Clinical Trial Site Workload & Data Capture Assessment

Welcome to the Clinical Trial Site Workload & Data Capture Assessment. This survey asks about your experience with clinical documentation and trial data capture over the past 30 days. Your responses will help identify opportunities to reduce site burden and improve data capture workflows. • Participation is voluntary and you may stop at any time. • There are no right or wrong answers — we want your honest perspective. • All responses are confidential and will be reported in aggregate only. • Estimated completion time: 8–10 minutes. Please proceed to begin.

In the past 12 months, have you worked on clinical trials at your site?

• Yes
• No

Outside of clinical trials, approximately how many hours per week did you spend on clinical documentation and data entry in the past 30 days?

• Less than 2 hours
• 2–5 hours
• 6–10 hours
• 11–20 hours
• 21–30 hours
• More than 30 hours

On average, how many hours per week did you spend on trial documentation and data entry in the past 30 days?

• Less than 2 hours
• 2–5 hours
• 6–10 hours
• 11–20 hours
• 21–30 hours
• More than 30 hours

Which tools did you use for trial data capture in the past 30 days? Select all that apply.

• Sponsor-specific EDC
• eSource platform
• EHR-to-EDC integration
• Paper source
• Spreadsheets (e.g., Excel)
• Other (please specify)

Please rank your top 3 biggest trial data capture pain points (1 = biggest).

1. Protocol complexity impacting data entry
2. Duplicate entry between source and EDC
3. System performance/downtime
4. High query volume
5. Training/retraining requirements
6. Scheduling/coordination conflicts

How confident are you that your site can meet sponsor data timelines over the next 3 months?

What type of site do you primarily work at?

• Academic medical center
• Community hospital
• Private practice
• Independent research site/SMO
• FQHC/Public clinic
• Other (please specify)

Thank you for your time. Your input will directly inform efforts to reduce site burden and improve data capture workflows. Your responses are confidential and will be reported in aggregate only.

What is your primary role in clinical trials at your site?

• Principal Investigator (PI)
• Sub-Investigator
• Study Coordinator/CRC
• Research Nurse
• Data Manager
• Pharmacist
• Other (please specify)

Overall, how burdensome was non-trial clinical documentation in the past 30 days?

Overall, how burdensome was trial data capture at your site in the past 30 days?

Which was your primary system for entering trial data in the past 30 days?

• Sponsor-specific EDC
• eSource platform
• EHR-to-EDC integration
• Paper source
• Spreadsheets (e.g., Excel)
• Other

Which of the following trial activities took the most of your time in the past 30 days? Please rank your top 3 (1 = most time).

1. Source documentation
2. EDC data entry
3. Query management/resolution
4. Visit scheduling/coordination
5. Regulatory/IRB documentation
6. Training/meetings

Based on your responses in this survey, please share any additional thoughts or feelings about site documentation or data capture.

How many years have you worked in clinical research (any role)?

• Less than 1 year
• 1–3 years
• 4–6 years
• 7–10 years
• 11–15 years
• More than 15 years

How many interventional trials did you actively support in the past 30 days?

• 0
• 1–2
• 3–5
• 6–10
• More than 10

Which systems took most of your non-trial documentation time in the past 30 days? Select all that apply.

• EHR
• Quality registry portals
• Prior authorization portals
• Spreadsheets
• Paper forms
• Other (please specify)

Thinking about your primary trial data entry system, how easy or difficult was it to navigate between forms and pages?

What one change would most reduce trial data capture burden at your site?

We'd like to understand your experience with trial documentation and data capture in more depth. An AI moderator will ask a few brief follow-up questions based on your earlier responses.

What patient population do you primarily serve?

• Adults
• Pediatrics
• Both

What was the single biggest barrier to efficient non-trial documentation in the past 30 days?

How easy or difficult was it to enter and save patient data in your primary system?

Which trial phases do you typically support? Select all that apply.

• Phase I
• Phase II
• Phase III
• Phase IV/Post-market
• Medical device studies
• Other (please specify)

How easy or difficult was it to manage and resolve queries in your primary system?

In which region do you primarily work?

• North America
• Western Europe
• Eastern Europe
• Latin America
• Asia-Pacific
• Middle East & Africa
• Other

How easy or difficult was it to generate reports or export data from your primary system?

Overall, how satisfied are you with your primary system for trial data entry?