Clinical Research and GCP Update

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CRITICAL sponsor findings - RSI

Solution

Problem • Issues with the accuracy of a tracker developed to track Investigator Brochure (IB) approval dates were identified and did not include the RSI approval dates for comparator products. Impact • Potential for the incorrect IBs and hence RSI to be used leading to under-reporting of SUSARs.

The tracker should be validated and tested. There should be documented quality checks that the tracker is accurate. The tracker should include RSI approval dates for comparators as well as IMP.

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Critical inspection findings - RSI

• The company’s procedures did not require that the RSI used at the onset of an event should be used to evaluate the case throughout the follow up period. ̶ This led to the incorrect version of the RSI being used for expectedness assessments during case evaluation with subsequent underreporting of SUSARs.

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© Brookwood Global (Canary Ltd) 2021

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