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Risk assessing Investigational Medicinal Products (IMPs)

Published Last updated See all updates
Topics: Clinical trialsService advice and planning

Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs.

This article forms part of a series
  1. The role of the sponsor pharmacy in clinical trials of investigational medicinal products (CTIMPs)
    1. Understanding local governance in CTIMPs
    2. Supporting funding applications for CTIMPs
    3. Understanding essential documentation for clinical trials submissions
    4. Risk assessing Investigational Medicinal Products (IMPs)
    5. Additional considerations for single or multi-centre trials
    6. Assuring the supply chain for IMPs and NIMPs
    7. Constructing a pharmacy manual for clinical trials
    8. Feasibility and setting up of clinical trials at delivery locations
    9. Monitoring and auditing clinical trials
    10. Closing clinical trials

Undertaking the risk assessment

The Sponsor Pharmacist should complete, or give input into, an IMP risk assessment prior to or in parallel with trial documents 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 modification is submitted to the authorities for approval 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.

Update history

  1. Article and attachment updated in line with amendments to clinical trials regulations.
  1. Published