4 Sites, Investigators, and Patient Positions

4.3.1.1 Creating Patient Positions with System-Generated Codes

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:

1. From the Design menu, select Patient Positions, then select Create/Delete Patients.

2. Select the study to modify, if necessary.

3. 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.

4. On the right side of the window, make sure the Location to Own Patients is correct. For each grouping of patient positions:

   1. Specify the number of patient positions to create in the Number to Create field.

   2. 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.

      Note:

      Do NOT include a slash (/) in the patient code as that will cause the Patient Data Report generation to fail.

      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

      
      

   3. Click the Create Positions button.

5. 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.

See "Deleting System-Generated Patient Positions".

4.3.1.2 Creating Patient Positions with User-Defined Codes

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.

1. From the Design menu, select Patient Positions, then select Alpha Patient Codes.

2. Select the study to modify, if necessary.

3. Click the Patient Positions button. The system displays all existing patient positions, including site/Investigator assignments.

4. From the Data menu, choose Insert Record.

5. 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.

   Note:

   Do NOT include a slash (/) in the patient code as that will cause the Patient Data Report generation to fail.

6. Select the Scr? box to designate the patient position as a Screening position.

7. Select the Repl? box to designate the patient position as a Replacement position.

8. You can assign the position to a site in this window. Use the list function to select a study site.

9. 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.

10. Save.

See "Deleting Alpha Code Patient Positions".

4.3.2.1 Manual Set Up

From Design, select Patient Positions, then select Patients, and then click the Patient Positions button. You can enter an eligibility date in the Patient Positions window for one or more patients at the same time.

4.3.2.2 Validation Procedure

You can make patients eligible for SDV as data is actually entered for them and they meet the criteria you define by creating a validation or derivation procedure for this purpose that populates a column in the PATIENT_POSITIONS table:

• Populate the SDV_ELIGIBLE_DATE column to make the patient eligible for automatic selection for SDV on the date entered.

• Populate SDV_INELIGIBLE_DATE column to prevent the patient from being selected for SDV.

For example:

• Eligible: If the Demography CRF is completed only after the Screening CRF is completed satisfactorily, you could write a procedure to make the patient eligible when data is entered and saved for the Demography CRF.

• Ineligible: If the responses in the Screening CRF are unsatisfactory, make the patient ineligible. If you have an existing screening procedure, you may wish to simply update that procedure. (RDC reports, but does not otherwise use this value.)

Finally, you can have your procedure populate the SDV_PROC_VERS column to indicate which version of your procedure derived the patient eligibility or ineligibility.

The eligibility procedure must be written to ensure that the SDV Eligible Date and SDV Ineligible Date fields do not both have not-null values at the same time. If one date is entered, the other must be null.

Using the OCL_UTILS Utility

Call the OCL_UTILS.UPDATE_SDV_PAT procedure from the utility to populate the SDV Eligibility or SDV Ineligibility fields dynamically. The OCL_UTILS procedure is compiled in the RXC user schema and located in the server code ($RXC_INSTALL).

1. Write a procedure that will be triggered by data you choose. See "Procedure Example" below.

2. Define your procedure to call the OCL_UTILS.UPDATE_SDV_PAT procedure, providing the input parameters as shown in Table 4-1, "Parameters in OCL_UTILS.UPDATE_SDV_PAT procedure". Pass a single date to the procedure. Whether to treat the date as an Eligibility date or an Ineligibility date depends on the flag setting.

Procedure Example For example, using expression as SEX = F and A as alias for a DCM Question Group, you can add the following lines to your procedure to update the SDV Eligibility Date, SDV Ineligibility Date, and the Procedure Version number for a patient:

If A.SEX = 'F'
THEN
ocl_utils.update_sdv_pat(rxcpdstd.v_mode,rxcpdstd.patients_rec.patient_positio
n_id, rxcpdstd.V_PROCEDURE_VERSION_SN,to_date(DE.DCM_DATE,'YYYYMMDD'),'Y');
ELSE
ocl_utils.update_sdv_pat(rxcpdstd.v_mode,rxcpdstd.patients_rec.patient_positio
n_id, rxcpdstd.V_PROCEDURE_VERSION_SN,to_date(DE.DCM_DATE,'YYYYMMDD'),'N');
END IF;
.
COMMIT;

See "Validation and Derivation Procedures".

4.3.2.3 Batch Load Job

You can use this option to submit a Patient SDV Import. Select Design, then Patient Positions and then Load Patient SDV Attributes. Enter the study for which to run the batch job. The parameters required are:

• Name of the Patient SDV File

• Allow batch upload to over-write eligibility values? Choose Y for the values specified in the input file to overwrite current values in the Patient Positions table.

4.3.2.4 Introducing a Patient SDV Plan in an Ongoing Study

Following are two options for introducing a patient SDV plan in an ongoing study.

• Create an eligibility procedure for an existing DCI

  This will calculate eligibility for both existing and new patients.

• Use a different approach for current vs. new patients

  For new patients, create a new DCI with a new eligibility procedure.

  For existing patients, manually specify or import the SDV eligibility status.

Once you have implemented your eligibility methodology, there are two other steps to be completed before SDV patient auto-selection can begin for a study-site:

• "Schedule the Pending Patient Updates job" in the Oracle Clinical Administrator's Guide

• Publish a patient SDV plan for the study site

For information on how patient auto-selection works, refer to "Auto-selecting Patients for SDV" in Oracle Clinical Remote Data Capture Onsite User's Guide.

Also, see more about "Publishing SDV plans for all Sites" in Oracle Clinical Conducting a Study.

4.3.3.1 Assigning Patient Positions from the Study Sites Window

To assign patient positions to sites and Investigators:

1. From the Design menu, select Investigators and Sites, then choose Study Sites.

2. Select the study, if necessary.

3. Click the Patients button. The system displays the current patient positions and their site assignments.

4. Assign the patient positions to the site by selecting the Assign? box.

5. Save.

4.3.3.2 Assigning Patient Positions from the Patient Positions Window

1. From the Design menu, select Patient Positions, then select Study Site Relations.

2. Select the study, if necessary.

3. Click the Patients button. The system displays the existing patient positions available to the site.

4. Assign the patient positions to the site by selecting the Assign? box.

5. Save.

4.3.3.3 Assigning Patient Positions by Range

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:

1. From the Design menu, select Patient Positions, then choose Study Site Relations.

2. Click the Sites button.

3. Select the study site.

4. 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.

5. Define the treatment range on the right side of the window.

6. Click the Assign Patients button. The system removes the instructions as it acts on them.

4.3.3.4 Assigning New Blocks of Patient Positions

From the Design menu, select Investigators and Sites, then select Study Sites, and click the New Patients button. Enter the number of patients and the start number. Then click the Assign Patients button to assign them to the study site.

4.3.6.1 Deleting System-Generated Patient Positions

To delete system-generated patient positions:

1. From the Design menu, select Patient Positions, then select Create/Delete Patients.

2. Select the study to modify, if necessary.

3. 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:

   1. the number of patient positions to delete in the Number to Delete field.

   2. the code of the first patient position to delete in the Number to Delete Start field.

4. Click the Delete Positions button.

5. If necessary, repeat this process for patient positions not included in these sequences.

4.3.6.2 Deleting Alpha Code Patient Positions

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:

1. From the Design menu, select Patient Positions, and choose Alpha Patient Codes [Patient Positions].

2. Select the patient position you want to delete.

3. 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.

4. Save.

4.3.7.1 Adding Patient Position Details

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 in the following fields:

• Enrollment Date: Date (DD-MON-YYYY) when the patient enrolled in the study. This is optional except when the Patient Position is associated with a Lab Assignment Criteria. You cannot change this field if the Frozen? 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 optional except when the Patient Position is associated with a Lab Assignment Criteria. You cannot change this field if Frozen? is checked. For query tasks, you can specify search criteria in this field.

• Sex: The patient's gender. This is optional. Acceptable values are M (Male) and F (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 Frozen? is checked. You can specify search criteria in this field and can use a derivation procedure—based on the response to a DCM Question—to complete this field automatically.

• Inits: The patient's initials. This is optional.It accepts up to 4 characters of mixed case. You cannot change this field if Frozen? is checked. For query tasks, you can specify search criteria in this field.

• Frozen?: If checked, the system prevents any changes to the data for this patient. This is a display-only field.

• Efficacy: If checked, this patient's data is included in an efficacy analysis.

• Safety: If checked, 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 edit 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 automatically.

• Reported Reference: An optional, additional patient identifier (up to 25 characters), which can be displayed in RDC Onsite. See "Adding a Customized Reference Field to the Search Pane." in RDC Onsite Administrator's Guide. You can edit this field only if the patient's Frozen? field is unchecked.

• First Name: The patient's given name. This field is optional.It can contain up to 15 characters of mixed case. You can edit 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 is optional. It can contain up to 15 characters of mixed case. You canedit 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.

• 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.

4.3.7.2 Batch Load Patient Enrollment Dates

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.

Load the file into the directory specified in the BDL_ROOT setting of the OCL_STATE local reference codelist. If BDL_USERDIRS in the same codelist is set to Y, load the file into the user-specific subdirectory for the user who will run the job. See the Oracle Clinical Administrator's Guide for more information.

Use the following format for batch loading patient enrollment dates:

• Study Code – 15 characters

• Patient Code – 10 characters

• Enrollment Date – YYYYMMDD

• Sex (optional) – M or F

• Birth Date – YYYYMMDD (optional)

To run the batch load, 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.

4.3.9.1 Assigning Patient Positions by Range

To assign a sequential range of patient positions:

1. Choose Patient Range in the Patient Selection Panel.

2. Enter a Patient Position or choose one in the from list of values.

3. Enter a Patient Position or choose one in the to list of values.

4. Enter, or choose All, Unassigned, or a valid Book name from the Patients Assigned To Book list of values.

5. Enter or choose a Target Book from the Target Book list of values.

6. Click Assign Book.

4.3.9.2 Assigning Patient Positions by Site

To assign all of the patient positions from one site:

1. Click All Patients at Site button.

2. Enter a site or choose one in the Select Site list of values.

3. Enter, or choose All, Unassigned, or a valid Book name from the Patients Assigned To Book list of values.

4. Enter or choose a Target Book from the Target Book list of values.

5. Click Assign Book.

4.3.9.3 Assigning Patient Positions by Study

To assign whole study populations to a new casebook:

1. Click All Patients for this Study button.

2. Enter, or choose All, Unassigned, or a valid Book name from the Patients Assigned To Book list of values.

3. Enter or choose a Target Book from the Target Book list of values.

4. Click Assign Book.

4.4.2.1 Linking Treatment Assignments by Range

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:

1. From the Design menu, select Patient Positions, then select Study Site Relations.

2. Click the Sites button.

3. Select the study site.

4. 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.

5. Define the treatment range on the right side of the window.

6. Click the Assign Treatments button. The system removes the instructions as it acts on them.

4.4.2.2 Linking Treatment Assignment Ranges to a Site

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.