6Managing Sites and Contacts for Clinical Trials
Managing Sites and Contacts for Clinical Trials
This chapter describes how to manage sites and contacts for clinical trials. It includes the following topics:
About Managing Sites and Contacts for Clinical Trials
This chapter describes the tasks that the administrator and end users perform to update and maintain information about:
Sites for clinical trials
Contacts (investigators and other site personnel)
Accounts (hospitals and clinics where you carry out the trials)
Employees on the site team
Regulatory documentation relevant to recording the trials
Contracts associated with individual sites
Siebel Adverse Events and Complaints Management feature set allows you to record the relationships among these six entities.
This chapter also describes setting up and using:
Activity plans for sites
Account and contact assessments
Scenario for Managing Sites and Contacts for Clinical Trials
This topic gives one example of how to manage sites and contacts for clinical trials. You might manage sites and contacts for clinical trials differently, depending on your business model.
To prepare for the clinical trial, the administrator sets up templates to generate activity plans for site initiation and to track documents. The administrator also creates templates that the CRA (clinical research associate) uses near the end of the trial to assess contacts and accounts associated with the trial. The administrator might have to update contact and account information before the CRA can begin work on the site. Another important task that the administrator might have to complete is to associate contracts with a site. Often, the administrator might have to associate multiple contracts with individual sites.
When the CRAs begin work on a new clinical trial, they must set up a number of site visits that dictate whether the site can carry out the trial. Then they add new information and update existing information about accounts, contacts, and sites, and about the affiliations and associations among them. Maintaining accurate data is critical to successful clinical trials.
When creating a new contact record, the CRAs request that the administrator enter the contact’s primary specialty. The CRAs cannot enter data in this field. Then the CRAs must appoint a team of employees to assign to that site so that the study manager can keep track of the members of each site team.
The CRAs plan how to carry out the protocol at the site by creating an activity plan for the site. This plan determines how to conduct the trial. The CRAs use the clinical protocol site template that the administrator creates. They also track any number of extra documents that are associated with a site. These documents can include regulatory or clinical trial documentation.
From time to time, the CRAs enter account or contact records incorrectly, or they discover that some account or contact records are obsolete. The CRA then puts in a request to the administrator to delete those accounts and contacts. The CRAs do not have the permissions to delete these records.
Before the clinical trial ends, the administrator or the study manager creates a contact assessment template that each CRA can use to evaluate the performance of the investigators at the conclusion of the trial.
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:
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.
Creating Clinical Protocol Site Templates
Activities can be associated directly with sites. For example, all sites carrying out the same protocol perform similar activities for site initiation, and submit similar documents to the regulatory agencies. When many activities are common to multiple sites, the clinical protocol site template helps CRAs (clinical research associates) create activities for the sites.
To create a clinical protocol site template, create an activity template with a Type field of Clinical Protocol Site. Make sure that Protocol Title field is complete and correct. For information about how to create activity templates, see Siebel Applications Administration Guide.
If an activity template with a Type field of Clinical Protocol Site is not associated with a protocol title, then users can apply the template to all sites in the Activity Plans view of the Site Management screen. If an activity template with a Type field of Clinical Protocol Site is associated with a protocol title, then users can apply the activity template only to the sites associated with the protocol.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Creating Contact and Account Assessment Templates
The purpose of the assessment is to determine a single total score or a percentage that you can use to rank a contact or account. For information about creating an assessment template, see Siebel Applications Administration Guide.
For contact assessment templates, set the template type to Contact. For account assessment templates, set the template type to Account.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Maintaining Contacts and Accounts
The end users are responsible for much of the day-to-day maintenance of their contact and account data. For information about managing contacts and accounts, see Siebel Life Sciences Guide.
However, the administrator is responsible for the following tasks:
Entering data into the primary specialty field for contacts.
Deleting contact and account records that are in error or are obsolete.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Associating Contracts with Sites
You can associate the contracts defining the total site payments with each site. Some sites might need only one contract that governs the entire payment for the site. However, you might have to associate multiple contracts with a site. Each contract can have multiple payees. You can associate multiple contracts and multiple payees with a site.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To associate a contract with a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site with which you want to associate a contract.
Navigate to the Contracts view.
In the Contracts list, create a new record and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Contract #
Displays the number assigned to this contract. This field is automatically populated.
Type
Select the type of contract to associate with the site.
Contract Amount
Type the amount of money that the contract is worth. If you enter multiple contracts, then the total value of all contract amounts equals the total contract amount for the site. This total appears in the Contract Amount field on the site form.
Payee Last Name
Select the name of the person who receives payments for the contract. You can enter multiple payees for the contract by using the multi-value picklist.
Address
Select the address associated with the payee.
Associating Accounts with Contracts
This topic describes how to associate accounts with a contract for clinical site. You can associate multiple accounts with a contract by adding them to the selected list in the Accounts MVG (multi value group). Set one account as the primary account. The first account that you add to the Accounts MVG is set as the primary account by default. You can change the primary account by selecting the Primary field in the Accounts MVG.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To associate an account with a contract
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site.
Navigate to the Contracts view.
Click the select button in the Account field to open the Accounts dialog box, and complete the following steps:
Move the record for an available account to the list of selected accounts.
The first account that you associate with the contract is the primary account by default.
Configure the primary account for the contract by selecting the Primary field.
Click OK.
Associating Accounts with Sites
You can associate the accounts for a clinical protocol and for a clinical region with sites.
After you complete this task, the account records appear in the Accounts view in the Protocol Site List view of the Site Management screen. The account records originate in the Accounts view in the Protocol List view of the Protocols screen or in the Accounts view in the Region List view of the Regions screen. In these Accounts views, you can change the field values in the account records.
The Account field and the Type field uniquely identify an account record for a site. You can associate an account for a clinical protocol or for a clinical region with a site only if the values in these two fields do not already exist for an account record associated with the site. Consequently, note the following:
If you change the value in either of these fields for an account record, and then reassociate that account record with the site, then a new account record is created for the site.
If you change other field values for an account record, and then reassociate that account record with the site, then a new account record is not created for the site, and the field values for the existing account record for the site do not change.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Associating Accounts for Clinical Protocols with Sites
The Accounts view of the Protocols screen is automatically populated with the account records that administrators set up in the Accounts view in the Protocol List view of the Administration - Clinical screen. Also, you can manually add other account records to the Accounts view of the Protocols screen.You can associate the account records in this view with specific sites.
To associate the accounts for a clinical protocol with sites
Navigate to the Protocols screen, then the Protocol List view.
In the Protocol list, drill down on the protocol number field of the protocol for which you want to associate accounts with sites.
Navigate to the Accounts view.
Select the accounts that you want to associate with sites.
Click Apply To Sites.
In the dialog box of site records applicable to the protocol, select the appropriate sites, and click OK.
Associating Accounts for Clinical Regions with Sites
The Accounts view of the Regions screen is automatically populated with the account records that administrators set up in the Accounts view in the Region List view of the Administration - Clinical screen. Also, you can manually add other account records to the Accounts view of the Regions screen.You can associate the account records in this view with specific sites.
To associate the accounts for a clinical region with sites
Navigate to the Regions screen, then the Region List view.
In the Region list, drill down on the Region field of the region for which you want to associate accounts with sites.
Navigate to the Accounts view.
Select the accounts that you want to associate with sites.
Click Apply To Sites.
In the dialog box of site records applicable to the region, select the appropriate sites, and click OK.
Associating Activities with Sites
You can associate activities for a clinical protocol and for a clinical region with sites.
After you complete this task, the activity records appear in the Activities view in the Protocol Site List view of the Site Management screen. The activity records originate in the Activities view in the Protocol List view of the Protocols screen or in the Activities view in the Region List view of the Regions screen. In these Activities views, you can change the field values in the activity records.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Associating Activities for Clinical Protocols with Sites
You can associate activity records for a clinical protocol with specific sites.
Each time you click the Apply To Sites button in the procedure in this topic, new activity records for the selected sites appear in the Activities view in the Protocol Site List view of the Site Management screen. These new activity records contain any changed field values in the originating activity records in the Activities view in the Protocol List view of the Protocols screen.
Also, these new activity records have no values in the First Name field and Last Name field, and not the values in these same fields in the originating activity records, because you must manually add the contacts who are associated with a site in the activity records for the site.
To associate the activities for a clinical protocol with sites
Navigate to the Protocols screen, then the Protocol List view.
In the Protocol list, drill down on the protocol number field of the protocol for which you want to associate activities with sites.
Navigate to the Activities view.
Select the activities that you want to associate with sites.
Click Apply To Sites.
In the dialog box of site records applicable to the protocol, select the appropriate sites, and click OK.
Associating Activities for Clinical Regions with Sites
You can associate activity records for a clinical region with specific sites.
Each time you click the Apply To Sites button in the procedure in this topic, new activity records for the selected sites appear in the Activities view in the Protocol Site List view of the Site Management screen. These new activity records contain any changed field values in the originating activity records in the Activities view in the Region List view of the Regions screen.
Also, these new activity records have no values in the First Name field and Last Name field, and not the values in these same fields in the originating activity records, because you must manually add the contacts who are associated with a site in the activity records for the site.
To associate the activities for a clinical region with sites
Navigate to the Regions screen, then the Region List view.
In the Region list, drill down on the Region field of the region for which you want to associate activities with sites.
Navigate to the Activities view.
Select the activities that you want to associate with sites.
Click Apply To Sites.
In the dialog box of site records applicable to the region, select the appropriate sites, and click OK.
Associating Documents with Sites
You can associate documents for a clinical protocol and for a clinical region with sites.
After you complete this task, the document records appear in the Document Tracking view in the Protocol Site List view of the Site Management screen. The document records originate in the Document Tracking view in the Protocol List view of the Protocols screen or in the Document Tracking view in the Region List view of the Regions screen. In these Document Tracking views, you can change the field values in the document records.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Associating Documents for Clinical Protocols with Sites
You can associate document records for a clinical protocol with specific sites.
Each time you click the Apply To Sites button in the procedure in this topic, new document records for the selected sites appear in the Document Tracking view in the Protocol Site List view of the Site Management screen. These new document records contain any changed field values in the originating document records in the Document Tracking view in the Protocol List view of the Protocols screen.
To associate the documents for a clinical protocol with sites
Navigate to the Protocols screen, then the Protocol List view.
In the Protocol list, drill down on the protocol number field of the protocol for which you want to associate documents with sites.
Navigate to the Document Tracking view.
Select the documents that you want to associate with sites.
Click Apply To Sites.
In the dialog box of site records applicable to the protocol, select the appropriate sites, and click OK.
Associating Documents for Clinical Regions with Sites
You can associate document records for a clinical region with specific sites.
Each time you click the Apply To Sites button in the procedure in this topic, new document records for the selected sites appear in the Document Tracking view in the Protocol Site List view of the Site Management screen. These new document records contain any changed field values in the originating document records in the Document Tracking view in the Region List view of the Regions screen.
To associate the documents for a clinical region with sites
Navigate to the Regions screen, then the Region List view.
In the Region list, drill down on the Region field of the region for which you want to associate documents with sites.
Navigate to the Document Tracking view.
Select the documents that you want to associate with sites.
Click Apply To Sites.
In the dialog box of site records applicable to the region, select the appropriate sites, and click OK.
Creating and Managing Site Visits
CRAs (clinical research associates) typically carry out the following types of visits to a site:
Site evaluation. A site visit to evaluate a site’s qualification for a study
Site initiation. A site visit to initiate a site
Site monitoring. A site visit to monitor study progress and to monitor and retrieve CRFs (case report forms)
Site close-out. A site visit to close out or terminate a site at the conclusion of a study
Unscheduled. (Optional) An unexpected site visit that a CRA can carry out
CRAs create these visits for each site for which they are responsible. When a CRA creates a site visit, it appears in the CRA’s calendar, the site investigator’s calendar, and the study manager’s calendar. Consequently, the study manager can keep track of all site visits for all CRAs. The calendar entry is a useful reminder for investigators of scheduled site visits.
You create site visits using the Protocol Site List view of the Site Management screen. From this view, CRAs can view all their site visits and all follow-up activities that arise from the visits. You can also view all site visits and follow-up activities associated with these visits. Study managers can also filter site visits to see the visits that are assigned to their teams, and view follow-up activities to assess the most pressing issues.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To create a site visit
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field for the site with which you want to create a visit.
Navigate to the Site Visits view.
Create a new record and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Visit Name
Type a descriptive name for the visit.
Visit Start
Select the date and time that the visit is due to occur. When you drill down on this field, you see the trip report for the visit.
Visit Status
Select the status of the site visit.
Trip Report Completed
Select the date that the trip report for this visit is complete.
Trip Report Status
Select the status of the trip report. The following values are available:
Not Started
In Progress
Completed
Submitted
Approved
Rejected
A preconfigured state model allows for a structured state transition. For more information about trip reports, see Administering and Using Clinical Trip Reports
Assigned To
Select the user ID of the person assigned to the site visit.
Monitoring Site Visits Using the Calendar
You can monitor all CRA (clinical research associate) visits to a site from the Calendar view. Use the calendar to view visits on a daily, weekly, or monthly basis.
Managing Contacts for Sites
A contact is a person working at a clinical site. Contacts include investigators, typically medical professionals who are also researchers, and site coordinators, who might be the practicing nurses administering the treatment plan according to the clinical protocol.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Associating Sites with Contacts
A record for the contact that you select in the PI Last Name field of the site record is automatically created in the Contacts view of the site. This record is automatically populated with a value of Principle Investigator in the Role field. You can associate the site with additional contacts.
To associate a site with a contact
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site that you want to associate with a contact.
Navigate to the Contacts view.
In the Current list, create a new record and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Role
Select the role of the contact. The Principle Investigator value for this field is automatically populated for the principle investigator of the site. In the Contacts view, you cannot change this value, or assign this value to another contact. To change the principle investigator for the site, you change the value in the PI Last Name field of the form for the site record.
Last Name
Select the last name of the contact. When you click the select button in this field, the Pick Contacts dialog box appears. Click the Affiliated Contacts button in this dialog box to view only those contacts who are affiliated with the account for the site. After you populate this field, you cannot change its value.
Start Date
Select the date that the contact record is effective. You can select a past date, but not a future date.
Archiving Contact Records for Sites
Instead of deleting inactive contact records, you archive these records so that you can view the history of contact records for the site. You cannot delete contact records for sites. When you archive an inactive contact record, you move the record from the Current view for site contacts to the History view for site contacts.
To archive the contact records for a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to archive contact records.
Navigate to the Contacts view.
Select one or more contact records to archive.
Click Archive, and complete the following steps:
In the Archive dialog box that appears, select the date that the contact record is inactive.
You can select a past date, but not a future date.
Click OK.
The contact record is moved from the Current view for site contacts to the History view for site contacts, and the date that you select appears in the End Date field of the History view.
Viewing the History of Contacts at Sites
If you change the value in the Role field for a site contact to assign a new role to the contact, then the contact record with the prior Role field value is automatically moved to the History view for the site contact. However, if you change the value in another field for a site contact, then the contact record with the prior field value is not automatically moved to this History view.
When you archive an inactive contact record, the record from the Current view for site contacts is automatically moved to the History view for site contacts.
To view the history of contacts at a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to view the history of contacts.
Navigate to the Contacts view.
The Current list of contacts for the site appears.
Navigate to the History view to see the history of contacts.
Some fields are described in the following table.
Field
Comments
Start Date
Displays the date that the contact record is effective.
End Date
Displays the date that the contact record is archived.
Adding Address Types for Sites
Users can add a specific type of addresses for each site.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To add an address type for a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to add an address type.
Navigate to the Addresses view.
In the Addresses list, create a new record and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Description
Type a description for the address.
Address Type
Select an address type from the list of values to associate with the site.
Address Line 1
Select the appropriate site location from the MVG (multi value group).
Assigning Employees to Site Teams
CRAs (clinical research associates) assign employees to the site team. You can roll up the team members and make them visible at the region and protocol levels.
Before you can add an employee to the site team, an administrator must set up the employee record. For more information, see Siebel Security Guide.
You can also automatically assign an employee to the site team using the Position Rollup button or Position Rolldown button. For more information, see Automatically Assigning Team Members Using the Position Rollup and Rolldown Buttons. For more information about removing employees from the site team, see About Removing Team Members From the Team of a Site.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To assign employees to the site team
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, select the site to which you want to add employees.
Edit the Team field of the site record.
The employees are added to the site team. You also roll up the employees to the region and protocol levels.
Creating Activity Plans for Sites
An activity plan for a site is a list of activities and documents associated with the site.
Although you can create activities without a template, using a clinical protocol site template as described in this topic makes creating activities for sites more efficient. For more information, see Creating Clinical Protocol Site Templates.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To create an activity plan for a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site to which you want to assign activities.
Navigate to the Activity Plans view.
In the Activity Plans list, create a new record and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Planned Start
Select the date and time to start the activity plan. Make sure that this date is correct before you choose a template. The due dates for the template-generated activities are based on this start date and on the lead time in the template.
Template
Select the template for the activity plan. Only templates with a type of Clinical Protocol Site and with a protocol that matches the protocol at the site are available for selection.
Only activities with type of Document or Site-Initiation appear in the document tracking views.
Lock Assignment
Select this field as necessary. If the activity is locked, then Assignment Manager cannot access it. If it is unlocked, then Assignment Manager can reassign it.
Edit the activities in the Activities list or create more activities.
Note: To view additional fields in this list, click Menu (the cogwheel icon) and select Columns Displayed.Some fields are described in the following table.
Field
Comments
Expected Date
Select the expected date for the activity. For document tracking, this field denotes date that the site is expected to return the signed document.
Sent Date
Select the sent date for the activity. For document tracking, this field denotes the date that you send the document to the site.
Received Date
Select the received date for the activity. For document tracking, this field denotes the date that the site returns the signed document.
Expiration Date
Select the expiration date for the activity. When you enter a date in this field, the Status field is automatically set to Done.
Status
Select the status of the activity. When you set this field to Done, the Completed Date field is automatically set to the current date.
Suppress Calendar
Select this field to indicate that the activity does not appear on the user’s calendar.
Applying Activity Templates to Sites
You can simultaneously apply one or multiple activity templates to one or multiple sites for a study. Activity records with a type of Document and Site-Initiation appear in the Document Tracking view of the Site Management screen. Activity records with a type of Correspondence appear in the Activities view of the Site Management screen.
The applied templates also appear in the Activity Plans view of the Site Management screen for each of the selected sites.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Applying Activity Templates to Sites in a Region
Complete the procedure in this topic to simultaneously apply one or multiple activity templates to multiple sites in a region.
To simultaneously apply one or multiple activity templates to multiple sites in a region
Navigate to the Regions screen, then the Region List view.
In the Region list, drill down on the Region field of the region to which you want to apply an activity template.
In the Sites view, select the sites to which you want to apply an activity template.
Click Apply Template.
From the Templates dialog, select one or multiple activity templates that you want to apply to the selected site, and click OK.
Applying Activity Templates to Sites in a Protocol
Complete the procedure in this topic to simultaneously apply one or multiple activity templates to multiple sites in a protocol.
To simultaneously apply one or multiple activity templates to multiple sites in a protocol
Navigate to the Protocols screen, then the Protocol List view.
In the Protocol list, drill down on the protocol number field of the protocol to which you want to apply an activity template.
Navigate to the Sites view.
In the Sites list, select the sites to which you want to apply an activity template.
Click Apply Template.
From the Templates dialog, select one or multiple activity templates that you want to apply to the selected site, and click OK.
Tracking and Adding Documents at Sites
During a clinical trial, CRAs (clinical research associates) collect and track numerous documents, including critical regulatory documents. CRAs can take advantage of the activity plans to generate a list of documents for tracking. In the document tracking views, they can also create their own lists of activities to track important dates.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Tracking Documentation Milestones
Complete the procedure in this topic to track documentation milestones.
To track documentation milestones
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to track documentation.
Navigate to the Document Tracking view.
A list of documents associated with the clinical trial appears.
Query for the appropriate document and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Activity
Displays a value of Document by default.
Name
Type the name of the document. This field is a hypertext link to the Attachments view.
Sent Date
Select the date that you send the document to the site.
Expected Date
Select the date that the site is expected to return the signed document.
Received Date
Select the date that the site returns the signed document.
Expiration Date
Select the date that the document expires.
Assigned To
Select the user ID of person assigned responsibility for the document.
Lock Assignment
Select this field as necessary. If the activity is locked, then Assignment Manager cannot access it. If it is unlocked, then Assignment Manager can reassign it.
Adding Documents to Sites
Complete the procedure in this topic to add a document to a site.
To add a document to a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to track documentation.
Navigate to the Document Tracking view.
A list of documents associated with the clinical trial appears.
Create a new record and complete the necessary fields.
Step off the record you just added and drill down on the Name field.
The Attachments view appears.
Create a new record and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Type
Displays the type of attachment.
Auto Update.
Select this field if you want to automatically update the file during synchronization. Synchronization applies only to local files. If a file is not local, then it is not updated during synchronization.
Creating Activities for Document Tracking
Users collect numerous documents during clinical trials, either as electronic files or as paper. You must track and periodically update these documents. You can associate documents with sites, regions, protocols, contacts, or accounts.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To create an activity for document tracking
Navigate to the Document Tracking screen.
In the Document Tracking list, create a new record and complete the necessary fields.
Note: You can associate an activity for document tracking with only one of the available tracking levels or entities.Some fields are described in the following table.
Field
Comments
Name
Type the document name.
In the Document Tracking list, you can click the link in this field to navigate to the associated Attachments view.
Site #, Region, Protocol, Contact, or Account.
Select a value in one of these five fields to assign the activity for document tracking to one of these five levels.
In the Document Tracking list, you can click the link the selected field to navigate to the Activities view.
Reviewing, Updating, and Adding Existing Documents for Tracking
Complete the procedure in this topic to review, update, and add existing documents for tracking.
Alternatively, you can create and review activities for document tracking in the Document Tracking view for a site. Similarly, you can create activities for document tracking at the protocol and region levels in the Document Tracking view for the protocol and region.
To review, update, and add existing documents for tracking
Navigate to the Document Tracking screen.
In the Document Tracking list, query for the document you want to update.
Drill down on the Name field of the document.
The associated Attachment view appears.
In the Attachment list, query for the document and drill down on the Name field of the document.
Open, update, and save the document.
Use the thread bar to return to the document record on the Document Tracking list.
Copy the original document record and revise the associated site number, Region, Protocol, Contact, or Account field.
Managing Tracking Activities for Case Report Forms
Users collect numerous CRFs (case report forms) during clinical trials, either as electronic files or as paper. You must track and periodically update these forms. You can associate CRFs with sites, regions, or protocols.
In addition to subject visit records, CRF tracking records are created when you apply a subject visit template.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Viewing Tracking Activities for Case Report Forms
Complete the procedure in this topic to view tracking activities for CRFs (case report forms).
To view tracking activities for a case report form
Navigate to the Document Tracking screen, then the CRF Tracking view.
The CRF Tracking list displays all of the tracking records.
Note: You can associate a tracking activity for a CRF with only one of the available tracking levels or entities.Some fields are described in the following table.
Field
Comments
Name
Displays the name of the subject visit for which you collect CRFs.
Protocol #, Region, or site #
Displays the protocol, region, or site assigned to CRF tracking.
Updating Existing Case Report Forms for Tracking
Complete the procedure in this topic to update existing CRFs (case report forms) for tracking.
Alternatively, you can update activities for CRF tracking from the CRF Tracking view of a site. Similarly, at the protocol and region levels, you can update activities for CRF tracking from the CRF Tracking view.
To update existing case report forms for tracking
Navigate to the Document Tracking screen, then the CRF Tracking view.
In the CRF Tracking list, query for the record you want to update.
Update and save the record.
You can revise the associated site number, Region, and protocol number field.
Tracking Case Report Forms
Users can track CRFs (case report forms) as part of a protocol, site, and region. They capture relevant information for each CRF record within a protocol, site and region. This information includes whether the CRFs are source verified, retrieved from a site, received in-house, or received by a data management process.
When you apply a subject visit template, in addition to creating subject visit records and the child activity records that exist in the current product, a duplicate set of visit records with a Type of Case Report Form are created (with the number of pages that the template specifies). These visit records with the number of CRF pages appear in the CRF Tracking view in the Protocol Site List view of the Site Management screen.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To track case report forms
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to track CRFs.
Navigate to the CRF Tracking view
In the CRF Tracking list, complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Activity
Select the activity associated with the site.
Activity Type
Displays the activity type for the CRF. Only activity records with this activity type appear in this view.
# CRF Pages
Type the number of pages in the CRF.
Retrieved
Select this field if the CRF is retrieved.
Retrieved Date
Select the date and time that the CRF is retrieved.
Received in House
Select the date and time that the CRA (clinical research associate) receives the CRF in house.
Received by Data Management
Select the date and time that a data management process receives the CRF.
Source Verified
Select this field if the CRF is a verified source document.
Source Verified Date
Select the date and time that the CRF is source verified.
Comments
Type relevant comments about the CRF.
Creating Correspondence Activities for Sites
You 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. You can create such activities for multiple sites. This feature provides an easy way to capture all forms of communication between a site and an employee, or between business partners, such as a CRO (clinical research organization) or central laboratory.
For each created correspondence activity, you create an activity record in the Activities view of the Contacts screen for each of the contacts.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Creating Correspondence Activities for Sites
Complete the procedure in this topic to create a correspondence activity for a site.
To create a correspondence activity for a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to create a correspondence activity.
Navigate to the Activities view.
In the Activities list, create a new record and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Activity
Displays a value of Correspondence by default.
Activity Type
Select an activity type. The following values are available:
Case Report Form
Email
Fax
Mail
Phone
Description
Type a brief description for the correspondence activity.
Screen #
Displays the number of screens for the correspondence.
Comments
Type relevant comments about the correspondence activity.
Last Name
Select the last name of the creator of the correspondence activity. This field is a required.
Creating New Role Correspondence for Sites
Complete the procedure in this topic to create a new role correspondence for a site.
To create a new role correspondence for a site
Navigate to the Protocols screen, then the Protocol List view.
In the Protocol list, drill down on the protocol number field of the protocol for which you want to create a new role.
Navigate to the Sites view
In the Sites list, select one or multiple sites to which you want to apply a new role for the correspondence.
Click New Correspondence.
From the Roles of Contacts dialog box, select the role or multi-select the roles that best describe the individual’s role, and click OK.
Creating Partner Correspondence Activities
You can track all correspondence (phone, fax, email, and letters that the postal service delivers) between business partners, such as a CRO (clinical research organization) or central laboratory.
To create partner correspondence activities
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to create a partner correspondence activity.
Navigate to the Activities view.
In the Activities list, create a new record and complete the necessary fields.
Adding Notes to Sites
When you work with site records, you often find that you want to make notes. In the Notes view, you can enter public notes or private notes. Use the link bar in the Notes view to switch between public and private notes. Anyone who can access the record can see a public note. Only the person who creates the note can see a private note.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To add a note to a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to add a note.
Navigate to the Notes view, then the Private Notes view or Public Notes view.
Create a new record and complete the necessary fields.
Some fields are described in the following table.
Field
Comments
Created By Name
Displays your user ID.
Created Date
Displays the system date.
Note Type
Select the type of note. Examples include Exclusion, Pre-existing Condition, Permanent, System, Temporary, Business Description, Regional Plans, and Contracts Process.
Note
Type the note text.
Click Check Spelling to make sure your note has no spelling errors.
Viewing the Status History for Sites
For each site, you can view information about how the Status field changed in the past.
To view the status history for a site
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to view the status history.
Navigate to the Status History view.
Some fields are described in the following table.
Field
Comments
Old Status
Displays the prior value in the Status field for the site record.
New Status
Displays the new value in the Status field for the site record.
Date
Displays the date and time that the prior value changed to the new value.
Employee Login
Displays the ID of the user who changed the Status field for the site record.
Assessing Contacts and Accounts
Assessments allow end users to calculate a single numerical value that expresses the fitness of a contact or account, according to a set of attributes in the assessment template. For example, you can assess an investigator to determine competence to carry out a large scale clinical trial in phase III, or you can assess a hospital to determine suitability to carry out a similar trial. The results of this assessment help CRAs (clinical research associates) find suitable investigators and hospitals for subsequent trials. For more information, see Creating Contact and Account Assessment Templates.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To assess a contact or account
Complete one of the following steps, depending on whether you want to assess a contact or account:
Navigate to the Contacts screen, then the Contacts List view, and in the Contacts list, drill down on the Last Name field of the contact that you want to assess.
Navigate to the Accounts screen, then the Accounts List view, and in the Accounts list, drill down on the Name field of the account that you want to assess.
Navigate to the Assessments view.
In the Assessments list, create a new record.
In the Template Name field, select the assessment template.
For more information, see Creating Contact and Account Assessment Templates.
The other fields in the record are populated when the record is saved.
In the Assessment Attributes list, for each attribute:
Select a value in the Value field of the attribute.
Add or edit comments in the Comment field of the attribute.
Generating Oracle BI Publisher Reports for Document Tracking
You can integrate Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) for generating reports. You can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical. For more information about using Siebel Reports and integrating with Oracle BI Publisher, see Siebel Reports Guide.
The following preconfigured reports apply to clinical document tracking:
Site Document Tracking
Protocol Level Document Tracking
Region Level Document Tracking
Protocol Document Tracking Across Sites
Regional Document Tracking Across Sites
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
Generating Reports for Site Document Tracking
This topic describes how to generate the preconfigured Site Document Tracking report for Oracle BI Publisher.
To generate a report for site document tracking
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to generate an Oracle BI Publisher report.
Navigate to the Document Tracking view.
On the application toolbar, click Reports.
In the Run Report pane, complete the appropriate fields.
Some fields are described in the following table.
Field
Comments
Report Name
Select the Site Document Tracking report.
Output Type
Select the output type for the report.
Click Submit.
The report runs.
Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.
A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.
Generating Reports for Protocol Level Document Tracking
This topic describes how to generate the preconfigured Protocol Level Document Tracking report for Oracle BI Publisher.
To generate a report for protocol level document tracking
Navigate to the Protocols screen, then the Protocol List view.
In the Protocol list, drill down on the protocol number field of the protocol for which you want to generate an Oracle BI Publisher report.
Navigate to the Document Tracking view.
On the application toolbar, click Reports.
In the Run Report pane, complete the appropriate fields.
Some fields are described in the following table.
Field
Comments
Report Name
Select the Protocol Level Document Tracking report.
Output Type
Select the output type for the report.
Click Submit.
The report runs.
Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.
A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.
Generating Reports for Region Level Document Tracking
This topic describes how to generate the preconfigured Region Level Document Tracking report for Oracle BI Publisher.
To generate a report for region level document tracking
Navigate to the Regions screen, then the Region List view.
In the Region list, drill down on the Region field of the region for which you want to generate an Oracle BI Publisher report.
Navigate to the Document Tracking view.
On the application toolbar, click Reports.
In the Run Report pane, complete the appropriate fields.
Some fields are described in the following table.
Field
Comments
Report Name
Select the Region Level Document Tracking report.
Output Type
Select the output type for the report.
Click Submit.
The report runs.
Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.
A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.
Generating Reports for Protocol Document Tracking Across Sites
This topic describes how to generate the preconfigured Protocol Document Tracking Across Sites report for Oracle BI Publisher.
To generate a report for protocol document tracking across sites
Navigate to the Site Management screen.
On the application toolbar, click Reports.
In the Run Report pane, complete the appropriate fields.
Some fields are described in the following table.
Field
Comments
Report Name
Select the Protocol Document Tracking Across Sites report.
Output Type
Select the output type for the report.
Click Submit.
The report runs.
Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.
A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.
Generating Reports for Regional Document Tracking Across Sites
This topic describes how to generate the preconfigured Regional Document Tracking Across Sites report for Oracle BI Publisher.
To generate a report for regional document tracking across sites
Navigate to the Site Management screen.
On the application toolbar, click Reports.
In the Run Report pane, complete the appropriate fields.
Some fields are described in the following table.
Field
Comments
Report Name
Select the Regional Document Tracking Across Sites report.
Output Type
Select the output type for the report.
Click Submit.
The report runs.
Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.
A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.
Generating Reports for Actual Visits
This topic describes how to generate the preconfigured Actual Visits report for Oracle BI Publisher. This report lists the completed subject visits for a site.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To generate a report for actual visits
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to generate an Oracle BI Publisher report.
On the application toolbar, click Reports.
In the Run Report pane, complete the appropriate fields.
Some fields are described in the following table.
Field
Comments
Report Name
Select the Actual Visits report.
Output Type
Select the output type for the report.
Click Submit.
The report runs.
Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.
A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.
Generating Reports for Planned and Actual Dates of Subject Visits
This topic describes how to generate the preconfigured Planned vs Actual Patient Dates report for Oracle BI Publisher. This report lists the planned and completed subject visit dates for a site.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To generate a report for planned and actual dates of subject visits
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to generate an Oracle BI Publisher report.
On the application toolbar, click Reports.
In the Run Report pane, complete the appropriate fields.
Some fields are described in the following table.
Field
Comments
Report Name
Select the Planned vs Actual Patient Dates report.
Output Type
Select the output type for the report.
Click Submit.
The report runs.
Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.
A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.