WI Event
The first date any BSC employee becomes aware of the event.
Aware Date
This is defined as any information provided to BSC that relates to an existing Event or Complaint record where BSC did not request the information via a GFE request.
Additional Information (AI)
A _______ is required to request additional information from the customer when Event or Complaint information is incomplete or vague.
Good Faith Effort (GFE)
This is a communication method within GCMS-TW to request information, or request a specific action task to entities within the BSC Department.
General Action (GA)
The date on which any BSC employee first becomes aware of information from any source, that reasonably suggests that a reportable event has occurred.
System to track devices from manufacture through the distribution chain.
Device Tracking
Populate the _________ field with the date the information was provided to either the Intake Group or the CMC
Additional Info Received Date
When the original request is unanswered, subsequent requests should be sent within one week of the first request, but no sooner than _____ days.
Four (4) business days
The ______ is the person creating the General Action and requesting the information or action.
Requestor
Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
Complaint
This is performed to determine whether an event has previously been reported and an Event record has already been created in the system.
Duplicate Search
In the AI child record, document the name of the individual who provided the information to BSC in the _______ field.
Informant
This template includes limited patient information, if provided, in the Complaint Details section of the template. For use when the recipient is a Boston Scientific employee (e.g., sale representative or field service engineer).
GFE Letter Template – Rep Request with Patient Details
A GA type wherein CMC will ask for an explanation of lab findings or requests additional testing by CIS, or requests administrative information (e.g., RGA Number, Tracking Number, etc.).
CMC Request
This is the date the event information was received by or provided to the Intake Agent. This may be the date the Complaint Notification Form (CNF) was received, the date the DRL received the telephone call, or the date an email/fax was received.
Event Notification Date
These codes are assigned to Event or Complaint records in GCMS-TW to codify the event that was reported. There are codes for observations related to the device or device performance and codes for observations regarding the patient or patient issues.
As Reported codes
The first date any BSC employee becomes aware of additional information for an existing event or complaint. Within GCMS-TW, this date is documented in the Additional Information record.
Additional Information Aware Date
An _______ will be completed by the Complaint Owner to determine the impact of the GFE response on the Complaint, and any related Complaints if one GFE record was created for multiple related Complaints.
Assessment
The purpose of the ________ is to provide information about the record when viewed on a Dashboard or report.
Short Description
The _______ are intended to provide guidance to Complaint Owners for regulatory reporting decisions and the rationale for reporting or not reporting.
Rationale Codes
This type of field contains values available for selection from an associated drop-down list where multiple values may be selected. To select more than one value, hold down the ‘Ctrl’ key while selecting the values with the mouse.
Multi-selection field
When there is more than one BSC product involved in a clinical event and the products are part of a device system , one Event/Complaint record for each product will be created. These records will be linked using the ___________ field in Reference Record tab in GCMS-TW to establish a relationship between the records and ensure that they can be processed together by the same Complaint Owner.
Complaint Same System
In the GFE child record, populate the _______ field to document whether a new regulatory report is required or when an existing regulatory report needs to be supplemented (both in this Complaint and any related Complaints, if applicable).
Regulatory Report Change
In the ________ state, the Requester must review the response to determine if it is complete and addresses the question or requested action.
Review Response
If there is more than one Rationale Code that could apply to the event, a primary code must be selected to populate the Rationale Code fields in the record. The _______ field can be used to add information regarding any additional Rationale Codes that apply to the event.
Decision Rationale