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Resources

ICR Project Management Forum 19th Oct

Tammy  Finnigan confirmed as expert speaker at the ICR Project Management Forum Held at Syneos Health, Farnborough on the 19th October, this session will answer the following questions: “Understanding Project Management can be a nightmare. Exactly what is the role? Where does it start? Where does it stop? What does a project manager do and where does their authority…

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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 27 : Can you please distinguish the difference between QTLs and risk indicator/thresholds?

“Can you please distinguish the difference between QTLs and risk indicator/thresholds? How does your interpretation align/differ from recent TransCelerate paper? “ ICH GCP Ref: 5.0.4 ; 5.0.7 Quality Tolerance Limits (QTLs) are set at a study/protocol level and are typically a sub-set of the KRIs that are being used to look at site quality. The intent of the QTL…

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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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