Phone prescreening: scripts and compliance

Why prescreen by phone?

Because screen failures are expensive. The average screen failure rate is 36.3% (Tufts CSDD), and 88% of sites say screen failures are not sufficiently covered (SCRS). Recruitment already takes substantial staff time, 3.7 hours per randomized patient in one trial (PMC); a five minute call that prevents a wasted visit is time well spent.

What goes into the script?

1. Introduction: who you are, the study, and that the call is voluntary.
2. Permission: ask if they are willing to answer a few questions, and explain how answers will be used.
3. Deciding criteria first: the three to six questions that most often disqualify, such as diagnosis, key medications, and age range.
4. Practical fit: travel, schedule, and visit frequency.
5. Next step: schedule a screening visit, or thank them and explain they do not appear to qualify.

What compliance rules apply?

• IRB review: FDA expects IRBs to review the information given to prospective subjects through recruitment materials (FDA); many IRBs review phone scripts too, so check yours.
• Privacy: collect only what is needed to decide eligibility, and protect it. Within a covered entity, HIPAA permits workforce members to contact potential subjects to seek authorization (University of Wisconsin).
• Records: keep a prescreening log of outcomes, without more personal detail than necessary.

How should calls be handled?

• Call within one business day of the inquiry.
• Use the same script every time so results are comparable.
• Track failure reasons; if one criterion fails most callers, adjust where your outreach is aimed.

Which sources pass prescreening most often?

Patients referred by their own physician, because the referring doctor already checked the obvious criteria. Tracking prescreen pass rates by source shows which channels deserve more budget. See lowering screen failure rates.