Accrual Stages

1. Consider National and Local Stakeholder Enthusiasm for the Study
   • Evaluate the level of scientific interest in the study from the field and your institution
   • Evaluate the level of commitment from the field and your institution with an eye toward study feasibility
   • Check for competing studies at your institution and nationally
2. Evaluate the Study for Recruitment Feasibility
   • Determine the availability of the study population at your institution and nationally
   • Assess and minimize the study burden on patients
   • Use feasibility studies to test recruitment strategies
3. Choose Study Sites Carefully
   • Evaluate the recruitment histories of potential sites
   • Determine the available resources of potential sites (e.g., staffing or facilities)
   • Look at the potential sites' competing studies
   • Look at the sites' interest level in the study—both scientific interest and their thoughts on feasibility
4. Prepare Study-Specific Materials
   • Prepare participant-friendly informed consent document
   • Create study-specific materials for participants
   • Ensure that materials are culturally appropriate

1. Evaluate Your Institution's Study Portfolio and Participant Population
   • Confirm that the study's scientific question is relevant and of interest to your institution
   • Assess where the study fits within your institution's portfolio of open studies and check for competing studies
   • Verify that there are no conflicts of interest in this study
   • Ensure that the study matches your patient population
   • Assess the financial burden the study will place on participants
   • Determine the level of study burden on participants and their support systems
2. Assess Your Institution's Infrastructure and Resources
   • Obtain feedback on the study from key staff
   • Assess the financial burden of the study on your institution
   • Assess the capacity of your institution to conduct the study
   • Determine if you have adequate staffing levels
3. Ensure Stakeholder Commitment
   • Ensure a clinical “champion”
   • Ensure staff buy-in
   • Ensure buy-in from experts/specialists who are needed to implement the study
   • Confirm buy-in at the institutional level
4. Create a Clinical Studies Friendly Environment
   • Provide a comfortable physical environment for participants in studies
   • Understand participants' perceptions of being part of a clinical study
   • Establish an efficient work environment to effectively conduct clinical studies
   • Discuss clinical study options with every patient
   • Ensure all staff members are trained in conducting clinical studies
   • Ensure staff is aware of your institution's available studies
5. Plan Internal Processes to Conduct the Study
   • Complete a study start-up checklist
   • Plan study logistics and scheduling
   • Dedicate staff and budget to recruitment in the beginning
   • Identify “go-to” research staff for the study
   • Provide study-specific training to staff
   • Pre-authorize insurance or develop alternate payment options for the study
   • Implement information technology (IT) processes for the study
6. Write a Comprehensive Recruitment and Retention Plan
   • Integrate recruitment and retention plans with institutional activities
   • Determine how to screen and identify potential participants
   • Prepare site-specific study promotional materials for potential participants
   • Address diverse and underserved populations
   • Include plans for community outreach
   • Include plans to work with referring physicians
   • Write a study-specific Evaluation Plan
   • Set milestones, metrics, goals, back-up plans
   • Set accrual performance thresholds (e.g., time from study opening to first participant enrollment)

1. Engage Intermediaries to Aid Accrual
   • Assure that plans to reach referring physicians are being executed
   • Assure community outreach plans are being executed
   • Generate advocate buy-in
   • Engage patient navigators
2. Identify Potentially Eligible Participants
   • Query your institution's paper or electronic medical record system(s)
   • Follow up with potentially eligible but non-consented individuals
   • Identify and report on participant non-adherence indicators
3. Engage Participants in the Informed Consent Process
   • Use plain language
   • Use participant-friendly materials
   • Present the study in a culturally appropriate manner
   • Seek the help of translators when needed
   • Emphasize the key role of the physician presenting the study
   • Present the study in a balanced manner—both pros and cons
   • Provide continued support as people consider their decision to participate and continue on the study
   • Manage communication of screening results and failures
   • Be aware of and monitor regulatory issues such as HIPAA regulations
4. Consider Participant Financial Issues
   • Establish relationships with insurance companies to facilitate coverage
   • Track insurance coverage concerns for the study
   • Work with specialists to identify alternative financing if a potential participant has no insurance
5. Maintain the Morale and Interest of Staff, Participants and Their Families
   • Watch for early signs of non-adherence and provide support to meet needs
   • Keep in touch with participants on studies (e.g., through newsletters or reminders)
   • Offer support groups, participant networking, lists of local and online support resources
   • Conduct satisfaction surveys with study participants
   • Regularly update staff on study accrual
   • Encourage staff to provide feedback about the study
6. Update Participants Regarding Study Related Events and Results
   • Keep contact lists current and note the best way to communicate with individual participants (e.g., through email, newsletter, telephone call)
   • Monitor media regularly and have a plan in place to respond to study-relevant media stories (to participants, to the media, and to stakeholders)
   • Have a plan for notifying participants/families, staff, and stakeholders if the study is put on hold or closes unexpectedly

More Information on Recruiting and Communicating With Participants

1. Communicate Regularly with Stakeholders and Referring Providers
   • Conduct regular staff meetings to discuss study accrual
   • Regularly communicate the study's accrual status to key staff/stakeholders and seek feedback
2. Monitor Study Progress and Accrual Metrics
   • Monitor recruitment and retention plan activities and adjust when necessary
   • Monitor promotion activities and adjust when necessary
   • Monitor evaluation goals, objectives, and activities
   • Review study accrual indicators against expected performance
   • Regularly assess the study's costs against its budget
   • Monitor screening data for diverse and underserved populations
   • Monitor the impact of operations and logistics on study accrual
3. Implement Alternative Recruitment Strategies When Accrual Milestones Are Not Achieved
   • Use data to decide whether to make changes or close the study
   • If changes are made, document expectations and monitor over a specific timeline
   • Determine if the state of the science has changed and accrual is unachievable

1. Analyze The Study's Accrual Data for Lessons Learned
   • Review accrual data and discern lessons learned to improve future studies
   • Determine the study's value to your institution
   • Analyze data from a terminated study
2. Report and Share Accrual Experiences with Others
   • Prepare and submit a summary of study-specific accrual findings and lessons learned to key stakeholders
   • Document and submit your experiences and findings to journals and at professional meetings