Clinical Study Management

This ERD (see the following figure) illustrates how clinical trials are managed. Each clinical trial starts with a protocol for a specific compound (product). Each protocol is conducted by sites and managed by site personnel. A protocol can have many versions and multiple protocols can roll up to a single program. Protocols can also roll up to regions. Subjects are screened and enrolled at protocol sites for specific protocol versions. Protocol sites are paid, based on the activities they complete. Visits and activities are generated for subjects based on templates defined for the protocol. The Clinical Research Associates perform site initiation activities for protocol sites and submit periodic trip reports. A protocol can also be associated with one or more projects. For a complete layout of projects, refer to Professional Services.

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
Affiliation	S_PTL_ST_CON_LS, S_PTL_STCONHIST
Application	S_CL_PGM_APP_LS
Clinical Payment	S_SRC_PAYMENT
Contact	S_CONTACT, S_PARTY
Contract	S_DOC_AGREE
Design	S_CL_DSGN_LS
Exception Activity	S_CL_ACT_EXC_LS
Position	S_POSTN
Product	S_PROD_INT
Program	S_CL_PGM_LS
Project	S_PROJ
Project Subcontractor	S_PROG_ORG
Project Subcontractor Contact	S_PROJ_ORG_CON
Protocol	S_CL_PTCL_LS
Protocol Site	S_PTCL_SITE_LS
Subject	S_CL_SUBJ_LS
Subject Status	S_CL_SUBJ_ST_LS
Subject Template	S_SUBJ_TMPL_LS
Template Version	S_SBJTMP_VER_LS
Template Visit	S_TMPL_PLANITEM
Trip Report	S_EVT_ACT
Visit	S_EVT_ACT