Stakeholder Identification in Clinical Trials

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is the primary purpose of Team Operating Principles?

To enhance team functioning and increase team effectiveness (correct)

To define project scope

To develop project schedule

To allocate project resources

What is the main objective of identifying stakeholders?

To develop project schedule

To identify stakeholders and understand their concerns (correct)

To allocate resources

To determine project scope

What is the primary purpose of resource estimates?

To identify stakeholders

To authorize expenses

To create a project schedule

To establish a preliminary budget with a level of confidence (correct)

What is the purpose of Lessons Learned?

To gain knowledge that can be applied to similar future projects Signup and view all the answers

What is an essential aspect of Stakeholder Management?

To identify stakeholders and understand their concerns Signup and view all the answers

What is an example of Team Operating Principles?

How to conduct meetings Signup and view all the answers

What is the primary purpose of a preliminary budget?

To provide a level of confidence in the estimate Signup and view all the answers

What is the primary purpose of identifying key stakeholders?

To understand their concerns and expectations Signup and view all the answers

Which stakeholder has a key interest in serious adverse events and progress?

Food and Drug Administration Signup and view all the answers

What is the primary purpose of establishing Team Operating Principles?

To ensure respect and collaboration among team members Signup and view all the answers

Which stakeholder has an interest in the protocol and safety reports?

Site Principal Investigators Signup and view all the answers

What is the primary goal of stakeholder management in project management?

To identify and prioritize stakeholder interests Signup and view all the answers

Which stakeholder has an interest in unexpected problems and progress?

Institutional Review Board Signup and view all the answers

What is the primary purpose of creating a list of project stakeholders?

To establish communication channels with stakeholders Signup and view all the answers

Which of the following is NOT a key stakeholder in the project?

Pharmaceutical Company (Customer) Signup and view all the answers

What is the primary benefit of establishing a stakeholder list?

To ensure effective communication and stakeholder management Signup and view all the answers

What is the primary purpose of creating a project charter?

To engage proactively and align with stakeholders Signup and view all the answers

What is a benefit of the chartering process in stakeholder management?

It reaches agreement on objectives and enhances stakeholder satisfaction Signup and view all the answers

What is a key aspect of team development in the project charter?

Sharing a project vision and objectives Signup and view all the answers

What is NOT a primary purpose of creating a project charter?

To identify and mitigate risks Signup and view all the answers

What is a benefit of a project charter in team development?

It creates an environment that encourages collaboration Signup and view all the answers

What is NOT a benefit of the chartering process?

It allocates resources effectively Signup and view all the answers

What is a key aspect of stakeholder management in the project charter?

Understanding stakeholder vision and objectives Signup and view all the answers

What is a benefit of engaging stakeholders in the project charter?

It reaches agreement on objectives and enhances stakeholder satisfaction Signup and view all the answers

Study Notes

Stakeholder List

A stakeholder list includes individuals and/or groups with an interest in the project.
Key stakeholders are the Institutional Review Board, Food and Drug Administration, and Site Principal Investigators.
Other stakeholders include the Pharmaceutical Company (Customer) and Research Subjects (Patients).

Stakeholder Interests

Institutional Review Board: unexpected problems, progress
Food and Drug Administration: serious adverse events, progress
Site Principal Investigators: protocol, safety reports, changes
Pharmaceutical Company (Customer): serious adverse events, progress
Research Subjects (Patients): purpose of study, risks and benefits, protocol

Team Operating Principles

Establish how meetings will be conducted, decisions will be made, and work will be done.
Enhance team functioning, increase team effectiveness, and ensure all parties are aware of what is expected.
Examples of Team Operating Principles include how to conduct meetings, treat each other with respect, accomplish work, and make decisions.

Project Charter

A primary purpose of the Charter is to engage proactively with customers and align with their vision for the project.
The Charter helps develop productive working relationships, reaches agreement on objectives, and enhances Stakeholder satisfaction.

Project Team

The Charter is a tool to begin team development by sharing a project vision and objectives.
Team roles and methods may be enumerated in a project Charter or an associated team Charter.

Resource Estimates

A preliminary budget includes a level of confidence in the estimate.
Identify expenses the Project Manager can authorize and those the Sponsor needs to control.

Stakeholder List and Analysis

Identify Stakeholders and what they care about.
Determine who the key Stakeholders are.

Lessons Learned

Lessons Learned are knowledge gained from one project that may be applicable to similar future projects.

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

Identify stakeholders and their priorities in clinical trials. This quiz covers institutional review boards, FDA, site principal investigators, and pharmaceutical companies.