|The One-hour Study Site Audit
Polaris Compliance Consultants
What if you only had one hour to conduct a site audit -- what would you look at? The question is absurd, of course, but the answers our auditors gave are illuminating.
Free GCP Training
Polaris Compliance Consultants, ACRP
In cooperation with Complion Inc., Mary McGuire will be presenting a webinar on behalf of Polaris entitled “What ICH E6(R2) Means for Research Sites.” The new guidance includes many new elements; an emphasis on, and revision to, ALCOA principles for study data, validation expectations for computer systems, risk-based trial management, and additional PI oversight responsibilities. What does this all mean, as a practical matter, for study sites? Register here for the October 24th presentation.
ACRP announces a free 5-hour online training program for clinical researchers entitled “Ethics and Human Subject Protection. The announcement follows a recent NIH decision to retire its Protecting Human Research Participants online course. ACRP contact hours are available for a small fee. Access the course here.
Check out this Checklist
InTouch Manufacturing Services
If you’re looking for a comprehensive GMP audit checklist, organized by factory system, you can stop looking now. It’s a lot more than a checklist, actually, and includes advice, tips, and reminders that our GMP subscribers will hopefully find helpful. Even if manufacturing is not your thing, you may find it useful to have a readable, thorough summary of the quality and compliance issues your GMP colleagues contend with.
Experiences of a Remote Site Monitor
Journal of Clinical Research Best Practices
In some RBM implementations, remote site monitors (RSMs) review many of the same things as on-site monitors review – they just do it off-site. Here’s a different take. Susan Radtke describes her RSM role
in which she does no source document review. Instead, she acts as the first point of contact for sites -- troubleshooting supply issues, answering questions about the protocol and vendor systems, and assisting in query resolution.
All Hail the Audit Trail!
Everything you need to know about everyone’s favorite metadata: when do audit trails apply, what they should and shouldn’t contain, what features they should have (the ability to sort sounds like an excellent idea!), accessibility, retention, etc. On-site and/or centralized monitors should routinely review audit trails at study sites to make sure the “story of the data” is complete.
IP vs Commercial Drug Manufacturing
Last year, we wrote a blog post describing some of the efforts that the research and manufacturing sides of the business need to coordinate during the clinical trial phase. You can read "When GCP and GMP Meet" here.
This new article provides a brief summary of the IP manufacturing process and how it differs from manufacturing commercial product:
Bose Speaker? How About a Bose Listener!
This month, FDA approved the first Over-The-Counter hearing aid. “The de novo clearance makes it the first hearing aid authorized by the agency that allows users to fit, program and control the device on their own, without help from a healthcare provider.”
Polaris Compliance Consultants News
Last month, our GCP Director Diane Tilley conducted a US RAC workshop on FDA inspections. North Carolina Regulatory Affairs Forum (NCRAF) offers these workshops to their members during the summer and fall every year in preparation for November’s RAC exam.
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