Resource Repository | Guidance

Filter by Category:

Principles for Compensating Patients for Patient Engagement Activities | The National Health Council

Audience: Industry,Guidance,Question: How can I collaborate with patients on specific clinical trial elements (e.g. protocol, regulatory)?

Principles for Compensating Patients for Patient Engagement Activities Principles for Compensating ...

Principles on Contracting Between Patient Advocates and Pharmaceutical Companies

Audience: Industry & PAG,Guidance,Question: Where can I find an example of a best practice in PAG and Industry collaboration?

Principles on Contracting Between Patient Advocates and Pharmaceutical Companies Principles on ...

Target Product Profile (TPP) Playbook

Audience: Industry & PAG,Best Practices from Patient Engagement Organization,Guidance

Target Product Profile (TPP) Playbook Target Product Profile (TPP) Playbook | Becca Kirby – ...

Patient Engagement Book of Good Practices

Audience: Industry & PAG,Best Practices from Patient Engagement Organization,Guidance

Patient Engagement Book of Good Practices Patient Engagement Book of Good Practices | PFMD “An ...

Institutional Review Board Written Procedures: Guidance for Institutions and IRBs

Audience: Industry & PAG,Guidance,Regulatory Resource

Institutional Review Board Written Procedures: Guidance for Institutions and IRBs Institutional ...

Clinical Trials Essentials: What You Need to Know to be a Part of the Latest Research

Audience: PAG,Building patient awareness of clinical trials,Guidance

Clinical Trials Essentials: What You Need to Know to be a Part of the Latest Research Clinical ...

Inclusion by Design: Building Equity in Clinical Trials Through the Lens of Metastatic Breast Cancer

Audience: Industry,Diversity & Engagement Modules,Guidance,Increasing diversity and inclusion in recruitment

Inclusion by Design: Building Equity in Clinical Trials Through the Lens of Metastatic Breast Cancer ...

FDA Guidance on Engaging Community and Advocates in Diversity

Audience: Industry,Collaboration Guidance Documents,Guidance,Increasing diversity and inclusion in recruitment,Regulatory Resource

FDA Guidance on Engaging Community and Advocates in Diversity Guidance on Engaging Community and ...

Creating a Best Practice Template for Participant Communication Plans in Global Health Clinical Studies

Audience: Industry & PAG,Building patient awareness of clinical trials,Communication Templates,Guidance

Creating a Best Practice Template for Participant Communication Plans in Global Health Clinical ...

Talking to Your Patient About a Clinical Trial

Audience: Industry & PAG,Building patient awareness of clinical trials,Clinical Trials & Recruitment,Guidance

Talking to Your Patient About a Clinical Trial Talking to Your Patient About a Clinical Trial | NIH ...

Determining Fair Market Value: Demystifying the Methodology Behind Patient Renumeration

Audience: Industry & PAG,Designing a patient-centric protocol,Guidance

Determining Fair Market Value: Demystifying the Methodology Behind Patient Renumeration Determining ...

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

Audience: Industry,Collaboration Guidance Documents,Designing a patient-centric protocol,Guidance,Regulatory Resource

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ...

Regulations: Good Clinical Practice and Clinical Trials

Audience: Industry,Collaboration Guidance Documents,Designing a patient-centric protocol,Guidance,Regulatory Resource

Regulations: Good Clinical Practice and Clinical Trials Regulations: Good Clinical Practice and ...

Enhancing Benefit-Risk Assessment in Regulatory Decision-Making

Audience: Industry,Demonstrating Value to Stakeholders,Designing a patient-centric protocol,Guidance,Regulatory Resource,Training Modules

Enhancing Benefit-Risk Assessment in Regulator Decision-Making Enhancing Benefit-Risk Assessment in ...

Assessment of the Use of Patient Experience Data in Regulatory Decision-Making

Audience: Industry,Guidance,Increasing diversity and inclusion in recruitment,Regulatory Resource,Training Modules,Utilizing Patient Experience and Registry Data

Assessment of the Use of Patient Experience Data in Regulatory Decision-Making Assessment of the Use ...

Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry

Audience: Industry,Diversity & Engagement Modules,Guidance,Increasing diversity and inclusion in recruitment,Regulatory Resource

Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, ...

Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

Audience: Industry,Diversity & Engagement Modules,Guidance,Increasing diversity and inclusion in recruitment,Regulatory Resource,Utilizing Patient Experience and Registry Data

Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data Developing and ...

FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

Audience: Industry,Diversity & Engagement Modules,Guidance,Increasing diversity and inclusion in recruitment,Regulatory Resource

FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the ...

Accelerating Clinical Trials: Best Practice for Recruitment and Retention

Audience: Industry & PAG,Clinical Trials & Recruitment,Guidance,Question: Where can I find a guidance on clinical trial recruitment or retention (e.g. recruitment plan)?,Reaching your patient recruitment goals

Accelerating Clinical Trials: Best Practice for Recruitment and Retention Accelerating Clinical ...

MRCT Resources

Audience: Industry & PAG,Clinical Trials & Recruitment,Guidance,Reaching your patient recruitment goals,Website

MRCT Resources MRCT Resources| MRCT Center of Brigham and Women’s Hospital and Harvard ...

Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ‘How-To’ Guide for Multi-Stakeholder Co-Creation

Audience: Industry & PAG,Collaboration Guidance Documents,Designing a patient-centric protocol,Guidance

Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ...

Disclaimer | Non-Discrimination | Privacy | Terms for Creating and Maintaining Sites