Free template
Screening and enrollment log template
A free screening log for research sites. Track every candidate who signs consent, the outcome of screening and the reason for every screen fail.
No sign-up needed to download.
Why sites keep one.
Sponsors often ask for screening logs to understand recruitment and screen-fail rates across sites.
Recording a reason for every screen fail helps you spot criteria that are hard to meet and supports screen-fail reimbursement in your budget.
Tips
- Use initials and study numbers only; keep identifiers in the source record.
- Write the inclusion or exclusion criterion number for screen fails so you can count them later.
- Keep one log per study.
What goes in each column
- Screening number
- Sequential number assigned at consent
- Date screened
- DD-MMM-YYYY
- Initials
- Candidate initials only, no full names
- Age
- Years
- Consent date
- Date informed consent was signed
- Consent version
- Version and date of the consent form
- Eligible (Y/N)
- Outcome of screening
- Screen-fail reason
- Criterion number not met, or other reason
- Enrolled (Y/N)
- Randomized or enrolled
- Participant ID
- Study ID if enrolled
- Staff initials
- Who completed the entry
Screening and enrollment log template
Study: ______________ Site: ______________ Page ___ of ___
| Screening number | Date screened | Initials | Age | Consent date | Consent version | Eligible (Y/N) | Screen-fail reason | Enrolled (Y/N) | Participant ID | Staff initials |
|---|---|---|---|---|---|---|---|---|---|---|
When this record is needed
Use screening and enrollment according to the protocol, sponsor requirements and your site procedures. ICH E6(R3) describes investigator oversight and essential records; 21 CFR 312.62 addresses applicable investigator records and retention. Neither source mandates this exact downloadable layout for every study.
Agree on the record’s owner, update frequency and filing location before using the template. A form should help reconstruct what happened, not create a parallel tracker with conflicting information. Keep original supporting records and use the approved study convention for identifiers and dates.
Filled example, not real study data
Sample record S-012 was screened on 27 October 2026 after consent version 2 was recorded. Staff document criterion 4 as not met, mark the screening outcome accordingly and leave the enrolled field as No. This is a made-up record, not a participant or a recommended eligibility finding.
The example is deliberately limited. Do not put live identifiers into a public download preview or email request. Adapt the field explanations with your study team, then check that an independent reviewer can identify the responsible person, event, date and supporting evidence without an oral explanation.
| Sample screening code | Consent version | Screened | Outcome | Reason |
|---|---|---|---|---|
| S-012 | Version 2 | 27-Oct-2026 | Not enrolled | Criterion 4 not met |
Review risks before monitoring
Common review risks include missing dates, unclear task or criterion references, signatures that cannot be tied to a person, and entries that contradict the source record. These are practical checks, not a claim about the frequency of findings in an inspection dataset. Review one row against its supporting evidence before treating the log as ready.
Do not overwrite an earlier entry to make the file look current. Record changes using your site’s correction procedure and retain the earlier information. A late explanation does not erase the original issue or change whether a deviation must be reported. Confirm reporting requirements with the protocol, sponsor and IRB.
How Kyros Trials handles the related work
The recruiting pipeline records screening stages and screen-fail reasons separately from randomized study progress. Staff make eligibility decisions. The screening log and consent evidence should be reconciled rather than treating an automated prescreen summary as the study screening result.
The template remains a free planning and record-format aid. Electronic workflows add record context and access controls, but your team still owns intended-use review, training, investigator oversight and retention. Inspect the corresponding workflow in a demo and compare it with your site’s procedure before switching from paper.
Questions people ask.
Answers to the questions research sites ask most.
Still have questions? Book a demo
Keep these logs in Kyros Trials instead.
Walk through your visit schedule, source records and sponsor billing with our team.
Book a 20-minute demo