Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?
The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?
The PI should ensure that source data is:
Which of the following should be considered when implementing a risk-based monitoring plan?
Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
