Entering Event Information

When entering event information in the AE Entry and Local Info tabs, be aware of the following:

• Click Add to add another row to the section.
• Click the Zoom icon to enter text or notes in a separate window. You can also check the spelling of the text in this separate window.

To enter text information:

1. Open the AE Entry tab.
   
2. Enter the available event information in each of the sections of the AE Entry tab as shown in the following tables.

   General Section

   Item	Description
   LAM Use Only	Select this check box if this event is for local usage only and will not be routed to Central.
   Central AE Case Number	The case number that is assigned to this event at Central will be entered here. No text can be entered in this field when initial event information is being entered.
   Report Type	Select the type of report.
   Receipt Date	Enter the Receipt Date. This date will be used at the Central end.
   Affiliate Date	Enter the date received.
   Country of Incidence	Select the country in which this event occurred.
   Local Reference Number	The number by which the event is identified is entered here. This number will be automatically generated if the system has been configured to automatically number local events.
   Case Narrative	Enables the user to enter a narrative description of the case.
   Case Comment	Enables the user to enter relevant comments about the case.
   Follow up Received	Enter the date on which follow up information was received at the local affiliate location.
   Safety Received	Enter the date on which the follow-up information was received by the Central safety office.
   Significant	Select this check box if significant follow-up information has been received.

   Patient Information Section

   Item	Description
   Initials	Enter the initials of the patient.
   Date of Birth	Enter the date of birth of the patient.
   Age/Age Unit	Enter the patient's age and the age units used.
   Gender	Enter the patient's sex.
   Patient ID	Enter the patient's identification number. Note: This field is available only if the event is associated with a clinical trial or other study.
   Study Number	Enter the study number. Note: This field is available only if the event is associated with a clinical trial or other study.

   Other Relevant History Section

   Item	Description
   Start Date	Enter the start date of the condition. You can enter a partial date if the actual date is not available. You can also choose not to enter a date.
   Stop Date	Enter the stop date of the condition. You can enter a partial date if the actual date is not available. You can also choose not to enter a date.
   Ongoing	Indicates whether the condition is continuing. If it is set to Yes or Unknown, the Stop date is disabled.
   Condition Type	Select a condition type from the list. The Administrator can adjust this list.
   Description as Reported	Enter the verbatim term used by the reporter, or patient, to describe the adverse event or product name.
   Notes	Enter any notes pertinent to relevant history.

   Reporter Information Section

   Item	Description
   Address	The address of the institution.
   City	The city where the institution is located.
   Country	The Country where the institution is located.
   Department	The name of the reporter's department
   Email Address	The email address for the reporter.
   FAX Number	The fax number for the reporter.
   First Name	The first name of the reporter.
   Health Authority Case Number	The Health Authority Case Number.
   Health Care Professional	Indicates whether the reporter is a health care professional.
   Institution	The name of the institution where the reporter is currently employed.
   Intermediary	Identifies the intermediary for the case.
   Last Name	The last name of the reporter.
   Middle Name	The middle name of the reporter.
   Occupation	Displays the occupation of the reporter.
   Postal Code	The postal code where the institution is located.
   Protect Confidentiality	Indicates that the reporter's identity is protected in expedited reports.
   Dosage Regimen Dose Description	User this field to describe non-standard dosages that cannot be adequately described using the dose, route, and frequency fields. Note that the initial value for this field defaults to the dose, route, and frequency information and can be amended as appropriate.
   Report Media	Displays the method used to report the case.
   Reporter Type	Identifies the reporter type.
   Sal.	Identifies the title of the reporter.
   State	The state where the institution is located.
   Suffix	Displays the reporter's suffix, if appropriate.

   Event Information Section

   Item	Description
   Onset Date	Enter the date/time the event started. You can enter a partial date if the complete date is unavailable.
   Stop Date	Enter the date/time the event stopped.
   Event Description	Enter the verbatim term used by the reporter to describe the adverse event. As you type, the system automatically copies the term in to the Description to be Coded field.
   Death	Click the appropriate box to select the Serious Criteria for the event.
   Hospitalized	Click the appropriate box to select the Serious Criteria for the event.
   Disability	Click the appropriate box to select the Serious Criteria for the event.
   Other	Click the appropriate box to select the Serious Criteria for the event.
   Other Text	Enter text to describe the other type of serious event.
   Medically Significant	Click the appropriate box to select the Serious Criteria for the event.
   Life Threatening	Click the appropriate box to select the Serious Criteria for the event.
   Intervention Required	Click the appropriate box to select the Serious Criteria for the event.
   Congenital Anomaly	Click the appropriate box to select the Serious Criteria for the event.
   Symptoms	Enter the appropriate symptoms for the cases.
   Outcome	Select the outcome of the event from the drop-down list (e.g., recovered, improved, fatal, etc.) The Administrator can adjust the information on this list. If Fatal is selected, Death is check in the list of seriousness criteria.
   Duration	The system automatically calculates this field from the event start and stop dates. If duration is greater than five (5) days, the system only displays days. You can enter or modify the duration manually.
   Diagnosis/Symptom	Click the appropriate radio button to indicate whether the event is a diagnosis. Clicking Yes marks this event as the primary event. In case of multiple diagnosis events, the event on the left is considered as the primary event. Click Relationships to display the Event-Relationships dialog. This enables you to group symptoms and signs with diagnoses.

3. Open the Local Info tab.
4. Enter the available case information in each of the sections of the Local Info tab as listed in the following tables.

   Contact Log Section

   Item	Description
   Date	Enter the date associated with the letter.
   Code	Enter the contact code associated with the letter.
   Description	Enter the description associated with the letter.
   User	Select the user to whom the letter is to be sent.
   Date Sent	Enter the date on which the letter was sent.

   Action Items Section

   Item	Description
   Date	Displays the date associated with the Action Item.
   Code	Displays the code associated with the Action Item.
   Description	Displays a description of the Action Item.
   User	Displays the user to whom the Action Item is assigned.
   Due Date	Displays the date on which the Action Item is due.
   Date Completed	Displays the date on which the Action Item was completed.

   Notes and Attachments Section

   Item	Description
   Attach Documentum Link	Displays the Documentum Lookup Dialog. Use this dialog to search for and select Documentum links.
   Attach File	Click Attach File to add an attachment. Browse to the location of the file on your system.
   Date	Enter the date associated with the note or attachment.
   Classification	Select the type to which the attachment belongs.
   Description	Enter the description of the attachment.
   Item	Description
   Keywords	Enter the keywords relevant to the attachment. To select a keyword from a list, click Select.
   Select	Click Select to enter a new keyword or select a keyword from the list.

   Routing Comments Section

   Item	Description
   Date	Displays the date on which the event information or follow-up information was routed to Central.
   Route By	Displays the user who was responsible for the routing.
   Comment	Displays the routing comments.

5. Add letters as necessary. Select Save in the Local Affiliate menu to save the case.

   Note:

   For follow-up information associated with an event, enter the follow-up information and then route the event to Central.

For more information, see:

• Adding a Letter