Process of Managing Sites and Contacts for Clinical Trials

This topic details sample tasks that administrators and end users often perform when managing site (including satellite site) and contact information. Your company might follow a different process according to its business requirements.

Perform the administrative tasks described in this topic before performing the related end-user tasks. For example, a clinical protocol site template must exist before you can create the corresponding activity plan for the site.

For information about creating a site for a clinical trail, see "Creating Sites for Clinical Trials". For information about creating a satellite site for a clinical trial, see "Creating Satellite Sites for Clinical Trials".

Administrator Procedures

The following list shows the tasks administrators typically perform to manage site and contact information:

• "Creating Clinical Protocol Site Templates". An administrator creates templates that detail the activities that users must perform at all sites that carry out the same protocol.

• "Creating Contact and Account Assessment Templates". An administrator or the study manager creates assessment templates that define weighted attributes for assessing a contact or account.

• "Maintaining Contacts and Accounts". An administrator maintains records of contact license numbers, and deletes erroneous or obsolete account and contact data.

• "Associating Contracts with Sites". An administrator or a study manager enters details about the contracts for a site and the payment details for each contract.

• "Associating Accounts with Contracts". An administrator or a study manager enters details about the accounts for a site.

• "Associating Accounts with Sites". An administrator applies the accounts for protocols and regions to site records.

• "Associating Activities with Sites". An administrator applies the activities for protocols and regions to site records.

• "Associating Documents with Sites". An administrator applies the documents for protocols and regions to site records.

End-User Procedures

The following list shows the tasks end users typically perform to manage site and contact information:

• "Creating and Managing Site Visits". CRAs (clinical research associates) create site visits to evaluate, initiate, monitor, and close out sites.

• "Managing Contacts for Sites". Users can associate sites with contacts, archive contact records for sites, and view the history of contacts at sites.

• "Adding Address Types for Sites". Users can add a specific type of addresses for each site.

• "Assigning Employees to Site Teams". Managers or CRAs add employees to the team associated with the site.

• "Creating Activity Plans for Sites". CRAs use the clinical protocol site template that an administrator creates to plan a list of activities for each site.

• "Applying Activity Templates to Sites". Users can simultaneously apply one or multiple activity templates to one or multiple sites for a study.

• "Tracking and Adding Documents at Sites". CRAs and regional study managers post clinical trial and regulatory documentation for review at the site, region, and protocol levels.

• "Creating Activities for Document Tracking". CRAs attach and track documents at the protocol, region, and site levels, or for accounts or contacts.

• "Managing Tracking Activities for Case Report Forms". Users can create tracking activities for CRFs (case report forms).

• "Tracking Case Report Forms". Users can create and track CRFs as part of a protocol, site, and region.

• "Creating Correspondence Activities for Sites". Users can track all correspondence (phone, fax, email, and letters that the postal service delivers) between a site and a study team member as correspondence activities for the site.

• "Adding Notes to Sites". Users can add notes to a site.

• "Viewing the Status History for Sites". Users can view the changes to the Status field for a site.

• "Assessing Contacts and Accounts". CRAs evaluate contacts and accounts by using the attributes in an assessment template.

• "Generating Oracle BI Publisher Reports for Document Tracking". Users can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical.

• "Generating Reports for Actual Visits". Users can generate a report for completed clinical subject visits.

• "Generating Reports for Planned and Actual Dates of Subject Visits". Users can generate a report for completed clinical subject visit dates.

Managing Satellite Sites and Contacts for Clinical Trials

You manage satellite sites and contacts for clinical trials in the same way that you manage normal sites and contacts for clinical trials. For more information, see the following topics:

• "Process of Managing Sites and Contacts for Clinical Trials".

• For information about creating a site for a clinical trail, see "Creating Sites for Clinical Trials".

• For information about creating a satellite site for a clinical trail, see "Creating Satellite Sites for Clinical Trials".

Satellite sites function in a similar way to normal sites. From a business perspective, it is important to track all the satellite sites for a parent site and ensure that the protocol guidelines are being followed at the satellite as defined for the parent site. Other important issues to note before starting to create and manage satellite sites for clinical trials include the following:

• A site can have multiple satellite sites, but each satellite site can have only one parent site.

• If a subject visit happens at a site, then all corresponding activities also happen at the same site.

• All roll up and roll down of information in the standard hierarchy for the parent site (Protocol - Region - Site) applies for the satellite site. This includes the roll up and roll down of the following information: position, payment, subject status, and contract amount.6-5

• Bulk actions carried out at the protocol and region level for the parent site (such as activity, account, document tracking, and payment generation) apply for the satellite site.

• The following data is consolidated from the parent site to the satellite site: subject enrolment, accrual payment, contract amount, and payment amount.

• The satellite site and parent site can be of different types. For example, even if the parent site is a Hospital and the satellite site is a Private Clinic, the same principal investigator conducts the study for both sites.

• The satellite site inherits the parent site's subject visit template version, principal investigator, team, and currency information by default. Any change in the subject visit template version, principal investigator, team, or currency information is rolled down from the parent site to the satellite.

• The subject enrollment of data from the satellite site is rolled up to the parent site.

• The payments and contract data from the satellite site is rolled up to the parent site.

• The following use cases are supported for satellite sites:

  • A subject is allocated to a satellite site and carries out all visits at the satellite site as part of the study.

  • A subject is allocated to a parent site and carries out some visits at the satellite site as part of the study.