Participant Experience Surveys

Content

• Work with patients and caregivers to determine the survey questions, the language level, etc. CTO has resources to help you engage patients and caregivers here.
• Focus questions on the study process, procedures, and experience only, rather than duplicating questions in study surveys.
• Focus questions on aspects of the study experience that the sponsor or site has the ability to change.
• If possible and relevant, look for ways to incorporate caregiver feedback into participant surveys (e.g., if a caregiver is required to attend study visits).
• Surveys should be easy to understand, access, and complete.
• Incorporate some open-ended questions, allowing participants to give feedback that may be meaningful to them and that is not otherwise captured in the questions.
• Surveys may need to be translated to the same language used for the consent form.

Process

• Depending on the study, more surveys may be a burden to
• Minimize the time required to complete a survey and see if the logistics related to completing surveys in stages is possible. A survey should take no more than 5-10 minutes to complete.
• The survey should be available to the participant to complete at a convenient time. For example, during a wait for study visits or tests.
• Implementation of digital surveys may cause issues for participants without access to technology or who have issues with technology. If someone does not have access to technology, a paper survey, or the option to complete the survey on a device at a site visit may be options.
• An alternative to a survey may be a review meeting (pre, mid, and post-study) with a trial team member, keeping in mind the relationship of the participant to that trial team member and the potential for complete or honest feedback.

Timing and Frequency

• A pre-study survey may be helpful to identify participant needs and expectations before the trial begins.

Follow-up to Survey Feedback

• Determine how feedback from surveys will be used to improve the participant experience in the clinical trial and ensure that there is a plan for a timely response and implementation of feedback.

Additional Considerations

• Individual, identifiable feedback should be collected by the trial team. Unidentified, aggregate feedback should be provided to the sponsor. Anonymous feedback should be the default unless there is a desire by the participant to allow provision of contact information for follow-up on any concerns.
• Ensure that the Research Ethics Board has reviewed the survey tool and plan for implementation of the survey.

• Study Participant Feedback Questionnaire Toolkit – Transcelerate Biopharma – this survey has been developed with a broad group of clinical trial stakeholders that can be utilized at different time points in a study to improve the participant experience. The survey can be downloaded and used by anyone.
• ResearchKit – Apple – is an open-source framework for utility in medical research. The survey function is a core component of this framework and can be customized to collect participant feedback within the context of a trial.

Note: This resource list is not exhaustive and listing a resource does not denote its endorsement or promotion.