SIEBEL CLINICAL TRIAL MANAGEMENT SYSTEM and associated Glossary

Oracle's SIEBEL CLINICAL TRIAL MANAGEMENT SYSTEM is a CRM software solution for managing Clinical trials. Siebel Clinical allows pharmaceutical companies, biotechnology companies, and contract research organizations (CROs) to better manage the clinical trial process, maintain quality of clinical trials,and manage investigator relationships. It provides a comprehensive set of tools for clinical research associates (CRAs), clinical investigators, and site coordinators, including a personalized Internet portal to conduct study activities more efficiently.

Generic terms related to Clinical Trials:

Clinical Trial: A systematic study of a test article (treatment, drug or device) in one or more human subjects. An investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

Subject/Trial subject: An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control.

Application. Application made to a health authority to market or license a new product.

Visit:. A clinical encounter for a subject in a trial. Visits are frequently referred to as occurring on Day X or during Week Y;

Sites: Sites are locations where clinical trials are conducted. They are typically a clinic or hospitals where investigators see subjects and perform study procedures, such as medical checks.

Product(Compound): A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. Products can also be devices such as Pacemakers

Program: Groups of Clinical Studies or Clinical Trials for the same compound.

Projects: Groups of Studies within a Program (Oracle Clinical Only)

Investigator: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Sub-investigator:  Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

Case Report Form:A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. The CRF is the way the Clinical Data for Patients is collected.

Clinical Research Associate (CRA): Person employed by a sponsor, or by a contract
research organization acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a clinical study. At some sites (primarily in academic settings), clinical research coordinators are called CRAs.

Clinical Research Coordinator (CRC): Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor’s visit. Synonyms: trial coordinator, study coordinator, research
coordinator, clinical coordinator, research nurse, protocol nurse.

Discrepancy:Problems found with data reported in the CRF pages by Investigators for specific Patients

Protocol/Study Protocol: The study protocol is the blueprint that all researchers will follow.

A study protocol is a document that describes, in detail, the plan for conducting the clinical study. The study protocol explains the purpose and function of the study as well as how to carry it out. Some specific things included in the protocol are the reason for the study, the number of participants, eligibility and exclusion criteria, details of the intervention or therapy the participants will receive (such as frequency and dosages), what data will be gathered, what demographic information about the participants will be gathered, steps for clinical caregivers to carry out, and the study endpoints. A single standard protocol must be used without deviation to ensure that the resulting data will be significant and reliable.

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SIEBEL CTMS:

Each clinical trial starts with a protocol for a specific compound (product). Each protocol is conducted at 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.

The entities and tables in Siebel CTMS are as shown below:

Entity                                             Tables
Account                                     S_ORG_EXT, S_PARTY
Activity                                      S_EVT_ACT
Address                                     S_ADDR_PER
Affiliation                                   S_PTCL_ST_CON_LS
Application                                 S_CL_PGM_APP_LS
Clinical Payment                         S_SRC_PAYMENT
Contact                                     S_CONTACT, S_PARTY
Design                                      S_CL_DSGN_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

A typical Clinical Trial Scenario:

The clinical director and the study manager, working for a clinical research organization, or pharmaceutical, biotech, or medical device company, have administrator responsibilities in Siebel Clinical to:
■ Set up a new treatment study program.
■ Create one or more protocols designed to assess the safety and efficacy of certain compounds in
the treatment of the disease.
■ Set up the geographic regions where the protocols are to be carried out.
■ Compile a list of documents that are critical to the study and implement tracking at the protocol,
region, and site levels, and for accounts and contacts.
■ Create a subject visit template to facilitate consistent application of the protocol across sites and
subjects. This template is used to set up subject visit schedules and activities according to the
guidelines laid out in the protocol.

When the program, protocol, and subject visit templates have been set up, the CRAs who are the
end users of the Siebel Clinical product do the following:

■ Enter data about the:
  ❏ Sites where the protocols are carried out.
  ❏ Members to be assigned to the teams at the site, region, and protocol levels.

  ❏ Accounts, institutions such as hospitals and clinics where the studies are conducted.
  ❏ Contacts, site personnel such as investigators, site coordinators, and nurse practitioners who carry out      the protocols.
  ❏ Subjects recruited for the clinical trial.
■ Screen and enroll subjects and, if necessary, rescreen the subjects.
■ Use the subject visit template to set up detailed schedules for the subjects’ visits to the sites.
■ Track required documents at the protocol, region, or site level, or for accounts or contacts.

Some major steps to be performed in Siebel CTMS to achieve the above mentioned scenario are:

1. Create a new Clinical Program. The clinical program is the highest-level initiative in Siebel Clinical. Protocols, regions, sites, and subjects must be associated with a program.

2. Setup a Protocol

3. Set Up Regions

4. Define a Subject Visit template. Subject visit templates allow you to set up a template schedule based on the protocol. The template is then used to generate screening, rescreening, and enrollment schedules for each subject, according to the subject’s screening, rescreening, and enrollment dates.

5. Create an Account and Contacts. An account is the institution from which clinical trials are managed. Typically, it is the facility where the investigators conduct the trials. More than one site can be associated with an account and one account can carry out multiple protocols. IRBs (institutional review boards), central labs, CROs(clinical research organizations), and other subcontractors may also be tracked as accounts. Contacts is the term used for personnel working at clinical sites. This includes the investigators, typically medical professionals who are also researchers and site coordinators, who may be the practicing nurses administering the treatment plan according to the clinical protocol.

6. Create a Site. The site is the group at an account, headed by a principal investigator, who carries out a particular protocol. In Siebel Clinical, a separate site record must exist for each unique combination protocol,
account, and principal investigator.

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Hierarchical relationship of programs, protocols, regions, and sites: