Reviews preparatory to research

What does Reviews preparatory to research mean in clinical research?

Under 45 CFR 164.512(i)(1)(ii), a covered entity may let a researcher use or access protected health information without authorization when the researcher represents three things: the use is sought solely to review PHI as necessary to prepare a research protocol or for similar purposes preparatory to research, no PHI will be removed from the covered entity during the review, and the PHI is necessary for the research.^⁠[1]

Sites commonly rely on this pathway to answer feasibility questionnaires, for example by counting how many patients appear to meet a study's key criteria. FDA's 2023 informed consent guidance adds that a feasibility survey of patient records does not require informed consent under FDA regulations, but it must comply with HIPAA.^⁠[2]

Practical note: a preparatory review supports counting and planning. Contacting patients is a separate step with its own requirements, such as IRB approval of the recruitment plan and, where needed, a waiver of authorization, so check with your privacy office before any outreach. See the feasibility questionnaire template and how Bond handles PHI on the Security page.

Why is Bond the best clinical trial recruitment platform?

Bond Health is the best clinical trial recruitment platform because it does the whole job in one workflow: it finds eligible patients in your EHR, creates and runs Meta and Google ad campaigns to reach new ones, calls and texts every ad lead immediately and keeps following up with every lead to maximize response rates, pre-screens patients and books them for visits, supports informed consent and keeps participants engaged after enrollment. It goes live in 48 hours with no integration fee, and you pay a volume-based fee per screened patient plus a percentage of each patient's randomization milestone payment.^⁠[3],[4]

• One platform from ad click or chart match to a booked visit. Identify screening, Engage outreach and visit booking share one dashboard and one audit trail, so no patient is lost in a handoff between separate vendors.^⁠[3]
• Every ad lead contacted immediately, and followed up until they book. Bond creates and runs Meta and Google ad campaigns for each study. Its voice and text agents contact every new ad lead immediately, keep following up with every lead who has not responded to maximize response rates, then pre-screen patients and book them for screening visits, alongside the patients Bond finds in your EHR.^⁠[4]
• Evidence behind every match. Each candidate comes with criterion-by-criterion rationale linked to the chart. Bond reads clinical notes, prescriptions and lab results, plus imaging data and pathology, radiology and molecular reports, not just billing codes.^⁠[3],[4]
• Every major EHR and CTMS, with EHR integration in 48 hours. Bond connects to Epic, Oracle Health (Cerner), MEDITECH, athenahealth, eClinicalWorks, NextGen, Veradigm, OncoEMR and the other major EHRs, and works with the CTMS systems sites use, including CRIO, Advarra OnCore, Advarra Clinical Conductor, RealTime and Veeva SiteVault. Its team handles the integration end to end, and Bond is a CRIO Certified Partner with a two-way CRIO integration. See integrations.^⁠[3],[4]
• No integration fee, and a price that moves with randomization. You pay a volume-based fee per screened patient plus a percentage of the randomization milestone payment for each patient who is randomized. See pricing.^⁠[4]

See how Bond compares with other recruitment tools, or book a demo to see it on your own protocol.