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A coordinated country approach to hospital pharmacies’ handling of clinical trials and the use of a common national brochure

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European Statement

Introductory Statements and Governance

Author(s)

Kirsten Lykke Vorbeck, Laila Rabbani, Somia Mohammad, Anne Bøiehøj, Lene Sehested, Majken Cardel, Lone Skovhauge, Lisbet Emmery Jørgensen

Why was it done?

Having different sponsors with individual requirements and interpretations of rules, means a lot of work. The brochure aims to save time on answering questions by describing to every sponsor how Danish Hospital Pharmacies proceed. By demonstrating that we all do many things in the same way and ultimately have the same requirements, we hope to be able to encourage sponsors to adopt a more unified or aligned approach.

What was done?

Through a collaboration of Danish hospital pharmacies, a working group on clinical trials meet regularly to discuss general procedures and challenges to our handling of clinical trials. Via this a common presentation of how we handle clinical trials and what we can offer has been described in a brochure that is given out to sponsors, investigators, clinical trial units (CTUs), clinical wards, monitors etc. The brochure also serves as an inspiration catalogue to hospital pharmacy colleagues.

How was it done?

In the working group we have discussed processes and which administrative and quality requirements we find reasonable and called for (from our point of view and that of our sponsors). We appreciate that we cannot do everything in exactly the same way, but we have tried to include as much as possible in the brochure leaving it up to the individual pharmacy to supplement with local procedures.

What has been achieved?

The brochure is evidence of our cooperation within Denmark. It has been distributed to relevant partners and to “Trial Nation”, a national entry point for companies who wish to conduct clinical trials in Denmark. It is intended as general information and to be handed out to new potential sponsors. It has resulted in an aligned and time-saving procedure.

What next?

Hospital pharmacies are small players in the field of clinical trials but nonetheless important ones. Working together to find general procedures not only helps ourselves to identify good practices but also means we can create a smoother handling of the trials and that we stand stronger when meeting the different requirements from sponsors. This cooperative approach has met with a good response. It promotes further cooperation between all parties, and it is recommended to be implemented in other healthcare settings.

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