Schoolwide Outcome:

Graduates achieve professional competencies as currently defined by their respective profession.

Objectives: SHP graduates will be able to:

1. Demonstrate appropriate content knowledge as required by either entry-level or post-professional practice
2. Demonstrate clinical, research and/or technical skills necessary for successful performance in the chosen discipline

Program Outcomes:

1. Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
2. Conduct informed consent, maintain privacy, and apply principles of human subject protections at all stages in drug and device development.
3. Plan and implement trial related activities in accordance with regulatory and legislative guidance to ensure safety, efficacy and quality in a clinical trial.
4. Apply an understanding of the history of ethical and cultural issues, informed consent, inclusion and exclusion criteria in regard to human subject protection and privacy as well as safety as it relates to the drug development process.
5. Identify and implement the practice of leadership and project management of the ethical and professional conflicts that are associated with the conduct of clinical research and project strategy.
6. Identify and explain the specific procedural, documentation and oversight requirements of principal investigators, sponsors, CROs and regulatory authorities that relate to the conduct of a clinical study.

Schoolwide Outcome:

Graduates exhibit professional behaviors such as cultural sensitivity, integrity, respect, compassion, and altruism, and demonstrate excellence in delivery of service and a commitment to their profession.

Objectives: SHP graduates will be able to:

1. Exhibit professional behaviors in all interactions
2. Exhibit a commitment to their profession through professional membership or participation in professional activities, and by interrelating with other professionals
3. Identify and evaluate the impact of culture and diversity on health beliefs, practices, and actions
4. Apply and/or demonstrate leadership principles and strategies in organization or professional settings

Program Outcomes:

1. Conduct consenting processes across a variety of research participants.
2. Conduct informed consent, maintain privacy, and apply principles of human subject protection at all stages in drug and device development. Describe how historical events with regards to subject protection informed changes in the code of federal regulations and other regulatory documents.
3. Apply an understanding of the history of ethical and cultural issues, informed consent, inclusion, and exclusion criteria in regard to human subject protection and privacy as well as safety as it relates to the drug development process.
4. Implement leadership and project management strategies to solving ethical and professional conflicts associated with the conduct of clinical research.

Schoolwide Outcome:

Graduates effectively communicate in oral, written, and technical formats.

Objectives: SHP graduates will be able to:

1. Express concepts in writing using proper grammar and stylistic guidelines
2. Appropriately document health information according to professional standards
3. Demonstrate critical thinking by synthesizing, organizing, presenting, and/or disseminating information following established guidelines at a level appropriate for the target audience
4. Adapt appropriate interactions and/or strategies in order to accommodate diverse audiences

Program Outcomes:

1. Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
2. Construct appropriate communications as they pertain to IRB application, FDA and global regulatory agencies, budget negotiations, and other filing opportunities.
3. Explain and interpret the flow of study data through electronic data capture programs and participate in data correction and queries.
4. Implement leadership and project management strategies to solving ethical and professional conflicts associated with the conduct of clinical research.

Schoolwide Outcome:

Graduates collaborate with health care team members and other stakeholders to facilitate the attainment of common goals.

Objectives: Within their scope of practice, SHP graduates will be able to:

1. Identify roles and responsibilities of team members in the provision of patient/client/community care
2. Identify opportunities and/or participate with others to set and achieve goals

Program Outcomes:

1. Implement regulatory and legislative guidance and regulations that ensure safety, efficacy, and quality for regulatory authority approval for the marketing authorization for a medical product. Identify red flags indicating ADRs may be present.
2. Implement leadership and project management strategies to solving ethical and professional conflicts associated with the conduct of clinical research.
3. Identify and implement the practice of leadership and project management through the role of key drug safety professionals with the drug safety function associated with the conduct of clinical research, product strategy and responding to regulatory authority inquiries.

Schoolwide Outcome:

Graduates identify, critically evaluate, and practice professional, ethical and legal decision-making.

Objectives: Within their scope of their profession, SHP graduates will be able to:

1. Maintain and/or adhere to professional ethics and legal requirements
2. Articulate ethical and legal decision making practices (process by which an ethical/legal decision was made)
3. Apply ethical and legal principles to Identify breaches of professional ethics or legal requirements

Program Outcomes:

1. Conduct informed consent, maintain privacy, and apply principles of human subject protection at all stages in drug and device development. Describe how historical events with regards to subject protection informed changes in the code of federal regulations and other regulatory documents.
2. Plan and implement trial related activities in accordance with regulatory and legislative guidance to ensure safety, efficacy and quality in a clinical trial.
3. Apply Good Clinical Practice with regards to study conduct and management, safety profile management, and the control and handling of investigational products to national and global trials.

Schoolwide Outcome:

Graduates incorporate educational strategies into their roles.

Objectives: Within the scope of their profession, SHP graduates will be able to:

1. Identify relevant educational content for a target audience
2. Plan, implement and/or evaluate an educational program appropriate for a target audiences

Program Outcomes:

1. Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
2. Conduct informed consent, maintain privacy, and apply principles of human subject protections at all stages in drug and device development.
3. Describe how historical events with regards to subject protection informed changes in the code of federal regulations and other regulatory documents.
4. Plan and implement trial related activities in accordance with regulatory and legislative guidance to ensure safety, efficacy and quality in a clinical trial.
5. Apply Good Clinical Practice with regards to study conduct and management, safety profile management, and the control and handling of investigational products to national and global trials.

Schoolwide Outcome:

Graduates apply methods of scientific inquiry and disseminate findings.

Objectives: SHP graduates will be able to:

1. Propose a problem/topic and appropriate methods to investigate it
2. Use systematic search techniques to find and critically appraise research and other sources of evidence
3. Summarize and disseminate findings to appropriate audiences

Program Outcomes:

1. Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
2. Utilize the principles of pharmacoepidemiology, pharmacogenomics and other drug safety sciences to analyze potential safety issues and understand the patient population and the risks in the drug development process.

Schoolwide Outcome:

Graduates identify, critically analyze, and solve a variety of challenges.

Objectives: SHP graduates will be able to:

1. Recognize and respond appropriately to various situations within their discipline regarding clinical, cultural, psychosocial, quality improvement and/or administrative problems
2. Design and/or implement solutions using best evidence and/or practice guidelines
3. Assess outcomes

Program Outcomes:

1. Apply Good Clinical Practice with regards to study conduct and management, safety profile management, and the control and handling of investigational products to national and global trials.
2. Implement leadership and project management strategies to solving ethical and professional conflicts associated with the conduct of clinical research.
3. Identify the data sources, data capture, data assessment (seriousness; labeledness /expectedness and causality), data management practices, database tools and MedDRA dictionary for narrative preparation and analysis of clinical and post-marketing safety data.

Schoolwide Outcome:

Graduates effectively access, manage and use scientific, health care and/or patient/client information while respecting the ownership and privacy of sources.

Objectives: SHP graduates will be able to:

1. Identify and access sources of evidence/information to inform the decision making process for scholarship or patient care
2. Analyze evidence/information for quality, economic, legal, and social implications
3. Demonstrate proficiency in information privacy regulations, e.g. HIPPA and PHI
4. Adapt to changing technology in their field

Program Outcomes:

1. Identify the data sources, data capture, data assessment (seriousness; labeledness /expectedness and causality), data management practices, database tools and MedDRA dictionary for narrative preparation and analysis of clinical and post-marketing safety data.
2. Describe how data sets the stage as a critical role in a clinical trial including electronic data capture, the importance of information technology in data collection, capture, management, and queries.
3. Explain and interpret the flow of study data through electronic data capture programs and participate in data correction and queries.

Schoolwide Outcome:

SHP graduates create a safe practice environment for themselves and their patients.

Objectives: Within their scope of practice, SHP graduates will be able to:

1. Recognize medical, behavioral, and public health emergencies
2. Demonstrate skills to create safe environments and respond to health emergencies

Program Outcomes:

1. Summarize the principles of pharmacoepidemiology, pharmacogenomics and other drug safety science to analyze potential safety issues and understand the patient population and the risks in the drug development process.