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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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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Q&A 19 : Does the Quality Risk Management Plan needs to be included in the CSR?

“I may have misunderstood, but did you say that the Quality Risk Management Plan needs to be included in the CSR?” IGH GCP Ref: 5.0.7 ICH E6 R2 5.0.7 Risk Reporting: The sponsor should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the…

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Q&A 17 : When detecting risk, we are detecting risk only on the critical data that was identified, correct?

“When detecting risk, we are detecting risk only on the critical data that was identified, correct? We are not looking at non-critical data for risks, e.g. the fluff?” IGH GCP Ref: 5.0.4 ; 5.0.5 ; 5.0.6 Risk is typically multi-variate, sometimes we will look at many indicators to get an idea of quality, there is not always a 1:1…

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Q&A 16 : Should the risk identification take place during the development of the protocol or when the protocol is finalized?

“When should the risk identification take place? During the development of the protocol or when the protocol is finalized? Who/what expertise would you expect to be at the risk identification meeting?” IGH GCP Ref: 5.0.1 It is an ongoing process, but should be initiated during the protocol development cycle, as early as possible, ideally with the robust synopsis where…

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Q&A 15 : Should you assess likelihood of risk recurrence?

“Your description of assessing probability is at odds with your earthquake insurance example – should you also assess likelihood of recurrence? Maybe something has occurred in a previous trial but you’ve installed mitigations for it?” IGH GCP Ref: 5.0.3 The point of the earthquake example is that risk management is often emotive – through personal experience people are more…

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