Clinical Research and GCP Update

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CRITICAL sponsor findings - RSI

Solutions

Problem • The version of the Reference Safety Information (RSI) used to assess expectedness of SARs was not documented (nor was there any procedural requirement to do so). Impact • Potential for the incorrect RSI to be used to evaluate expectedness.

The RSI is trial-specific. Make sure that you identify the RSI and ensure that the version to be used in the trial is documented.

Make sure that your SOP requires this.

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CRITICAL sponsor findings - RSI

Solution

Problem • There was no process in place to ensure the Reference Safety Information (RSI) had been approved by the MHRA prior to implementation. Impact • The incorrect version of the RSI was used for expectedness assessments during case evaluation with subsequent under reporting of SUSARs and the subsequent impact on DSURs.

Use only the RSI approved by the regulatory authority for all evaluations of expectedness. Do not use unauthorised updates. Effectively communicate to all concerned which RSI is to be used.

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© Brookwood Global (Canary Ltd) 2021

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