Investigations

Investigations are a record of surveillance activities conducted by the DDU.

Investigations and Enquiries can be linked to a Patient, Health Practitioner, or Organisation.

Investigation Search

1. From the navigation menu, select Investigations.
2. (If required) Modify the Date Range filter.
3. (If required) Apply additional filters to each column header.

   Investigation Search displays all the investigations in ScriptCheckSA, with their Date, Number, Status, Investigation Reason, etc ... It also provides a count of Open Tasks and Investigations associated with each Investigation.

4. Click to open Investigation Details and edit (if required).

Create Investigation

1. From Investigation Search, select Create Investigations, then provide summary details about this investigation:

   Date raised

   Today's date (Read-only)

   Raised by

   Name of the logged in user (Read only)

   Status

   Mandatory

   • Open (Default)
   • Closed - All fields change to read-only. The event can no longer be edited, except for Notes.
   • Reopened - A Closed investigation can be reopened. Most fields can be edited again. Once all editing is completed, the investigation can be Closed again.

   Source

   Mandatory

   Select from the list.

   If you select any option containing Other, enter the relevant details in the text field.

   Actions taken

   Select from the list.

   Multiple selections are allowed.

   If you select any option containing Other, enter the relevant details in the text field.

   Patients

   When the investigation is started from the Patient profile, patient details are pre-populated.

   While the investigation is Open, Search for patient records to link to the investigation.

   Search

   Link this investigation to the relevant patient(s), if applicable.

   The patient details displayed Patient Search Results are sourced from the patient profile.

   1. Expand the Patients section.
   2. Enter at least one character in First Name or Surname. Optionally, enter one or more character in Date of Birth, or the patient's IHI Number, then select Search.

      A list of matching patients displays in Patient Search Results.

   3. From Patient Search Results, select the relevant entry.
   4. Click through to view more patient details and make any required changes. 
   5. Select the relevant entry and add it to the Patient section. 

      Select is disabled if the patient only has a medication history.

      If the patient you want to link to only has a medication history, you must first create a patient profile for this patient.

      See Patient Profile

   6. Once the selected patient has been added, do one of the following (if required):
      • View patient - Open the profile to view the full patient details and make any required changes.
      • Remove patient - If your patient selection is incorrect.

        

   Practitioners

   While the investigation is Open, Search for a practitioner record to link to the investigation.

   Search

   1. Search by Name, Surname, or Unique ID.

      You must enter at least one character in either the First name or Surname fields or a valid ID number.

      A list of matching practitioners displays in Practitioners Search Results.

   2. In Practitioners Search Results, use the column headers to sort or filter the results.

   3. Select the relevant entry.

   4. Click through to view the full practitioners details and make the required changes.

   5. Select the practitioner to add it to the grid.

   6. (If required) In the grid, select delete to remove a line entry. For example, if your profile selection is incorrect.

      

   7. Once the selected entry has been added to the grid, do one of the following (if required):

      • View practitioners - Open the profile to view in Practitioners Details and make any required changes.

      • Remove practitioners - If your prescriber selection is incorrect.

   8. Save your changes to return to the Authority.

   Add Address

   (If required) Use Prescriber Address to change or add one or more addresses for the selected prescriber.

   These details are specific to this regulatory event (authority, enquiry, investigation). They persist even if the prescriber's profile is updated.

   Organisations

   While the investigation is Open, Add Organisation records to link to the investigation.

   Add Organisation

   1. Enter at least one character in Name, Suburb, Postcode or enter the Pharmacy Approval Number.

      

   2. If required, apply additional filters to each column header.
   3. Select the relevant entry (or entries), then Save to add it to the grid (or Cancel to return to the previous page).
   4. If you cannot find the organisation, select Create Organisation to be re-directed to the Organisations page.

      See Organisations

   Contacts

   While the investigation is Open, Add Contact details of any relevant parties associated with this investigation.

   Add contact

   Provide name, address and role details about the contact person:

   

   Other actions:

   • Remove - Remove a contact from the grid. The regulatory event must be Open.
   • Cancel - Close the contact form without saving your changes.
   • Save - Save the contact details, then confirm at the prompt.
   Descriptions

   When the investigation is saved, the description is saved like a note and cannot be overwritten. Further recommended actions can then be added.

   Accepts up to 2000 characters.

   Enter information to describe the purpose of this regulatory event in the text field.

   Each entry saved in the Description field is accompanied by a Date/Time stamp and the name of the logged in user.

   Up to 20 descriptions are displayed in reverse chronological order.

   • Select Show More ... to display older entries.
   Recommended actions

   When the enquiry is saved, your recommended actions are saved as a note and cannot be overwritten. Further recommended actions can then be added.

   Accepts up to 2000 characters.

   Enter information about the actions recommended by DDU as result of this Enquiry or Investigation.

   Each saved entry is accompanied by a Date/Time stamp and the name of the logged in user.

   Up to 20 entries are displayed in reverse chronological order.

   • Select Show More ... to display older entries.
   Medicines

   The list displays the medicines being investigated as part the investigation.

   Add Medicine

   Select and add medicines that are associated with this investigation.

   Select medicines from the Medicine Group

   1. From Medicine Group, select the medicine group that is relevant to the investigation.

      To refine the list, do one of the following:

      • Enter a medicine name (generic or brand), then Search .

        — or —

        Apply additional filters to each column header.

      For each line item, the Monitored Medicine List displays the Generic name, Brand name, Strength, Formulation, MPUU, TPUU, PBS code (when applicable), and the Unit of Measure (UoM).

   2. Select the line entries that are relevant.
   3. Select Add to Investigation to add your selection .

      Ensure you have selected all the required lines.

      You have not selected all items, Please select any unselected medicines that are required (use the page controls if necessary).

      You are returned to your investigation page where your selection displays in the Medicines grid.

   4. In the Medicines grid, complete the required information (Dose, UoM, Formulation and Frequency) that is specific to the investigation.

   Edit your selection in the medicines grid

   1. For each line entry in the Medicines grid, enter or select additional details about Dose, UoM, Formulation and Frequency.

      

   2. Save your changes.

   Remove Medicine

   • Select to remove a line entry from the Medicines grid.

     

   Enquiries

   Create Enquiry

   Create a new enquiry and link it to this investigation.

   Refer to Enquiries.

   View Enquiries

   The Enquiries grid displays up to 50 enquiries associated with this investigation, in reverse chronological order.

   You can only create and link an enquiry while this investigation is Open.

   Save - The enquiry is linked to this investigation.

   Cancel - The enquiry is created, but not linked to this investigation.

   Tasks

   View Task

   Related tasks display (10 per page) in reverse chronological order in the grid.

   • (If required) Apply additional filters to each column header.
   • (if required) Select any column header to sort.

   Create Task

   

   When the logged in user has the Regulator role, the Create task screen displays with Status set to Open (by default).

   • Priority - (Optional) Low, Medium, High

   • Status - (Mandatory) Open or Closed

   • Assigned to - (Mandatory) Select the relevant user role.

     All tasks assigned to your user role display on the Tasks Dashboard.

   • Due Date - (Mandatory) Must be a future date.

   • Date Created - (Read-only) Today's date

   • Administrative task type - Select from the list.

   • Regulatory task type - Select from the list.

   • Notes - 1000 characters max.

   When the logged in user has the Regulator Support role, the Create task screen displays default values for the most common task type for this role:

   • Priority: Low

   • Status: Open

   • Assigned to: Regulator

   • Due date: 14 business days after Date created (excluding weekends)

   • Administrative task type: Upload document for review.

   • Regulatory task type: This field is not displayed.

   When all the mandatory fields have been completed, Save is enabled.

   The task is visible on the Dashboard screen to users with the relevant role.

   Your investigation has been updated successfully.

   Correspondence

   Attach any digital copy of letters associated with this patient.

   • Date of document - Date the document was created or obtained by the user.

   • Document type - Select from the list.

   • Source

     • Inbound - Received by DDU (Default).

     • Outbound - Initiated by DDU.

   • Sender/Recipient - Either the person or organisation who provided the document, or for whose benefit the document was uploaded.

   • Sensitive - By default, all uploaded documents are flagged as Sensitive. Practitioners cannot view this document in the Practitioner portal, unless the flag is removed.

     Correspondence attached to an organisation cannot be viewed or accessed by practitioners.

   • Choose file - Select a single file to be uploaded. Max size is 4 MB.

   • Drop file here - Drag-and-drop a file to be uploaded.

   • Upload - The document is uploaded to ScriptCheckSA.

     Your document has been successfully uploaded.

     If the document's file type is not allowed, or if malware is detected, the upload is not permitted.

     The document selected is not a permitted file type.

     The document selected did not pass the malware scan and has been rejected.

   • Cancel - The document is not uploaded.

   Edit document details

   Select Edit to modify the document details displayed in the grid.

   If the document was uploaded, all Document Details can be edited.

   If the document was generated by ScriptCheckSA, you can only modify two entries.

   • Document status: To be reviewed, In review, Review completed

   • Sensitive: Remove this flag if you want the document to be displayed in the Practitioner portal.

   

   View correspondence (in grid)

   All correspondence is displayed in the grid in reverse chronological order.

   • Open - Select the Filename to open the attached document (and download it).

   • Edit - Select Edit to modify the document details displayed in the grid.

   • Delete - Select Delete to remove the document from the grid. This only applies to uploaded documents.

     

   Your document has been deleted successfully.

   Notes

   Notes can be added after this investigation is Closed.

   Optional

   Notes are visible to other regulators.

   1. Enter your note (up to 1000 characters), then Save.

      The Notes section displays 20 of the most recently added notes, sorted in reverse chronological order.

      Each note displays with a Date/Time stamp and the name of the user who created it.

   2. Select Show more to display all notes.

2. Save the investigation.

   If any information required is missing or invalid, Save is disabled.

   Upon saving, ScriptCheckSA generates an Investigation Number for the investigation.

   A success message is displayed.

   Your investigation has been updated successfully.