Every person screened, the outcome, and the reason if they did not enrol. A good screening log answers recruitment questions during the study and gives you the numbers for the CONSORT flow diagram at the end.
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Screened
48
Enrolled
27
Screen failures
19
Key points
Template
| Column | Content |
|---|---|
| Screening number | Sequential per site, assigned at consent. |
| Date of consent | Date the participant signed consent for screening. |
| Age and sex | Optional, for recruitment reporting; no names. |
| Outcome | Eligible and enrolled, screen failure, withdrew before enrolment, in screening. |
| Screen-failure reason | Inclusion or exclusion criterion number, plus a short note. |
| Enrolment or randomisation number | The participant number assigned at enrolment. |
| Date of enrolment | Date of randomisation or first dose, as defined in the protocol. |
| Rescreen link | Original screening number if this is a rescreen. |
| Staff initials | Person completing the entry. |
Adapt to your protocol. A separate pre-screening log can record people approached or identified before consent, without identifying details.
Which log is which
Sites often keep several related logs, and the names vary. A pre-screening log counts people identified as potential candidates before consent, usually with minimal non-identifying information and the reason they were not approached or declined. The screening log starts at consent and records the screening outcome. The enrolment log lists participants who were enrolled, in order. The identification code list links study numbers to names and is kept confidential at the site so that participants can be identified if needed.
In an electronic system, the screening and enrolment logs can come straight from the data: every screened participant has a record with a screening outcome, and enrolled participants have their participant number. That removes a common source of discrepancies between the paper log and the database. See eligibility screening eCRF for the form behind it.
Free-text reasons such as "labs out of range" cannot be counted. Recording the criterion number shows which criteria exclude the most people, which is exactly the evidence a steering committee needs when considering a protocol amendment to improve recruitment.
Screened
212
Screen failure rate
38%
Rescreened
11
In Capture
Adding a participant follows a guided screening flow: numbers are assigned in sequence, rescreens are handled separately from new participants, and screen-failure reasons are recorded. Site-level numbering, the enrolment funnel on the dashboard and exports by site and date give you the screening and enrolment log without a separate spreadsheet.
Start screening
Screen new subject
Not screened before
Rescreen subject
Needs a new screening number
ICF date
14-Sep-2026
Year of birth
1971
Sex
Female
Walk through the guided screening flow in the free sandbox.
Rescreening
Protocols usually allow rescreening in limited situations, for example when a participant failed on a temporary criterion such as an intercurrent infection, and often cap the number of rescreens. A rescreened participant usually signs consent again if required, receives a new screening number, and is linked to the original attempt so the log shows one person, not two.
Monitors check rescreens closely, because repeated attempts until someone qualifies can undermine eligibility criteria. Keeping the link and reason visible in the log makes that review simple.
Before the first participant
Screening and enrolment numbers defined per site.
Protocol criteria numbered and used as reasons.
Identification code list kept separately at the site.
Allowed reasons, limits and linking.
Whether and how to count people before consent.
Screen-failure reasons reviewed monthly.
A record of everyone who entered screening, with the outcome and the reason for any screen failure.
ICH GCP lists a subject screening log among the essential documents kept at the site.
No. Names belong in the confidential identification code list held at the site.
The screening log covers everyone screened; the enrolment log lists only those enrolled, in order.
With a new screening number linked to the original attempt, following the protocol's rescreening rules.
Yes. The guided screening flow records screening numbers, outcomes and screen-failure reasons, which can be exported by site and date.
Keep exploring
Guided screening with reasons and numbering. Free sandbox.