CTTI Recommendations and Tools for Sponsors and Patient Groups to Engage CTTI Recommendations and Tools for Sponsors and Patient Groups to Engage | Clinical Trials Transformation Initiative Patient groups have increasingly been recognized as equal partners in clinical research, and their collaboration can lead to better research questions and more Read more…
CTTI Prioritization Tool for Sponsors and Patient Groups CTTI Prioritization Tool for Sponsors and Patient Groups | Clinical Trials Transformation Initiative Clinical Trials Transformation Initiative Prioritization Tool for Sponsors and Patient Groups. View Here
Informed Consent for Clinical Trials Informed Consent for Clinical Trials | FDA Informational page on the FDA website covering the requirements for informed consent in clinical trials. The page includes an explanation of informed consent, what information is required to be collected from participants, participant rights, and language suggestions. View Read more…
Institutional Review Board Written Procedures: Guidance for Institutions and IRBs Institutional Review Board Written Procedures: Guidance for Institutions and IRBs | OHRP A guidance from the Department of Health and Human Services (HHS’s) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) on procedures for IRB Read more…
MJFF Retention Toolkit MJFF Retention Toolkit | MJFF Templates for retaining patients throughout the duration of a clinical trial. Resources: Guide to the Retention Toolkit Retention Plan Template IV. Facilitate Study Participation Study Reminders & Information Participant Intro Letter Template Calendar of Activities Template Calendar of Activities Sample Appointment Card Read more…
Mutual Confidentiality Agreement Example Mutual Confidentiality Agreement Example | Template Shared by PALADIN Member Sample template for a unilateral confidentiality agreement between a patient advocacy group and industry partner. Download Here
Master Services Agreement Template Master Services Agreement Template | Template Shared by PALADIN Member Sample template Master Services Agreement (MSA) for use in PAG-Industry collaboration engagements. View and Download Here
Trust Builder: Supporting Patient Conversations About Mistrust Beliefs in Clinical Trials Printable Tool Trust Builder: Supporting Patient Conversations About Mistrust Beliefs in Clinical Trials Printable Tool | AAN and Sanofi CT staff or sponsors to build relationships with PAGs groups; information to life science to better to understand patients and Read more…
Conversation Starter to Support Patients/HCPS Dialogue: What Do Patients Frequently Ask About Clinical Studies? Conversation Starter to Support Patients/HCPS Dialogue: What Do Patients Frequently Ask About Clinical Studies? | | AAN and Sanofi Tool from AAN and Sanofi for healthcare professionals to initiate discussions about clinical trials with patients before Read more…
MJFF Patient Engagement Request Form MJFF Patient Engagement Request Form | Template Shared by PALADIN Member Sample request form that Patient Advocacy Groups can use when pharmaceutical companies want to engage in a partnership View & Download Here
Research Study Thank You Caregiver Sample Research Study Thank You Caregiver Sample | Sample Shared by PALADIN Member Sample thank you to a caregiver of a person who has participated in a study. View & Download Here
Family Caregiver Roles in Medical Product Development Family Caregiver Roles in Medical Product Development | NAC This document describes the role of caregivers in medical product development. View Here
Caregiver Recommendations for Enhancing Clinical Trial Participation Diversity Caregiver Recommendations for Enhancing Clinical Trial Participation Diversity | NAC Recommendations from caregivers to enhance clinical research participation View Here
Clinical Trials Essentials: What You Need to Know to be a Part of the Latest Research Clinical Trials Essentials: What You Need to Know to be a Part of the Latest Research | NBDF This resource aims to provide patients with information and guidance regarding clinical trials and their participation. Read more…
Use of an Online Portal to Facilitate Clinical Trial Recruitment: A Preliminary Analysis of Fox Trial Finder Use of an Online Portal to Facilitate Clinical Trial Recruitment: A Preliminary Analysis of Fox Trial Finder | Journal of Parkinson’s Disease “An example of ways that potential actions patient advocacy groups can Read more…
First-of-its-kind consortium brings together advocacy and industry organizations to address efficiencies across disease types that have the potential to speed the development of medicines for patients.
MRCT Post Trial Responsibilities Toolkit MRCT Post Trial Responsibilities Toolkit | MRCT Center of Brigham and Women’s Hospital and Harvard “This Toolkit was developed by the PTR Workgrouporganized by the MRCT Center and designed to be a practical yet flexible mechanism for planning, decision making and implementing post-trial responsibilities (PTR), Read more…
Case Studies Case Studies | MRCT Center of Brigham and Women’s Hospital and Harvard The MRCT Center worked with stakeholders to develop case studies that illustrate efforts for diversity, equity, and inclusion that have been successfully integrated into the clinical research enterprise, and examples of therapeutic response differences that warrant Read more…
Return of Individual Research Results Return of Individual Research Results | MRCT Center of Brigham and Women’s Hospital and Harvard Guidance covering practical considerations for returning Individual Research Results (IRR): who should return it, when should it be returned, and and how can/should participants choose to receive it. Also downloadable Read more…
Clinical Research Glossary Clinical Research Glossary | MRCT Center of Brigham and Women’s Hospital and Harvard This plain language resource, designed in collaboration with patients and patient advocates, is visually engaging with plain language content, definitions, images and other helpful information for clinical research professionals to use in creating research Read more…