Stakeholder Identification in Clinical Trials

UnaffectedMarimba avatar
UnaffectedMarimba
·
·
Download

Start Quiz

Study Flashcards

24 Questions

What is the primary purpose of Team Operating Principles?

To enhance team functioning and increase team effectiveness

What is the main objective of identifying stakeholders?

To identify stakeholders and understand their concerns

What is the primary purpose of resource estimates?

To establish a preliminary budget with a level of confidence

What is the purpose of Lessons Learned?

To gain knowledge that can be applied to similar future projects

What is an essential aspect of Stakeholder Management?

To identify stakeholders and understand their concerns

What is an example of Team Operating Principles?

How to conduct meetings

What is the primary purpose of a preliminary budget?

To provide a level of confidence in the estimate

What is the primary purpose of identifying key stakeholders?

To understand their concerns and expectations

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

Food and Drug Administration

What is the primary purpose of establishing Team Operating Principles?

To ensure respect and collaboration among team members

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

Site Principal Investigators

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

To identify and prioritize stakeholder interests

Which stakeholder has an interest in unexpected problems and progress?

Institutional Review Board

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

To establish communication channels with stakeholders

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

Pharmaceutical Company (Customer)

What is the primary benefit of establishing a stakeholder list?

To ensure effective communication and stakeholder management

What is the primary purpose of creating a project charter?

To engage proactively and align with stakeholders

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

It reaches agreement on objectives and enhances stakeholder satisfaction

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

Sharing a project vision and objectives

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

To identify and mitigate risks

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

It creates an environment that encourages collaboration

What is NOT a benefit of the chartering process?

It allocates resources effectively

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

Understanding stakeholder vision and objectives

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

It reaches agreement on objectives and enhances stakeholder satisfaction

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.

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

Make Your Own Quizzes and Flashcards

Convert your notes into interactive study material.

Get started for free

More Quizzes Like This

Use Quizgecko on...
Browser
Browser