OpenRIMS-PVM - User Manual Chapter 8

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1        Spontaneous Reporting

PViMS provides the mechanism to register spontaneous reports by the public. While these reports form part of the overall PViMS adverse event repository where Pharmacovigilance activities can be performed against the report, they do not form part of the analysis.

Note: spontaneous reporting is available to the public and no login to PViMS is required.

1.1        Accessing Spontaneous Reporting

When you enter the correct URL to access PViMS, the system navigates you the login page. This page contains the primary link to register a spontaneous report.

To register a spontaneous report, click on the Public button. The system will navigate you to a page where you can enter the spontaneous report.

1.1.1       Add a New Report

Spontaneous reports are composed of the following sections:

Patient Information Information related to the patient who suffered the adverse event
Product Information Information related to the medication that potentially caused the adverse event
Test Result Any test results that are relevant to the adverse event
Reaction and Treatment Details of the adverse event
Reporter Information Details of the person who has logged the adverse event

1.1.1.1       Patient Information

The Patient Information section captures basic patient demographic information about the person who suffered the adverse event.

To enter patient information, enter text in the corresponding fields (e.g., Initials of Patient). Or click the arrow in a selected field to display a list of values and select one value from the list.  All elements with a red asterisk are mandatory.

Fields in the Patient Information section are described below:

Initials of Patient Identification of the patient is facilitated through the capturing of their initials in a text field
Identification Number Identification of the patient is facilitated through the capturing of their ID Number in a text field
Identification Type Dropdown list to select the patient’s type of identity number specified
Patient Date of Birth Either specify the patient’s date of birth
Age Or specify the patient’s age
Age Unit of Measure If age is specified, specify the unit type for the age (e.g. days, months etc.)
Patient Weight (kg) The weight of the page at the time of the adverse event, in kilograms
Sex Dropdown list to specify the gender of the patient
Ethnic Group of Patient Dropdown list to specify the ethnic group of the patient


Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.

1.1.1.2       Product Information

The Product Information section captures a list of medications that the patient was taking at the time of the adverse event.

To enter medication information, click the Add Product Information item button. Once a product has been added, you are able to remove or edit the medication using the appropriate button next to the medication.

Fields in the Product Information Section are described below:

Product The name of the medication that the patient was taking (generic or brand name)
Drug Strength Free format description of the drug strength, e.g. 250
Drug Strength Unit Dropdown list specifying the unit of the drug strength, e.g., mg
Product Suspected Is this product suspected of causing the adverse event
Dose Number Drug dosage
Dose Unit Dropdown list specifying the unit of the drug dosage
Route of Administration Dropdown list specifying how the drug has been administered
Start and End Date When did the patient start the drug and if they have completed taking the drug, when was the last date of administration
Treatment Duration How long has the patient been on the drug
Treatment Duration Unit Dropdown list specifying the unit for the duration
Indication Indication for why the patient is taking this drug
Frequency How frequently is the patient taking the drug
Batch Number The batch number the drug forms part of
Action Taken What action was taken when the adverse event occurred
Product Challenge Was a challenge performed on the product when suspected of the adverse event
Product Rechallenge Was a rechallenge performed


Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.

1.1.1.3       Test Results

The Test Results section captures a list of test results that are applicable to the adverse event.

To enter test results, click the Add Test Results item button. Once a test has been added, you are able to remove the result or edit the test using the appropriate button.

Fields in the Test Results Section are described below:

Test Date The date the test was conducted
Test Name The name of the test conducted
Test Result The result of the test conducted
Test Unit Any unit associated to the test result
Low- and High-Test Range Test result range that is considered normal
More Information More information associated to the test result?


Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.

1.1.1.4       Reaction and Treatment

The Reaction and Treatment section captures details of the adverse event.

To enter reaction and treatment information, enter text in the corresponding fields (e.g., Description of Reaction). Or click the arrow in a selected field (e.g.) to display a list of values and select one value from the list. All elements with a red asterisk are mandatory.


Fields in the Reaction and Treatment Section are described below:

Description of Reaction A description of the adverse event
Start Date of Reaction The date the reaction first appeared in the patient
Estimated Start Date of Reaction Only specify this date if the exact start date is not known
Reactions Did the patient experience a reaction
Treatment for Reaction Was a treatment given for the reaction itself
What Treatment Given for Reaction If a treatment was given for the reaction, what treatment was it
Reaction Outcome What was the outcome of the reaction
Recovery Date If the patient has recovered, what is the date of the recovery
Deceased Date If the patient has died from the adverse event, what was the date of death
Other Relevant Info Is there other information relevant to the adverse event


Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.

1.1.1.5       Reporter Information

The Reporter Information section captures details of the person who has reported the event.

To enter reporter information, enter text in the corresponding fields (e.g. Name or Initials of person reporting the event). Or click the arrow in a selected field (e.g.) to display a list of values and select one value from the list. All elements with a red asterisk are mandatory.


Fields in the Reporter Information Section are described below:

Name or Initials The name or initials of the person reporting the event
Telephone Number Contact number of the person reporting the event
Email Address Email address of the person reporting the event
Profession The profession of the person who has reported the event
Reference Number Reference number for the event that has been reported
Place of Practice At which facility does the reporter work
Confidentiality Should the report remain confidential


Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.

Click the Save Report button to submit the report or the Cancel button to cancel the registration of the spontaneous report and return to the login screen. Please note that the Save button will only be activated once all mandatory fields and field validations are completed successfully.