Pharmacy

The Pharmacy team can offer advice relating to the feasibility of a study covering:

• costs, location, staffing availability
• technical agreement - a contract between Imperial (as Sponsor) and the manufacturer of the drug covering the product being supplied, formulation, total quantity, how packaged, how labelled, analytical testing, batch release, shipping, recalls etc, including who is responsible for what

For CTIMP studies the Pharmacy team plays an important role preparing a range of approvals and documentation, such as:

• new clinical trial notification form (MF14)
• technical agreement - a contract between Imperial (as Sponsor) and the manufacturer of the drug covering the product being supplied, formulation, total quantity, how packaged, how labelled, analytical testing, batch release, shipping, recalls etc, including who is responsible for what
• pharmacy agreement - a contract between Imperial (as Sponsor) and the external site Pharmacy, to say what the site pharmacy will receive and from whom, and what the site pharmacy responsibilities are, such as temperature monitoring, checking through QP batch release certificates and quarantining any drug without a satisfactory release.