Patient recruitment

How to build a patient database for your research site

By TrialNotice · Updated
Hands typing on a laptop showing a table of rows with green, blue, and orange tags beside a potted plant
Short answerA research site's patient database is a list of people who have agreed to be contacted about future studies, built from the site's own patients, past participants, screen failures, and referred patients. HIPAA allows researchers within a covered entity to review records to identify candidates under the preparatory to research provision, but information cannot leave the covered entity without authorization or an IRB waiver, so the database should rest on documented permission to contact.
This article is general information, not legal advice. Confirm your approach with your IRB and privacy officer.

Why does a site need its own database?

Because your own records are the fastest patient source you have, and a database keeps them working across studies instead of starting from zero each time.

How does HIPAA apply?

  • Reviewing your own records. Under the preparatory to research provision, a covered entity may allow researchers to review records to prepare for research, but not collect the information for research use (University of Wisconsin).
  • Contacting candidates. A covered entity may let researchers within its own workforce contact potential subjects to seek their authorization (University of Wisconsin).
  • Moving data outside the entity requires patient authorization or an IRB or Privacy Board waiver (Applied Clinical Trials, CenterWatch).
  • Common Rule review. Some institutions note that reviewing records for recruitment may itself be treated as a research activity needing IRB review (Brown University).

What sources feed the database?

  1. Your practice's patients who agree to be contacted about research.
  2. Past participants who completed a study and want to hear about future ones.
  3. Screen failures who did not qualify for one study but may qualify for another, with permission.
  4. Referred patients sent by local physicians.
  5. Community events and inquiries, using IRB approved materials.

What should each record capture?

  • Documented permission to contact, with the date and scope.
  • Conditions and key history relevant to your therapeutic areas.
  • Preferred contact method and times.
  • Source, including the referring physician where applicable.
  • Study history: screened, enrolled, completed, or declined.

How do you keep it current?

Databases decay as people move, change treatment, or lose interest. Refresh permissions on a schedule, remove people who opt out promptly, and keep adding new candidates. A physician referral network is the most reliable refill: local physicians see new patients every week but refer less than 0.2% of them today (Tufts CSDD).

Related: how to recruit more patients for a clinical trial.

Get your study in front of the right local physicians

TrialNotice builds a physician referral pipeline around one active study. We identify relevant local physicians within driving distance of your site, send study aligned direct mail, follow up by email and LinkedIn, track engagement with recipient level QR codes, and route warm responses into your site team's workflow.

Talk to TrialNotice

Sources

  1. University of Wisconsin Madison, HIPAA for Researchers FAQ
  2. Applied Clinical Trials, "The HIPAA Privacy Rule, Research, and IRBs"
  3. CenterWatch, "Can you use patient Electronic Health Records to identify and recruit subjects?"
  4. Brown University, HIPAA Privacy Rule Guidance for research
  5. Applied Clinical Trials, "Tufts CSDD Study Explores Low Recruitment Rates"

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