Q&A 14 : Wouldn’t a risk quantification calculation based on sum of squares be more reasonable?

“RE quantification of risk: the variables are orthogonal. Wouldn’t a calculation based on sum of squares be more reasonable?” IGH GCP Ref: 5.0.3 You are correct, that the variables are uncorrelated and hence can be treated independently, and your approach would make good sense. At this stage in the industry’s maturity in this area we are trying to keep…

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Q&A 13 : What is the definition of ‘safety’? Protecting subject ‘safety’?

“What is the definition of ‘safety’? Protecting subject ‘safety’? I believe this really means AE/SAE, etc. However, as a CRA we often hear it referenced to ‘safety’ labs. e.g., general chem, haematology, etc. These are referred to safety labs and may have no bearing on critical data. Isn’t it the PI’s responsibility to review these ‘safety labs’ and track…

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Q&A 12 : Where would secondary objectives fall as a structural risk, essential or non-essential?

“Where would secondary objectives fall as a structural risk, essential or non-essential?” IGH GCP Ref: 5.0.1 ; 5.0.2 Each objective should be evaluated in terms of it’s importance to the program and drug safety profile. It would not be accurate to state that all secondary or exploratory objectives are non-essential, but they should be questioned/challenged in terms of their…

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Q&A 11 : If PI needs continuous access to CRF data, how do we address that many PIs do not seem to access EDC until the end of trial (just to Sign)?

“If PI needs continuous access to CRF data, how do we address that many PIs do not seem to access EDC until the end of trial (just to Sign)?” IGH GCP Ref: 8.1 The two requirements are not related. The first comment about the PI not completing training to access the EDC until the end of the trial, is…

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Q&A 10 : E-data handling – what is the impact beyond IT, e.g. is DM responsible for checking all updates that EDC vendor makes?

“E-data handling – what is the impact beyond IT, e.g. is DM responsible for checking all updates that EDC vendor makes.” IGH GCP Ref: 1.65 ; 5.5.3 No, but the EDC vendor and their SDLC/CSV SOPs should be assessed as part of the vendor assessment/qualification process conducted by QA.   Tammy Finnegan, COO  tammy.finnigan@tritrials.com Click here to see all…

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Q&A 9 : Do the e-data handling requirements apply to all vendors?

“Do the e-data handling requirements apply to all vendors, e.g. regulatory vendors we might use for electronic publishing of regulatory submissions (eCTD format)?” IGH GCP Ref: 1.65 ; 5.5.3 Yes. Best practice would be to review what the vendor is required to do and if their scope would potentially impact subject protection and/or data integrity. Based on the outcome…

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Q&A 8 : What is best practice regarding implementing risk mgmt., should it be a new process or integrated into existing processes?

“What is best practice regarding implementing risk mgmt., should it be a new process or integrated into existing processes?” IGH GCP Ref: 5.0.1 ; 5.0.2 ; 5.0.3 ; 5.0.4 Best practice would be both, a risk assessment and mgmt. SOP that sets out the process, responsible functions etc. and then integrate this process into existing processes where applicable, e.g….

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Q&A 7 : Does root cause analysis (RCA) have to be documented for all CAPAs and to what extent?

“Does root cause analysis (RCA) have to be documented for all CAPAs and to what extent?” IGH GCP Ref: 5.2 RCA is only required for non-compliance that impact or has the potential to impact subject rights and/or reliability of trial results/data integrity. RCA should be part of the CAPA process, and the process should state when RCA is required…

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Q&A 6 : If site does not have means to access CRF data/essential document data through CDs, could memory sticks be used?

“If site does not have means to access CRF data/essential document data through CDs, could memory sticks be used?” IGH GCP Ref: 8.1 Yes, the important point is that we check with the site that they will be able to access the data on the media provided and that the site confirms access. Memory sticks have been used as…

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Q&A 5 : Do you see the changes in CSV as new or just catching up with the current validation process that the FDA guidelines cover?

“Do you see the changes in CSV as new or just catching up with the current validation process that the FDA guidelines cover?” IGH GCP Ref: 1.65 ; 5.5.3 Mainly catching up with FDA guidelines and GaMP guidelines, GaMP5 allows for a risk based approach to validation, which is supported in E6 R2.   Tammy Finnegan, COO  tammy.finnigan@tritrials.com Click…

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Q&A 4 : If monitoring is done by outside vendor, who holds the vendor management plan?

“If monitoring is done by outside vendor (aside from CRO doing data management and statistics, for example), who holds the vendor management plan?” IGH GCP Ref: 5.05 This will depend on the who holds the contract and the terms of the contract. I would suggest if sponsor holds the contract with the monitoring vendor, they should be responsible for…

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Q&A 3 : What are the regulatory authorities thoughts regarding introduction of bias or influencing go/no go decisions if data is being evaluated on an ongoing basis?

“What are the regulatory authorities thoughts regarding introduction of bias or influencing go/no go decisions if data is being evaluated on an ongoing basis?” IGH GCP Ref: 5.18.1 The intent of the central data review/monitoring is not to evaluate the data from the point of view of objectives, this would still be completed by the normal methods, e.g. adjudication,…

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Q&A 1 : How are the regulators viewing non brick and mortar sites (i.e. telehealth)? How does this fit in the new Quality Management system?

“How are the regulators viewing non brick and mortar sites (i.e. telehealth)? How does this fit in the new Quality Management system?” IGH GCP Ref: 5.0 Quality Management still applies, in fact, more so in this scenario. The risks to the critical variables should still be assessed and controlled, and the provision for central monitoring activities should very much…

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R2 survey results June 2018

Only 12% of companies reporting R2 readiness In June this year we conducted an industry survey on ICH E6 (R2) readiness, and had over 100 responses.  Only 12 % said they have completed their readiness programs.  Even more surprising, 27% of respondents said they haven’t even started yet. Given the adoption of R2 by EMA, FDA and Health Canada…

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