Cluster 381: board review irb approved institutional consent informed signed form written Cluster 758: authorized legally irb representative board applicable review document approved understand Cluster 818: signed consent informed given study document patients approved registration prior Cluster 1043: board irb review approved sign document institutional informed consent understand Cluster 1047: irb board review approved sign understand able institutional document informed Cluster 1255: institutional regulatory dated accordance board review guidelines signed irb approved Cluster 2366: signed written informed consent provide provided irb subjects study approved Cluster 2455: conforms federal consent guidelines approved institutional form provide signed able