GCP Issue Management

Although ICH GCP are “Guidelines”, they are rule setting and legally binding in Europe. Some rules defined in ICH GCP, such as the requirement that every patient must give free informed consent before entering a clinical trial, are straightforward and do not require much interpretation. However, on purpose ICH GCP – and this also holds true for FDA, EMA and national legislation/rules – do not regulate every detail but leave room for interpretation. A GCP issue may emerge when teams have interpreted the “wiggle room” too extensively.

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A GCP issue may also result from “simple” non-compliance with some of the GCP or regulatory rules. This of course requires correction and more often than not formalised corrective and preventive actions (CAPAs). When defining and implementing CAPAs the right balance or equipoise is mission critical. Being too conservative could result in the loss of data for a submission (e.g. patients or even entire sites excluded from analysis) whereas being too cavalier could result in critical inspection findings and a regulatory action such as a warning letter or rejection of the submission.

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How can Widler & Schiemann assist you should your organization be faced with a GCP issue?
Widler & Schiemann have combined more than 35 years of experience in the GCP field and are viewed by many of their peers in the industry as thought-leaders in compliance matters and issues. They are active members of industry peer groups such as the EFGCP Audit Working party, DGGF GCP working party, DIA GCP SIAC, DIA QRM SIAC, etc. that are a resource to obtain feedback from other experts in the GCP community and thus establish in an anonymized manner a benchmark opinion on issues.

Widler & Schiemann will work with your teams and management to determine the root cause of a potential or established GCP issue, perform a regulatory risk and impact assessment and develop together with your teams a pragmatic and sound CAPA plan. If required, they will also join your team to meet with Health Authorities as a follow-up on serious GCP issues / noncompliance.

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