Randomisation

Our data management and statistics teams can provide advice in the methodology for randomisation and unblinding, and set up of the clinical trial randomisation system.

Services at Derby CTU include:
 

• development of randomisation methodology and specification
   
• simulation of randomisation method to check balance across stratification factors
   
• building and testing a randomisation system, electronic, telephone or paper
   
• maintain the randomisation system and unblinding procedures
   
• providing automated email alerts (blind or unblind) for each randomisation event
   
• providing reports, blinded and unblinded, of group allocation

We can provide an online randomisation using the integrated module within our electronic data capture (EDC) system, Dacima™ Software, or independently to our EDC using Sealed Envelope Ltd © for any study design, including cross-over and double blinded Randomised Controlled Trials. Both systems can be accessed 24 hours a day. We also have experience in setting up a paper based randomisation using sealed envelopes for studies where the online randomisation is not feasible.

Methods of randomisation supported by our CTU include, but are not limited to:
 

• simple randomisation
   
• mixed blocks randomisation
   
• stratified randomisation
   
• minimisation
   

Please get in touch with us as soon as you have a research idea so as to get the appropriate support.