 CFR 312.120 requirements
- Description of supporting information for foreign investigator qualifications, foreign research facility requirements and study monitoring documentation
- IEC documentation to meet 21 CFR 312.3. What the FDA considers an adequately constituted IEC
- Foreign study informed consent, incentives, protocol adherence documentation
- Documentation of GCP and requirements for training of foreign investigators
- Required criteria, contents and submission of a waiver request
- Maintenance and access to foreign records
- Participants will achieve a higher level of confidence for conducting non-IND foreign clinical trials that will be used to support marketing applications in the US
- Participants will have references and resources to guide them when including foreign clinical study results in marketing applications.
Who will benefit:
- Clinical Research Professionals
- Clinical Protocol Developers
- Clinical Study Managers
- Regulatory Managers
- Clinical Study Directors
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