Recruitment & Retention Compendium
The Recruitment and Retention Initiative (R&R) strives to promote a research friendly environment and to continuously improve the quality, efficiency, and equity of clinical and translational research by improving patient recruitment and retention in clinical trials though supporting investigators, coordinators, patients and the community.
See below a curated compendium of guidance, tools, policies and templates relevant to R&R.
Sources: Columbia University, CUIMC, NIH and other federal health agencies, other academic medical centers, trusted public sources.
General Recruitment and Retention Guidance
Tools
- Toolkit with suggestions on promotion techniques, tips, and tricks for recruitment and retention and dissemination, and follow-up guidance
- Tips to ensure successful research recruitment with a focus on community-based approach
- Recruitment playbook organized by study phase, study type, population, and cost
Guidance
- Toolkit of external resources gathered from other universities
- R&R content, design, outreach, templates, and courses
- Recruitment guidelines and best practices for equity in research
- Participant recruitment, retention, and adherence plan guideline and step by step checklist
- Engaging African American community members in research studies
- Engaging hispanic/latinx community members in research studies
- Engaging LGBTQIA+ community members in research studies
- Engaging older adult community members in research studies
- Engaging community members with disabilites in research studies
- Engaging urban youth community members in research studies
Columbia University Recruitment and Retention Resources
Tools
- Spanish Translation Services
- RecruitMe - A web-based recruitment platform for Columbia investigators to connect with interested research participants.
- Research Match - Free recruitment registry and feasibility analysis tool for researchers at participating academic institutions across the country. (External Program not CU/CUIMC).
- Criteria2Query Consultation - A natural language interface for cohort identification by clinical researchers; please request a consultation with one of our informatics team members.
- AllofUs - A national research program for genetics.
- Collaborators for Multisite Studies - Our Network Capacity team connects researchers at CUIMC to research studies and trials, proposed through regional and national networks such as, the Trial Innovation Network, HEAL, INSIGHT Clinical Research Network (the NYC members of PCORNet), and others.
Templates
- Addendum to the informed consent document
- Sample information sheet w/ consent and HIPAA authorization
- Consent Form templates for minimal risk research (assent form ages 7-11)
- Consent Form templates for minimal risk research (assent form ages 12-17)
- Consent Form templates for minimal risk research (no recording)
- Consent Form templates for minimal risk research (studies involving audio/ video recording)
- Consent Form for genetic/genomic studies
- Cover sheet for consent forms for genetic/genomic studies
- Consent form templates for genetic/genomic research (assent form ages 7-12)
Guidance
- Columbia Clinical Research Handbook (2021)
- Consent Form Requirements for Studies Linked in Epic
- List of CU IRB protocol and consent form resources (templates, pre-review, submitting a protocol, etc.)
- Human research policy guide
- Clinical Trials Office Regulatory Binder - Overview of essential regulatory files to be maintained for clinical research, as well as useful templates.
Policy
- IRB electronic informed consent policy/ guidance
- IRB Informed Consent policy
- IRB policy on clinical research involving children
- IRB policy on clinical research involving pregnant persons
- IRB policy on enrollment of non-English speaking research participants
- IRB policy on reimbursement of research participants
- General research policies/ conflict of interest policies/ stem cell research policies
- University Policies Website - List of Columbia Universities non-academic policies.
- Sponsored Projects Handbook – Provides oversight for governmental and private organizational funded projects, in accordance with University policies.
- Animal Research Handbook – Reference for faculty and staff engaged in research using animals.
- Environmental Health and Safety Handbook - Reference for faculty and staff conducting research with hazardous materials.
- Research Radiation Safety Handbook - Reference for faculty and staff conducting research using sources of ionizing radiation.
- Postdoctoral Officers Handbook - Guidance on policies, procedures, and offerings for Columbia University Postdocs.
Specialized Services and Consultations
- Clinical Trial Design and Innovation– Provides assistance with trial design, protocol development, various data aspects, and trial implementation.
- Community Study Promotion Assistance - Irving Institute CECR team offers study promotion through our local community.
- Clinical Research Informatics Consultation – Data driven feasibility assessment and cohort identification at CUIMC.
- Research Ethics and Human Subjects Consultations - Consultations on ethics and regulatory issues from experts Please visit this consultation webpage.
- IRB Liaison Service – Reviews investigators submitted protocols and improves overall quality and efficiency of IRB submissions.
- Clinical Trials Office Support for Trial Registration and Results Entry - Resources and information on clinical research for investigators.
- Clinical Trials Office IND/IDE Assistance Program (IAP) - Aids Columbia University Faculty members holding an Investigational New Drug (IND) or Investigational Device Exemption (IDE) at all stages of an investigation.
- Clinical Research Resource - Research facilities including exam rooms, phlebotomy, and lab services for adult and pediatric populations as well as training for all research personnel.
- Submitting a Clinical Trial with CTO - Resources and information from the Clinical Trials Office on best practices for clinical trials.
Trainings
- Research Coordinator Trainings – Research coordinator seminar series and group trainings available to the Columbia University community.
- Clinical Trials Offices’ Clinical Research Coordinator Training Program - Provides standardized basic introductory training to clinical research coordinators and staff who perform related duties. More information here
NIH Clinical Trial Resources
Tools
Templates
- Informed consent document
- Informed Consent Version Tracker
- Informed consent for secondary research with data and specimens document
- Clinical intervention study protocol
- Screening and enrollment log
- Participant visit checklist
- Participant inclusion exclusion criteria form
- Data and Safety Monitoring Plan (DSMP) Template and Guidelines
- DSMP Checklist
Guidance
- Consent Templates and Guidance
- Checklist of strategies and guidance for communicating to the public about research
- Guidance on inclusion of women and minorities in studies
- Inclusion Outreach Toolkit: How to Engage, Recruit, and Retain Women in Clinical Research
- Clear Communication Guidelines
- Recruitment Considerations
- Recruitment and Retention Tips
- Data Management Tips
Health Literacy Resources
Tools
Guidance
- CDC - Background and Basics
- CDC - Guiding principles for inclusive communication
- CDC - Guide for Creating Easy-to-Understand Materials
- CDC - Preferred Terms for Select Population Groups & Communities
- Research guide to help improve health literacy skills
- U.S. Gov – Guidelines, trainings, and examples of plain language usage
- American Medical Association - Advancing health equity- guide to language narratives and concepts
- Health literacy in clinical research principles and assistance w/ integration
- Helpful recruitment language and terminology
Social Media and Recruitment Materials
Templates
Guidance
- CDC - Describes the different social media platforms and how best to utilize each platform
- CDC - Provides guidance and lessons learned for which social media method is the most effective for your type of study
- Guidelines, recommendations, and resources for creating content and design for participant recruitment and retention materials
- Creating effective recruitment flyers
- Social media best practices playbook
- Best practices and information placement for recruitment flyers
- Recruitment flyer design and advertising assistance
- Top social media platforms to utilize for recruitment, and advantages of social media usage
- Guide to determine if social media is a good fit for your study, and how best to incorporate social media usage in your study recruitment plans
Contact
Sheila M. O'Byrne
622 West 168th Street, 10th Floor
New York, NY 10032
United States- Email so2017@cumc.columbia.edu