SOP-303
Screening, Eligibility Verification and Enrollment
- Number
- SOP-303
- Category
- Study Conduct
- Edition
- Reference Edition 1.3
- Approx. pages
- 7
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This SOP describes how [SITE NAME] screens consented participants, verifies and documents that each participant meets every eligibility criterion before randomization or first dose, registers participants in the sponsor's interactive response technology (IRT) system, and documents screen failures, rescreening and enrollment.
2. Scope
This SOP applies to every study at [SITE NAME] from the time a participant signs consent until the participant is enrolled or recorded as a screen failure. Pre-screening before consent is in SOP-300. Consent is in SOP-301. Randomization procedures and blinding are in SOP-305. Where the protocol, sponsor or IRB requirement is stricter than this SOP, the site follows the stricter requirement.
The protocol defines when a participant counts as "enrolled" (for example at consent, at randomization, or at first dose). This SOP uses the protocol's definition.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Is responsible for enrolling only eligible participants. Confirms eligibility, or delegates confirmation to a Sub-I, and signs F-303-02 before randomization or first dose. Decides on criteria that require clinical judgment. Reports eligibility errors. |
| Sub-Investigator (Sub-I) | Confirms eligibility and signs F-303-02 when delegated. |
| Clinical Research Coordinator (CRC) | Schedules and performs delegated screening procedures after consent. Collects source for each criterion. Prepares F-303-02. Maintains F-303-01. Registers participants in IRT. Completes enrollment documentation. When delegated eligibility review and acting as second reviewer, checks F-303-02 against source for checklists they did not prepare. |
| Regulatory Coordinator | Confirms the current protocol version and IRB approval are in place before screening starts and after each amendment. |
| Quality Lead | Includes eligibility in internal QC (SOP-700). Trends eligibility errors and opens CAPA when needed (SOP-703). |
4. Definitions
| Term | Definition |
|---|---|
| Screening | Protocol-required procedures, done after consent, to determine whether a participant meets the eligibility criteria. |
| Eligibility criteria | The inclusion and exclusion criteria in the current IRB-approved protocol. |
| Screen failure | A consented participant who does not meet the eligibility criteria, or who withdraws or is withdrawn before enrollment. |
| Rescreening | Repeating screening for a participant who previously failed screening, when the protocol allows it. |
| Enrollment | The point in the protocol at which a participant becomes part of the study population, as defined by the protocol. |
| Interactive response technology (IRT) | The sponsor's system for registration, randomization and IP assignment (also called IWRS or IxRS). |
| Participant identification code | The unique code assigned to each participant and used in place of identity in data reported to the sponsor (ICH E6(R3) Annex 1, 2.12.8). |
| Source | Original records in which trial data are first recorded, and certified copies of them (SOP-306). |
5. Procedure
5.1 Before screening starts
5.1.1
The Regulatory Coordinator confirms that the study is activated (SOP-205), the protocol version in use is IRB-approved, and the screening and eligibility tools reflect the current protocol amendment. After each amendment that changes eligibility, the CRC updates F-303-02 for the study and the PI or Lead CRC trains the team before the amendment is used.
5.1.2
The CRC builds the study-specific F-303-02 from the current protocol. Each inclusion and exclusion criterion appears verbatim or with its protocol number, with columns for:
- met or not met
- the source used to verify it (for example laboratory report and date, imaging report, medical record note and date, investigator assessment, participant interview)
- the date of the source and whether it falls within the protocol window
- the initials of the person who verified it
5.1.3
Where the sponsor supplies an eligibility checklist, the site may use it if it contains the source and window information in section 5.1.2, or adds the missing columns.
5.1.4
The CRC checks enrollment availability with the sponsor (for example competitive enrollment, cohort slots, stratum caps) before scheduling screening.
5.2 Screening procedures and the screening log
5.2.1
No screening procedure is done until the participant has signed the consent form, unless the procedure is part of the participant's normal medical care and the protocol allows its results to be used (SOP-301). This includes research-only laboratory tests, imaging, questionnaires and medication washouts.
5.2.2
The CRC assigns the screening number per the protocol or IRT instructions and records the participant on F-303-01 at consent. F-303-01 contains:
- screening number and participant identification code
- date of consent and consent version
- screening visit dates
- outcome: enrolled (with date and randomization or enrollment number), screen failure (with the primary reason as a criterion number or category), or withdrawn before enrollment
- rescreening link to any earlier screening number
- staff initials
5.2.3
F-303-01 does not need full name or medical record number if the site keeps a separate confidential participant identification code list that links the code to the person's identity. The code list is kept at the site and is not sent to the sponsor (ICH E6(R3) Appendix C: participant identification code list and enrolment log).
5.2.4
Screening procedures are done only by staff delegated for them on F-302-01, within the protocol's screening window, and in the order the protocol requires (for example fasting before certain labs, washout before baseline).
5.2.5
Adverse events during screening are recorded and reported as the protocol requires (SOP-500; ICH E6(R3) Annex 1, 2.7.2(a)).
5.3 Verifying each criterion
5.3.1
The CRC completes F-303-02 as screening results become available. Every criterion is supported by source that the monitor can find. A criterion is not marked "met" based on the participant's word alone unless the protocol allows self-report, in which case the source note records that the information came from the participant.
5.3.2
For medical history criteria, the CRC obtains records from the participant's other providers where the criterion depends on them (for example diagnosis date, prior therapy, prior test results). An investigator reviews outside records and signs and dates them, or documents the review in a note, before they are used as source.
5.3.3
Criteria that require clinical judgment (for example "in the opinion of the investigator", clinically significant findings, life expectancy, ability to comply) are assessed and documented by an investigator in a signed and dated note.
5.3.4
Laboratory and test values are checked against the protocol limits and units, using the reference ranges on file for the laboratory that ran the test (SOP-312). The CRC records the actual value, not just "within range".
5.3.5
A test may be repeated to confirm eligibility only if the protocol allows a retest, and only within the protocol's rules. A value is not repeated or a measurement taken again only to produce a qualifying result.
5.3.6
Exclusion criteria concerning other research (for example participation in another study within a set period) are checked by asking the participant and reviewing available records. Where the protocol or a site decision requires it, the CRC also checks a research participant registry and files the result.
5.3.7
If any criterion is unclear, the CRC asks the PI. If the PI cannot resolve the meaning from the protocol, the PI asks the sponsor for a written interpretation, and the CRC files the answer in the ISF. A sponsor's interpretation of what a criterion means is not the same as permission to enroll someone who does not meet it (section 5.5).
5.4 Review and investigator sign-off
5.4.1
When F-303-02 is complete, a second reviewer (a staff member delegated eligibility review on F-302-01 who did not prepare the checklist) checks every criterion against the source before investigator sign-off.
5.4.2
The PI, or a Sub-I delegated eligibility confirmation on F-302-01, reviews F-303-02 with the source, confirms that the participant meets every inclusion criterion and no exclusion criterion, and signs and dates F-303-02 (with time where randomization or dosing is on the same day). At [SITE NAME], eligibility confirmation is an investigator task (SOP-302, section 5.2.2; ICH E6(R3) Annex 1, 2.7.1(a)).
5.4.3
Investigator sign-off must be complete before randomization, IRT registration that assigns treatment, or the first dose of investigational product, whichever comes first.
5.4.4
Where the protocol requires sponsor review of an eligibility packet before enrollment, the CRC sends the redacted packet as the sponsor instructs and waits for written confirmation. Sponsor confirmation does not replace investigator sign-off.
5.4.5
If any eligibility value or condition could have changed between screening and the day of randomization or dosing (for example a baseline lab on the day of dosing, vital signs, pregnancy test), the CRC rechecks the criteria the protocol requires on that day, and the investigator confirms them before dosing.
5.5 No eligibility waivers
5.5.1
[SITE NAME] does not enroll a participant who does not meet every eligibility criterion of the current IRB-approved protocol. The site does not request or accept an eligibility "waiver", "exemption" or "exception" from the sponsor, the CRO or a medical monitor for an individual participant.
5.5.2
Federal regulations require the investigator to conduct the study according to the signed investigator statement and investigational plan (21 CFR 312.60; 21 CFR 812.100 and 812.110(b)). There is no regulatory mechanism for a sponsor to authorize enrollment of an individual who does not meet the IRB-approved criteria. Enrolling a participant who does not meet the criteria is a failure to follow the investigational plan, which FDA cites in inspection findings. A change to eligibility criteria requires a protocol amendment approved by the IRB, and by FDA where required, before it is applied to anyone.
5.5.3
If a sponsor representative offers or approves an exception, the CRC declines, tells the PI, and records the communication in the study file.
5.6 Screen failures and rescreening
5.6.1
When a participant does not meet a criterion, the CRC tells the PI. The investigator confirms the screen failure, and the CRC or investigator tells the participant, and with the participant's agreement, their own doctor of any clinically significant findings.
5.6.2
The CRC records the screen failure and primary reason on F-303-01, and completes the screen failure entry in IRT and EDC as the protocol requires. Screen failure source records and consent forms are kept with the study records (SOP-402).
5.6.3
Screening payments follow SOP-310.
5.6.4
A participant may be rescreened only if the protocol allows it, and only under the protocol's conditions (for example the number of rescreens allowed, the reasons for which rescreening is permitted, and any required interval). Sponsor approval of a rescreen is obtained in writing where the protocol requires it.
5.6.5
For rescreening, the CRC assigns a new screening number if the protocol or IRT requires it, links it to the earlier number on F-303-01, confirms the consent is still valid or re-consents on the current version as the protocol requires (SOP-301), repeats the procedures the protocol requires, and completes a new F-303-02.
5.7 Registration in IRT
5.7.1
Only staff delegated IRT tasks on F-302-01 with their own IRT account register participants. Shared or borrowed accounts are not used.
5.7.2
The CRC registers or randomizes the participant only after investigator sign-off on F-303-02 (section 5.4.3). The CRC checks stratification factors and other entered values against source before submitting, because many IRT entries cannot be reversed by the site.
5.7.3
The CRC prints or saves the IRT confirmation (participant number, randomization number, kit numbers, date and time) and files it in the participant's research record. IRT confirmation emails are kept as source or certified copies per SOP-306.
5.7.4
If an IRT entry is wrong (for example wrong stratum, wrong participant, wrong kit), the CRC does not attempt a workaround. The CRC tells the PI and contacts the sponsor or IRT helpdesk the same day, follows their instructions, and records a deviation per SOP-308. Randomization and blinding procedures are in SOP-305.
5.8 Enrollment documentation
5.8.1
On enrollment, the CRC:
- records the enrollment date and number on F-303-01
- writes an enrollment note in the source that confirms consent was obtained before any study procedure, the consent version, investigator eligibility sign-off with date, and the randomization or enrollment number
- enters the participant in EDC per SOP-307
- notes study participation in the participant's medical record where the site keeps one (SOP-306)
- gives the participant the study contact information and any sponsor-provided participant card
- with the participant's agreement, informs the participant's primary care physician of their participation (ICH E6(R3) Annex 1, 2.7.1(d))
- registers the participant as a research participant in the site's billing system where needed, per SOP-202
5.8.2
The Regulatory Coordinator reports enrollment numbers to the IRB at continuing review or as the IRB requires (SOP-203).
5.9 Eligibility errors found after enrollment
5.9.1
Anyone who finds that an enrolled participant did not meet a criterion tells the PI the same day.
5.9.2
The PI assesses the participant's safety and notifies the sponsor within [DEFAULT: 1 business day] of discovery, or the protocol or sponsor time if shorter. The decision whether the participant continues on investigational product or in the study is made by the PI with the sponsor, per the protocol, with participant safety first. The PI decides what to tell the participant and records the decision.
5.9.3
The CRC records the event as a protocol deviation on F-308-01 per SOP-308, and the Regulatory Coordinator reports it to the IRB if [CENTRAL IRB NAME] policy requires.
5.9.4
Records are not changed to make a participant appear eligible. Corrections to source follow SOP-306.
5.9.5
The Quality Lead reviews the cause and opens a CAPA when the error reflects a process gap (SOP-703).
6. Related Forms and SOPs
- F-303-01 Screening and Enrollment Log
- F-303-02 Eligibility Verification Checklist
- F-302-01 Delegation of Authority Log
- F-308-01 Protocol Deviation Log
- F-905-01 Cross-Entity Data Flow Register (Model N only)
- SOP-202 Medicare Coverage Analysis and Research Billing Compliance
- SOP-203 IRB Submissions, Approval and Continuing Oversight
- SOP-205 Site Qualification, Initiation and Study Activation
- SOP-300 Participant Recruitment, Pre-Screening and Advertising
- SOP-301 Informed Consent Process and Documentation
- SOP-302 Delegation of Authority
- SOP-305 Randomization, Blinding and Emergency Unblinding
- SOP-306 Source Documentation and Data Integrity (ALCOA+)
- SOP-307 Case Report Forms, EDC Entry and Query Resolution
- SOP-308 Protocol Deviations and Noncompliance
- SOP-310 Participant Payments and Reimbursement
- SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
- SOP-402 Record Retention, Archiving and Destruction
- SOP-500 Adverse Event Identification, Assessment and Recording
- SOP-700 Internal Quality Control and Quality Assurance Audits
- SOP-703 Corrective and Preventive Action (CAPA)
- SOP-905 Network Data, Systems, Privacy and Records Across Sites (Model N only)
- Appendix B Central and Site Responsibility Matrix (Model N only)
7. References
| Reference | Title |
|---|---|
| 21 CFR 312.60 | General responsibilities of investigators |
| 21 CFR 312.62(b) | Case histories |
| 21 CFR 812.100 and 812.110(b) | Investigator responsibilities; compliance with agreement, investigational plan and FDA requirements (devices) |
| 21 CFR 50.20 and 50.27 | General requirements for informed consent; documentation of informed consent |
| ICH E6(R3) Annex 1, 2.5 | Compliance with Protocol |
| ICH E6(R3) Annex 1, 2.7 | Participant Medical Care and Safety Reporting |
| ICH E6(R3) Annex 1, 2.11 | Randomisation Procedures and Unblinding |
| ICH E6(R3) Annex 1, 2.12 | Records |
| ICH E6(R3) Appendix C | Essential Records (participant identification code list and enrolment log; participants screening log) |
| FDA Guidance (1998) | Screening Tests Prior to Study Enrollment |
| FDA Guidance (2009) | Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects |
| Compliance Program 7348.811 | Bioresearch Monitoring: Clinical Investigators and Sponsor-Investigators |
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