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Supporting funding applications for CTIMPs

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Topics: Clinical trialsService advice and planning

Sponsor pharmacy role in funding applications and establishing costs for sponsor activities

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 Investigational Medicinal Product (IMP) supply
    7. Constructing a pharmacy manual for clinical trials
    8. Feasibility and setting up of clinical trials at participating sites
    9. Monitoring and auditing clinical trials by participating sites
    10. Closing clinical trials

Calculating costs

Costs for activities related (but not limited) to the following must be included as per Attribution of costs for research and development (AcoRD):

  • sourcing, manufacturing and distribution
  • QP certification (incorporating importation and regulatory requirements)
  • host site pharmacy set up, close out
  • host site IMP management of the trial

Excess treatment costs (ETC) (including negative ETCs) must be calculated at this stage. Access to the IMP at the end of the trial/exit strategy for the participants should also be clarified at this stage and the detail included in patient information leaflets for provision during the consent process.

Consideration at this point should be given for any planned reimbursements to sites related to medications and placebos used in the trial.