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values | text
stringclasses 212
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|---|---|---|---|---|---|---|---|
PI Last Name
|
Select the last name of the principal investigator for the site.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
No Subject Info
|
Select this field to indicate that no subject information is available for a site. Only summary information about subject enrollment is available for such a site. 36
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Versions
|
Read-only field.The version of the subject visit template, which is inherited from the parent site. Only one version can be active at a time. The active template is used when activities are generated for a subject. For more information about protocol versions, see Tracking and Revising Team Assignment History
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
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.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Paid To Date
|
Displays the amount of money that you paid to date to the investigators.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Earned To Date
|
The amount of money that investigators earned to date. Activate for Synchronization Select this field to activate the site for synchronization. This field is required for integration with Oracle Health Sciences InForm. When this field is checked, a new integration object for the protocol site is sent to Oracle Health Sciences InForm. The integration object creates the site in Oracle Health Sciences InForm, or updates the site, if it already exists. This field is read-only until the following conditions are met: ◦ The Synchronize Active Study Sites field of the protocol is set to true. ◦ The Primary Site Address field is populated.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Primary Site Address
|
Select the primary address for the site. This field sets the primary location of the site for the study in Siebel Clinical. The Addresses dialog box displays all addresses for the site. This field is required for integration with Oracle Health Sciences InForm, and populates the site address when the site is created in Oracle Health Sciences InForm. 42
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Satellite Site Number
|
Type the number to assign to the satellite site.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
PI First Name
|
The first name of the principal investigator for the site (read-only field). # Planned Subjects Type the number of planned subjects for the protocol.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Site Initiated
|
The date the satellite site was created. This field is blank by default.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Site Terminated
|
The date the satellite site was terminated. This field is blank by default. 40
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Satellite Site Count
|
Displays the number of satellite sites associated with this site. 8. Assign subject visits to the satellite site as follows: a. Navigate to the Subjects view. b. Create a new Subject record and complete the necessary fields. c. Drill down on the Screening # field. d. Create a new Visit Plan record and complete the necessary fields. Some fields are shown in the following table. For more information about subjects visits, see Defining Subject Visits.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Assigned To
|
Select the users assigned to the trip report. The team member who creates the trip report is the primary owner.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Sequence
|
Type the sequence number of the visit. Typically, the first visit has a sequence number of 1.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Name
|
Type the name of the version of the training plan.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Clinical Region
|
Clinical Remove Position From Site
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Assessment
|
Type in the name of the template.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Clinical Protocol
|
SWI LS Clinical Create Site Visit Geo
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Order
|
(Read-only) Displays the order number for the question when you save the assessment template record. Administrators set up the order number for each question when they set up the template.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Category
|
Select the type of training applicable to the training topic.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Technology
|
◦ Data Collection, CRF source ◦
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Endpoints
|
◦ Organization Experience ◦ Investigational Product/Study Medication ◦ IP Logistics/Supply Chain ◦
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Weight
|
(Read-only) Displays the weight for the attribute when you save the assessment template record. Administrators set up the weight for each attribute when they set up the template. This field is essentially ranks the importance of the category. If all categories have a default value of 1.0, then all categories are of equal importance.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Considerations
|
Type in any additional information relevant to the assessment question that should also be considered. Any information that you enter in this field automatically appears on screen (for example, as a tool tip) when the user places the mouse over the respective question during an assessment. 4. In the Question Values list, create records to further describe the assessment questions you created in the previous step, and complete the necessary fields as shown in the following table.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Value
|
Select the value that applies to the option that you select in the Type field. For Impact and Probability, the values available are: ◦ High (3) ◦ Medium (2) ◦ Low (1) For Detectability, the values available are: ◦ Difficult to detect 3) ◦ Medium to detect (2) ◦ Easy to detect (1)
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Score
|
Displays the sum of the Weight field multiplied by the Score field for the assessment attributes that are associated with the template. This field is populated after you assign values to assessment attributes.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Template Name
|
Select a template that includes the appropriate attributes to assess the program, protocol, region, or site.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Updated
|
Displays the date and time that the field was modified. 160
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Percent
|
Displays as a percentage the result of the Score field for the template divided by the Maximum Score field for the template. This field is populated after you assign values to assessment attributes.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Maximum Score
|
Displays the highest score possible for the template that you select. For each assessment attribute in the template, the Weight field is multiplied by the highest value possible in the Score field. The sum of these results is the maximum score for the template. 4. In the Assessment Questions list, enter a value for each question to assess the program, protocol, region, or site in the clinical trial. Some fields are described in the following table.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Impact
|
Select an impact value for the question, which can be one of the following: ◦ High (3) ◦ Medium (2) ◦ Low (1) This value determines the impact of the individual risk on the trial.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Probability
|
Select a probability value for the question, which can be one of the following: ◦ High (3) ◦ Medium (2) ◦ Low (1) This value determines the probability of occurrence of the individual risk.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Detectability
|
Select a detectability value for the question, which can be one of the following: ◦ Difficult to detect 3) ◦ Medium to detect (2) ◦ Easy to detect (1) The higher the detectability of individual risk, the lower the overall risk to the trial
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Risk Score
|
(Read-only) Displays the risk assessment score for the individual question. Individual risk scores are calculated automatically from the values in the following fields: Impact, Probability, Detectability, Weight. The default formula for calculating individual risk score is product of Impact, Probability, Detectability and Weight.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Risk Level
|
Select a value that specifies the type of risk assessment template, which can be one of the following: ◦
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Rationale
|
If required, type in any explanatory information to capture the rationale for category risk level assessment. 49
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Functional Impact
|
Select a functional impact value for the attribute, which can be one of the following: ◦ Medical Monitoring Plan ◦
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Data Plan
|
◦ Statistical Analysis Plan ◦
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Communication Plan
|
This field highlights the specific functional plans that might be impacted by this assessment.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Mitigation
|
If required, type in the mitigation actions or plans for categories with the highest category risk score. 50
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Administering Clinical Subjects and Clinical Visits
|
To monitor status accruals for clinical subjects by visit type 1. Navigate to the Protocols, Regions, or Site Management screen. 2. In the list, select the record for which you want to create the charts. 3. Navigate to the Charts view. 4. Select values from the drop-down lists as follows: a. From the first drop-down list, select Subject Status Analysis. b. From the second drop-down list, select Subject Accruals. c. From the third drop-down list, select the time frame. d. From the fourth drop-down list, select the display type, such as bar chart or pie chart. 5. Click Go. Using Audit Trail for Changes to Subject Status The Status Audit Trail view provides a detailed history of the changes to Subject Status records, including the dates and times of the changes and details of the users who make the changes. To use the audit trail for changes to subject status 1. Navigate to the Subjects screen, then the Subject List view. 2. In the Subject list, drill down on the screening number field of the subject. 3. Navigate to the Status Audit Trail view. Some fields are described in the following table.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Version
|
The version number of the trip report.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Obsolete
|
When you create a new version of the subject visit template, the Status field is populated with a value of In Progress.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Change Summary
|
Type a summary of changes to the version of the subject visit template. Defining Subject Visits This topic describes how to define subject visits in a subject visit template. 53
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Visit Type
|
The type of site visit.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
End of Study
|
You can add, modify, or delete values for the Visit Type field.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Planned
|
Select this field to define a subject visit as a planned visit. This field is selected by default.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Status Tracking Visit
|
Select this field to enable automatic tracking of the status in the Subject Status MVG (multi value group) for each visit type. You can set only one visit as the status tracking visit for each visit type. For example, if TreatmentPhase1, TreatmentPhase2, and TreatmentPhase3 clinical visits exist for a Treatment visit type, then you can set only TreatmentPhase3 as the status tracking visit. When you select the Status Tracking Visit field for a visit, the following status records are automatically created in the Subject Status MVG when each predefined visit type is processed: ◦ A Visit Type value of Screening creates a Screened status record in the Subject Status MVG. ◦ A Visit Type value of Re-Screening creates a Re-screened status record in the Subject Status MVG. ◦ A Visit Type value of Enrollment creates an Enrolled status record in the Subject Status MVG. ◦ A Visit Type value of End of Study creates a Completed status record in the Subject Status MVG. You can manually override the automatic value in the Subject Status MVG. Any create, update, or delete operations on the tracked status fields trigger automatic create, update, and delete operations in the Subject Status MVG. Automatic status tracking is not enabled for custom values in the Visit Type list. 54
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Lead
|
Type the lead time from the start date. You define the start date in the Schedule Date field when scheduling the subject.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Lead Units
|
Select the units for the lead time.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Min
|
Type the time before the lead time that the visit can occur. For example, if Min is 1 and Min/Max Units is days, then the visit can occur one day before the scheduled date. Do not leave this field empty.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Max
|
Type the time after the lead time that the visit can occur. For example, if Max is 2 and Min/Max Units is days, then the visit can occur up to two days after the scheduled visit. Do not leave this field empty. Min/Max Units Select the units for the Min and Max values. Do not leave this field empty. # CRF Pages Type the number of CRF (case report form) pages.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Withdrawn
|
The Subject record automatically updates as follows: • A record with a Status field value of Withdrawn is added to the Subject Status MVG, and the value in the Withdrawn Date field is copied to the Date field of the Subject Status MVG. • The Status field is updated to Withdrawn. When a Screen Failure or Early Terminated event occurs, all remaining visits for the subject are deleted. For more information, see the LS Subject Terminate Study Status Value 1 user property in User Properties for Business Components in Siebel Clinical. Applying Protocol Amendments to Sites and Clinical
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Duration
|
Type an estimate of the numeric value for the time that is needed to complete the training topic. 176
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Payment Flag
|
Select this field to indicate that you pay the investigator for this activity. This flag is selected by default. For more information about payments, see Setting Up and Making Clinical Payments 56
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Payment Amount
|
Type the standard amount that you pay the investigator for this activity. You can adjust this amount for each site or each individual. Approving Subject Visit Templates Setting the status of a subject visit template to approved sets the subject visit template as read-only. You can modify only the Approved Date field of an approved subject visit template. To approve a clinical subject visit template 1. Navigate to the Administration - Clinical screen, then the Visit Templates view. 2. In the Template Versions list, select the version of the template to approve. 3. Enter the date in the Approval Date field. 4. Select Approved in the Status field. About Automatic Tracking of Subject Status This topic describes the fields that the mechanism for automatically tracking subject status uses, and the automatic operations that they trigger in the Subject Status MVG (multi value group). The Subject Status MVG contains a history of the subject’s status. It contains the following fields. • Date. The date that users change or update the status. • Status. The status of the subject, for example, Screened, Enrolled, or Re-screened. • Primary. A flag that sets the current status. This field appears in the Status field of the Subjects view. • Comments. Comments about the subject status. • Visit Type. The type of clinical subject visit, such as Screening or Enrollment. This field is null for status records, such as Randomized and Withdrawn. Status Tracking Fields that Trigger Create and Delete Operations on Records in Subject Status MVG The following table lists the status tracking fields that trigger create and delete operations on the records in the Subject Status MVG. The records in the Subject Status MVG are automatically updated as follows: • Populating a status tracking field listed in the following table automatically creates the corresponding status record in the Subject Status MVG, including Status, Date, and Visit Type fields, where applicable • Deleting a status tracking field listed in the following table automatically deletes the entire corresponding status record in the Subject Status MVG, including the Status, Date, and Visit Type fields, where applicable. 57
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Status Tracking Field
|
Field of Subject Status MVG Automatically Updated Creating Records for Clinical Subjects CRAs (clinical research associates) can enter information about clinical subjects. When they create the subject record, the subject visit template that is active for the site is used to set up a schedule of visits and activities for the subject. To create a record for a clinical subject 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site to which you want to add a subject. 3. Navigate to the Subjects view. 4. In the Subjects list, create a new record and complete the necessary fields. Some fields are shown in the following table.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Completed
|
The end user completed the trip report, and it is ready for the end user to submit for review.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Override Status
|
Status field in the Subject Status MVG is updated to Missed, or the status value in the Visit Plans list for that visit. 58
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Subject Status MVG
|
The following table lists the status tracking fields that trigger update operations on the Date and Status fields of the Subject Status MVG. The fields of the Subject Status MVG are automatically updated as follows: • Populating or updating a status tracking field listed in the following table automatically triggers an update to the corresponding Date or Status field value in the Subject Status MVG. • Deleting a status tracking field listed in the following table automatically triggers a delete operation on the corresponding Date or Status field value in the Subject Status MVG.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Randomized Date
|
Select the date that you randomize the subject into an arm of the trial. 6. Save the record. The Subject record automatically updates as follows: ◦ A Randomized status record is added to the Subject Status MVG (multi value group), and the value in the Randomized Date field is copied to the Date field of the Subject Status MVG. ◦ The Status field is updated to Randomized. Overriding Initial Subject Status You can override the initial subject status for a status tracking clinical visit by selecting a new status in the Override Status field. For example, for a status tracking clinical visit with a Missed value, you can subsequently set the Override Status field to Completed. 65
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Screen Failure Date
|
Displays the date that the subject fails screening. 5. Click Schedule. The Schedule applet is launched. 6. Select a date in the Schedule Date field, and click OK. The subject visits record updates as follows: ◦ All the visits in the active subject visit template are copied to the Visit Plans list. ◦ The Visit Type, Name, Start Date, Planned, Status Tracking Visit, and Status fields are copied from the subject visit template. ◦ The planned dates and due dates are calculated using the lead time in the subject visit template and the start date in the Schedule Date field. The planned dates and due dates are calculated as follows: planned or due date equals schedule date plus lead time. Note: You can also schedule subjects through workflows. Set the Enroll Screen Rescreen Through WorkFlow user property to true to execute the schedule subject tasks in workflows instead of executing these tasks through applets and business component methods. If the Enroll Screen Rescreen Through WorkFlow user property is set to true, then workflows in other user properties are executed according to context. You can change workflow names to execute custom workflows. You can also modify other workflows and business service methods according to your needs. For more information about the Enroll Screen Rescreen Through WorkFlow user property, see User Properties for Business Components in Siebel Clinical. 61
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Withdrawn Date
|
Displays the date that the subject withdraws from the clinical trial.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Early Terminated Date
|
Displays the date that the subject’s participation in the trial terminates.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
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pdf
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glossary.json
| null | null |
Completed Date
|
Select the resolution date and time of the follow-up issue. You must populate this field because the filter in the All Follow-Up Items list uses this date to determine the closed follow-up items to show. 6. Set the Trip Report Status field to Submitted. The report is submitted to the reviewer for review. Completing Questionnaires for Clinical Trip Reports This topic describes how to complete a questionnaire for a clinical trip report. You launch the questionnaire in the SmartScript player from the Questions view of the trip report. Questions and responses along with comments (if any) are saved in the Questions list. To complete a questionnaire for a clinical trip report 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for the required trip report. The Trip Report form for the selected site visit appears. 147
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"clinical-trial-management-system-guide.pdf"
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Subject ID
|
Type a unique identifier for the subject.
|
[
"clinical-trial-management-system-guide.pdf"
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Encounter Date
|
Select the date that the subject first registers for the trial. Screening # Displays the screening number for the subject. This field is automatically generated from the Subject ID field and the Encounter Date field. The screening number is automatically generated after you enter the Subject ID field and the Encounter Date field, and save the record.
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[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
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Enrollment ID
|
Type the principal ID number for the subject.
|
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"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
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glossary.json
| null | null |
Randomization ID
|
Type an ID number for the subject, which you can use in randomized studies where both an enrollment ID and a randomization ID are required. Informed Consent Dates Select the date that the subject signs the informed consent form for participation in the clinical trial. You must obtain informed consent prior to initiation of any clinical screening procedures.
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"clinical-trial-management-system-guide.pdf"
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clinical-trial-management-system-guide.pdf
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pdf
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glossary.json
| null | null |
Screen Failure Reason
|
Select the reason the subject fails screening.
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"clinical-trial-management-system-guide.pdf"
] |
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Withdrawn Reason
|
Select the reason the subject withdraws from the clinical trial. Early Termination Reason Select the reason the subject’s participation in the trial terminates early. The following values are available: ◦
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
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glossary.json
| null | null |
Lost to Follow-Up
|
◦ Non-Compliance with Study Drug ◦
|
[
"clinical-trial-management-system-guide.pdf"
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clinical-trial-management-system-guide.pdf
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glossary.json
| null | null |
Screen Failure
|
The Subject record automatically updates as follows: 69
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"clinical-trial-management-system-guide.pdf"
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Not Done
|
Scheduling Clinical Subjects Scheduling a subject applies the activated subject visit template. You enter a single start date for all subject visit types in the Schedule Date field. 60
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"clinical-trial-management-system-guide.pdf"
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Fixed Date
|
The remaining subject visit dates are rescheduled using the date in the Reschedule applet. Last Completed Visit Date The remaining subject visit dates are rescheduled using the delay between Planed Date and Completed Date for the last completed visit. The rescheduled dates for the planned dates and due sates are calculated as follows: Planned or Due Date equals Planned Date or Due Date plus Delay Administering Subject Visits in Batch Mode The Visit Types view displays the subject visit plan by visit type. Each distinct visit type for the subject appears in the Visit Types applet, with a read-only field indicating whether or not each visit type is planned for the subject. Associated 62
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"clinical-trial-management-system-guide.pdf"
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Random ID
|
Type the ID number assigned to the subject for the randomized trial.
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"clinical-trial-management-system-guide.pdf"
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clinical-trial-management-system-guide.pdf
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glossary.json
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Missed
|
5. For a completed visit, enter the completion date in the Completed Date field. Transferring Clinical Subjects The subject transfer feature allows you to manage the transfer of subjects from one study site to another, with options to retain the subject’s visit data and also the destination study site’s visit template. During subject transfers, the payment exceptions from the destination site are applied and the payment data is recalculated. A history of all subject transfers is tracked at the subject and the site level. To ensure more robust data audit trails, you can no longer delete subjects and sites. To transfer clinical subjects 1. Navigate to the Subjects screen, then the Subject List view. 2. In the Subject list, select the subject that you want to transfer. 3. Click Transfer to open the Transfer applet. 4. In the Transfer applet, complete the fields as shown in the following table.
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[
"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
| null | null |
Informed Consent Date
|
Select an informed consent date if prompted.
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"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
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Scheduled Date
|
The start date for the destination site’s clinical subject visits.
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[
"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
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Reason
|
Select a reason for the subject transfer from the Reason drop-down list.
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"clinical-trial-management-system-guide.pdf"
] |
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Transfer Date
|
The date of the subject transfer. 5. If the destination site’s Subject Visit Template version differs from the originating site, then you are prompted with a message similar to the following: Would you like to delete uncompleted visits from the old version and completed visits from the new version? Click OK to confirm the deletion of non applicable visits. After confirmation, the subject transfer process completes, new visits and payment exceptions are applied as defined by the destination site, and the transfer history for the subject and the site is updated accordingly. For more information, see Viewing Subject Transfer Information for Clinical Subjects and Sites. Viewing Subject Transfer Information for Clinical
|
[
"clinical-trial-management-system-guide.pdf"
] |
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Subjects and Sites
|
The Transfer History and Subject Transfer History views show all the subject transfer information for subjects and sites respectively. To view subject transfer information for clinical subjects and sites 1. View the subject transfer information for a subject as follows: a. Navigate to the Site Management screen, then the Protocol Site List view. b. Drill down on the Site # field of the site that you want. c. Navigate to the Subjects view. d. Drill down on the Screening # field of the subject for which you want to view subject transfer information. The Visits view of the Subjects screen appears showing the Visit Plans. e. Navigate to the Transfer History view. The Transfer History view appears showing all subject transfers against the subject. The view includes the following information for each subject transfer: Source Site Name, Destination Site Name, Transfer Date, Transferred By, Status at Transfer, Description. 2. View the subject transfer information for a site as follows: a. Navigate to the Site Management screen, then the Protocol Site List view. b. Drill down on the Site # field of the site for which you want to view subject transfer information. c. Navigate to the Subject Transfer History view. The Subject Transfer History view appears showing all subject transfers against the site as follows: - The Subject In applet lists all subject visits transferred to the site. 67
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"clinical-trial-management-system-guide.pdf"
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Done
|
Select the date that the visit occurred.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
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glossary.json
| null | null |
Done Flag
|
Select this field to indicate that the visit occurred.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
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glossary.json
| null | null |
Calendar Planned
|
Select the date and time that the subject visit is due. This field value is automatically populated in the Due field.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
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glossary.json
| null | null |
Lock Assignment
|
Lock the assignment as required by selecting this field. 4. If required, click the plus (+) icon to create additional activity plans. 5. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 6. If required, click Cancel at any time to cancel the task. 7. Click the check box next to each activity plan that you want to associate with the site and then click Submit to submit the task - that is, create the activity plan(s) for the site. Creating Activity Plans for Existing Protocols The following procedure shows how to create activity plans for existing protocols using Siebel Clinical task-based UI. To create an activity plan for an existing protocol 1. Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical. 2. Click Other Protocol Tasks in the Task Pane applet. 3. Select the record that you want in the Protocols list and then click Next. 4. Select Yes for Activity Plans and then click Next. 5. Enter activity plan details on the page that appears - all fields are described Creating Activity Plans for Sites. 6. If required, click the plus (+) icon to create additional activity plans. 7. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 8. If required, click Cancel at any time to cancel the task. 9. Click the check box next to each activity plan that you want to associate with the protocol and then click Submit to submit the task - that is, create the activity plan(s) for the protocol. Creating Activity Plans for Existing Regions 197
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"clinical-trial-management-system-guide.pdf"
] |
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Early Terminated
|
You can track additional custom subject statuses by configuring additional values for this property type. This property takes the following comma-delimited list of parameters: "[Business Component Field Name]", "[DateField]", "[Status Value" • [Business Component Field Name] is the name of the business component field that is tracked for automatic status tracking, for example, Randomization ID. • [Date Field] is the name of the corresponding date field that is tracked for automatic status tracking, for example, Randomized Date. • [Status Value] is the corresponding status value that is tracked for automatic status tracking, for example, Randomized. Status Tracking Field 1
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"clinical-trial-management-system-guide.pdf"
] |
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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 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. 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. 3. In the Protocol Site list, drill down on the site number field of the site record. 4. Navigate to the Subjects view. 5. In the Subjects list, create a new record and complete the necessary fields as shown in the following table. For more information, see Creating Records for Clinical Subjects. Alternatively, you can select an existing subject record to update it.
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"clinical-trial-management-system-guide.pdf"
] |
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| null | null |
Early Termination
|
In addition to automatically deleting non-applicable visits for protocol amendments, visits that are scheduled and deemed non-applicable by early termination are deleted. Visits that are not scheduled through a template are not deleted. The following rules apply to deleting the appropriate visits: 1. Delete non-applicable, scheduled visits after a subject terminates the study. When the Status field of a subject is changed to Early Terminated and the Early Terminated date is populated, all future visits are deleted. Future visits are visits with a Due date and an Early Terminated date. 2. Delete non-applicable, scheduled visits after a subject fails screening. When the Status field of a subject is changed to Screen Failure and the Screen Failure date is populated, all future visits are deleted. Future visits are visits with a Due date and a Screen Failure date. About Rolling Up Information for Subject Enrollment Siebel Clinical supports clinical organizations in better managing subject enrollment for their trials in real-time. To implement this tracking, subject information is rolled up from the site level to the region level and then to the protocol level or directly from the site level to the protocol level. However, frequently this data is not available to the clinical organization, which presents significant business challenges. For example, if organizations out source trials to CROs (clinical research organizations), then the clinical organizations cannot always receive subject level information. The enhanced subject rollup functionality provides accurate subject enrollment data at the region and protocol level, when subject level information is not available for each site or region. Characteristics of Trials Where Subject Level Data is Available for
|
[
"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
| null | null |
Each Site
|
Trials, for which subject level information is available for each site, display the following rollup characteristics: • Subject enrollment information is automatically rolled up from the subject level to the site level, from the subject level to the region level, and from the subject level to the protocol level. • When a subject is the first subject to enroll for a site, region, or protocol, the date in the First Subject Enrolled field for that site, region, or protocol, is automatically populated. 73
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"clinical-trial-management-system-guide.pdf"
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for Each Site
|
Trials, for which subject level information is not available for a site, display the following characteristics: • You can select the No Subject Info field for sites that do not have subject level information. • CRAs (clinical research associates) can enter information in the following fields for sites that do not have subject or site level information: ◦ # Screened ◦ # Re-Screened ◦ # Screen Failure ◦ # Enrolled ◦ # Completed ◦ # Early Terminated ◦ First Subject Enrolled ◦ Last Subject Off Study ◦
|
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"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
| null | null |
Terminated Date
|
◦ First Site Initiated Date ◦ Last Site Terminated Date • Information that you manually for regions without site data is rolled up in the same manner as the information for regions with subject data. Viewing Status Accruals for Clinical Subjects of Sites Clinical subject data is automatically rolled up to the clinical site record. The Status Field RollUp user properties determine the criteria for the automatic rollup of subject status accruals to the clinical site record. For more information about these user properties, see User Properties for Business Components in Siebel Clinical. You must select the Status Tracking Visit field (in the Visits list in the Visit Templates view of the Administration - Clinical screen) to automatically create subject status accruals for pairs of a visit type value and a subject status value. For more information about the Status Tracking Visit field, see Defining Subject Visits. The task in this topic describes how to view subject status accruals for each visit type and subject status of a clinical site. To view status accruals for clinical subjects of a site 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to view subject accruals. 3. Navigate to the Subject Status Accruals view. Some fields are described in the following table.
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"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
| null | null |
Total Accrual Number
|
Displays the number of current and past subject status accruals that are automatically created for the site visit.
|
[
"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
| null | null |
Regions
|
The Payments view of the Regions screen is automatically populated with the existing payment records for the sites that are associated with the region. These payment records apply to the complete payment activities for those sites. In this view, you can generate payment records for complete, unpaid payment activities for the sites in the region. To generate payment records for sites associated with a clinical region 1. Navigate to the Regions screen, then the Region List view. 2. In the Region list, drill down on the Region field of the region for which you want to generate payment records for sites. 3. Navigate to the Payments view. If payment records exist in this view, then the selected payment record is irrelevant to this procedure. 4. Click Generate Payment. A dialog box of site records applicable to the region appears. Your system administrator can set the Popup Visibility Type property to configure the records that appear in this dialog box. For more information about this property, see Applet Properties in Siebel Clinical. 5. In the dialog box of site records applicable to the region, select the appropriate sites, and click OK. The complete payments are removed from the Payment Activities view in the Protocol Site List view of the Site Management screen. Payment records for each unique contract, account and payee combination are generated in the Payments view in the Protocol Site List view of the Site Management screen. You must again access the Payments view in the Region List view of the Regions screen to view the generated payments. For the protocol that is associated with the selected sites, the generated payments also appear in the Payments view in the Protocol List view of the Protocols screen. 6. (Optional) To access a notification containing details about the payment generation, click Notification on the menu toobar. Your system administrator can set the WF properties to configure notifications for bulk payments. For more information about these properties, see Applet Properties in Siebel Clinical. For more information about using notifications, see Siebel Fundamentals Guide . Generating Payment Records for Unplanned Payment
|
[
"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
| null | null |
Protocols
|
The Payments view of the Protocols screen is automatically populated with the existing payment records for the sites that are associated with the protocol. These payment records apply to the complete payment activities for those sites. In this view, you can generate payment records for complete, unpaid payment activities for the sites in the protocol. To generate payment records for sites associated with a clinical protocol 1. Navigate to the Protocols screen, then the Protocol List view. 2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to generate payment records for sites. 3. Navigate to the Payments view. If payment records exist in this view, then the selected payment record is irrelevant to this procedure. 4. Click Generate Payment. A dialog box of site records applicable to the protocol appears. Your system administrator can set the Popup Visibility Type property to configure the records that appear in this dialog box. For more information about this property, see Applet Properties in Siebel Clinical. 5. In the dialog box of site records applicable to the protocol, select the appropriate sites, and click OK. The complete payments are removed from the Payment Activities view in the Protocol Site List view of the Site Management screen. Payment records for each unique contract, account and payee combination are generated in the Payments view in the Protocol Site List view of the Site Management screen. You must again access the Payments view in the Protocol List view of the Protocols screen to view the generated payments. For the region that is associated with the selected sites, the generated payments also appear in the Payments view in the Region List view of the Regions screen. 6. (Optional) To access a notification containing details about the payment generation, click Notification on the menu toobar. Your system administrator can set the WF properties to configure notifications for bulk payments. For more information about these properties, see Applet Properties in Siebel Clinical. For more information about using notifications, see Siebel Fundamentals Guide . 134
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"clinical-trial-management-system-guide.pdf"
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| null | null |
Employee Login
|
Displays the username of the user who changed the record.
|
[
"clinical-trial-management-system-guide.pdf"
] |
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|
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glossary.json
| null | null |
Business Component
|
Displays the business component for the record where the database change occurred.
|
[
"clinical-trial-management-system-guide.pdf"
] |
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|
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glossary.json
| null | null |
Field
|
Displays the name of the field where the change occurred.
|
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"clinical-trial-management-system-guide.pdf"
] |
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glossary.json
| null | null |
Operation
|
Displays the type of operation that was performed, for example, New Record, or Modify.
|
[
"clinical-trial-management-system-guide.pdf"
] |
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|
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glossary.json
| null | null |
Old Value
|
Displays the value in the field before the database change occurred.
|
[
"clinical-trial-management-system-guide.pdf"
] |
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|
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|
glossary.json
| null | null |
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