Software Support and Maintenance – IBM Clinical Trial Management System for Sites offering
IBM Clinical Trial Management System (CTMS) for Sites Support teams (“CTMS Support” or “Support”) are available to assist with customer support issues of varying degrees of severity. There may be occasions where Support may not be able to answer all your questions, but will engage other groups within the company to help provide answers, including Operations or Product Development.
CTMS Support will provide a tiered support model (see Support Service Level). Tier I and Tier II are considered “Baseline” support available to all customers as part of their product subscription. Tier III is offered for an additional Consulting Services fee, at the discretion of Clinical Development Support.
Response Times Objectives and Rapid Response Definitions
Response time objectives described herein are intended to describe CTMS Support’s goals, differentiated from those of any other IBM teams. They represent our target, not a guarantee of performance, unless specified otherwise in your contract with IBM.
Any tickets requiring rapid response will be escalated outside of normal tier support and designated as “Rapid Response.” The term “Rapid Response” is applied to any ticket that meets the following criteria:
- Business critical functionality is inoperable or critical interface has failed. This applies to a production environment and indicates an inability to access services resulting in a critical impact on operations.
- The cause of the issue is or could reasonably be assumed to be a technical cause over which IBM has direct control. If during troubleshooting an issue is determined to be of an external nature, Rapid Response protocol will be disengaged.
Support Service Level versus Consulting
Support shall be made available upon request from a customer, subject to payment of the fees specified in the applicable Order. There may be occasions where Support may not be able to answer all questions, but instead transfers incidents to other groups within the company. These transfers, if identified as being outside the scope of Baseline Support, fall under billable Consulting terms and require approval of the customer to proceed further. Clinical Development teams strive to identify issues that fall outside Baseline Support within the first 2 contacts between customers and our Support team.
IBM will offer 24-hour-a-day, 7-day-a-week support access for Tier I support and for any tickets that fall under Clinical Development Rapid Response terms. All Tier II or Tier III tickets, once designated as such, will be processed during normal business hours (9am-5pm Eastern Time, Monday through Friday, excluding US Holidays).
CTMS Support prioritizes work in order of incident severity, like most other IBM portfolios. The following table defines product-specific severity levels and targets for response to customers each time an incident is reported or status is requested.
|
Severity-1 |
Critical impact |
Critical business impact/service down: Business critical functionality is inoperable or critical interface has failed. This applies to a production environment and indicates an inability to access services resulting in a critical impact on operations. |
1-hour response time target (maximum) |
|
Severity-2 |
Significant |
Significant business impact: A service business feature or function of the service is severely restricted in its use or you are in jeopardy of missing business deadlines. |
2 business hours |
|
Severity-3 |
Some |
Customer can continue with a workaround but impact may increase if a resolution is not forthcoming. A medium impact on a caller that involves partial or limited loss of non-critical functionality, but a workaround exists that allows for the continuance of normal operations. |
4 business hours |
|
Severity-4 |
Minimum |
Customer does not need resolution to continue work; no impact is seen on the caller and they can await a resolution to continue work. Involves no loss in functionality or is a general usage question, including questions that reference product documentation or request enhancements. |
1 business day |
While Clinical Development Support will consult the customer regularly throughout the life of an incident about what severity it should be assigned, Clinical Development Support reserves the right to designate the severity of any Support ticket to ensure proper handling.
CTMS Support Tiers
This section outlines the terms of Baseline Support versus consulting/services, and outlines which requests should fall under ‘reasonable effort’ basis.
Tier I Support: Any ticket directly related to the application in which we can resolve with minimal troubleshooting. These tickets typically take under 45-60 minutes of effort by CTMS Support.
Tier I Sample Tickets Include:
- Site navigation
- Browser related
- Searching for patient information
- Creating search parameters
- Documentation export
- Determine escalation path to ether tier II or tier III
Tier I Exclusion Criteria include, but may not be limited to the following:
- Solutions cannot be found within our online manual at the time of request
- Any request requiring direct access to a study that the support personnel does not have access to
- Any hardware troubleshooting (connection to internet)
Tier II Support: Any ticket directly related to the application in which some troubleshooting is required.
Tier II Sample Tickets Include:
- Budgeting/Financial items
- Report Creation
- Potential Training or Retrainings
- Determine escalation path to tier III
- Data interventions, in cases where normal application use has created duplicate or problematic data that is preventing users from performing necessary actions in the program
Tier III Support (Consulting): Any ticket directly or indirectly linked to the application in which customer-specific scenarios are required to understand. These tickets may be resolved same-day, or may require multiple contacts and business days to resolve. Issues that typically require more than 60 minutes of work time to resolve are not considered ‘Support’ Tier I or Tier II for Clinical Development. Such tickets usually result in the customer being advised to seek Tier III guidance. Tier III guidance falls outside the scope of Baseline support and fees are charged for services rendered.
Tier III Sample Tickets include:
- Training sessions
- Business process or application best practice consultations
- Data interventions to clean up previously entered data
- Report Building consulting (consulting fees may apply once consulting is approved)
- For more information on Tier III and Services Consulting, please see the governing Service Description for this product.
Refusal of Support
Although IBM offers additional resolution paths outside CTMS Support for issues not included in Baseline Support (i.e. Tier III consulting), IBM CTMS Support has the right to refuse service for any issue originating outside of the CTMS offering. This includes but is not limited to: hardware support, unsupported browser use, and tools integrating into CTMS Development that are not managed as commercially available product offerings by IBM CTMS Development teams. Also, any topic that might be outside the realm of our expertise (example: protocol-specific medical or clinical opinion) explicitly falls outside our terms of Baseline support.
Serviceability
To maintain competitiveness and evolve to service our customers' ongoing needs, IBM reserves the right to modify the terms and/or methods of support expressed in this document at any time.