| Oracle® Clinical Creating a Study Release 4.6.2 E18820-01 |
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PDF · Mobi · ePub |
| Oracle® Clinical Creating a Study Release 4.6.2 E18820-01 |
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PDF · Mobi · ePub |
This chapter describes defining sites, Investigators, and patient positions, and assigning them to a study. A study may already have sites assigned at the planning level (see "Maintaining Site Records").
This chapter describes the following tasks:
Oracle Clinical refers to the locations where patients receive treatment as sites. You create site records, then you assign them to studies. A study site is a site that has been assigned to a study. Like Investigator records, site records are not restricted to particular studies.
You can create site records from the Maintain Study Sites window. A study site record is independent of study associations: you can assign a site to any studies. To create a site record, from the Design menu, select Investigators and Sites, and select Sites. You can change site records until you designate a site record as active.
The Site Code value can be up to ten characters, and must be unique within a domain. The system determines the owning location. The Name field can be up to 60 characters in length. Select the Active box when you are ready to make the site record available for assignment to studies.
You can assign sites to a study from the Maintain Study Sites window. From the Design menu, select Investigators and Sites, then choose Study Sites. In this window you can describe in detail how to employ the site in your study. This window is also the starting point for assigning Investigators and patient positions to a study.
Note:
If you are using the Oracle Clinical - Siebel Clinical integration for your study you do not need to define study sites. The definition is populated automatically from Siebel Clinical.If you have already selected a study during a session, the system takes it by default. If you intend to work on another study, be sure to change studies first. If you have not selected a study during this session, the system first presents a Select a Study dialog box. The system then displays all of the site records currently assigned to the selected study.
To add a site assignment to a study, use the list function to select another site in a new record row. The system populates most of the fields. Leave the Study Site field blank to force the system to generate the code value for you.
As a convenience, the Study Sites window has buttons that take you to related windows in the system. These extra buttons are:
Site Details Displays the address and owning database. (Defined in the Maintain Sites window. See "Creating Site Records" for details.)
Assignments Clicking this button takes you directly to the Maintain Investigators window, where you can assign Investigators to a site by selecting from a list of active Investigators. (See "Assigning Investigators to Study Sites" for more information about this window.)
Patients You can link a study's patient positions to a site. Select the Assign? box for each existing patient position to assign to the selected study site code. The system populates all other fields.
New Patients Assign patient positions codes to a site by range. Enter the number of patients and the start number. Then click the Assign Patients button to assign them to the study site.
As with sites, you can create general records to represent the Investigators who are responsible for collecting data at the sites in any study.
To create and maintain an Investigator record, work in the Maintain Investigators window. From the Design menu, select Investigators and Sites, then choose Investigators. In the Investigators window you can create, update, or delete Investigator records. See the next section for assigning an Investigator to a study site—a site assigned to a particular study.
Note:
If you are using the Oracle Clinical - Siebel Clinical integration for your study you do not need to define Investigators. The definitions are populated automatically from Siebel Clinical.Note:
If you are using the Oracle Clinical - Siebel Clinical integration for your study you do not need to assign Investigators to study sites. The assignment is imported automatically from Siebel Clinical.A study site has exactly one Investigator in charge; however, that assignment can change over time, and a single Investigator might be responsible for several sites. To assign an Investigator to a site:
From the Design menu, select Investigators and Sites, then choose Study Sites. The system displays all sites associated with the selected study.
Select a site.
Click the Assignments button. The system displays a history of Investigator assignments to the selected site, if any. Use the list function to select an Investigator record.
Enter an Investigator code. You can use the list function to locate a particular Investigator.
Enter information regarding the assignment like start and end dates, and the number of patients required.
Save. The system designates the new Investigator as current, removing that designation from the Investigator previously in that position.
To view details about a particular Investigator, click the Investigator Details button. (See "Creating Investigator Records" for more information).
This section describes the following Patient Position maintenance tasks:
Patient positions are codes that represent the people you enroll in a study. They are used as the unique ID for patients enrolled in a study.
To see consolidated information about the patient positions in a study, navigate to the Design menu, select Patient Positions, then Patients, and then click the Patient Positions button.
You can create patient position code assignments that end in consecutive, system-generated numbers, or you can use your own format.
Use the Create and Delete Patient Positions window to create multiple patient positions at once, with codes that are either entirely numerical or that have a single character at the beginning.
To specify the number of patient positions to create:
From the Design menu, select Patient Positions, then select Create/Delete Patients.
Select the study to modify, if necessary.
Click the Create Positions button.
The system displays the current Screening, Patients, and Replacement patient positions assigned to the study on the left side of the window.
On the right side of the window, make sure the Location to Own Patients is correct. For each grouping of patient positions:
Specify the number of patient positions to create in the Number to Create field.
Specify the code assignment of the first patient position to create in the Start [Scr|Repl] Patient field.
You can specify just a number, or you can add an optional single-letter alphabetical prefix such as S for Screening patients and R for Replacements, or the code name of the study or site. The system generates consecutive integers, appended to your prefix, if any. For example:
| Current Number | Number to Create | Start Patient | Positions Created |
|---|---|---|---|
| 0 | 5 | 1 | 1, 2, 3, 4, 5 |
| 0 | 5 | R1 | R1, R2, R3, R4, R5 |
Click the Create Positions button.
Click the Back button.
If you enter a patient code that is already in use, the system returns an error.
If any patient position has a patient code that matches a treatment code on a treatment assignment, the system links them. The system reports how many Screening, Normal, and Replacement patient positions it creates.
To display the existing patient position blocks in a study, from the Design menu, select Studies, choose Easy Design, and click the Display PP button. To display individual patient position details, from the Design menu, select Patient Positions, and choose Patients (Patient Positions button). Oracle Clinical generates the patient position codes in each block, incrementing each successive code by one. The system displays an alert upon completion of the task.
Use the Alpha Patient Codes window to create patient position codes if the Oracle Clinical-generated codes do not conform to your organization's coding format. You can create codes of mixed characters and numbers with a maximum length of 10. You must create patient positions one at a time.
Note:
The only way to delete patients positions with alpha codes is by selecting one patient at a time in this window and choosing Delete Record from the Data menu.From the Design menu, select Patient Positions, then select Alpha Patient Codes.
Select the study to modify, if necessary.
Click the Patient Positions button. The system displays all existing patient positions, including site/Investigator assignments.
From the Data menu, choose Insert Record.
Enter the new patient position code in the column labeled Patient. The code can have up to ten characters. You must enter the complete patient position code. The system does not append anything.
Select the Scr? box to designate the patient position as a Screening position.
Select the Repl? box to designate the patient position as a Replacement position.
You can assign the position to a site in this window. Use the list function to select a study site.
If you assign the patient position to a site, you can use the list function to assign an Investigator from this site.
Repeat Steps 4-9 as often as necessary to enter all the patient positions you need.
Save.
This section describes several approaches to assigning patient positions to sites. Since only one Investigator can be in charge of a site for a particular study, by assigning a patient position to a study site, you also assign it to an Investigator. You can make this assignment from two different environments in Oracle Clinical:
To assign patient positions to sites and Investigators:
From the Design menu, select Investigators and Sites, then choose Study Sites.
Select the study, if necessary.
Click the Patients button. The system displays the current patient positions and their site assignments.
Assign the patient positions to the site by selecting the Assign? box.
Save.
From the Design menu, select Patient Positions, then select Study Site Relations.
Select the study, if necessary.
Click the Patients button. The system displays the existing patient positions available to the site.
Assign the patient positions to the site by selecting the Assign? box.
Save.
You can also assign a range of positions to a study site. To select a range of patient positions or screening patient positions to link to the selected study site:
From the Design menu, select Patient Positions, then choose Study Site Relations.
Click the Sites button.
Select the study site.
Click the Patient Ranges button. The left side of the window displays the current state of the system and refreshes each time you make a change.
Define the treatment range on the right side of the window.
Click the Assign Patients button. The system removes the instructions as it acts on them.
If you are replicating data among many locations, you must create all patient positions required for a study at the study-owning location. However, users at other locations can use only patient positions that are owned by their location. You must therefore change the ownership of the patient positions required by all other locations.
After you assign a patient position to a non-study-owning location, you cannot change its owning location again unless you first reassign it to the study-owning location; see "Retrieving Patient Positions".
To change a specified number of patient positions from the current location to another:
From the Design menu, select Patient Positions, then select Create/Delete Patients.
Select the study to modify, if necessary.
Click the Change Owning Location button.
The system displays the current Screening, Patients, and Replacement patient positions assigned to the study on the left side of the window. On the right side of the window, for each grouping of patient positions, enter:
the number of patient positions to change in the Number to Update field.
the starting assignment code of the first patient position in the Start field.
Click the Change Owning Location button.
If you are replicating data among many locations, the study-owning location controls the assignments of all patient positions. If a patient position owned by a different location must change ownership, the study-owning location must reclaim, or retrieve, ownership of the patient position first. This utility is only available at the study-owning site.
To retrieve patient positions, from the Design menu, select Patient Positions, then select Retrieve Patients.
Use the list function to select the site that currently owns the patient position. The system populates the Source Study Title field.
Use the list function to select the study that owns the patient position. If there is only one study at that site, the system populates the field for you.
Click the Retrieve Patients button.
Save.
You can delete a patient position only if its patient enrolled date is not set, and no received DCIs exist for the patient. If you delete a patient position, the system breaks any links to treatment assignments or study sites.
To view existing patient positions, from the Design menu, select Patient Positions, then choose Patients.
You can delete multiple patient positions, including those with an alphabetical prefix, at the same time if:
they were generated by the system (not created individually in the Alpha Patient Codes window)
they are sequential
If the patient positions have alpha codes, you must delete them one by one in the Alpha Patient Codes window (see "Deleting Alpha Code Patient Positions").
To delete system-generated patient positions:
From the Design menu, select Patient Positions, then select Create/Delete Patients.
Select the study to modify, if necessary.
Click the Delete Positions button.
The system displays the current Screening, Normal, and Replacement patient positions assigned to the study on the left side of the window.
On the right side of the window, for each grouping of patient positions, specify:
the number of patient positions to delete in the Number to Delete field.
the code of the first patient position to delete in the Number to Delete Start field.
Click the Delete Positions button.
If necessary, repeat this process for patient positions not included in these sequences.
To delete patient positions with user-specified alpha codes (see "Creating Patient Positions with User-Defined Codes"), you must go to the Alpha Patient Codes window and delete them one at a time:
From the Design menu, select Patient Positions, and choose Alpha Patient Codes [Patient Positions].
Select the patient position you want to delete.
From the Data menu, choose Delete Record.
Repeat Steps 3 and 4 as many times as necessary to delete all the patient positions you need to delete.
Save.
Patient positions are codes that represent the people you enroll in a study. They are used as the unique ID for patients enrolled in a study. You enroll a patient in a study by entering any of the following data against a patient position:
Patient enrollment date
Patient's last name
Patient's initials
Patient's data of birth
Note:
Although Patient Initials and Date of Birth are optional in Oracle Clinical, you may want to make a policy to always enter them because they are required by Oracle Clinical Labs functionality and by Siebel Clinical; see Chapter 15, "Lab Ranges" and Chapter 18, "Integrating with a Clinical Trial Management System".You can do this several ways, including:
During study design in the Maintain Patient Positions window; see "Adding Patient Position Details".
As a batch job; see "Batch Load Patient Enrollment Dates"
During initial login and data entry in Oracle Clinical; this is covered in Oracle Clinical Conducting a Study.
During data entry in Oracle Clinical Remote Data Capture; this is covered in Oracle Clinical Remote Data Capture Onsite User's Guide and Oracle Clinical Remote Data Capture Classic Data Entry User's Guide .
Using a derivation Procedure that reads the response value of a Question defined for the purpose of collecting the enrollment date and populates the value of the PATIENT_ENROLLMENT_DATE column in the PATIENT_POSITIONS table with the value.
You can also view enrollment information in Labs, Lab Assignment Criteria, View Patient Positions; see "Missing Data in Patient Positions".
The system requires that you update the PATIENT_STATUS_CODE column of the PATIENT_STATUSES table to determine when patients are enrolled in a study for the purpose of the enrollment form and reports. You can define additional patient statuses and update them as appropriate for each user if you want to; see "Maintaining Patient Statuses".
To enroll patients in a study you must associate them with a patient position. You can do this in the Maintain Patient Positions window. To access the Maintain Patient Positions window, from the Design menu, select Patient Positions, then Patients, and then click Patient Positions. If necessary, select a study from the Special menu.
The Maintain Patient Positions window displays the patient positions that are owned by your location. The following fields are display-only:
Patient: A unique code for an existing patient position.
Scr'ing?: (Screening) If selected, the patient position was created for a Screening patient.
Repl-ment?: (Replacement) If selected, the patient position was created for a Replacement patient.
You can enter values for a particular patient most other fields. The remaining fields are:
Enrollment Date: Date (DD-MON-YYYY) when the patient enrolled in the study. This is an optional field except when the Patient Position is associated with a Lab Assignment Criteria. You cannot change this field if the Frozen? field is checked. You can specify search criteria in this field. You can use a derivation procedure—based on the response to a DCM Question—to complete this field.
Birth Date: This is an optional field, but must be completed if the Patient Position is associated with a Lab Assignment Criteria. You cannot change this field if the Frozen? field is checked. For query tasks, you can specify search criteria in this field.
Sex: The patient's gender. This field is optional, with values M for Male and F for Female. The system may use the value in this field to determine the appropriate normal range for a patient's laboratory responses. You cannot change this field if the Frozen? field is checked. You can specify search criteria in this field. You can use a derivation procedure—based on the response to a DCM Question—to complete this field.
Inits: The patient's initials. This field, up to 4 characters of mixed case, is optional. You cannot change this field if the Frozen? field is checked. For query tasks, you can specify search criteria in this field.
Frozen?: If this field is checked, the system prevents any changes to the data for this patient. This is a display-only field.
Efficacy: A check in this field indicates this patient's data is included in an efficacy analysis.
Safety: A check in this field indicates this patient's data is included in a safety analysis.
I/E Date: The date (DD-MON-YYYY) when the decision was made to include or exclude this patient's data in efficacy and/or safety analyses. You can change this field only if the patient's Frozen? field is unchecked.
Term Date: The date (DD-MON-YYYY) the patient was terminated from this clinical study. This is an optional field. You can use a derivation procedure, based on the response to a DCM Question, to complete this field.
Reported Reference: The patient's reported code identification (up to 25 characters) for a previous study. This is an optional field that the system cannot verify. You can change the value of this field only if the patient's Frozen? field is unchecked.
First Name: The patient's given name. This field, up to 15 characters of mixed case, is optional. You can change the value of this field only if the patient's Frozen? field is unchecked. You can specify search criteria in this field.
Last Name: The patient's family name. This field, up to 15 characters of mixed case, is optional. You can change the value of this field only if the patient's Frozen? field is unchecked. You can specify search criteria in this field.
Death Date: The date (DD-MON-YYYY) the patient died, if any.
Owning Location: The code of the database location that owns this patient position.
DCI Book Name: The DCI Book assigned to this patient position. The list of values includes active DCI Books associated with the study.
If you have an ASCII data file of patients' enrollment dates containing patient codes and dates—either from a phone enrollment or external randomization system—you can use the Load Patient Enrollment Dates PSUB submission window to load them into the system. The format for batch loading these dates follows, with length in characters:
Study Code – 15 characters
Patient Code – 10 characters
Enrollment Date, in format YYYYMMDD – 8 characters
Sex (optional) – 1 character: M or F
Birth Date, in format YYYYMMDD (optional) – 8 characters
From the Design menu, select Patient Positions, then select Load Enrollment Dates. The system sets the enrollment date on the patient position. The system ignores a date if it matches the date from the file. If the dates are different, the system records the date and generates an error in the log file.
Note:
Do not leave an empty line in the load file. The system treats each line in the load file as a record. If there is an empty line, the system takes that as an empty record and invokes an error.You can define patient positions in different studies to be the same person. The Link Patient Position utility enables you to link the records for the two patient position codes together. You can link any number of patients together, but if you attempt to link patient positions with different dates of birth or sex, the system prompts you to verify your request. Two situations where you may need to do this are:
Tracking a patient's participation in Phase 1 or volunteer studies
Rollover studies where patients are in two successive studies
From the Design menu, select Patient Positions, and select Link Patient Positions. You can indicate that the data collected from more than one patient position code originates from the same patient. Your company must write an extract macro, incorporating the primary key CLINICAL_SUBJECT_ID, to process the link you make here. For instance, you can combine screening data recorded against a screening patient position code with randomized data recorded against a regular patient position code, or link data from a short term and rollover study. Choose a study, then click the Patient Positions button. Select the patient to link to another patient position.
To link patient positions:
Following the path given earlier, select the study, if it differs from the study of the current session.
Click the Patient Positions button.
Select the patient position to link to another patient position.
Click the Link to Other Patients button.
Enter the study name that contains the target patient position. Use the list function to view a list of available studies.
Enter the patient position code for the target patient position.
Save.
Repeat this procedure for each link.
Since your study may require that you not divulge information about patients that could identify them, the system limits you to indicating that the same patient fills two or more patient positions.
Oracle Clinical 4.6 adds the option to assign or reassign groups of Patient Positions by range, site, or study.
Navigate to Design, Patient Positions, Patients. Select a study and then click the Patient Positions button to open the Maintain Patient Positions window. Click the Assign DCI Book button to open the Maintain DCI Book Assignments window.
For example, if an active study definition changes because of a protocol amendment, groups of patient positions may require changes to a unique set or sequence of data collection. In previous releases of Oracle Clinical, you assigned patient positions individually, which could be difficult for large studies. Oracle Clinical 4.6 allows you to assign groups of patient positions in one operation.
To assign a sequential range of patient positions:
Choose Patient Range in the Patient Selection Panel.
Enter a Patient Position or choose one in the from list of values.
Enter a Patient Position or choose one in the to list of values.
Enter, or choose All, Unassigned, or a valid Book name from the Patients Assigned To Book list of values.
Enter or choose a Target Book from the Target Book list of values.
Click Assign Book.
To assign all of the patient positions from one site:
Click All Patients at Site button.
Enter a site or choose one in the Select Site list of values.
Enter, or choose All, Unassigned, or a valid Book name from the Patients Assigned To Book list of values.
Enter or choose a Target Book from the Target Book list of values.
Click Assign Book.
To assign whole study populations to a new casebook:
Click All Patients for this Study button.
Enter, or choose All, Unassigned, or a valid Book name from the Patients Assigned To Book list of values.
Enter or choose a Target Book from the Target Book list of values.
Click Assign Book.
This section describes treatment assignments.
From the Design menu, select Patient Positions, choose Study Site Relations, click the Sites button, and click the Treatment Assignments button.
You can assign selected treatment assignments from all available treatment assignments for this study from this menu path. Use the Treatment Ranges utility, below, to assign sequences of treatment assignments that are coded consecutively, or the Randomizations button to narrow the selection of treatment assignments to a particular randomization.
To assign selected treatment assignments:
Select a randomization to assign randomized treatment assignments.
Click the Treatment Assignments button. You have reached this stage by selecting Patient Positions from the Design menu, then selecting Study Site Relations, and clicking the Sites button. You can also reach this display by selecting Patient Positions from the Design menu, then choosing Study Site Relations, clicking the Sites button, and then the Randomizations button; this narrows the selection to treatment assignments from a particular randomization. The remaining instructions are the same for both menu paths.
Select the Assign? box for each treatment assignment. The system populates the Site field with the current site selection.
Save.
Typically, you link patient positions to study sites, and their treatment assignments with them. You must link treatment assignments to a study site only when they do not match patient positions.
To assign or remove individual treatment assignments from a study site:
From the Design menu, select Patient Positions, then choose Study Site Relations.
Select the live clinical study version of interest. If your currently selected study does not have a live version, the system prompts to see if you want to view all studies. If your study has a live version, but you do not have it currently selected, the system prompts to see if you want to switch to the live version.
Click the Sites button. The system displays the Maintain Study Site Relationships window, listing all the study's sites.
Select a site. You can only select a study site while in this window; you cannot insert, update, or delete a study site here. (To assign sites to studies in the Investigator subsystem, from the Design menu, select Investigators and Sites, then choose Study Sites.)
Choose between viewing all available treatment assignments or those of a randomization:
either: Click the Treatment Assignments button. The system displays all treatment assignments available for the study and site.
or: Click the Randomizations button. The system displays the randomizations assigned to the study.
Select a randomization.
Click the Treatment Assignment button. The system displays all treatment assignments assigned to the selected randomization.
Select the Assign? box for each treatment assignment you want to link to your study site. Deselect the Assign? box for each treatment assignment you do not want linked to your study site.
Save.
Typically, you can assign patient positions and their treatment assignments to study sites. You have to assign treatment assignments to a study site only when they do not match patients automatically. To select treatment assignments to link to the selected study site, work in the Link Treatment Assignments by Range window:
From the Design menu, select Patient Positions, then select Study Site Relations.
Click the Sites button.
Select the study site.
Click the Treatment Ranges button. The left side of the window displays the current state of the system and refreshes each time a you make a change.
Define the treatment range on the right side of the window.
Click the Assign Treatments button. The system removes the instructions as it acts on them.
From the Design menu, select Patient Positions, choose Study Site Relations, click the Sites button, and then the Treatment Ranges button.
You can assign ranges of consecutively coded treatment assignments to sites. Following the path given earlier, select study and site. The window displays the site's current treatment assignments on the left side of the window. The system assigns the individual treatment assignment codes according to the number and start code number you specify on the right side of the window.
Circumstances sometimes require going against data blinding controls to access information on treatment patterns for a particular patient.
If an Investigator opens an occluded label for a patient, you record the blind break this represents in this window. But you cannot disclose the treatment pattern assigned to a patient in this window.
Oracle Clinical provides an emergency mechanism for obtaining a patient's treatment details. If you use this mechanism, the system generates a blind break record. The system stores blind breaks you document and system-generated blind breaks together.
Associated with the Blind Breaks form are three windows, each accessed from a corresponding navigation button.
Note that you cannot delete records of blind breaks. You can cancel them, but the system retains a record of canceled breaks.
To create or review a blind break:
From the Design menu, select Patient Positions, then choose Blind Breaks.
Select the clinical study associated with the patent positions you want. If you have already accessed a clinical study during this Oracle Clinical session, the system presents it; otherwise this window lists all clinical studies.
Click the Patients button. The system displays the Patient Positions window.
In the Patient Positions window, you can choose to do the following tasks. Save your work when you finish.
Viewing an existing blind break
Select the patient position code with the blind break. The patient positions appear in patient code sequence.
Click the Show Blind Breaks button.
If there are no blind breaks for the selected patient position, this window does not appear; instead, a message states that no blind breaks exist. You can only select a blind break while in this window. You cannot insert, amend, or delete blind breaks here. The blind breaks appear in order of their creation.
Canceling an existing blind break:
Select the patient position code with the blind break. The patient positions appear in patient code sequence.
Click the Show Blind Breaks button.
Select the blind break to modify.
Click the Modify Blind Breaks button.
Enter a description of why you are canceling the blind break.
Creating a new blind break:
Click the Create Blind Break button.
Enter the information about the blind break.
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