| 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 |
In Oracle Clinical the term strata means groupings of patients that have common characteristics; they are representations of particular expressions of factors. Randomization is the process of hiding patients' treatments by assigning treatment patterns to patient positions in an unpredictable order. Patient positions represent potential study participants
Once defined, you can use strata in any study, as needed. You can construct them by combining factors. Each factor describes a single characteristic, such as sex or age. Implementing the system's stratification utilities can minimize confounding a study's statistical results due to the uneven distribution of treatments to patients.
This section contains the following topics:
Oracle Clinical provides stratification utilities to ensure that the groups you select are mutually exclusive and represent a full cross-section of your study's population. For example, you could stratify a study according to the following groups:
male smokers over 65
male nonsmokers over 65
males 40 to 65
female smokers 45 to 65
females over 65
You create strata with a view to preserving statistical significance. For example, superficially the following two examples of stratification for a study seem to be the same. However, these stratification patterns impose different constraints on randomization.
two strata: male smokers; male nonsmokers and women
three strata: male smokers; male nonsmokers; women
The first could result in a randomization where 100 patient positions include male smokers, but 200 other patient positions include either male nonsmokers or females.
The second stratification pattern could result in a randomization where 100 patient positions include male smokers, and 200 include male nonsmokers and females. Both stratifications could be useful, but each would have a different statistical significance.
As a first step in creating strata, clinical study enrollment criteria, clinical study termination criteria, and treatment regimens, you create factors. Factors are attributes of a patient you can measure, rather than the actual values of attributes in individual cases.
To reach the Maintain Factors window, from the Design menu, select Strata, then select Factors.
Ranges represent variables requiring further qualification to make them meaningful to the study. Examples are AGE, WEIGHT, and BLOOD PRESSURE, which require maximum and minimum values to specify their roles in the study.
Values, on the other hand, are variables such as BLOOD GROUP, which require only a single value to make them meaningful.
The Range/Value box in the Factors window designates a variable as either a range or a value. You can change the flag only if the factor is not used by any clinical study enrollment criteria, clinical study termination criteria, treatment regimen, or strata; otherwise you get an error message.
A retired factor can still relate to existing strata, but cannot be used to create a new stratum. A retired factor can be reactivated by setting the Active? box back to selected.
You can delete a factor only if it is not being used by any strata, clinical study enrollment criteria, clinical study termination criteria, or treatment regimen. You get an error message if you try to delete a factor that is in use. For a factor, define a code, description, either a value or range, and whether it is available for assignment to strata. You must create all of the factors needed to compose each stratum.
To create, modify, and delete single strata, created for use in all clinical studies, use the Maintain Single Strata window. To access this window, from the Design menu, select Strata, then Single Strata; this initially displays the Factors window.
You select a factor from the Factors window list of all active factors before you can proceed to create a single stratum. This is the factor for which you create or update the single stratum.
You cannot insert, update, or delete factors from this window. You can only select a factor for which to create a single stratum
The Strata button in the Factors window of the Maintain Single Strata window displays the Strata window. Here you can create, update, or delete single strata for the factor you selected in the Factors window.
A new stratum can only be created for an active factor.
You can delete a single stratum only if it is not used in any combined strata or combined combination strata, and if no study stratification factors assign it to a clinical study version. To delete the stratum, select Delete Record.
The minimum/maximum values and the single value are mutually exclusive: if your factor is of type RANGE, you must enter minimum and maximum values; if the factor is of type VALUE, you must enter a single value. Select a factor to define single strata. You can create the factor records by selecting Strata from the Design menu, and choosing Factors. Then click the Strata button.
You link single strata to create combination strata, logically linked by AND, or combined combination strata, logically linked by OR.
To link single strata with an AND statement, open the Maintain Combination Strata window: from the Design menu, select Strata, then choose Combination Strata.
To link single strata with an OR statement, open the Maintain Combination Strata window: from the Design menu, select Strata, then choose Combined Comb Strata.
Because the two modules operate identically in every other respect, the following instructions apply to both modules.
Each window has one field, Description, which is required and must be unique. Enter a description of the stratum, indicating the presence of AND or OR logic.
The forms for maintaining Combination Strata and Combined Combination Strata each have an associated Available Factors window and a Strata for Factor window, reached by pressing the Factor or Strata button, respectively. These windows allow you to change the selected Combination or Combined Combination Stratum by adding or removing constituent (strata).
Select a factor and then click Strata to see the strata assigned to the factor. This window displays the strata for the factor selected earlier. Click the Add or Remove button to create the set of strata in the strata you are creating.
The following buttons appear in the Strata for Factor window. Add or remove special factor-related strata to the selected combination stratum with these buttons:
Add assigns the selected stratum to the strata.
Remove removes the selected stratum.
The assignment of a stratum to a clinical study version is a study stratification factor. To create and maintain study stratification factors, follow the steps in this section.
To assign a stratum to a clinical study version, navigate to Design, Strata, then Stratification. Select a clinical study version to work with from the list. The system selects the most recently accessed clinical study version during the current session. If you have not selected a study, the window displays all existing clinical study versions.
To reach the Study Factors window, which lists the strata assigned to the study, navigate to Design, Strata, Stratification, and click the Stratum Assigned to the Study button. Stratum Description is the lone field for this window. It is a display-only description of the stratum that the factor is for.
Two function-specific buttons appear in the Study Stratification Factors window:
Factors displays the Factors window. Assign one or more of the associated strata to your study.
Details of the Stratum displays the Strata window in single-record format. You can also reach the Strata window from the Factors window, via the Strata window. Select a stratum to work with while in this window.
The following buttons are in the Strata window:
Details of the Stratum displays the window Details of Selected Stratum. It shows the details of a stratum assigned to a study or of a stratum for a factor before assignment to a study.
Assign Stratum to Clinical Study enables you to add a stratum to the list of assigned strata.
A study's treatment patterns specify the drugs to be administered and the medical procedures to be performed. You assign them to patient positions, creating treatment assignments.
The treatment code of a treatment assignment must be unique within a clinical study version, and so randomizations must not overlap. Recipes (instructions creating a randomization, including the treatment patterns involved, their ratio, and the number of related treatment assignments) are overlapping when they contain the same treatment assignment.
For example, Recipe A creates treatment codes 1 to 10; Recipe B creates 1 to 20. Your recipes can overlap, if necessary, while you experiment with alternate recipes. But you cannot use overlapping recipes when creating randomizations. To prevent overlap, when you enter parameters for a randomization the system validates within a recipe to trap for overlapping definitions. However, because the system does not detect overlaps between recipes until you randomize, it is then that you receive an error if you try to create a treatment assignment with a code already in use.
Oracle Clinical assumes that, due to experimental design requirements, your company separates the role of an unblinded randomization analyst, who generates a randomization, from the blinded person who enters the randomization recipe.
The sequence for entering randomization recipes and attributes is flexible; you can continue to modify recipes until you generate a randomization from them. Once it is generated, however, you can only make changes that expand the randomization but that do not change the existing treatment assignments.
Access refers to tasks involved in an interim analysis. An interim analysis is when a quick assessment is made of the study results to decide if it should continue or if it should be stopped because of lack of efficacy (or safety).
Several functions control who can perform an interim analysis, when, and on what data. In particular, the randomization access status code controls who is allowed to see the randomization in a study. It can have the following values:
| Value | Meaning |
|---|---|
| Open | The study is open label from the start; everybody can see the randomization details. |
| Closed | The study is currently blinded, so only unblinded users can see the randomization details. |
| Release | The study was initially blinded (Closed) but is now over and the randomization opened, or released, for analysis. |
| Access | Allows specified users access to the randomization to perform an interim analysis. (See "Creating or Revoking an Access View".) |
| Multi | Access controlled at the phase level and not at the study level. |
A dummy randomization is available to establish the analysis environment. It has no correlation to the real randomization; however, you can use it to test reporting and extracting facilities. The system creates the dummy randomization when you randomize the study. The actual randomization becomes available for analysis when the study's blinding stage is complete.
Most functions within the Randomization subsystem require the privilege RXC_RAND. Typically companies limit RXC_RAND privileges to a small group of specialized users who are not members of the study management teams.
While a study is still blind, only privileged users have access to its randomization. If an emergency situation occurs, the system provides ways to disclose a patient's treatment pattern. (See "Disclosing Patient Treatment Assignments".) If disclosure occurs, the system generates a record of the disclosure as a blind break.
Oracle Clinical offers four types of randomization: version-level, strata-level, version block-level, and strata block-level—each described in the following sections.
If you create either a version-blocked or strata-level blocked randomization, and you intend to create only one randomization recipe, you can use the easy randomization utility available for these randomization types. From the Design menu, select Version Blocked Randomization (or Strata Blocked Randomization), then select Easy Randomization. Except for allowing only one recipe, the Easy Randomization utilities are identical to the equivalent standard Randomization utilities; if you want different recipes—for example, different ratios of treatment patterns for different patients—use the standard utilities.
The version type of randomization generates sequential treatment assignments for the same treatment pattern. There is nothing random about this method—the recipe explicitly defines what you produce. For example, kits 1 to 10 on Treatment Pattern A, 11 to 20 on Treatment Pattern B, etc. Designers typically apply version randomization to Phase I open label-type studies.
The system assigns the following type codes to version-level randomizations:
SVTP: Study Version Level, Treatment Pattern
SVTPX: Study Version Level, Treatment Pattern, Extra Assignments Only
The system maintains the recipe within the treatment pattern records. For each treatment pattern, you can specify how many treatment assignments you require and the code from which to start coding them.
To create a version-level randomization, from the Design menu, select Randomization, choose Version Randomization, then select Treatment Patterns. Choose a study, then click the Treatment Patterns button. Specify the parameters of your recipe and use the Regimens in Treatment Pattern and Drugs buttons to access windows to further specify the randomization. Click the Copy Treatment Pattern button to copy a pre-existing treatment pattern within your study.
To create a version-level randomization from a specific treatment assignment, from the Design menu, select Randomization, choose Version Randomization, then select Treatment Assignments.
The strata-level type of randomization is similar to the version-level randomization described above, except that each stratum in the study can have its own set of treatment assignments. For example, males can use kits 1 to 10 on Treatment Pattern A, 11 to 20 on Treatment Pattern B; females can use kits 100 to 110 on Pattern A, etc. This is also designed to apply to Phase I open label-type studies.
The following type codes are assigned to stratum-level randomizations:
STFP: Stratum Level, Treatment Pattern
SFTPX: Stratum Level, Treatment Pattern, Extra Only
From the Design menu, select Randomization, choose Strata Randomization, and then select Treatment Patterns. Choose a study, then click the Treatment Patterns button. Specify the treatment pattern information, then use the Regimens in Treatment Pattern and Drugs buttons to access windows to further specify the treatment pattern. Click the Copy Treatment Pattern button to copy a treatment pattern already existing in your study.
To maintain the strata assigned to a study, from the Design menu, select Randomization, choose Strata Randomization, and then Stratification. Choose a study, then click the Stratum Assigned to the Study button to view the descriptions of the strata assigned to the study. Click the Factors button to associate the strata to a factor; click the buttons, Details of the Stratum, and Treatment Patterns to refine the randomization.
To create a strata-level randomization from a specific strata, from the Design menu, select Randomization, choose Strata Randomization, and then Treatment Assignments. Select the strata and click the Randomize button.
The version block-level type of randomization generates a random set of treatment assignments. Within the randomization, each block of treatment assignments contains the same combination of treatment patterns but in different sequences. For example, two patterns A and B and a block size of four could produce ABBA BABA ABAB BBAA ABBA, etc.
The following type codes are assigned to study version block definition-level randomization:
SVBD: Study Version Level, Block Definition
SVBDX: Study Version Level, Block Definition, Extra Only
To create a version-blocked level randomization, from the Design menu, select Randomization, choose Version Blocked Randomizations, and then Treatment Patterns. Choose a study, then click the Treatment Patterns button. Specify the parameters of your recipe and use the Regimens in Treatment Pattern and Drugs buttons to access windows to further specify the randomization. Click the Copy Treatment Pattern button to copy a pre-existing treatment pattern within your study.
To create a version block-level randomization, from the Design menu, select Randomization, choose Version Randomization, then select Block Definition. Choose a study, then click the Block Definitions button. Specify the parameters of your recipe, then click the Treatment Pattern button to further specify the randomization. Click the Copy Treatment Pattern button to copy an existing treatment pattern in your study.
To create a version block-level randomization from a specific treatment assignment, navigate to Design, Randomization, Version Blocked Randomization, and then Treatment Assignments.
The strata block-level type of randomization is similar to the version block definition-level described above, except that the randomization belongs to a stratum of the study.
The following type codes are assigned to the stratum version block definition-level randomization:
SFBD: Stratum Level, Block Definition
SFBDX: Stratum Level, Block Definition Extra Only
To create a strata block-level randomization, from the Design menu, select Randomization, choose Strata Blocked Randomization, and then Treatment Patterns. Choose a study, then click the Treatment Patterns button. Specify your treatment patterns, and use the Regimens in Treatment Pattern and Drugs buttons to access windows to further specify the treatment pattern. Click the Copy Treatment Pattern button to copy a treatment pattern that exists in your study.
To create a version block-level randomization, from the Design menu, select Randomization, choose Strata Blocked Randomization, and then Block Definition. Choose a study, then click the Block Definitions button. Specify the parameters of your recipe, then click the Treatment Pattern button to further specify the randomization. Click the Copy Treatment Pattern button to copy a treatment pattern existing in your study.
To create a strata block defined-level randomization from a specific set of treatment assignments, from the Design menu, select Randomization, choose Strata Blocked Randomization, and then Treatment Assignments. Select a strata and block definition, then click the Randomization button.
Oracle Clinical randomization includes utilities to remove randomizations, to lock—that is, to prevent changes to randomization treatment assignments—and to unlock locked randomizations. Open the Randomizations window by navigating to Design, Randomization, Randomization Type, then Treatment Assignments, and clicking the Show Randomizations button.
To test for changes to a randomization, click the Verify button in this window. Oracle Clinical regenerates the randomization using the original seed number, and creates a list of differences between the original randomization and the verification randomization. The report is named randval.out.
Note:
Randomization reports are formatted in landscape mode, so be sure to configure your page setup to this mode before printing a hard copy of the report.Oracle Clinical provides utilities to transfer the details of a randomization in or out of Oracle Clinical. These utilities handle the following situations:
Downloading a copy of a study's randomization details from Oracle Clinical for use in another application
Loading legacy randomization details into Oracle Clinical
Unusual randomization requirements that Oracle Clinical's standard functionality cannot emulate
Note:
If you batch load a legacy 'Block' Randomization into Oracle Clinical, it will not result in a block randomization. The batch load process will never populate TREATMENT_ASSIGNMENTS.RANDOM_BLOCK_ID or create blocks. If you want a block randomization, you should use the Oracle Clinical functionality.In addition, if you download an Oracle Clinical system-generated randomization, edit it, and batch load it back into Oracle Clinical, the previously populated RANDOM_BLOCK_ID is no longer populated.
Before you can batch load a randomization into Oracle Clinical, you must define the treatment patterns and strata. Create strata by navigating to, Strata, then Stratification. Define treatment patterns by navigating to Design, Treatments, then Treatment Patterns. Batch loading a stratification randomization is the same as manual creation, except that you cannot specify the number of treatment kits.
See "Maintaining a Study Stratification Factor" for a description of stratification factors.
You can create an ASCII file of all the randomization details in a study. Navigate to Design, Randomization, Randomization Batch Load, then Download Randomization.
This PSUB submission function requires one parameter, Description, which the system applies as the name of the ASCII output file. The formats for the file are shown in this section.
If you intend to force in a randomization (Download, edit, and reload a randomization), the system limits you to the following changes:
The tables in this section specify the format of the data for the different randomization types.
First Card Type - All Randomization Types
| From: | To: | Parameter |
|---|---|---|
| 1 | - 10 | "STUDY" |
| 11 | - 25 | Study Code |
| 26 | - 35 | Version Code |
Stratum Card Type - For Stratified Randomizations Only One card for each stratum involved in the randomization.
| From: | To: | Parameter |
|---|---|---|
| 1 | - 10 | "STRATUM" |
| 11 | - 21 | Stratum Id |
| 22 | - 51 | Stratum Description |
| 53 | - 61 | Starting Treatment Assignment Code |
| 62 | - 73 | Ending Treatment Assignment Code |
Non-stratum Card Type -For Non-stratified Randomizations Only One card for the entire randomization.
| From: | To: | Parameter |
|---|---|---|
| 1 | - 10 | "NOSTRATUM" |
| 11 | - 51 | Null |
| 52 | - 61 | Starting Treatment Assignment Code |
| 62 | - 71 | Ending Treatment Assignment Code |
Treatment Pattern Card Type - For All Randomizations One card for each treatment pattern involved in the study.
| From: | To: | Parameter |
|---|---|---|
| 1 | - 10 | "PATTERN" |
| 11 | - 25 | Pattern Code |
| 28 | - 80 | Treatment Pattern Description |
Treatment Assignment Card Type - For All Randomizations One card for each treatment assignment in the randomization.
| From: | To: | Parameter |
|---|---|---|
| 1 | - 10 | "TRTASG" |
| 11 | - 20 | Treatment Assignment Code |
| 21 | - 30 | Patient Code |
| 31 | Latest Assignment Flag | |
| 32 | Replacement Patient Flag | |
| 33 | - 47 | Owning Location Code |
Match the structure of the force-in file to the left or right column
| Either | Or | ||||||
|---|---|---|---|---|---|---|---|
| STUDY | STUDY | ||||||
| STRATUM | NOSTRATUM | ||||||
| PATTERN | PATTERN | ||||||
| TRTASG | TRTASG | ||||||
| TRTASG | TRTASG | ||||||
| etc. | PATTERN | ||||||
| PATTERN | TRTASG | ||||||
| TRTASG | TRTASG | ||||||
| PATTERN | PATTERN | ||||||
| TRTASG | TRTASG | ||||||
| STRATUM | TRTASG | ||||||
| PATTERN | |||||||
| TRTASG | |||||||
| PATTERN | |||||||
| TRTASG | |||||||
| PATTERN | |||||||
| TRTASG |
This form reloads an ASCII file containing the randomizations for a study, checking that it meets all randomization requirements. It is a standard PSUB submission form. From the Randomization menu, select Randomization Batch Load, and choose Validate and Load Randomization. The system checks that the treatment patterns exist within the clinical study and that there are no existing locked treatment assignments. It then deletes all the existing randomization information and re-creates it from the file.
Move the ASCII file containing the randomization into your home directory on the server. Enter its name in the Description field.
When you have a randomization created outside the system—a converted randomization—Oracle Clinical reads the randomization from the file and loads it into the database, translating external codes into the corresponding design codes for strata and treatment patterns. The system takes this input and creates treatment assignments and randomization records. Oracle Clinical also validates that the load process ran successfully. Before you can execute the load, the clinical study, clinical study version, treatment patterns, and, possibly, strata, have to exist.
To load and validate a converted randomization:
Navigate to Design, Randomization, Randomization Batch Load, and Load a Converted Randomization.
Reformat a flat file from the existing legacy randomization system into Oracle Clinical's format. See "Converted File Format".
Transfer the file to the computer running Oracle Clinical and store it in your home directory.
Use the Maintain Conversion Specifications module to inform Oracle Clinical how to translate the treatment pattern and strata codes supplied by your legacy system into Oracle Clinical codes. See "Entering Conversion Parameters". Some randomization systems treat replacement patients as different strata. Oracle Clinical does not require this, so if a stratum exists only to separate replacement patients from normal patients, you can flag it as a replacement stratum and map it to the same stratum in Oracle Clinical as the normal stratum from the legacy system.
Load the converted randomization into Oracle Clinical.
Check the output report for any errors encountered in loading the data.
Optionally, run a report to read the original data file and compare it with the Oracle Clinical database to confirm that the data loaded correctly. See "Validating a Loaded Randomization".
Unlike downloading, editing, and loading Oracle Clinical data—processes that identify everything with Oracle Clinical codes and structure—converting and loading legacy data allows for code translation and for merging strata. It is more powerful but also more complex. Oracle recommends using the download format, if possible.
When converting randomization data from legacy systems into Oracle Clinical, you need to create conversion specifications to match the external data to Oracle Clinical parameters.
If the treatment pattern in the legacy system is based on the same code as the treatment pattern in Oracle Clinical, there is no need to enter a conversion parameter.
From the Randomization menu, select Randomization Batch Load, choose Enter Conversion Parameters, and then select the study. The Version window of Maintain Conversion Specifications has two buttons:
Strata opens the Strata window, where you map the strata from the legacy system to the corresponding target Oracle Clinical codes. You can map each target stratum to more than one legacy stratum. Since some legacy systems use strata differently from Oracle Clinical's normal and replacement assignments, you can set a flag to indicate that Oracle Clinical merges the strata into Oracle Clinical's replacement assignments.
Patterns opens the Treatment Pattern Conversions window of the Maintain Conversions window, where you map the legacy treatment pattern code (Old Pattern field) to the corresponding Oracle Clinical code. You can have only a one-to-one correspondence.
The file format must conform to the following requirements:
Left-align all character fields, with no leading zeros.
Right-align and zero-fill all numeric fields.
Left-align the version code, adding trailing spaces to fill the 10-character code.
Treatment and patient codes are character fields but are limited to a single, leading, non-numeric character. Right-align these fields, and do not add leading zeros; for example, S1001.
| From: | To: | Parameter | Type | Length |
|---|---|---|---|---|
| 1 | -10 | "STUDY" | CHAR | 9 |
| 11 | - 25 | Study Code | CHAR | 15 |
| 25 | - 34 | Null | CHAR | 10 |
| 35 | - 45 | Starting Seed number | NUMBER | 11 |
| 46 | - 56 | Ending Seed number | NUMBER | 11 |
| 57 | - 59 | Block size | NUMBER | 3 |
| From: | To: | Parameter | Type | Length |
|---|---|---|---|---|
| 1 | - 9 | "STRATUM" | CHAR | 9 |
| 11 | - 14 | Investigator code | NUMBER | 5 |
| 15 | - 16 | Stratum number | NUMBER | 2 |
| 17 | - 31 | Stratum abbreviation | CHAR | 15 |
| 32 | - 41 | Starting patient number | CHAR | 10 |
| 42 | - 51 | Ending patient number | CHAR | 10 |
| From: | To: | Parameter | Type | Length |
|---|---|---|---|---|
| 1 | - 9 | "PATTERN" | CHAR | 9 |
| 10 | - 24 | Pattern Code | CHAR | 15 |
| 18 | - 80 | Pattern Description | CHAR | 63 |
| From: | To: | Parameter | Type | Length |
|---|---|---|---|---|
| 1 | - 9 | "PATIENT" | CHAR | 9 |
| 10 | - 19 | Patient Code | CHAR | 10 |
| 20 | -34 | Owning Location | CHAR | 15 |
| STUDY | |||
| STRATUM | |||
| PATTERN | |||
| PATIENT | |||
| PATIENT | |||
| etc. | |||
| PATTERN | |||
| PATIENT | |||
| PATTERN | |||
| PATIENT | |||
| STRATUM | |||
| PATTERN | |||
| PATIENT | |||
| PATTERN | |||
| PATIENT | |||
| PATTERN | |||
| PATIENT | |||
| PATTERN | |||
| PATIENT |
If required, you can run a report to read the original data file and compare it with the Oracle Clinical database to confirm that the load was correct. From the Design menu, select Randomization, choose Randomization Batch Load, and then Validate Loaded Randomization. The Randomization Take-on display of the PSUB submission form appears. Enter the name of the loaded randomization file in the Description field.
You can perform the following tasks by navigating to Design, Randomization, and then Randomization Maintenance:
Replicating randomizations is a similar process to replicating clinical studies. The system records information you enter in this module into system tables, including Treatment Pattern Block Definitions, Treatment Assignments, and Randomizations.
You cannot replicate a randomization between studies. You must replicate the study first, then add the randomization to it.
To replicate a study's randomization:
From the Design menu, select Randomization, choose Randomization Maintenance, and then Replicate Randomization. The Replicate a Clinical Study form appears, displaying the Study Selections window.
Click the Replicate Randomization button.
Use the list function to select from the studies with randomizations available for replication.
Use the list function to select the study to which to replicate the randomization (the target study).
Click the Replicate Randomization button.
Mirror randomization takes an existing randomization and creates a new randomization of replacement treatment assignments starting at a new code. For example:
1 to 10 NORMAL, 100 to 110 REPLACEMENT.
The main use is when a site receives supplies for a group of patients and a corresponding set of replacement patients. Then there is an instruction that if, for example, patient 7 drops out, enroll the next patient into 107. This maintains balance in the study's randomization.
From the Design menu, select Randomization, choose Randomization Maintenance, and then Mirror Randomization.
Choose the study to which to add mirrored treatment assignments.
Click Show Randomizations. The Copy Randomizations window displays the selected study's randomization details.
Click Copy. A pop-up window appears where you can specify the starting code.
This section describes updating the status of the randomization. The information you enter here is a basis for creating clinical study history records.
To update clinical study statuses:
From the Design menu, select Randomization, choose Randomization Maintenance, and then Randomization Statuses.
Select the study of interest.
Use the list and query functions, if necessary, to locate the study.
Enter the study status code.
To modify the study's randomization access, click the Phases button. A window appears titled Amend the Randomization Access Status.
Clicking the Amend the Study Status button lets you change the planning status only, and even to do this, you must have planning attributes privileges. You can modify the Randomization Access Status only if you have access to the randomization attributes. The studies display in study code sequence. You can scroll or query to the study of interest. You can only modify a clinical study's status; you cannot insert or delete studies here.
When you click the Phases button, the system displays the phases of the live version of the current study. You can work with only the live version of a study while you are in the Amend Study Statuses module. If there is no live version of the current study, the system alerts you with a message.
An access view enables specified users to see the true randomization within a study without un-blinding the study to everybody. The randomization only appears in the view while the randomization status of the study is set to ACCESS.
This technique controls who can perform an interim analysis, for which study, and when. If necessary, you can edit the view to additionally limit the data it displays. For example, you can limit it to display only the first 50 patient treatment assignments, or only patients who have completed the study.
Note:
If you are working in a UNIX environment, put double quotes around the $ sign in the account names. For example,
OPS"$"ABCD.The PSUB form Create Access View creates an access view for a study. It is a standard PSUB submission form. To access this form, from the Design menu, select Randomization, choose Randomization Maintenance, and then Create Access View.
The PSUB form Revoke Access Grants revokes the select privilege from a user on an access view for a study. It is a standard PSUB submission form. To access this form, from the Design menu, select Randomization, choose Randomization Maintenance, and then Revoke an Access View.
Oracle Clinical provides the cohort view to show patients assigned to their correct cohorts (groups) without revealing which treatment pattern each cohort is for.
To access this form, from the Design menu, select Randomization, then Randomization Maintenance, and choose Create Cohort View. The view has the same security safeguards as the Access View. You can use the PSUB submission form to create the view.
The system assigns dummy codes to the study's treatment patterns by a hidden algorithm. The algorithm decodes the real treatment pattern into letters—A, B, C, etc., then generates the cohort view.
To access the cohort view, the study must have randomization access status, regardless of your privileges.
Note:
If you are working in a UNIX environment, put double quotes around the $ sign in the account names. For example,OPS"$"ABCD.Use the Revoke Cohort Grants PSUB submission form to control the grants to access a study's cohort view. From the Design menu, select Randomization, then Randomization Maintenance, and choose Revoke Cohort View.
Take the Patients window as a starting point to manage patient positions.From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, and click the Patients button. The system lists the patient positions in patient code sequence.
Select the patient position to manage. You can only select a patient position while in this window. You cannot insert, update, or delete a patient position.
The operations you can perform from this window are:
Changing the Latest Treatment Assignment to a Different Treatment Pattern
Replacing a Patient Position with Another Patient at the Same Site
Replacing a Patient Position with Another Patient in the Same Study
Linking a Patient Position to an Existing Treatment Assignment
From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and the Disclose button, selecting the appropriate study and patient position, to the Treatment Patterns Assigned to Patient form. The system displays the treatment pattern records in assignment time sequence.
You can also navigate to the Amending Treatment Patterns Assigned to Patient window via the Change... button. See the next section for instructions on changing treatment pattern assignments.
To change the treatment pattern assigned to a patient position without creating a new treatment assignment, you work from the Amending Treatment Patterns Assigned to Patient window. From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and the Change button, selecting the appropriate study and patient position. (This window is also available from the Change button in the Treatment Patterns Assigned to Patient window.)
Changing an assignment indicates that the treatment a patient receives is different from the treatment the randomization assigned to the patient. This is the way you can correct mistakes in packaging or labeling.
Enter the treatment code to change in the Treatment Code for this Assignment field.
Complete the Date and Reason for Change fields.
Select the row of the pattern to change the treatment to from the Code/Pattern fields.
Click the Change Select Treatment Assignment To This Treatment Pattern button. You must click this button to save your work.
You can replace the current patient position with a replacement patient already assigned to the same site. From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Site Replace button, selecting the appropriate study and patient position. The system displays the Patient Replacement at the Same Site popup window, with the replacement patient controlled by the Patient Replacement Rule Type.
A code on the clinical study version, the Patient Replacement Rule Type, controls how this part of the module operates. Study designers set it in either the Clinical Studies or Easy Study Design modules. The Patient Replacement Rule Type has one of three values:
NONE – No replacement of patient positions allowed.
NEXT – The next sequential replacement patient position not currently enrolled, regardless of treatment.
SAME – The next replacement patient position not currently enrolled that is assigned the same treatment pattern as the one being replaced.
The Replace Selected Patient With This One button confirms the patient position replacement and sets the patient enrolled date on the replacement patient to the current date.
To replace the current patient position with a replacement patient not linked to any study site, from the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Study Replace button, selecting the appropriate study and patient position. The system displays the Patient Replacement not assigned to any site popup window, with the replacement patient controlled by the Patient Replacement Rule Type.
A code on the clinical study version, the Patient Replacement Rule Type, controls how this part of the module operates. Study designers set it in either the Clinical Studies or Easy Study Design modules. The Patient Replacement Rule Type has one of three values:
NONE – No replacement of patients allowed.
NEXT – The next sequential replacement patient position not currently enrolled, regardless of treatment.
SAME – The next replacement patient position not currently enrolled that is assigned the same treatment pattern as the one being replaced.
Clicking the Replace Selected Patient With This One button confirms the patient position replacement and sets the patient enrolled date on the replacement patient to the current date.
To link the current patient position to an existing treatment assignment, from the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Link Asg button, selecting the appropriate study and patient position. A popup window appears, Link Treatment Assignment.
This function is most useful in studies where the Kit codes or Treatment Assignment codes are not the same as the patient codes. The differences could be a result of a second randomization in the study, or of management of limited drug supplies.
Clicking the Link Selected Patient To This Treatment Assignment button confirms the patient position linkage and assigns the new treatment code to the patient.
You may have patients who receive more than one randomization during a study and, at the end, you have to assign the patients a reporting treatment pattern for analysis. For these, and similar circumstances, Oracle Clinical provides a utility to create a new treatment assignment to assign to a patient position.
From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Create Asg button, selecting the appropriate study and patient position. The Create and Assign Treatment to Patient window provides a new treatment assignment code field and a list acceptable treatment patterns to assign to it. After you enter the fields and select a treatment pattern, you must click the Create a New Treatment Assignment Using This Treatment Pattern button to confirm the patient treatment assignment and create a new treatment assignment to allocate the selected treatment pattern to this patient.
You can break the link between a patient position and a treatment assignment. The treatment assignment is then available for reassignment. From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Unlink Asg button, selecting the appropriate study and patient position. In the Unlink the Treatment Assigned for Patient window, you see a list of all the treatment assignments for the selected patient position. Select the treatment assignment you want to unlink, and click the Unlink/Remove This Treatment Assignment From The Selected Patient button, confirming the patient treatment unlink and breaking the link between the patient position and the treatment assignment.
Oracle Clinical provides a separate menu path to the Link Patients and Treatment Assignments window: From the Design menu, select Randomization, choose Randomization Maintenance, then select Link Patient Treatment Assignments, click the Patients button, and then the Link Asg button.
This method can be used to allow a blinded user to link patient positions to treatment assignments without knowing what treatment pattern is involved.
Oracle Clinical provides a facility for study management members who must disclose the treatment assigned to a patient for emergency medical reasons, but do not have RXC_RAND privileges (see "Randomization Privileges"), and do not have access to the Maintain Treatment Assignment, Disclose Asg menu path. The system creates a blind break with each disclosure.
From the Design menu, select Randomization, choose Randomization Maintenance, then select Disclose Patient Treatment Assignments, click the Patients button, selecting the appropriate study and patient position. The treatment pattern records display in assignment time sequence. Select the patient and click Disclose.
If you have the role RXC_DER, the system generates a blind break record before displaying the patient's current treatment assignment. Select Yes to confirm the disclosure and continue, or No to cancel the request and exit. This action always creates a blind break and should be your last choice. Use the Disclose option in the Maintain Treatment Assignments form to avoid creating a blind break whenever possible.
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