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Understanding local governance in CTIMPs

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Topics: Clinical trialsRegulatory

Sponsor pharmacy's role in ensuring appropriate local governance arrangements for 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 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

Chief Pharmacist responsibilities

The Chief Pharmacist is responsible for overall pharmacy service provision although it is expected that a designated member of pharmacy staff will assume operational responsibility for the pharmacy clinical trial service.

Delegated responsibilities

When the member of pharmacy staff is also acting in the role of Sponsor pharmacy, it is recommended that a statement listing the roles and responsibilities including those to be delegated to the pharmacy by the chief investigator/Sponsor is created. This can be specific for each CTIMP.

Sponsor pharmacy responsibilities

Some organisations will have dedicated Sponsor pharmacy teams that are integrated into the Research and Innovation Departments. Lines of reporting accountability must be clear when pharmacy teams are acting on behalf of the Sponsor.

The Sponsor Pharmacy must review any contract to ensure appropriate IMP management and oversight, when delegated this responsibility by Sponsor.

Considerations for innovative medicinal products

Sponsor pharmacy teams should be aware that for some innovative medicinal products there may be additional requirements to consider.

For example, there are specific regulations and guidelines to adhere to when the investigational medicinal product is classed as an advanced therapy (ATIMPs), including: GCP for ATMPs, GMP for ATMPs and “The Role of Pharmacy in the successful delivery of ATMPs – information for Chief Pharmacists, (Edition 1, Feb 2017)”.

Supporting document

This template will assist sponsor to allocate roles and responsibilities to key stakeholders.