• Degree of “Blindness”
– Open Label Study
• A non blinded study. All participating parties know the treatment groupwhich to which the study subjects have been assigned. In many open labelstudies, there is only one treatment group with all subjects receiving thesame treatment (e.g., the investigational drug at a single dose).
– Single Blinded Study
• Investigator and possibly study staff know the treatment group to whichstudy subjects have been assigned
– Double Blinded Study
• Neither the investigator nor other study personnel nor study subjects knowto which treatment group the subjects have been assigned. In fact, no oneknows to which treatment group the subjects are assigned except the individuals at the Sponsor or the CRO that generated the Randomization Code,
which is kept under lock and key until Database Lock
- – Note
- • The greater the degree of blinding in a clinical trial, the more expensive thetrial.