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Question 18/65
Scenario: Vittronics Ltd.
Please read this scenario prior to answering the question
Vittronics Ltd. is a leading medical device manufacturer in the highly competitive market for Migraine Headache Pain Management (MHPM) devices. These tiny wireless devices are implanted in the brain and can deliver a precise electric shock when the wearable Pain Control Unit (PCU) detects an increase in stress induced by the onset of a migraine headache.
This technology will be a breakthrough in the treatment of this condition, and several competitors are striving to be the first to introduce a product into the market. However, all of them must demonstrate the effectiveness and safety of their products in a set of clinical trials that will satisfy the regulatory requirements of the countries in the target markets.
The Enterprise Architecture group at Vittronics has been engaged in an architecture development project to create a Secure Private Immersive Collaborative Environment (SPICE) that will allow researchers at its product development laboratories worldwide to share information about their independent clinical trials.
The Vittronics Enterprise Architecture group is a mature organization that has been utilizing TOGAF for several years. They have recently upgraded to TOGAF 9. The Vittronics Architecture Development Method (VADM) is strictly based on the TOGAF 9 Architecture Development Method (ADM) with extensions required to support current good manufacturing practices and good laboratory practices in their target markets.
The SPICE project team has now completed the Business, Information Systems, and Technology Architecture phases and has produced a complete set of deliverables for each phase. Due to the highly sensitive nature of the information that is managed in SPICE, special care was taken to ensure that each architecture domain included an examination of the security and privacy issues that are relevant for each domain. A corresponding SPICE Security Architecture has been defined.
The Executive Vice President for Clinical Research is the sponsor of the Enterprise Architecture activity.
Refer to the Vittronics Ltd Scenario:
You are serving as the Lead Architect for the SPICE project team.
As required by TOGAF, the SPICE project team res completed a Business Transformation Readiness Assessment in Phase A (Architecture Vision). In that assessment, it was determined that there are risks associated with the adoption of the Immersive Collaborative Environment. Despite a clear expression of the vision and the business need for utilizing SPICE to accelerate the clinical trials, the researchers have been resisting the change because of concerns about safeguarding individually identifiable information about the subjects who were participating in the trials.
You have been asked to recommend how this situation be managed in the implementation planning phases.
Based on TOGAF 9, which of the following is the best answer?
Please read this scenario prior to answering the question
Vittronics Ltd. is a leading medical device manufacturer in the highly competitive market for Migraine Headache Pain Management (MHPM) devices. These tiny wireless devices are implanted in the brain and can deliver a precise electric shock when the wearable Pain Control Unit (PCU) detects an increase in stress induced by the onset of a migraine headache.
This technology will be a breakthrough in the treatment of this condition, and several competitors are striving to be the first to introduce a product into the market. However, all of them must demonstrate the effectiveness and safety of their products in a set of clinical trials that will satisfy the regulatory requirements of the countries in the target markets.
The Enterprise Architecture group at Vittronics has been engaged in an architecture development project to create a Secure Private Immersive Collaborative Environment (SPICE) that will allow researchers at its product development laboratories worldwide to share information about their independent clinical trials.
The Vittronics Enterprise Architecture group is a mature organization that has been utilizing TOGAF for several years. They have recently upgraded to TOGAF 9. The Vittronics Architecture Development Method (VADM) is strictly based on the TOGAF 9 Architecture Development Method (ADM) with extensions required to support current good manufacturing practices and good laboratory practices in their target markets.
The SPICE project team has now completed the Business, Information Systems, and Technology Architecture phases and has produced a complete set of deliverables for each phase. Due to the highly sensitive nature of the information that is managed in SPICE, special care was taken to ensure that each architecture domain included an examination of the security and privacy issues that are relevant for each domain. A corresponding SPICE Security Architecture has been defined.
The Executive Vice President for Clinical Research is the sponsor of the Enterprise Architecture activity.
Refer to the Vittronics Ltd Scenario:
You are serving as the Lead Architect for the SPICE project team.
As required by TOGAF, the SPICE project team res completed a Business Transformation Readiness Assessment in Phase A (Architecture Vision). In that assessment, it was determined that there are risks associated with the adoption of the Immersive Collaborative Environment. Despite a clear expression of the vision and the business need for utilizing SPICE to accelerate the clinical trials, the researchers have been resisting the change because of concerns about safeguarding individually identifiable information about the subjects who were participating in the trials.
You have been asked to recommend how this situation be managed in the implementation planning phases.
Based on TOGAF 9, which of the following is the best answer?
