Protocol Development

Before seeking approvals for a research project to commence, the protocol should be finalised, as this constitutes part of the application. A protocol should include sufficient detail to enable, if circumstances were to require it, someone previously unfamiliar with the study to continue from the point that another researcher has left it. If support departments are involved, such as pharmacy, pathology or radiology, it is important to discuss the implications of the study during the protocol development stage with them.

The HRA provide guidance on the creation of a protocol and provide example templates for CTIMP and qualitative studies.

Protocol registration – do I need to register my study?

The International Committee of Medical Journal Editors (ICMJE) require most clinical research studies to be listed on a public register before they can be considered for publication. This means that if you plan to publish your research in a journal that follows the ICMJE guidelines you will need to list your study on an independent, free to access, validated public register.

All clinical trials must be registered BEFORE the first patient is recruited.

Lancaster University recommends using one of the following registers:

•             EudraCT is the European clinical trials database of all clinical trials. Registration is compulsory for every clinical trial with at least one site in the European community, and provides a unique identification number for the trial. You can do this online.

•             International Standard Randomised Controlled Trial Number Register (ISRCTN). There may be a charge for registration. Some funding bodies require ISRCTN registration.