Route Maps

Getting Started with the Route Maps

The Route Maps are designed to help people involved in the management of clinical trials. The site focus is on trials of medicines subject to the UK Regulations that implement the EU Clinical Trials Directive. The route maps show you where processes and good practice have wider relevance.

Thinking about the specifics of your
Clinical Trial(s)

Before using the Route Maps, take time to think about your trial and its setting. The UK Regulations make use of the flexibility allowed in the EU Directive. The intention is to implement its requirements taking account of the nature of the trial and the risks to be controlled. The resources in the Route Maps indicate approaches that may be appropriate in the r ight circumstances.

So, before using the Route Maps consider the following:

• The research question

The nature of the intervention will determine whether the trial is subject to the Regulations. The Route Maps contain advice on management arrangements for different kinds of trial.
• Where you are in the trial process

You have three Maps covering different "ages" of trial and stage in the trial process. The key stages are identified as "stations." Click on a station and you will find one or more "resources". Resources provide advice and links to other sites.
• The expertise of your trials team and organisation
Some resources on this site are addressed to the needs of trialists, others are of particular interest to R&D Managers. Using the resources may reveal gaps in the capacity of your trials team or organisation to support trials to the required standards. Organisations vary considerably in how they approach their responsibilities to support high quality clinical trials. Good practice notes for organisations that manage a portfolio of trials, are available here.

Using the maps

You have three Maps, which are described on the right.

• Move along each map from left to right. That is the direction in which the processes flow.
• Some processes can be done in parallel.
• Click on a station and you will be taken to a description of the process and a list of relevant resources. Some stations have a submap.
• Each map identifies Statutory Requirements in red.
• Good Practice is identified in blue. In some situations, good practice can be considered mandatory (e.g. by funders and the NHS) although it does not have statutory force. For the most part good practice is advisory. If the resource contains mandatory good practice, this will be specified in the resource description.
• Processes and requirements with relevance beyond the EU Directive are signified with an open station symbol.

List View

An alternative to the maps has been provided, called the List View, here the same information is displayed in a list. You can select the List View at any stage whilst using the route maps.

Documents

There are many documents available for download from this website. You will need to have Adobe Acrobat Reader installed on your machine to be able to read them.