OpenRIMS-PVM - User Manual Chapter 4
1 Clinical Portal
At the Home/Patient Search page, you will be presented with the following options:
● Patients
● Encounters
● Cohorts
● Feedback
● Appointments
● Forms
● Synchronise
| The clinical portal is the centralized hub for all patient and adverse drug event data collection, patient information and standardized patient care.
Note: the following roles have access to the clinical portal: Administrator. The administrator has FULL permissions to the clinical portal. Registration Clerk. The registration clerk is able to add and amend a patient record and create appointments. Data Capturer. A data capturer is able to add and amend a patient record and add and amend an encounter record. Clinician. A clinician is able to add and amend a patient record and add and amend an encounter record. |
| Click on the user profile menu option which appears when clicking on the profile icon to view roles and facilities you currently have access to. |
1.1 Patients
In the Patients function you can Search for patients, Add a new patient, and Edit patient information.
1.1.1 Search for Patients
The Patient Search function can be accessed through the Patients menu.
There are five ways to search for a patient. You can search by:
● Facility
● Patient Unique ID
● First Name and Last Name
● Date of Birth
● Custom Attribute
1.1.1.1 Search by Facility
· Click the arrow in the Facility field to select from the facility drop down list
· Select the facility you would like to search against specifically or select All Facilities if you would like to search against all facilities
· Click the Search button
| You will only be able to search against facilities that you have been assigned access to. Please speak to your system administrator if you are unable to search against the necessary facility |
The system will display a list of patients according to the filter selected, please note the Unique ID of the patient in column 1.
1.1.1.2 Search by Patient Unique ID
| Each patient is allocated a unique system id when they are created in the system. It is possible to search for this patient using this id. |
If you know the patient’s unique ID, enter it in the Unique ID field and click Search.
1.1.1.3 Search by First Name or Last Name
You can also search by the patient’s First name or Last Name. Enter the name(s) in one or both of these areas and click the Search button.
| It is possible to do a partial search by entering any three letters of the First or Last names. The system will return all matching records if a partial search is executed. |
1.1.1.4 Search by Date of Birth
You can also search by the patient’s Date of Birth. Select the date of birth and click the Search button.
1.1.1.5 Search by Custom Attribute
The final search filter available is the ability to search by a Custom Attribute.
| Custom attributes can be activated for filtering by the system administrator. Please consult your administrator if you would like to activate the ability to filter by a specific attribute. |
· Select the custom attribute variable that you would like to search against (e.g., Medical Record Number)
· Enter the search value you would like to filter against and click the Search button.
1.1.2 Return to the Patient Search Page
You can return to the Patient Search page from any place in the system by using the Menu Bar.
1.1.2.1 Menu Bar
| The menu bar is located on the left-hand side of the page. |
1.1.3 View an Existing Patient
After selecting the appropriate search filter and you have clicked the Search button, the system will present all matches as displayed in a table.
The columns in the table are described below:
| ID | Unique identification number assigned by the system |
| First Name | Patient’s first name as captured in the system |
| Last Name | Patient’s last name as captured in the system |
| Facility name | Facility associated with the patient |
| Medical record number | ID number associated with the patient |
| Date of Birth (Age) | Patients date of Birth and Age indicator
· |
| Last Encounter | Last encounter date, the date the patient last visited the facility |
| Action | Ability to view the patient’s information |
· To view a patient entered in the system, locate the patient in the patient table.
· Click the View Patient icon in the Actions column.
· The system will then open the Patient View page and allow you to view the demographics for this patient.
| Patient View has been segregated into the following core sections:
● Additional Information ● Clinical Information ● Audit Information ● Condition Groups ● Analytical Reporting |
1.1.3.1 Patient Information – Basic and Detail Information
The Patient Information tab is divided into Basic Information, Detail Information and N
Patient demographic information will by enlarge remain rather static but should be verified and updated on a visit by visit basis to reflect up to date information. Various attributes defined as part of detail information can be used as risk factors when identifying signals in the analytical portal and therefore remain critical through the clinical portal data collection process.
1.1.3.2 Patient Information – Notes
The Notes tab is where you can note generic information relating to the patient at the discretion of the clinician.
1.1.3.3 Additional information - Appointments
The appointments tab can be used to track upcoming appointments for the patient. This function can be leveraged to track additional clinical or demographic information if sufficient information was not collected in any of the patient’s previous encounters.
The columns in the appointments table are described below:
| Appointment Date | Date of the appointment |
| Reason | Reason for the appointment |
| Outcome | Did the patient arrive for their appointment?
Did the patient miss their appointment? |
| Actions | Ability to edit the appointment information or to
delete the appointment from the calendar |
1.1.3.4 Additional Information - Attachments
The attachments tab can be used to store physical file attachments for the associated patient. The number of attachments and size of attachments are configurable parameters within PViMS and can be adjusted based on your site’s requirements.
| The following file types are supported within PViMS:
· MS Excel 2003-2007 Document · MS Word Document · MS Excel Document · Portable Document Format · Image | JPEG · Image | PNG · Image | BMP · XML Document |
The columns in the attachments table are described below:
| Type | Describes the file type (e.g., PDF, Word, Excel) |
| Name | Name of the file |
| Description | Description of the file entered |
| Created by | Name of the person who uploaded the file, and date of upload |
| Action | Ability to download or delete the file |
1.1.3.5 Additional Information - Encounters
The encounters tab can be used to track all facility visits by the patient. Encounters effectively form part of the holistic longitudinal record for the patient and store contextual clinical data collected during that visit.
The columns in the encounters table are described below:
| Date | Date of the encounter |
| Type | Type of encounter when the encounter was created (e.g., Pre-treatment Visit, Treatment initiation Visit, Unscheduled Visit) |
| Action | Ability to View an encounter |
1.1.3.6 Additional Information - Patient Status
The patient status tab can be used to track if the patient is currently active or if the patient is now deceased. Status change is driven by an effective date for efficient accurate analysis.
The columns in the status table are described below:
| Effective Date | The effective date of the status change |
| Status | To indicate if the patient is active or inactive |
| Created | Name of the person who effected the status change, and date of this status change |
1.1.3.7 Additional Information - Cohorts
The cohort tab can be used to track what cohorts a patient has been enrolled in. Analysis can be subdivided by cohort to target signal detection effectively.
The columns in the Cohorts table are described below:
| Cohort | Name of cohort |
| Cohort Start | Date the cohort started |
| Enrolled Date | Date the patient was enrolled in the cohort |
| De-enrolled Date | Date the patient was de-enrolled from the cohort |
| Action | Ability to enroll, de-enroll, or remove patient from a cohort |
1.1.3.8 Clinical information – Patient Conditions
The patient condition tab can be used to track a history of concomitant conditions the patient has experienced. Being exposed to concomitant conditions as well as specific types of concomitant conditions can be used as risk factors to signal detection within the analytical portal.
The columns in the Patient Conditions table are described below:
| Condition Name | Medical term for the patient’s diagnosis (or symptoms if diagnosis is not available) |
| Start Date | Date the condition started |
| Outcome Date | Date the condition ended |
| Outcome | Outcome of the Condition |
| Actions | Ability to Edit or Delete the condition |
1.1.3.9 Clinical information – Adverse Events
The adverse events tab can be used to track a history of adverse events the patient has experienced. The registration of an adverse event as part of the patient’s longitudinal clinical record, results in the creation of a new adverse event report within the analytical portal for consumption by the designated Pharmacovigilance team. Progress against this registration can be tracked in the Analytical Reporting widget within the patient view.
The columns in the Adverse Events table are described below:
| Description | Description of the event from the MedDRA dictionary |
| Onset Date | Date the event started |
| Reported Date | Date the event was reported to the facility |
| Resolution Date | Date the event was resolved or stabilized |
| Is Serious | Is this a serious reaction? |
| Actions | Ability to Edit or Delete the adverse event |
1.1.3.10 Clinical information – Patient Medications
The patient medications tab can be used to track a history of medications the patient has been exposed to. A comprehensive medications history is critical to ensure accurate signal detection within the analytical portal.
The columns in the Patient Medication table are described below:
| Drug Name | Name of drug from the country drug dictionary |
| Dose | Number of units |
| Dose Unit | Unit of dose (e.g., mg, mEq, IU) |
| Dose Frequency | Number of times per day the dose is administered |
| Start Date | Date the patient started taking the medicine |
| End Date | Date the patient stopped taking the medicine |
| Indication Type | Purpose of medication (e.g., treat primary condition, treat pre-existing condition, or to tread and adverse event) |
| Actions | Ability to Edit or Delete the Patient Medication |
1.1.3.11 Clinical information – Tests and Procedures
The tests and procedures tab can be used to track a history of tests and procedures the patient has been exposed to.
The columns in the Tests and Procedures table are described below:
| Test | Name of lab test or clinical evaluation |
| Test Date | Date the test was conducted |
| Test Result (Coded) | Qualitative test result |
| Test Result (Value) | Quantitative test result - Number of units |
| Test Unit | Type of unit |
| Actions | Ability to Edit or Delete Tests and Procedures |
1.1.3.12 Identifiers and Audit information - Identifiers
The Identifiers section displays the following unique identifiers stored per patient record:
· The patient’s Unique ID assigned by the system
· A Globally Unique Identifier (GUID) assigned by the system
1.1.3.13 Identifiers and Audit information – Audit Information
The Audit section keeps a user record of any patient information changes.
| Created | Gives the User Name of the person who created the file and the Date it was created |
| Updated | Gives the User Name of the person who last updated the information and the Date of the update |
1.1.4 Add a New Patient
Adding a new patient to the PViMS database requires the completion of a patient search. This is to mitigate the potential risk of registering a patient more than once. If you are not able to find the patient in the existing database, you can add a new patient by clicking on Add Patient button.
The system will open a new Patient pop up form with several sections needing to be captured.
1.1.4.1 Basic Information
The Basic Information section captures basic patient demographic information.
To enter patient information, enter text in the corresponding fields (e.g., First Name, Last Name). Or click the arrow in a selected field to display a list of values and select one value from the list. Please ensure that all elements with an asterisk (mandatory) are captured.
Fields in the Basic Information Section are described below:
| First name | Text field to enter the patient’s first name |
| Last name | Text field to enter the patient’s last name |
| Middle name | Text field to enter the patient’s first name |
| Facility | Dropdown list to select the patient’s facility |
| Date of birth | Date field to select the patient’s date of birth |
| All fields marked with an asterisk (*) are compulsory fields that must be completed before proceeding.
|
1.1.4.2 Detail Information
The Detail Information section captures comprehensive patient demographic information.
To enter patient information, enter text in the corresponding fields (e.g., Medical Record Number, Medical Record Number Type, etc.). Or click the arrow in a selected field to display a list of values, and select one value from the list (e.g., Gender).
Fields in the Patient Demographic Information section are described below:
| Medical Record Number | Text field to enter the patient’s medical record number |
| Medical Record Number Type | Dropdown menu to select the medical record type |
| Patient Identity Number | Text field to enter the patient’s identity number |
| Identity Type | Dropdown menu to select the identity type |
| Gender | Dropdown menu to select the patient’s gender |
| Marital Status | Dropdown menu to select the patient’s marital status |
| Employment Status | Dropdown menu to select the patient’s employment status |
| Occupation | Text field to enter the patient’s occupation |
| Language | Dropdown menu to select the patient’s language |
| Address | Text field to enter the patient’s address |
| Address Line 2 | Text field to enter the patient’s address |
| City | Text field to enter the patient’s address |
| State | Text field to enter the patient’s address |
| Postal Code | Text field to enter the patient’s address |
| Patient Contact Number | Text field to enter the patient’s contact number |
| Country of Birth | Dropdown menu to select the patient’s country of birth |
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4.1.1
4.1.2
4.1.3
4.1.4
4.1.4.1
4.1.4.2
4.1.4.3 Primary Condition Group
The Primary Condition Group section allows you to assign a patient to a patient condition based on their medical condition (e.g., TB, HIV, and Malaria). The patient must be assigned to a patient condition group for their data is to be included when using the Analytical Portal.
To assign a Primary Condition Group click the arrow in the Condition field. The system will display a list of conditions to choose from. Select the appropriate condition by clicking on the corresponding condition in the list.
The system will then prompt you to select the MedDRA term associated with the condition in the MedDRA Terms field.
You also have the option to assign a patient to a cohort established by the public health program. To assign a patient to a cohort, click the arrow in the Cohorts field. The system will display a list of Cohorts. Click the cohort the patient should belong to in the list and enter the date the patient was enrolled in the cohort.
| You will only be able to allocate patients to cohorts that are assigned to this specific condition group. |
Enter the Start and Outcome dates (only enter the outcome date if one is applicable) for the condition and any Comments regarding the condition if appropriate.
4.1.4.4 Encounter information
| PViMS Term - Encounter
A patient’s longitudinal health record is composed of multiple encounters. An encounter is effectively a signal that a patient has been seen by a health care provider such as a clinician and clinical data has been collected in context with this encounter. |
Click the arrow in the Encounter Type field. The system will display an Encounter Type list. Click the appropriate Encounter Type from the list.
Set the priority for the encounter by clicking on the arrow in the Priority field. The system will display a Priority list. Select a Priority option from the list.
Finally enter the encounter date in the Encounter Date field. The encounter date will be the date the patient was registered at the facility.
When all information for the page has been entered, click the Save button or click the Cancel button to cancel the action.
The system will then take you back to the to the Patient View page where you can Add or Edit, patient information described in Section 4.1.7.
4.1.5 Condition Groups
The Condition Groups tab which is accessible from within the patient view provides the name of the condition group the patient is assigned to, and the start of the condition. The condition column indicates whether the case is Open or Closed.
| Only Open conditions will be displayed on the Patient View page.
A patient can be assigned to more than one condition group at the same time (e.g., the TB condition group and the HIV condition group). |
4.1.6 Analytical Reporting
The Analytical Reporting tab which is accessible from within the patient view provides the current status of any pharmacovigilance activities that have been conducted within the analytical portal against adverse events that have been registered against this patient.
By clicking on the View Adverse Event icon, the system will display an adverse event pop up form for this event where you will be able to view a comprehensive history of pharmacovigilance activities and any terminology that has been set.
4.1.7 Add or Edit Patient Information
You can add or edit patient information at the Patient View page. But first, you need to locate the patient you would like to amend by searching for the patient using the Patient Search function. Click on the patient menu to access the Patient Search screen.
Enter the appropriate search criteria and click the search button. You will be presented with a list of patients that match the search criteria entered.
Click the View Patient icon and the system will display the Patient View page for the selected patient.
To update patient information, click the Update Patient button and the system will pop up a patient edit form where you can edit basic and detailed information as well as patient notes.
Make changes as appropriate then click the Save button to continue or click the Cancel button to undo the action and go back to the previous page.
After clicking the Save button the system will update the patient record and display the Patient View page with the updated information and a Patient Saved Successfully confirmation message.
4.1.8 Add or Edit Additional Information
On the Patient View page, you can Add or Edit information in the Additional Information section.
4.1.8.1 Add Appointments
At the Appointments tab click the Add Appointments button, after which the system will open the Add Appointment pop up form.
· Enter the Appointment Date. The appointment date may only be in the future and within the next 2 years
· Enter the Reason for the appointment
· Click the Save button to create the appointment or click the Cancel button to cancel the action and go back to the previous page
· After clicking on Save the system will confirm the update has completed successfully and will display the updated table under the Appointments tab
4.1.8.2 Edit an Appointment
To edit an existing appointment, locate the appointment in the table. Click the Update Appointment icon in the action column for the appointment to be edited after which the system will open the Update Appointment pop up form.
Make changes as needed then click the Save button to complete the edit or click the Cancel button to undo your changes and return to the previous page.
The system will display the updated Appointment Table.
4.1.8.3 Add an Attachment
Select the Attachments Tab to view the list of attachments.
To add an attachment, click the Add Attachment button after which the system will open the Add Appointment pop up form. Click the Choose File button to search for the file to be attached.
Select the file to upload and click the Open button.
The system will return to the Add Attachment form and will reflect that the file that was selected. You can add a description in the Description field.
Click the Save button to complete the attachment upload or click the Cancel button to undo your changes and return to the previous page.
The system will show a confirmation message and an updated Attachments Table listing the newly added attachment.
4.1.8.4 Download an Attachment
There are two ways of downloading an attachment to your local computer for viewing. By clicking on the Download All button, all attachments associated with this patient will be compressed into a single zip file and downloaded to your local computer.
To download a single attachment, locate the attachment in the table and click the Download Attachment icon in the action column next to the attachment to download.
The system will show a message that the attachment has been Downloaded Successfully. The downloaded file will typically appear in your computer’s Downloads or My Documents folder.
4.1.8.5 Add an Encounter
Select the Encounters Tab to view a list of encounters.
Click the Add Encounter button to add a new encounter for this patient.
After clicking the Add Encounter button, the system will open the Add Encounter pop up form.
· Select the date of encounter using the date pop up control.
· Click the arrow in the Encounter Type field. The system will display an Encounter Type list to select from. Select the Encounter Type.
· Click the arrow in the Priority field. The system will display a Priority list to select from. Select the Priority.
· Enter any free format Notes regarding the encounter as appropriate.
· Click the Save button to save the new encounter or click the Cancel button to undo the action and return to the previous page.
· After clicking on Save the system will confirm the save has completed successfully and will display the updated table under the Encounters tab.
Refer to the Encounters Section for details on how to Add or Edit Encounter information.
4.1.8.6 Patient Status – Read Only
Select the Patient Status Tab to view a history of status changes.
The information in the Status table is read only and cannot be updated from this page. A patient’s status will change from Active to Deceased when the system is updated in the Condition Group section in the Encounter View (e.g., the patient completed treatment, died, or lost to follow-up).
4.1.8.7 Cohort Enrolment
Click the Cohorts tab to a view a list of cohorts that the patient is or can be enrolled into.
To enroll a patient in a cohort, first locate the Cohort in the table. Click the Enroll Patient icon in the action column for the cohort in which to enroll the patient.
| You may only enroll the patient into a cohort that is assigned to the same condition group the patient belongs to. So, for instance, an HIV patient may not be enrolled into a TB cohort. |
The system will display a Cohort Enrollment pop up form.
Enter the date the patient was enrolled in the cohort. Click the Save button to confirm or click the Cancel button to undo the action and return to the previous page.
After clicking on the Save button the system will display the updated information in the Cohort table.
4.2 Encounters
4.2.1 Search for an Encounter
The Encounter Search function can be accessed through the Encounters menu.
There are six ways to search for an encounter. You can search by:
● Facility
● Patient Unique ID
● First Name and Last Name
● Criteria
● Date Range
● Custom Attributes
4.2.1.1 Search by Facility
· Click the arrow in the Facility field to select from the facility drop down list.
· Select the facility you would like to search against specifically or select All Facilities if you would like to search against all facilities.
· Enter the Search From date and the Search To for the date range to search as it is compulsory to enter a date range.
· Click the Search button.
| You will only be able to search facilities that you have been assigned access to. Please speak to your system administrator if you are unable to search against the necessary facility. |
The system will display a list of encounters or appointments according to the filter selected.
4.2.1.2 Search by Patient Unique ID
| Each patient is allocated a unique system ID when they are created in the system. It is possible to search for encounters using this ID.
|
· If you know the patient’s unique ID, enter it in the Unique ID field.
· Click the Search button.
4.2.1.3 Search by First Name or Last Name
· You can also search by the patient’s First name or Last Name. Enter the name(s) in one or both of these areas.
· Click the Search button.
| It is possible to do a partial search by entering the first letters of the First or Last names. The system will return all matching records if a partial search is executed. |
4.2.1.4 Search by Criteria
· You can also search by additional Encounter Criteria. Click the arrow in the Criteria field. The system will display a list of criteria to choose from. Select the Criteria you would like to filter on.
· Click the Search button.
1.1.4.3 Search by Custom Attribute
The final search filter available is the ability to search by a Custom Attribute.
| Custom attributes can be activated for filtering by the system administrator. Please consult your administrator if you would like to activate the ability to filter by a specific attribute. |
· Select the custom attribute variable that you would like to search against (e.g., Medical Record Number).
· Enter the search value you would like to filter against and click the Search button.
4.2.2 View an Existing Encounter
After selecting the appropriate search filter and clicking the Search button, the system will present all matches as displayed in a table.
The columns in the encounter table are described below:
| ID | Unique encounter ID number assigned by the system |
| First Name | Patient’s first name |
| Last Name | Patient’s last name |
| Facility name | Facility where patient is registered |
| Encounter type | Type of encounter (e.g., pre-treatment, treatment initiation, scheduled follow-up or unscheduled visits |
| Encounter date | Date the encounter occurred |
| Action | Ability to view the encounter |
· To view an encounter entered in the system, locate the encounter in the encounter table.
· Click the View Encounter icon in the Action column.
· The system will then open the Encounter View.
The Encounter View is sub-divided into the following sections:
● Medical Details
● First-Line Susceptibility
● Second-Line Susceptibility
● TB Condition
● Notes
| Medical Details and Notes tabs will be displayed for each patient.
TB Condition, First-Line Susceptibility, and Second-Line Susceptibility tabs will only appear for patients in the TB Condition Group as they are specific to tuberculosis. The system administrator is responsible for managing the Condition Group specific tabs. |
4.2.3 Add or Edit Encounter Information
To edit Encounter Information, click the Update Encounter button after which the system will display an encounter pop up form.
4.2.3.1 Medical Details
Fields on the Medical Details page are described below:
| Weight | Numeric field to enter the patient’s weight in kilograms |
| Height | Numeric field to enter the patient’s height in centimeters |
| BMI | Auto calculated by the system |
| Pregnancy Status | Dropdown list to indicate yes, no, uncertain or NA |
| Date of last menstrual period | Date field to enter the patient’s LMP |
| Estimated gestation (weeks) | Numeric field to enter patient’s gestational period in weeks |
| Breastfeeding mother | Dropdown list to indicate yes, no, NA or unknown |
| Injecting drug use within the past year | Dropdown list to indicate yes, no, or unknown |
| Excessive alcohol use within the past year | Dropdown list to indicate yes, no, or unknown |
| Tobacco use within the past year | Dropdown list to indicate yes, no, or unknown |
Add or Edit information on the page as appropriate. After all changes have been made, click the Save button to continue or click the Cancel button to undo the action and go back to the previous page.
After clicking the Save button, the system will update the Medical Details page.
4.2.3.2 First-line Susceptibility
Select the First-line Susceptibility tab, after which the system will display clinical data related to determining susceptibility for first-line drugs.
| TB Condition, First-Line Susceptibility, and Second-Line Susceptibility tabs will only appear for patients in the TB Condition Group as they are specific to tuberculosis. |
Fields on the First-line Susceptibility page for each medicine are described below:
| Medicine susceptibility by any laboratory test(s) | Dropdown list of test results; Indeterminate, Resistant, Susceptible, Unknown |
| Medicine confirmation | Dropdown list of diagnostic tools; LPA, Unknown, Xpert, DST |
Add information or make changes to the fields on the page as appropriate. Click the Save button to continue or click the Cancel button to undo the action and return to the previous page.
After clicking the Save button the system will update the First-line Susceptibility page accordingly.
4.2.3.3 Second-line Susceptibility
Select the Second-line Susceptibility tab, after which the system will display clinical data related to determining susceptibility for second-line drugs.
| TB Condition, First-Line Susceptibility, and Second-Line Susceptibility tabs will only appear for patients in the TB Condition Group as they are specific to tuberculosis. |
Fields on the Second-line Susceptibility page for each medicine are described below:
| Medicine susceptibility by any laboratory test(s) | Dropdown list of test results; Indeterminate, Resistant, Susceptible, Unknown |
| Medicine confirmation | Dropdown list of diagnostic tools; LPA, Unknown, Xpert, DST |
Add information or make changes to the fields on the page as appropriate. Click the Save button to continue or click the Cancel button to undo the action and return to the previous page.
After clicking the Save button the system will update the Second-line Susceptibility page accordingly.
4.2.3.4 TB Condition
Select the TB Condition tab, after which the system will display clinical data related to TB.
| TB Condition, First-Line Susceptibility, and Second-Line Susceptibility tabs will only appear for patients in the TB Condition Group as they are specific to tuberculosis. |
Fields on the TB Conditions page are described below:
| Previous TB treatment? | Dropdown list of responses; No, Unknown, Yes |
| Site of TB | Dropdown list of anatomical sites |
| Documented HIV infection | Dropdown list of responses; No, Unknown, Yes |
Add information or make changes to the fields on the page as appropriate. Click the Save button to continue or click the Cancel button to undo the action and return to the previous page.
After clicking the Save button the system will update the TB Conditions page accordingly.
4.2.3.5 Notes
Select the Notes tab, after which the system will display the free format notes field for this patient’s encounter.
Add information or make changes to the notes as appropriate. Click the Save button to continue or click the Cancel button to undo the action and return to the previous page.
After clicking the Save button the system will update the Notes page accordingly.
4.2.4 Add or Edit Clinical Information
The Clinical Information section is divided into four tabs:
● Patient Conditions
● Adverse Events
● Patient Medication
● Tests and Procedures
4.2.4.1 Add Patient Condition
At the Conditions tab click the Add Condition button, after which the system will display an Add Condition pop up form.
● Select the MedDra term for the condition by clicking on the plus icon.
● Select the term type for the term and enter the condition name in the Find by term field. Click the Search button (magnifying glass) and the system with then provide a list of results from the MedDRA dictionary that match the term that you have searched on.
● Click the right arrow for the corresponding term that you would like to select.
● Enter a free format description of the condition as defined by the reporter or patient.
● Enter the Start Date and complete the remaining fields as appropriate.
● Click the Save button to create the condition or click the Cancel button to cancel the action and go back to the previous page.
· After clicking on Save the system will display the updated the table under the Conditions tab.
The fields on the Add Condition form are described below:
| Condition description | A free format description of the condition by the reporter or patient |
| Term type | Dropdown list of MedDRA term hierarchy; Lowest level term, Preferred term, High level term, High level group term, or System organ class |
| Find by term | Text field; Enter name of condition |
| Term results | System generated list; Select appropriate term |
| Start date | Text field; Enter date condition started |
| Outcome | Dropdown list of Outcomes; Select either Fatal, Not Recovered/Not Resolved, Recovered/Resolved, Recovered/Recovered with Sequelae, Recovering/Resolving, or Unknown |
| Outcome Date | Date field; Enter condition outcome date |
| Treatment Outcome | Dropdown list of Outcomes; Select either Cured, Died, Lost to Follow-up, Not evaluated, Treatment Completed, or Treatment Failed |
| Comments | Text field; Enter comments about the condition not captured on the page |
| Condition Ongoing | Dropdown list of options; Select either No, Unknown, or Yes |
The Term Type field displays the level of MedDRA hierarchy terms (from very general to very specific) to display. The table below describes the five levels.
At the most specific level, called “Lowest Level Terms” (LLTs), there are more than 70,000 terms that parallel how information is communicated. These LLTs reflect how an observation might be reported in practice. This level directly supports assigning MedDRA terms within the PViMS database. |
When the new condition is a Condition Group Term, a corresponding Condition Group button will appear in the encounter view.
4.2.4.2 Edit a Patient Condition
In either the patient or encounter view for the patient, navigate to the Clinical Information tab. Within the Condition tab, find the condition to edit in the table and click the Edit Condition icon after which the system will display the Edit Condition pop up form.
Add information or make changes to the page Source Description, MedDra Term, Start Date, Outcome Date, Condition Outcome, Treatment Outcome, Comments, or Condition Ongoing fields as appropriate.
NOTE: The system will not allow you to change the Patient’s Condition MedDRA Term. To change the MedDRA Term you will need to delete the record and enter the Patient
Condition as a new entry.
Click the Save button or click the Cancel button to cancel the action and return to the previous page. If the patient’s outcome is fatal, the patient’s status will be updated to deceased.
4.2.4.3 Add Adverse Event
At the Adverse Events tab click the Add Adverse Event button, after which the system will display an Add Adverse Event pop up form.
● Select the MedDra term for the adverse event by clicking on the plus icon.
● Select the term type for the term and enter the adverse event in the Find by term field. Click the Search button (magnifying glass) and the system with then provide a list of results from the MedDRA dictionary that match the term that you have searched on.
● Click the right arrow for the corresponding term that you would like to select.
● Enter a free format description of the adverse event as defined by the reporter or patient.
● Enter the Onset Date and complete the remaining fields as appropriate.
● Click the Save button to create the adverse event or click the Cancel button to cancel the action and go back to the previous page.
· After clicking on Save the system will display the updated the table under the Adverse Events tab.
The fields on the Add Adverse Event form are described below:
| Term type | Dropdown list of MedDRA term hierarchy;
Lowest level term, Preferred term, High level term, High level group term, or System organ class |
| Find by term | Text field; Enter name of adverse event |
| Term results | System generated list; Select appropriate term from list |
| Event description
(As stated by patient or reporter) |
Text field; enter event term as stated in the medical records |
| Onset date | Date field; Enter date condition started |
| Resolution date | Date field; Enter condition outcome date |
| Intensity (Severity) | Dropdown list; Select from Mild, Moderate, or Severe |
| Treatment of Reaction | Dropdown list; Select from No Treatment, Non-Medical Treatment, Medical Treatment, Dialysis, Surgery, or Unknown |
| Was the AE attributed to one or more drugs? | Dropdown list; Select from Yes, No, or Unknown |
| Expected or Unexpected AE | Dropdown list; Select from Expected or Unexpected |
| Outcome | Dropdown list of Outcomes; Select either Fatal, Not Recovered/Not Resolved, Recovered/Resolved, Recovered/Recovered with Sequelae, Recovering/Resolving, or Unknown |
| Was the event reported to national PV? | Dropdown list; Select from Yes, No, or Unknown |
| Is the adverse event serious? | Dropdown list; Select from Yes, No, or Unknown |
| Seriousness | Dropdown list; Select from Congenital Anomaly or Birth Defect, Persistent or Significant Disability or Incapacity, Death, Initial or Prolonged Hospitalization, Life-threatening, or a Medically Important event |
| Admission Date
(will only appear if Hospitalized) |
Date field; Enter date patient was admitted |
| Discharge Date
(will only appear if Hospitalized) |
Date field; Enter date patient was discharged |
| Date of Death
(will only appear if reason for Seriousness is Death) |
Date field; Enter date patient died |
| Autopsy Done?
(will only appear if reason for Seriousness is Death) |
Dropdown list; Select from Yes or No |
| Severity Grade | Dropdown list; Select from Grade 1, Grade 2, Grade 3, Grade 4, or Grade 5 |
| Severity Grading Scale | Dropdown list; Select the SAE Grading Reference (e.g., DAIDS, CTCAE) |
| Full Name of Reporter | Text field; Enter name of the person who reported the event |
| Date of Report | Date field; enter the date the event was first reported by the facility |
| Type of Reporter | Dropdown list; Select from Physician, Pharmacist, Other Health Professional, Lawyer, Consumer or Other Non-Health Professional |
| Reporter Contact Number | Text field; Enter a contact number for the reporter |
| FDA SAE Number
(For use only by FDA officers) |
Text field; Enter the SAE file number assigned by the FDA |
4.2.4.4 Edit an Adverse Event
In either the patient or encounter view for the patient, navigate to the Clinical Information tab. Within the Adverse Event tab, find the adverse event you would like to edit within the table and click the Update Adverse Event icon. The system will display the Update Adverse Event pop up form.
NOTE: The system will not allow you to change the Patient’s Adverse Event MedDRA Term. To change the MedDRA Term you will need to delete the record and enter the Patient
Adverse Event as a new entry.
Add information or make changes to the page as appropriate.
Click the Save button or click the Cancel button to cancel the action and return to the previous page
4.2.4.5 Add a Patient Medication
At the Medications tab click the Add Medication button, after which the system will display an Add Medication pop up form.
● Enter a free format description of the medication as defined by the reporter or patient.
● Select the medication by clicking on the plus icon.
● Select the option you would like to use for searching for the medication. You can either search by active ingredient or the product name
● Enter the active ingredient or product name in the Find by term field. Click the Search button (magnifying glass) and the system with then provide a list of results from the list of concepts that match the term that you have searched on.
● Click the right arrow for the corresponding medication that you would like to select.
● Enter the Start Date and complete the remaining fields as appropriate.
● Click the Save button to create the medication or click the Cancel button to cancel the action and go back to the previous page.
· After clicking on Save the system will display the updated the table under the Medications tab.
The fields on the Add Medication form are described below:
| Medication description
(As stated by patient or reporter) |
Text field; enter medicine term as stated in the medical records |
| Find by term | Text field; Enter name of medication |
| Term results | System generated list; Select appropriate medication from list |
| Start Date | Text field; Enter date patient started taking the medication |
| End Date | Text field; Enter date patient stopped taking the medication |
| Dose | Text field; Enter the dose prescribed |
| Dose Unit | Dropdown list; Select the unit prescribed |
| Dose Frequency | Text field; Enter the dose frequency prescribed |
| Route | Dropdown list; Select the route of administration |
| Frequency in days per week | Dropdown list; Select number of days per week the medicine is administered |
| Still On Medication | Dropdown list; Select Yes or No |
| Indication | Text field; Enter the reason the medicine was prescribed |
| Type of Indication | Dropdown list; Select Primary, Pre-existing Condition, or Treat AE |
| Reason For Stopping | Dropdown list; Select from the list provided (e.g., Adverse Event, Cost, Course Completed) |
| Clinician action taken with regard to medicine if related to AE | Dropdown list; Select Dose Not Changed, Dose Reduced, Drug Interrupted, Drug Withdrawn, or Not Applicable |
| Batch Number | Text field; Enter the medicine Batch Number |
| Effect OF Dechallenge (D) & Rechallenge (R) | Dropdown list; Select from the list provided (e.g., Not Applicable, D – AE improved/resolved when medicine dose reduced/interrupted/withdrawn, R – AE Recurred on medicine re-admission/dose increase) |
4.2.4.6 Edit an Existing Patient Medication
In either the patient or encounter view for the patient, navigate to the Clinical Information tab. Within the Medications tab, find the medication you would like to edit within the table and click the Update Medication icon. The system will display the Update Medication pop up form.
NOTE: The system will not allow you to change the Medication name. To change the Medication, you will need to delete the record and enter the Medication as a new entry.
Add information or make changes to the page as appropriate.
Click the Save button or click the Cancel button to cancel the action and return to the previous page.
4.2.4.7 Add a Test or Procedure
At the Tests and Procedures tab click the Add Test and Procedure button, after which the system will display an Add Test and Procedure pop up form.
● Select the test or procedure.
● Enter the date the patient had the test completed.
● Complete any other fields for which you have data.
● Click the Save button to create the test or procedure or click the Cancel button to cancel the action and go back to the previous page.
· After clicking on Save the system will display the updated the table under the Tests and Procedures tab.
The fields on the Add Test and Procedure form are described below:
| Lab test | Dropdown list; Select name of the Test or Procedure (e.g., Blood Glucose, Chest X-ray) |
| Test date | Text field (dates only); Enter date the Test or Procedure was performed |
| Test result (coded) | Dropdown list; Select qualitative Test or Procedure result (e.g., Positive, Negative, Normal, Abnormal) if appropriate |
| Test result (value) | Text field (numbers only); Enter the value for the test result |
| Test Unit | Dropdown list; select corresponding unit for the Test or Procedure Result (e.g., %, mg, millisecond) |
| Reference Range – Lower Limit | Text field (numbers only); Enter the value for the lower limit of normal defined by the laboratory |
| Reference Range – Upper Limit | Text field (numbers only); Enter the value for the upper limit of normal defined by the laboratory |
| Comments | Text field; Enter additional information about the Test or Procedure if needed |
4.2.4.8 Edit an Existing Test or Procedure
In either the patient or encounter view for the patient, navigate to the Clinical Information tab. Within the Tests and Procedures tab, find the test or procedure you would like to edit within the table and click the Update Test and Procedure icon. The system will display the Update Test and Procedure pop up form.
NOTE: The system will not allow you to change the Test or Procedure name. To change the Test or Procedure name you will need to delete the record and enter the Test or Procedure as a new entry.
Add information or make changes to the page as appropriate.
Click the Save button or click the Cancel button to cancel the action and return to the previous page.
4.3 Cohorts
| Cohorts can be used to track a sub-group of patients within a Condition Group. Cohorts in the system are determined by the Public Health Program or the System Administrator. |
4.3.1 View Cohorts
The Cohort function can be accessed through the Cohorts menu.
The system will display the Cohorts page, which lists all currently registered cohorts in the system.
Find the Cohort you would like to view in the table. Click the View Cohort icon in the Action Column for the cohort to view.
The system will display the Cohort View page with a table listing all of the patients enrolled in that cohort.
From the Cohort View page, you are able to view a patient enrolled in the cohort. Find the patient to view in the table.
Click the View Patient button in the Action column for the patient to view. The system will display the Patient View page.
4.4 Feedback
| Feedback can be used to track all analysis concluded by the Pharmacovigilance technician for all adverse events logged within the clinical portal. Feedback is generated by the system as causality and terminology has been set by the technician. |
4.4.1 View Feedback
The Feedback function can be accessed through the PV Feedback menu.
The system will display the feedback page, which provides the user with the ability to view feedback via a new and search by term tab.
4.4.2 View New Feedback
The New feedback tab represents all new feedback that has been generated by the technician within a recent time period. This period is administrable by your system administrator within the administrator portal. The number in the red circle represents the number of new reports that have recent feedback.
To view feedback for a report, click on the visibility icon for the report you would like to view feedback for.
The system will navigate the user to a View Adverse Event pop up form where the user will be able to view the following feedback:
· Terminology and Causality. Ability to view MedDRA term and causality per medication as set by the technician
· PV Analytical History. Ability to view a full history of all activity by the technician
· Basic and Detailed Information. Adverse event information captured in the clinical portal
4.4.3 Search for Feedback for Report
The Search by term tab allows the user to search for feedback for a report using the following criteria:
· Patient name
· MedDRA term as set by the clinician and technician
· Report identifier
· Medications
The search function uses a partial term to search all reports on the terms noted above. For instance, searching for the term Accelerated returns all reports that have that partial term in the MedDRA term for the report.
4.5 Appointments
| Appointments can be used to monitor an patient return date to the facility. This is particularly effective for patients in a cohort where ongoing monitoring for adverse events is expected. |
4.5.1 View Appointments
The Appointments function can be accessed through the Appointments menu.
The system will display the Appointments page, which lists all appointments registered within the system for a given date range.
The columns in the appointments table are described below:
| Patient name | Reflecting the patient’s name and surname as captured in the system when the appointment was scheduled. |
| Details | Reason for the appointment |
| Appointment date | The date of the appointment |
| Activity | Has the patient arrived for their appointment?
Has the patient missed their appointment? |
| Action | Ability to view patient
Ability to view encounter Ability to mark the appointment as Did Not Arrive |
| PViMS Term - Did Not Arrive
If an appointment is marked as Did Not Arrive, this means the patient has been confirmed as missing their appointment. This status serves to confirm this scenario in situations where encounters are retrospectively captured into the system in a delayed data capture mode. |
4.5.2 View Appointments for a specified day
Enter the specified day in the Show Appointments For field and click the Search button. The system will display the Appointments page for the specified day.
4.5.3 View Patient Record
Select the patient in the table whose record you wish to view and click the View Patient icon. The system will display the Patient View page for the selected patient.
4.5.4 Mark Appointment as Did Not Arrive
Select the patient in the table whose record you wish to confirm as did not arrive and click the Did Not Arrive icon.
Click the Did Not Arrive icon to confirm that the patient did not arrive for their visit.
The system will update the appointment with the update reflected in the appointments table.
| You will not be able to mark an appointment as DNA until at least 3 days have passed from the original appointment date. |
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4.6 Deleting Records
User rights assignment policies determine which Users or User Profile groups are able to delete records from the system. Check with your administrator regarding user right assignments.
| After deletion the record is placed in an archive, thus not permanently deleted from the system. |
4.6.1 Patient View - Additional Information
4.6.1.1 Delete an Appointment
Within the Patient View, at the Appointments tab, find the appointment you would like to delete.
| You will only have the opportunity to delete appointments within the future. Existing appointments will need to be cancelled. |
Click the Delete Appointment icon after which the system will take you to a Delete Appointment pop up form.
Enter a reason for the deletion (this is compulsory) and click on the Delete button to delete the appointment or click the Cancel button to undo the action.
After confirming the deletion, the system will update the Appointment table.
4.6.1.2 Delete an attachment
Within the Patient View, at the Attachments tab, once you have uploaded an attachment, the attachment can easily be removed again.
Click the Delete Attachment icon after which the system will take you to a Delete Attachment pop up form.
Enter a reason for the deletion (this is compulsory) and click on the Delete button to delete the attachment or click the Cancel button to undo the action. After confirming the deletion, the system will update the Attachment table.
4.6.1.3 Delete an Encounter
Within the Patient View, at the Encounters tab, locate the Encounter you would like to remove and click the View Encounter icon.
The system will navigate you to the Encounter View.
Click the Delete Encounter button after which the system will pop up a Delete Encounter form.
Enter a reason for the deletion (this is compulsory) and click on the Delete button to delete the encounter or click the Cancel button to undo the action. After confirming the deletion, the system will update the Encounter table.
4.6.1.4 De-enroll a Patient from a Cohort
Within the Patient View, at the Cohorts tab, find the Cohort you would like to de-enroll the patient from.
Click the De-enroll icon after which the system will display a Cohort De-enrollment confirmation pop up form.
Enter the de-enrollment date and click the Save button. The system will display the updated Cohorts Table.
4.6.1.5 Deleting A Cohort Enrolment
Within the Patient View, at the Cohorts tab, find the Cohort you would like to delete the enrolment for .
Click the Delete icon after which the system will display a Cohort Enrollment Deletion confirmation pop up form.
Enter the reason for deletion and click the Delete button. The system will display the updated Cohorts Table.
| Deleting a cohort enrolment allows the patient to be re-enrolled into that cohort. De-enrollment means the patient cannot be re-enrolled into the same cohort again. |
4.6.2 Encounter View – Clinical Information
4.6.2.1 Delete A Patient Condition
Within the Encounter or Patient View, at the Patient Conditions tab and locate the condition you would like to delete.
Click the Delete Condition icon after which the system will take you to a Delete Condition pop up form.
Enter a reason for the deletion (this is compulsory) and click on the Delete button to delete the condition or click the cancel button to undo the action. After confirming the deletion, the system will update the Patient Condition table.
4.6.2.2 Delete an Adverse Event
Within the Encounter or Patient View, at the Adverse Events tab and locate the event you would like to delete.
Click the Delete Adverse Event icon after which the system will take you to a Delete Adverse Event pop up form.
Enter a reason for the deletion (this is compulsory) and click on the Delete button to delete the adverse event or click the Cancel button to undo the action. After confirming the deletion, the system will update the Adverse Events table.
4.6.2.3 Delete A Patient Medication
Within the Encounter or Patient View, at the Patient Medications tab and locate the medication you would like to delete.
Click the Delete Medication icon after which the system will take you to a Delete Patient Medication pop up form.
Enter a reason for the deletion (this is compulsory) and click on the Delete button to delete the medication or click the Cancel button to undo the action. After confirming the deletion, the system will update the Patient Medications table.
4.6.2.4 Delete A Test and Procedure
Within the Encounter or Patient View, at the Tests and Procedures tab and locate the test and procedure you would like to delete.
Click the Delete Test and Procedure icon after which the system will take you to a Delete Test and Procedure pop up form.
Enter a reason for the deletion (this is compulsory) and click on the Delete button to delete the test and procedure or click the Cancel button to undo the action. After confirming the deletion, the system will update the Tests and Procedures table.
4.6.3 Delete an Entire Patient Record
Within the Patient View, click the Delete button to delete an entire patient record.
The system will take you to a Delete Patient pop up form.
Enter a reason for the deletion (this is compulsory) and click on the Delete button to delete the patient or click the Cancel button to undo the action. After confirming the deletion, the return you to the patient search form.
| Deleting a patient will archive all patient information and will remove the patient from any analysis they may have been part of previously. |