OpenRIMS-PVM - Admin Manual Chapter 1
1 Reference Data
1.1 Condition Groups
Condition groups facilitate collective analysis across similar adverse event groups.
The condition groups administration function can be accessed through the Administration à Reference Data menu and is accessible to administrators of the system.
Once you have clicked on this menu, the system will navigate you to the Manage Condition Groups reference page where the system will return a list of conditions that have been configured within the system.
The system will return the list and the total number of conditions that have been found and will provide the option of adding a new condition group.
Click the View Terminologies Button to view all MedDRA terms that have been associated with that condition.
1.1.1 Adding a New Condition Group
To add a new condition group, click on the Add Condition Group Button.
The system will navigate you to the admin page for adding a new condition group. Enter details of the condition group as per the description of each field below.
| Description | The unique name of the condition group
This field is mandatory |
| Chronic | Is this condition chronic |
Once information has been entered, proceed to the MedDRA terms tab to select all MedDRA terms that have been associated to this condition group.
Enter the search term to locate the MedDRA term and click search. Once you have selected the corresponding LLT, click the Add Button to add the term to the condition group.
Once you have finished, click the Save button to submit the request or click the Cancel button to cancel the action and return to the condition list.
| Please note, when analysing data, condition groups are used to aggregate analysis across disparate MedDRA terms using the condition group as the unifier. If an adverse event is not incorporated into analysis, this is likely due to the term not being associated to the condition group |
1.1.2 Editing an Existing Condition Group
To edit an existing condition group, click on the Edit Condition Group Button alongside the corresponding condition.
The system will navigate you to the admin page for editing a condition group. You are able to add new lab tests, medications and MedDRA terms associated to the condition group in this admin function as well as remove existing items.
1.2 Scale Gradings
Scale gradings provide addition descriptions that assist in the grading of an adverse event based on the scale used.
The scale gradings administration function can be accessed through the Administration à Reference Data menu and is accessible to administrators of the system.
Once you have clicked on this menu, the system will navigate you to the Manage Scale Gradings reference page where the system will return a list of grades that have been configured within the system.
The system will return the list and the total number of grades that have been found and will provide the option of adding a new scale grading.
1.2.1 Adding a New Scale Grading
To add a new scale grading, click on the Add Scale Grading Button.
The system will navigate you to the admin page for adding a new scale grading.
| Scale | The scale that the grade is being associated to
This field is mandatory |
| MedDRA Event | The MedDRA event that the definition is for |
Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the test and procedure list. The system will automatically create a place holder per grade.
To edit the definition for the specific grade, click the Edit Grade Button for the corresponding grade.
The system will pop up a grade definition modal form. Update details of the grade definition and click the Save button to submit the request or click the Cancel button to cancel the action and return to the grade list.
1.2.2 Editing an Existing Scale Grading
To edit an existing grade scaling, click on the Edit Scale Grading Button alongside the corresponding scale.
The system will navigate you to the admin page for editing a scale grading. To edit the definition for the specific grade, click the Edit Grade Button for the corresponding grade.
The system will pop up a grade definition modal form. Update details of the grade definition and click the Save button to submit the request or click the Cancel button to cancel the action and return to the grade list.
1.3 Tests Results
The test results administration function can be accessed through the Administration à Reference Data menu and is accessible to administrators of the system.
Once you have clicked on this menu, the system will navigate you to the Manage Test Results reference page where the system will return a list of results that have been configured within the system.
The system will return the list and the total number of results that have been found and will provide the option of adding a new test result.
1.3.1 Adding a New Test Result
To add a new test result, click on the Add Test Result Button.
The system will pop up an add new test result modal form. Enter details of the test result as per the description of each field below.
| Description | Details of the test and procedure
This field is mandatory |
Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the test and procedure list.
1.3.2 Editing an Existing Test Result
To edit an existing test result, click on the Edit Test Result Button alongside the corresponding test result.
The system will pop up a test result modal form. Update details of the test result and click the Save button to submit the request or click the Cancel button to cancel the action and return to the test and procedure list.
1.3.3 Delete an Existing Test Result
To delete an existing test result, click on the Delete Test Result Button alongside the corresponding test result.
The system will pop up a test result modal form. Confirm the details of the test result you would like to delete and click the Delete button to submit the request or click the Cancel button to cancel the action and return to the test and procedure list.
1.4 Tests and Procedures
The tests and procedures administration function can be accessed through the Administration à Reference Data menu and is accessible to administrators of the system.
Once you have clicked on this menu, the system will navigate you to the Manage Tests and Procedures reference page where the system will return a list of tests and procedures that have been configured within the system.
The system will return the list and the total number of tests and procedures that have been found and will provide the option of adding a new test and procedure.
1.4.1 Adding a New Test and Procedure
To add a new test and procedure, click on the Add Test and Procedure Button.
The system will pop up an add new test and procedure modal form. Enter details of the test and procedure as per the description of each field below.
| Description | Details of the test and procedure
This field is mandatory |
Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the test and procedure list.
1.4.2 Editing an Existing Test and Procedure
To edit an existing test and procedure, click on the Edit Test and Procedure Button alongside the corresponding test and procedure.
The system will pop up a test and procedure modal form. Update details of the test and procedure and click the Save button to submit the request or click the Cancel button to cancel the action and return to the test and procedure list.
1.4.3 Delete an Existing Test and Procedure
To delete an existing test and procedure, click on the Delete Test and Procedure Button alongside the corresponding test and procedure.
The system will pop up a test and procedure modal form. Confirm the details of the test and procedure you would like to delete and click the Delete button to submit the request or click the Cancel button to cancel the action and return to the test and procedure list.
1.5 Medicines
The medicine administration function can be accessed through the Administration à Reference Data menu and is accessible to administrators of the system.
Once you have clicked on this menu, the system will navigate you to the Manage Medicines reference page where the system will return a list of medicines that have been configured within the system.
The system will return the list and the total number of medicines that have been found and will provide the option of adding a new medication.
1.5.1 Adding a New Medication
To add a new medication, click on the Add Medication Button.
The system will pop up an add new medication modal form. Enter details of the medication as per the description of each field below.
| Drug Name | The trade name of the medication
This field is mandatory |
| Pack Size | The pack size of the medication |
| Strength | The strength of the medication |
| Catalog | The unique catalog number of the medication |
| Form | The form of the medication |
Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the medicine list.
1.5.2 Editing an Existing Medication
To edit an existing medication, click on the Edit Medication Button alongside the corresponding medication.
The system will pop up a medication modal form. Update details of the medication and click the Save button to submit the request or click the Cancel button to cancel the action and return to the medicine list.
1.5.3 Delete an Existing Medication
To delete an existing medication, click on the Delete Medication Button alongside the corresponding medication.
The system will pop up a medication modal form. Confirm the details of the medication you would like to delete and click the Delete button to submit the request or click the Cancel button to cancel the action and return to the medicine list.
1.6 MedDRA Terminology
| Search for existing MedDRA terms and import a new MedDRA dataset. MedDRA reference data is used when assigning a MedDRA term to a spontaneous report |
The MedDRA administration function can be accessed through the Administration à Reference Data menu and is accessible to administrators of the system.
Once you have clicked on this menu, the system will navigate you to the Manage MedDRA Terms reference page. To search for a MedDRA term, select the term type and enter a term to search for. Click the Search button to search for the corresponding term.
The system will return the list and the total number of terms that have been found.
| Please note, it is not possible to add a new term, edit or delete an existing term. Modifications to each term can only be facilitated through the MedDRA import function. |
1.6.1 Importing a New MedDRA dataset
To import a new MedDRA dataset, download the latest MedASCII files from http://www.meddra.org and compress these files into a ZIP file named medascii.zip. The zip file must be comprised of the following individual files: -
| Soc.asc, hlgt.asc, hlt.asc, llt.asc, pt | Contains full set of reference data for each class |
| soc_hlgt.asc | Link HLGT terms to SOC parent class |
| hlgt_hlt.asc | Link HLT terms to HLGT parent class |
| hlt_pt.asc | Link PT terms to HLT parent class |
Once you have created the medascii.zip file, upload this file by clicking on the Choose File button. Browse to the location of the medascii.zip file and click the Open button. Click the Import button to import the latest reference set.
| Please note, this process may take some time to complete. |
Once the process has completed, the latest version number will be displayed.