dated signed informed consent written specific procedures study provision prior 
signed form consent informed icf study specific patient approved prior 
specific signed informed consent procedures study prior written obtained initiation 
procedures obtained informed consent written prior screening signed study specific 
performed written related provide obtained procedures informed consent participation ability 
procedures provide informed consent written study prior specific screening related 
provision consent informed procedures specific written study prior signed participate 
performing evaluations authorization procedures obtained written hipaa related protocol screening 
provided consent informed written subject study procedures activities participate prior