Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs

Undertaking the risk assessment

The Sponsor Lead Pharmacist should complete, or give input in to, an IMP risk assessment prior to or in parallel with document review.

This IMP risk assessment will feed back into the general risk assessment performed by the Sponsor and in turn, to the monitoring plan when appropriate.

Multiple IMPs

When more than one IMP is involved, a separate IMP risk assessment can be used for each product.

This IMP risk assessment should be amended if a substantial amendment is approved that has the potential to change the previously identified risks.

Supporting document

This template will assist sponsor to complete a risk assessment related to IMP activities. Sponsor pharmacy input is required.

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