Cluster 174: dated signed informed consent written specific procedures study provision prior Cluster 422: signed form consent informed icf study specific patient approved prior Cluster 460: specific signed informed consent procedures study prior written obtained initiation Cluster 536: procedures obtained informed consent written prior screening signed study specific Cluster 885: performed written related provide obtained procedures informed consent participation ability Cluster 1189: procedures provide informed consent written study prior specific screening related Cluster 1316: provision consent informed procedures specific written study prior signed participate Cluster 2038: performing evaluations authorization procedures obtained written hipaa related protocol screening Cluster 2464: provided consent informed written subject study procedures activities participate prior