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Review medical data for ICSR

The Medical Review page provides you with overall ICSR information that requires your attention conveniently compiled in one place. With the available functionality, the medical reviewer can conveniently assess data from the Case Narrative, Case Assessment, and Event Assessment blocks.

To review medical data for ICSR

  1. In the PV application header, select the ICSR tab.

  2. On the ICSR List page that opens, in the table, locate the ICSR record for which you want to review medical data. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR form page that opens, from the toolbar, select Medical Review medical_review_icon.png.

    Accessing medical review
    Figure 2. Accessing medical review

  4. On the page that opens, under the Medical Review tab, view and manage the data as explained in the following table.

    Reviewing medical data
    Figure 3. Reviewing medical data

    Element

    Details

    Case Narrative

    The data is pulled from the Narrative form of your ICSR.

    Select arrow_fold_icon.png or arrow_unfold_icon.png next to the block title to collapse or expand the block contents for a convenient form view.

    Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Other Information*

    Represents details of the clinical course, therapeutic measures, treatment outcomes, and other important information related to the patient who has experienced the reported adverse reaction or event.

    You can edit this field manually or by using translation or autogeneration features.

    Once saved, the changes are synchronized to the respective field of the Narrative form of the ICSR.

    Reporter's Comments

    Represents the event-related comments provided by the reporter including diagnosis information and causality assessment.

    You can edit this field manually or by using translation or autogeneration features.

    Once saved, the changes are synchronized to the respective field of the Narrative form of the ICSR.

    Company's Comments

    Represents the company's assessment of the case including expectedness and causality based on the case information, narrative, and reporter's comments

    You can edit this field manually or by using translation or autogeneration features.

    Once saved, the changes are synchronized to the respective field of the Narrative form of the ICSR.

    Translation

    Select translation_icon.png to add the field translation.

    This option is unavailable if the translation view is enabled.

    Generate Narrative

    Select generate_narrative_icon.png to autogenerate the narrative and AOSE details.

    Case Assessment

    The data is pulled from the General form of your ICSR.

    Select arrow_fold_icon.png or arrow_unfold_icon.png next to the block title to collapse or expand the block contents for a convenient form view.

    Case Serious

    Select Yes or No to state the case seriousness according to criteria defined by regulatory authorities and international guidelines.

    The value in this field is set to Yes automatically if at least one event is recorded as serious in the Event form. If none of the events is recorded as serious, then the value in this field is set to No automatically.

    You can edit this field as needed. Once saved, the changes are synchronized to the respective field of the General form of your ICSR.

    To change the value manually disregarding the preconfigured system logic of case seriousness calculation, select the Manual checkbox.

    Notes for Case Serious Change

    Enter the reason or additional information to explain why the case seriousness is changed.

    Case Causality

    Select either Related or Not Related causality for the manually created ICSR.

    The value in this field is automatically calculated from the Causality as Reported and Causality as Determined fields' values according to the configured rules.

    The auto-calculation rules can be configured according to customer requirements by the EDETEK administrator.

    You can edit this field as needed. Once saved, the changes are synchronized to the respective field of the General form of your ICSR.

    To change the value manually disregarding the preconfigured system logic of case causality calculation, next to the field, select the Manual checkbox.

    Notes for Case Causality Change

    Enter the reason or additional information to explain why the case causality is changed.

    Case Expectedness

    Select either Expected or Unexpected to state the expectedness of the case for the suspect product(s).

    The value in this field is set to Unexpected automatically if at least one recorded event has been assessed as unexpected in the Assessment form.

    To change the value manually disregarding the preconfigured system logic of case expectedness calculation, next to the field, select the Manual checkbox.

    Notes for Case Expectedness Change

    Enter the reason or additional information to explain why the case expectedness is changed, if indeed.

    Case Outcome

    This field is read-only and populates based on the values of the Outcome of Reaction / Event at the Time of Last Observation field of the Events form.

    The rules for the outcome auto-calculation can be adjusted according to customer requirements by the EDETEK administrator.

    You can find the currently configured rules in Appendix E. Case outcome rules.

    Manual

    Select the Manual checkbox next to the field to change the field value manually disregarding the preconfigured system calculation logic. If the Manual checkbox is cleared, upon saving, the system recalculates the value according to the preconfigured rules.

    For instance, you have changed the case seriousness value to No without selecting the Manual checkbox, and there is one event recorded as serious for your case. Thus, upon saving, the system recalculates the value to Yes.

    Event Assessment

    The data is pulled from the Assessment form of your ICSR.

    Product

    Represents the name of the product that is considered to be a suspect in the AE case.

    The product trade name is displayed in the first line. If the trade name is empty, the product name is displayed.

    The product's generic name is displayed in the second line. If the generic name is empty, the product name is displayed.

    Select the value to go to the respective product record of the Product form in the ICSR.

    Event PT (Description) / LLT

    Represents the Preferred Term (PT), event verbatim term, and the Lowest Level Term (LLT) of the event.

    Select the event name value to go to the respective event details page within the Event form of your ICSR.

    If the event is coded, the green check icon appears next to it. Select the icon to view the MedDRA hierarchy.

    Viewing event MedDRA hierarchy
    Figure 4. Viewing event MedDRA hierarchy

    Causality as Reported

    Represents the reported result of causality assessment automatically populated by the system based on the Causality Assessment block values of the Assessment form of your ICSR. The calculation follows the configured rules.

    The autocalculation rules can be configured according to customer requirements by the EDETEK administrator. You can find the currently configured rules in Appendix B. Causality as reported rules.

    Select the value to open the Causality Assessment dialog and review, add, delete, or edit the causality details.

    Viewing causality assessment details
    Figure 5. Viewing causality assessment details

    The fields of this dialog are identical to the ones in the Causality Assessment block of the Assessment form.

    Causality as Determined

    Represents the result of company causality automatically populated by the system based on the Causality Assessment block values of the Assessment form of your ICSR. The calculation follows the configured rules according to the configured rules.

    The autocalculation rules can be configured according to customer requirements by the EDETEK administrator. You can find the currently configured rules in Appendix C. Causality as determined rules.

    Select the value to open the Causality Assessment dialog (same as for Causality as Reported) and review, add, or update the causality details.

    Seriousness

    Severity

    Duration

    Represents the seriousness, severity, and the duration of the event as follows:

    • For a serious event, the value reflects the seriousness criteria specified in the Event form, such as F for Results in Death, LT for Life Threatening, H for Caused / Prolonged Hospitalization, OTH for Other Medically Important Condition, DIS for Disabling / Incapacitatingand, CON for Congenital Anomaly / Birth Defect, IME for Important Medical Event, and so on. For a non-serious event, the Non-serious value is displayed.

    • The severity value is populated from the CTC AE Grades field of the Event form.

    • The duration value is based on the values from the Duration Number of Reaction / Event and Duration Unit of Reaction / Event fields of the Event form.

    Data Sheet

    Represents the data sheet associated with the product. This can be IB, SmPC, and so on. From the data sheet, the expectedness of the event is calculated.

    Select the value to open the dialog and review the list of expected events (terms list) from the data sheet.

    Viewing data sheet terms
    Figure 6. Viewing data sheet terms

    In PV, you can configure data sheets for a specific product family. To learn more about the data sheet configuration, see the Configure product family section.

    Event Expectedness

    Indicates if the event is expected or not for the suspect product. The expectedness is calculated by the system automatically based on the associated data sheet, as follows:

    • Expected expected_value.png: this value in green is populated if the associated data sheet lists the occurred event as expected for the product.

    • Unexpected unexpected_value.png: this value in red is populated if the associated data sheet does not have the occurred event in the list of expected for the product.

    You can select the value manually here, but upon clicking Generate Record for the Assessment form, the system recalculates the value according to the preconfigured logic.

    If you recode the product or event, you also need to select the Generate Record icon in the Assessment form manually to update the automatically calculated value.

    To enter an assessment for an AE, the product must be coded to the Company Drug Dictionary (CDD) via the Product functionality, so that the application can determine which data sheet to use for judgment, and the event must be coded to MedDRA.

    Workspace toolbar

    Translation View

    Select bilingual_view_icon_gray.png to review the translated version of the medical data. From the field that appears, select the target translation language.

    Selecting language of translation view
    Figure 7. Selecting language of translation view

    Currently, only English and Chinese translation languages are supported in PV.

    You can go back to the original language view by selecting Translation View bilingual_view_icon_red.png.

    Return

    Select return_route_icon.png to return the ICSR workflow route.

    Forward

    Select forward_route_icon.png to forward the ICSR workflow route.

    CIOMS-I Export

    Select More more_icon.png > CIOMS-I Export export_icon.png to export a draft CIOMS-1 report only to check the case assessments and entries easily following the CIOMS-1 template as we proceed with case processing and review. The exported file has the Draft watermark.

    Exporting draft CIOMS-I report
    Figure 8. Exporting draft CIOMS-I report

    Learn more about the CIOMS-I export functionality in the Export CIOMS-I report section.

    MedWatch3500A Export

    Select More more_icon.png > MedWatch3500A Export export_icon.png to export a draft MedWatch 3500A report only to check the case assessments and entries easily following the MedWatch 3500A template as we proceed with case processing and review. The exported file has the Draft watermark.

    Exporting draft MedWatch 3500A report
    Figure 9. Exporting draft MedWatch 3500A report

    Learn more about the MedWatch 3500A export functionality in the Export MedWatch 3500A report section.

    SAVE

    Select diskette_icon.png to save the implemented changes.

    Back to List

    Select arrow_left_icon.png to exit the medical review and return to the ICSR details page.

Once saved, the data is updated and populated to the respective ICSR forms.

In this section:

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

In the pharmaceutical industry, a medicinal product or drug that is being monitored for its safety and efficacy. A product can be a prescription drug, biologic, vaccine, herbal medicine, or any other health-related product that is used to diagnose, treat, prevent, or alleviate medical conditions in humans.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

A MedDRA distinct descriptor (single medical concept) for a symptom, sign, disease diagnosis, therapeutic indication, investigation, surgical or medical procedure, and medical social or family history characteristic. Each PT has at least one Lowest Level Term (LLT) (itself) and synonyms and lexical variants (for example, abbreviations, different word order, or else). Each LLT is linked to only one PT.

The most specific level of MedDRA with more than 80,000 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 a user database.

See also: current LLT and retired LLT

A document that contains comprehensive and up-to-date safety information about a medicinal product. It is also commonly known as the Summary of Product Characteristics (SmPC) or Prescribing Information in different regions or countries. The PDS/SmPC provides essential details about the product's composition, indications, contraindications, dosage and administration, clinical pharmacology, pharmacokinetics, interactions, adverse reactions, warnings, precautions, and other important safety information.

A comprehensive document prepared by the sponsor or manufacturer of an investigational drug or medicinal product. It is primarily intended for use by clinical investigators who are conducting clinical trials to evaluate the safety and efficacy of the investigational product.

A crucial document that provides detailed information about a medicinal product, including its composition, therapeutic indications, dosing, contraindications, precautions, and the known safety profile. The SmPC is primarily intended for healthcare professionals and is prepared and approved by MAH or a pharmaceutical company and is a legal requirement for all authorized medicinal products in many countries. It serves as the basis for prescribing, dispensing, and administering medication to patients and is an essential reference for healthcare professionals in clinical practice.