Posting: # 19600
My BE study met a randomization error during the operation. In the protocol, we pre-define that the subject will take random number follow subject id increasing. But in the site SOP, it requests that the subject must take a vital signs test before they take random number. If the vital signs of a subject is unqualified in the first time. He or she will take another measurement after ten minutes. If this subject's second vital signs measurement is OK, he or she will take a random number. The question is other subject will take the random number directly without waiting the result of that subject's second measurement. For example, subject id S001 take random number 001, and S002's VS is unqualified, then S003 will take random number 002 directly whether S002's second VS measurement is qualified or not. In fact, per protocol define if S002 is OK in the second measurement, S002 shall take 002 rather S003. The truth is after the second time is OK, S002 will take a very last random number such as 020, etc. My problem is whether this is a major protocol deviation? And how can we find the impact of this mistake through statistics way. Many thanks.
Edit: Category changed; see also this post #1. [Helmut]