What needs to be in place before a study can be carried out?

There are a number of things which must be in place before a study can be carried out.

Need to be in place

Research Ethics Committee Approval (REC)

All research carried out in the NHS must be approved by a Department of Health recognised Research Ethics Committee (REC).

Research & Development approval (R&D)

This is approved by the local hospital management and involves a check that any implications for the services are taken account of.

Trial specific training

Staff who are going to be involved in trials require training in how to enrol patients, give the treatment and complete any follow up assessments.

Good Clinical Practice (GCP) training

Despite its name this refers to a general research training and focuses mainly on a set of rules and regulations by which clinical trials should be conducted. Online course are available and staff involved in research should have an up-to-date GCP certificate.

A protocol

A protocol is a document which describes why the trial is being done and gives a detailed description of how it will be done. You will find most of the answers about any trial in the protocol.

Approved study documentation

This will include: patient information sheets, patient consent forms and data collection forms.

Trial specific equipment

This might include access to a computer or FAX machine to send data to the trial coordinating centre or for example a centrifuge or dedicated freezer to deal with blood samples, an automated blood measuring cuff, or a secure room/filing cabinet to store study documentation in.

Does NOT need to be in place

Local Social Services approval

The local Social Services Department are not involved.

Guinea pigs

These are sweet, furry animals which make ideal pets but are not required for trials. Unfortunately some health care staff refer to patients who volunteer for trials as “guinea pigs”. This is not helpful!

Advocate/Lawyer

We are talking about research trials, not legal trials!