Managing Partial Source Data Verification

This chapter covers how to manage partial source data verification. It includes the following topics:

About Partial Source Data Verification

To ensure that all of the data collected during the clinical trial is complete, accurate, and verifiable, companies use SDV (source data verification). This key process involves many on-site visits and verification of all the data in the CRF (case report form).

The number of clinical trials is growing, and these trials are becoming more complex. Also, regulatory agencies are more closely monitoring the drug approval process. Consequently, the cost of these trials is drastically rising, and companies and CROs (clinical research organizations) face challenges in keeping budget and time issues for trials under control. Consequently, more companies and CROs are adopting risk based monitoring for their clinical trials. Risk based monitoring moves from the traditional methods involving 100% or complete SDV to PSDV (partial source data verification). It introduces strategic on-site monitoring that is based on risks and assessments about important aspects of clinical trials.

For PSDV, you plan the SDV process by using statistical and historical information about the clinical sites and the involved personnel and about events that occur at various points in the clinical trial. This planning involves decisions at various levels of the clinical trial. Some information included in partial source verification follows:

Percentage of CRFs to verify
Specific CRFs to verify
Specific pages of the CRFs to verify
Adverse events at specific points in the clinical trial

Setting Up Partial Source Data Verification for Clinical Protocols

This topic describes how to set up PSDV (partial source data verification) for clinical protocols. You set up this verification by entering PSDV values in some fields when you create a record for a clinical protocol. These values are automatically populated in the same fields for all of the regions and sites that you associate with the clinical protocol. However, you can change these automatically populated values.

If you update the PSDV values in the fields of a clinical protocol, then the updated values are not automatically populated in the same fields of the regions and sites that are already associated with the clinical protocol. If you associate new regions and sites with the clinical protocol, then the updated values are automatically populated in the same fields of the new regions and sites.

If you update the value (from Complete to Partial) in the SDV Policy field for a site that is associated with the clinical protocol, then the PSDV values in the fields of the clinical protocol are automatically populated in the same fields of the site.

To set up partial source data verification for a clinical protocol

Navigate to the Administration - Clinical screen, then the Protocol List view.
In the Protocol list, create a new record and complete the necessary fields.
For more information, see Setting Up Clinical Protocols.
Alternatively, you can select an existing protocol record to update it.
In the Protocol list, drill down on the protocol number field of the protocol record.
Navigate to the More Info view.

Scroll down to the Partial Source Data Verification section and complete the PSDV fields.

The PSDV fields are described in the following table.

Field	Comments
Number of Initial Subjects	Type the number of initial subjects with CRFs (case report forms) to completely verify.
Subject Auto-Select Rate	For the total number of subjects less the number of initial subjects, type the percentage with CRFs that are part of SDV (source data verification).

Setting Up Partial Source Data Verification for Clinical Regions

This topic describes how to set up PSDV (partial source data verification) for clinical regions. You set up this verification by entering PSDV values in some fields when you create a record for a clinical region. These values are automatically populated in the same fields for all of the sites that you associate with the clinical region. However, you can change these automatically populated values.

If you update the PSDV values in the fields of a clinical region, then the updated values are not automatically populated in the same fields of the sites that are already associated with the clinical region. If you associate new sites with the clinical region, then the updated values are automatically populated in the same fields of the new sites.

If you update the value (from Complete to Partial) in the SDV Policy field for a site that is associated with the clinical region, then the PSDV values in the fields of the clinical region are automatically populated in the same fields of the site.

To set up partial source data verification for a clinical region

Navigate to the Administration - Clinical screen, then the Region List view.
In the Region list, create a new record and complete the necessary fields.
For more information, see Setting Up Clinical Regions. Alternatively, you can select an existing region record to update it.
In the Region list, drill down on the Region field of the region record.
Navigate to the More Info view.

Scroll down to the Partial Source Data Verification section and complete the PSDV fields.

The PSDV fields are described in the following table.

Field	Comments
Number of Initial Subjects	Type the number of initial subjects with CRFs (case report forms) to completely verify.
Subject Auto-Select Rate	For the total number of subjects less the number of initial subjects, type the percentage with CRFs that are part of SDV (source data verification).

Setting Up Partial Source Data Verification for Subject Visit Templates

This topic describes how to set up PSDV (partial source data verification) for subject visit templates. You set up this verification by entering PSDV values in some fields when you create a record for a subject visit template. These values are automatically populated in the same fields for all of the CRF (case report form) tracking records that are associated with the subject visit template.

To set up partial source data verification for a subject visit template

Navigate to the Administration - Clinical screen, then the Visit Templates view.
In the Subject Visit Templates list, create a new record and complete the necessary fields.
For more information, see Creating Subject Visit Templates.
Alternatively, you can select an existing subject visit template record.
Scroll down to the Template Versions list, create a new record and complete the necessary fields.
For more information, see Defining Versions for Subject Visit Templates.
Alternatively, you can select an existing version record.

Scroll down to the Visits list, create a new record and complete the necessary fields.

Alternatively, you can select an existing visit record to update it.

The PSDV fields are described in the following table.

Field	Comments
SDV Required	Select this field if SDV (source data verification) is necessary for the subject visit associated with the template.
Page Numbers to Verify	Type the page numbers of the CRF that are included in PSDV. If SDV is necessary for all the CRF pages, then enter All Pages. This field provides information to CRAs (clinical research associates) when they review CRFs, and does not affect processing in Siebel Clinical Trial Management System.

Setting Up Partial Source Data Verification for Sites

This topic describes how to set up PSDV (partial source data verification) for sites. You set up this verification by entering PSDV values in some fields when you create or update a record for a site.

To set up partial source data verification for a site

Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, create a new record and complete the necessary fields.
For more information, see Creating Sites for Clinical Trials.
Alternatively, you can select an existing site record to update it.
In the Protocol Site list, drill down on the site number field of the site record.
Navigate to the More Info view.

Scroll down to the Integration section and the Partial Source Data Verification section and complete the PSDV fields.

The PSDV fields are described in the following table.

Field	Comments
Use CDMS Auto-Select Rule	If you use an integrated CDMS (clinical data management system), such as Oracle Health Sciences InForm, then select this field to indicate that the PSDV fields in the site record are not used in PSDV. In this scenario, the SDV Required field for the appropriate subject records is populated from the CDMS. Clear this field to indicate that the PSDV fields in the site record are used in PSDV. When you save the record after you select this field, the SDV Policy field is automatically populated with a value of External. This field is disabled until you complete the following tasks in the designated order: Integrate Oracle Health Sciences InForm studies with Siebel clinical. For more information, see Overview of Clinical Data Management System Integration. Select a value in the Primary Site Address field in the Integration section. You set up selectable addresses in the Addresses view of the Site Management screen. Select the Activate for Synchronization field in the Integration section.
SDV Policy	Select the policy for SDV (source data verification). Valid values include Complete, Partial, and External. The default value is Complete. When the value is Complete, all of the subjects associated with the site record are part of complete SDV, and the SDV Required field in those subject records is set to Yes.
Number of Initial Subjects	Type the number of initial subjects with CRFs (case report forms) to completely verify. You can change this field only if the SDV Policy field has a value of Partial. If the protocol or region record that is associated with this site already has a value in this same field, then that value is automatically populated in this field. However, you can change this automatically populated value.
Subject Auto-Select Rate	For the total number of subjects less the number of initial subjects, type the percentage with CRFs that are part of SDV. You can change this field only if the SDV Policy field has a value of Partial. If the protocol or region record that is associated with this site already has a value in this same field, then that value is automatically populated in this field. However, you can change this automatically populated value.
Total Subjects Requiring SDV	Displays the number of subjects who are included in SDV. This field is read-only. The calculation of this field value follows: (Number of Initial Subjects) plus [(Total Subjects in the Site Pool) less (Number of Initial Subjects) times Subject Auto-Select Rate] For more information about this field, see Recalculating Clinical Subjects Requiring Source Data Verification.
Total Subjects in Site Pool	Displays the number of subjects in the site pool. This field is read-only.

Setting Up Partial Source Data Verification for Clinical Subjects

This topic describes how to set up PSDV (partial source data verification) for clinical subjects. You set up this verification by entering PSDV values in some fields when you create or update a record for a clinical subject.

To set up partial source data verification for a clinical subject

Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, create a new record and complete the necessary fields.
For more information, see Creating Sites for Clinical Trials.
Alternatively, you can select an existing site record.
In the Protocol Site list, drill down on the site number field of the site record.
Navigate to the Subjects view.

In the Subjects list, create a new record and complete the necessary fields.

For more information, see Creating Records for Clinical Subjects.

Alternatively, you can select an existing subject record to update it.

The PSDV fields are described in the following table.

Field	Comments
SDV Required	Displays an indication of whether SDV (source data verification) is necessary for the CRFs (case report forms) of the subject. The value in this field can change in the following ways: Manual. You can manually change the field value. To change the field value, drill down on the screening number field of the subject record to navigate to the subject form. Site. The field value can be automatically populated using the PSDV field values of the site record that is associated with the subject record. If the value in the SDV Policy field for the associated site record is Complete, then the SDV Required field for the subject record is Yes. If the value in the SDV Policy field for the associated site record is Partial, then the SDV Required field for the subject record can be Yes or No. The value depends on the other PSDV field values. Status. This field can be automatically populated when a status rule set exists for the Status field of the subject record. If such a rule set exists, then this field is automatically populated with a value of Yes or No. To set up this status rule set in Siebel Tools, enter values in the SDV Subject Status user properties of the Clinical Subject business component. For example, enter the following value in the SDV Subject Status 1 user property: `"Early Terminated","Adverse Effect","Y"`. Then enter the following value in the SDV Subject Status 2 user property: `"Screen Failure","", "Y"`. In this example, if a subject terminates a study early because of an adverse effect, or if a subject fails screening, then the SDV Required field is automatically populated with a value of Yes. Set the CL Highest Preference SDV Rule system preference to determine the priority order in which to implement these 3 methods (Manual, Site, and Status) to change the SDV Required field of a subject record. For more information, see System Preferences in Siebel Clinical.
SDV Last Updated Source	Displays the reason for the value in the SDV Required field. This field is read-only. It can have the following values: Site. The value in the SDV Required field is the result of the PSDV fields of the site record that is associated with the subject record. The subject records with this value are included in the site pool. Subject Status. The value in the SDV Required field is the result of a status rule set for the Status field of the subject record. The subject records with this value are included in the status pool. Manual. The user selected the value in the SDV Required field for the subject record. The subject records with this value are included in the subject pool. External. The value in the SDV Required field is the result of incoming data from an integrated CDMS (clinical data management system).

Field

Comments

SDV Required

Displays an indication of whether SDV (source data verification) is necessary for the CRFs (case report forms) of the subject. The value in this field can change in the following ways:

Manual. You can manually change the field value. To change the field value, drill down on the screening number field of the subject record to navigate to the subject form.
Site. The field value can be automatically populated using the PSDV field values of the site record that is associated with the subject record.
If the value in the SDV Policy field for the associated site record is Complete, then the SDV Required field for the subject record is Yes.
If the value in the SDV Policy field for the associated site record is Partial, then the SDV Required field for the subject record can be Yes or No. The value depends on the other PSDV field values.
Status. This field can be automatically populated when a status rule set exists for the Status field of the subject record. If such a rule set exists, then this field is automatically populated with a value of Yes or No.
To set up this status rule set in Siebel Tools, enter values in the SDV Subject Status user properties of the Clinical Subject business component.
For example, enter the following value in the SDV Subject Status 1 user property: "Early Terminated","Adverse Effect","Y". Then enter the following value in the SDV Subject Status 2 user property: "Screen Failure","", "Y". In this example, if a subject terminates a study early because of an adverse effect, or if a subject fails screening, then the SDV Required field is automatically populated with a value of Yes.

Set the CL Highest Preference SDV Rule system preference to determine the priority order in which to implement these 3 methods (Manual, Site, and Status) to change the SDV Required field of a subject record. For more information, see System Preferences in Siebel Clinical.

SDV Last Updated Source

Displays the reason for the value in the SDV Required field. This field is read-only. It can have the following values:

Site. The value in the SDV Required field is the result of the PSDV fields of the site record that is associated with the subject record. The subject records with this value are included in the site pool.

Subject Status. The value in the SDV Required field is the result of a status rule set for the Status field of the subject record. The subject records with this value are included in the status pool.

Manual. The user selected the value in the SDV Required field for the subject record. The subject records with this value are included in the subject pool.

External. The value in the SDV Required field is the result of incoming data from an integrated CDMS (clinical data management system).

Viewing Case Report Forms for Partial Source Data Verification

This topic describes how to view the CRFs (case report forms) applicable to PSDV (partial source data verification). During a site visit, CRAs (clinical research associates) do not review all CRFs and all pages on those CRFs. The field values for PSDV in the subject visit template that is associated with the site visit determine the information that appears in the PSDV fields of CRFs. The CRA restricts the review to the information in these PSDV fields.

To view the case report forms for partial source data verification

Complete one of the following steps:
1. Navigate to the Site Management screen, then the Protocol Site List view, and drill down on the site number field of the site record in the Protocol Site list.
2. Navigate to the Protocols screen, then the Protocol List view, and drill down on the protocol number field of the protocol record in the Protocol list.
3. Navigate to the Regions screen, then the Region List view, and drill down on the Region field of the region record in the Region list.
4. Navigate to the Document Tracking screen.

Navigate to the CRF Tracking view.

The PSDV fields are described in the following table.

Field	Comments
SDV Required	Displays an indication of whether SDV (source data verification) is necessary for the site visit. This field is read-only, and automatically populated from the value of the same field in the subject visit template that is associated with this CRF tracking record.
Page Numbers to Verify	Displays the page numbers of the CRF that are included in PSDV. This field is read-only, and automatically populated from the value of the same field in the subject visit template that is associated with this CRF tracking record.

Field

Comments

SDV Required

Displays an indication of whether SDV (source data verification) is necessary for the site visit.

This field is read-only, and automatically populated from the value of the same field in the subject visit template that is associated with this CRF tracking record.

Page Numbers to Verify

Displays the page numbers of the CRF that are included in PSDV.

This field is read-only, and automatically populated from the value of the same field in the subject visit template that is associated with this CRF tracking record.

Tracking Case Report Forms for Partial Source Data Verification During Site Visits

This topic describes how to track the CRFs (case report forms) for PSDV (partial source data verification) during a site visit. During a site visit, CRAs (clinical research associates) do not review all CRFs and all pages on those CRFs. The field values for PSDV in the subject visit template that is associated with the site visit determine the information that appears in the PSDV fields of CRFs. The CRA restricts the review to the information in these PSDV fields.

To track the case report forms for partial source data verification during a site visit

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to track case report forms for partial source data verification.
Navigate to the Case Report Forms Tracking view.
To add case report forms for scheduled subject visits, complete the following steps:
1. Click Add Scheduled.
2. Select the subject visits in the dialog box that appears.
3. Click OK.
  The case report forms for selected subject visits appear in the Case Report Forms Tracking view. For a description of the PSDV fields that appear in this view, see Viewing Case Report Forms for Partial Source Data Verification.
To add case report forms for unscheduled subject visits, complete the following steps:
1. Click Add Unscheduled.
2. Select the subject visits in the dialog box that appears.
3. Click OK.
  The case report forms for selected subject visits appear in the Case Report Forms Tracking view. For a description of the PSDV fields that appear in this view, see Viewing Case Report Forms for Partial Source Data Verification.

Complete the necessary fields in the case report forms.

Some fields are described in the following table.

Field	Comments
Source Verified	Select this field when you verify the CRF against the source document.
Retrieved	Select this field when you retrieve the CRFs from the site.
Page Numbers Verified	Type the CRF page numbers that you verify.
Charts Reviewed Date	Select the date and time that you review the clinical charts.
Forms Signed Date	Select the date and time that you sign the CRFs.

Recalculating Clinical Subjects Requiring Source Data Verification

If you change the value in the Number of Initial Subjects field or the Subject Auto-Select Rate field of a site record, then you must recalculate the value in the Total Subjects Requiring SDV field of that site record.

If you change the number of subjects in the site pool by changing the value in the SDV Required field of the site’s subject records, then you must recalculate the value in the Total Subjects Requiring SDV field of the site record. If you change the number of subjects in other pools, such as the subject pool and the status pool, then you do not have to recalculate the value in Total Subjects Requiring SDV field because these other pools are not included in the calculation of this field. For more information about pools, see Setting Up Partial Source Data Verification for Clinical Subjects.

To recalculate the subjects requiring source data verification

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 a site record.
Navigate to the More Info view.
Click Reapply Auto-Select Rate.
If the value in the Number of Initial Subjects field or the Subject Auto-Select Rate field changed, then the value in the Total Subjects Requiring SDV field is recalculated, and this recalculation considers the subjects in the site pool.

About Partial Source Data Verification for Protocol Amendments

When you change a subject visit template, you create a new version of that template. This new version results in a protocol amendment. When you apply the protocol amendment to the subjects, the following processing occurs:

The subject visits that are no longer valid are deleted.
CRF (case report form) records associated with the subject visits are deleted.
New subject visits are created.
New CRFs are created with values for PSDV (partial source data verification) fields from the latest version of the subject visit template.
For CRFs that already have values for PSDV fields, new CRFs are also created. The values for fields that are not available in the subject visit template are copied from the prior CRFs to the new CRFs, and the values for PSDV fields are copied from latest version of the subject visit template to the new CRFs.
Activities are created according to the protocol amendment.