Clinical Trial Laboratories

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When planning a clinical trial it is important to involve the laboratory team from the outset in developing the protocol and preparing the trial budget to ensure the laboratory element is feasible and appropriate and the planned analyses can be carried out.

The laboratory team can also make sure that the sampling requested is going to obtain the right volumes of blood and that these amounts are acceptable and fall within any applicable guidelines.

It is also important to confirm a trial is logisitcally possible and it is often the laboratory component that determines this. Key questions should be asked:

• How far do the samples need to travel once collected?
• Do they need to be kept at a certain temperature?
• How long do the samples take to process for the assays required in the protocol? This is very important as it will determine how many samples the lab can handle and thereby dictates the number of subject per day that can be recruited
• Do we have the reagents and equipment or can these be realistically put in the budget?
• What training will the lab and clinical staff need
• Do we need any new lab and clinical SOP's for the planned analysis?

We will be expanding this section and providing template documents such as sample tracking systems, requisition forms, and operating procedures. As with the rest of this site the intention is to create a forum for sharing best practices and methods, so please take part in this by contributing your suggestions and share your experience with us. Any example documents or templates would also benefit other researchers.

You can access and download numerous lab logs and templates, such as drug accountability logs, IMP SOPs, pharmacy accountability forms, etc - at our extensive Templates Library.