Clinical Study Site Management

This ERD (see the following figure) is an extension of Clinical Study Management and illustrates:

  • Activities related to subjects participating in clinical studies and the list of visit types to be scheduled for this subject.

  • How site visit logs are maintained. Clinical Research Associates visit different targeted sites depending on research requirements and their visits are logged.

  • How organizations, such as vendors, sponsors, clinical research organizations, central laboratories, and institutional review boards, are associated with clinical protocol and clinical protocol sites.

  • How summaries of subject visits are organized by visit type and by protocol site.

Clinical Study Site Management: This image is described in the surrounding text.

The following table lists the entities in this ERD and their corresponding tables.

Entity Table

Account

S_ORG_EXT, S_PARTY

Activity

S_EVT_ACT

Address

S_ADDR_PER_S_CON_ADDR

Affiliation

S_PTCL_ST_CON_LS

Contact

S_CONTACT, S_PARTY

Protocol

S_CL_PTCL_LS

Protocol Site

S_PTCL_SITE_LS

Protocol Organization

S_PTCL_ORG_LS

Protocol Site Organization

S_PTCLST_ORG_LS

Site Status Summary

S_CL_SIT_ST_SUM

Subject

S_CL_SUBJ_LS

Subject Status

S_CL_SUBJ_ST_LS

Subject Template

S_SUBJ_TMPL_LS

Subject Visit Type

S_CL_SUBJVST_TP

Template Version

S_SBJTMP_VER_LS

Template Visit

S_TMPL_PLANITEM

Visit

S_EVT_ACT

Visit Log

S_SITE_VST_LOG