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Duncan Hall speaking at MCC Clinical Trial Risk & Performance Management Summit

Duncan Hall, TRI CEO and founder, is a panellist at the MCC Clinical Trial Risk & Performance Management Summit.  Duncan is taking part in the session on Risk Management Emerging Practices and the Impact of ICHE6(R2) Updates which covers the following topics: Current risk assessment practices Challenges with risk tools released prior to ICHE6(R2) Realigning methodologies to support review of…

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Duncan Hall speaking at CBI Risk-Based Trial Management Conference

Duncan Hall, TRI CEO and founder, is speaking at the CBR Risk-Based Trial Management and Monitoring conference in Philadelphia on the 8th November.  His session will cover Operationalizing Centralized Monitoring. “Are you challenged with implementing Centralized and Risk-Based Monitoring to become R2 compliant?  What if there was a quick and easy way to compare, monitor and manage all your…

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The R2 story – what is it, why it’s needed & why now?

Lots of people don’t understand what R2 is and why it’s needed. And unless you understand the fundamental reasons for its creation and adoption, it’s easy to dismiss it as ‘just more bureaucracy’.  But it isn’t.  It’s much more important than that, and here’s the reasons why. The way clinical trials are conducted has changed dramatically over the last…

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The best questions from 3 years of webinars and training

Over the past three years we’ve trained over 1,000 people in webinars, on-line training sessions and face-to-face sessions.  Most of that training has been done by Tammy Finnigan, our COO.  She’s the person ‘on the hook’ to answer when someone asks a difficult question.  Fortunately for us, she has a wealth of experience in Quality Management, Risk Based Monitoring,…

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Q&A 33 : How should known Risks be handled?

“How should known Risks be handled? Risks are always identified as potential facts right? I mean errors done with the ICF for example (as not timely approved by ECs although used) are already deviations, not risks.” ICH GCP Ref: 5.0 ; 5.0.2 I like to think of this using the simple worked example below. Fact: Known Information e.g. the…

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Q&A 32 : What if the risk is out of the CRO’s management/control?

“What if the risk is out of the CRO’s management/control, though still having probability & magnitude. As the budget assigned to sites for example?” ICH GCP Ref: 5.0 ; 5.0.1 – 5.0.7 ; 5.2.2 This is important from the CROs perspective. I think documenting the risk and agreeing the control mechanisms with the sponsor is critical in this scenario,…

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Q&A 31 : What is the responsibility if the CRO is in charge of drafting the protocol?

“What is the responsibility if the CRO is in charge of drafting the protocol?” ICH GCP Ref: 5.0 ; 5.0.1 – 5.0.7 ; 5.2.2 A risk assessment (ideally jointly with the sponsor) should be conducted, beginning with evaluating what is critical and identifying/evaluating the risk around it, where possible agreeing risk reduction/elimination with the sponsor and if not, then…

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Q&A 28 : Would you generally consider an “important” process like consent a “critical” process from a risk management perspective?

“Would you generally consider an “important” process like consent a “critical” process from a risk management perspective – for example if you have an optimized process for consenting, no historical issues with the consent process, and nothing unique about the study that would increase risk (vulnerable subjects or multiple consents), could you omit the consent process from your list…

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Q&A 24 : Does validation and compliance apply to the use of Adobe for the creation of electronic signatures?

“During the discussion surrounding electronic data and ensuring validation, compliance to 21cfr11, etc.. does this requirement apply to the use of Adobe for the creation of electronic signatures? Adobe is not validated.. this is why I ask.” ICH GCP Ref: 1.65 ; 5.5.3 It depends on how Adobe is being used, if it is stated in process that you…

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Q&A 23 : How do you see the implementation of Quality Tolerance Limits happening and being aligned with the Risks assessed for the trial?

“How do you see the implementation of Quality Tolerance Limits happening and being aligned with the Risks assessed for the trial?” ICH GCP Ref: 5.0.1 ; 5.0.2 ; 5.0.4 ; 5.0.6 ; 5.0.7 This is a great question! Quality Tolerance Limits should be set for critical data/process that could jeopardise the overall integrity of the trial data, or that…

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Q&A 22 : What’s the current status on establishing a widely recognised risk assessment tool for clinical monitoring?

“What’s the current status on establishing a widely recognised risk assessment tool for clinical monitoring? I have the impression countries are individually setting up their tools as of how to evaluate risk criteria on the basis of available literature, but there’s no harmonised approach globally, yet. “ ICH GCP Ref: 5.0.1 ; 5.0.2 ; 5.0.3 ; 5.0.4 ; 5.18.1 There…

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Q&A 21 : Can you please comment about the FDA release of E6(R2) March 2018, and why section 9. Paperwork Reduction Act of 1995 was added?

“Can you please comment about the FDA release of E6(R2) March 2018, and why 9. Paperwork Reduction Act of 1995 was added. Also why does the ich.org not even have this version posted? “ FDA Version of E6 R2 Section 9 We don’t claim to be experts on the Paperwork Reduction Act of 1995, but I think in this…

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Q&A 20 : Is R2 implemented in national legislation?

“Is R2 implemented in national legislation?” Not directly, but if it has been adopted by the regulatory agency in your country, you can be cited against it. What this means in terms of law will vary by country.   Tammy Finnegan, COO  tammy.finnigan@tritrials.com Click here to see all the Q&As

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