Step 2 – Accessing capacity and capability

Accessing capacity and capability

Once the sponsor of the study you wish to join has approved you joining as a new site you need to check whether the infrastructure within your own department and the supporting departments is able to support the study.

Remember, research requires the collection of data, informed consent and the maintenance of trial documentation in accordance with ICH GCP, all of which is additional to standard practice. It must not be assumed that current staff will be able to assist with the research.  If your department is research active there may be staff in place who are able to support you.  If not you may require additional resources.

Support departments may have their own departmental requirement which means they need additional resource or alternatively need to plan to support the study. Involvement in a study may include some additional funding which can be used to support the study or your department.

It is essential that the feasibility of the study is considered early on. The best way to do this is to contact the R&D department as soon as the sponsor of the study has approved you as a site.  R&D will issue a R&D Clinical Evaluation form which is to be completed and returned to R&D. This form will register your trial with R&D.

The completed evaluation form will be sent out for review by the leads of the support services. If the study is deemed feasible you are able to continue with your application.

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