SOP-300

Participant Recruitment, Pre-Screening and Advertising

Number: SOP-300
Category: Study Conduct
Edition: Reference Edition 1.3
Approx. pages: 10

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On this page

1. Purpose
2. Scope
3. Responsibilities
4. Definitions
5. Procedure
6. Related Forms and SOPs
7. References

1. Purpose

This SOP describes how [SITE NAME] finds and approaches potential trial participants. It covers recruitment planning, IRB approval of every participant-facing recruitment material, use of medical records and databases to identify candidates under HIPAA, pre-screening conversations and the pre-screening log, limits on incentives, oversight of recruitment vendors, and reaching the population the study is meant to serve.

2. Scope

This SOP applies to every recruitment activity for every study at [SITE NAME], at all locations, whether the activity is run by site staff, a sponsor, a CRO or a recruitment vendor. It covers print, broadcast, digital and social media advertising, the site website, emails, letters, text messages, phone outreach, referral letters, chart and database review, and pre-screening by phone, online questionnaire or in person.

It ends when a candidate is referred for the consent discussion. Section 5.10 holds the library's single rule on what pre-screening may happen before IRB approval and before study activation; SOP-200, SOP-203 and SOP-205 point to it. Informed consent is in SOP-301. Screening procedures done after consent are in SOP-303. Participant payments are in SOP-310. Privacy rules that apply across all activities are in SOP-400.

Where the protocol, sponsor or IRB requirement is stricter than this SOP, the site follows the stricter requirement.

3. Responsibilities

Role	Responsibilities
Principal Investigator (PI)	Approves the study recruitment plan. Reviews recruitment materials before IRB submission. Confirms recruitment methods do not coerce or unduly influence. Oversees delegated recruitment and pre-screening activities.
Site Director	Approves site-level advertising, website content and recruitment vendor use. Approves recruitment budgets. Monitors recruitment performance across studies.
Regulatory Coordinator	Submits recruitment materials to the IRB, files approvals in the Investigator Site File (ISF), and maintains F-300-02 Recruitment Material Tracking Log.
Recruitment Specialist	Runs outreach and pre-screening activities as delegated. Uses only IRB-approved materials and scripts. Maintains F-300-01 Pre-Screening Log.
Clinical Research Coordinator (CRC)	Performs pre-screening and record review when delegated. Refers candidates for consent. Maintains F-300-01 where no Recruitment Specialist is assigned.
Finance / Contracts Lead	Reviews payment terms with recruitment vendors and sponsors for compliance with sections 5.6 and 5.7.
Privacy Officer	Designated under SOP-400. Approves preparatory-to-research representation forms, reviews paid recruitment communications for HIPAA marketing rules, and confirms any pathway for 42 CFR Part 2 records.
Quality Lead	Includes recruitment materials and pre-screening logs in internal QC reviews (SOP-700). Reviews any complaint about recruitment conduct.
All Research Staff	Use only current IRB-approved recruitment materials. Do not give medical advice or make eligibility decisions during pre-screening. Do not accept or offer finder's fees.

4. Definitions

Term	Definition
Recruitment material	Any material intended to be seen or heard by potential participants to invite them into a study: ads, flyers, posters, scripts, emails, letters, text messages, social media posts and paid ads, web and landing pages, videos, and online pre-screening questionnaires.
Pre-screening	Activities before informed consent that identify people who may be eligible, using information that already exists or that the person volunteers (for example answers to IRB-approved questions or review of existing records). Pre-screening never includes study-specific procedures.
Protected health information (PHI)	Individually identifiable health information held or transmitted by a HIPAA covered entity or its business associate (45 CFR 160.103).
Covered entity	A health plan, health care clearinghouse, or health care provider that transmits health information electronically in connection with standard transactions (45 CFR 160.103).
Preparatory to research	A HIPAA permission (45 CFR 164.512(i)(1)(ii)) that lets a covered entity use or disclose PHI to prepare a research protocol or identify potential participants, on the researcher's representation that PHI is needed for that purpose and will not be removed from the covered entity.
Partial waiver of authorization	An IRB or Privacy Board approval (45 CFR 164.512(i)(1)(i)) that permits use or disclosure of PHI for a limited purpose, such as recruitment, without the individual's authorization.
Research volunteer database	A list maintained by the site of people who have agreed in writing to be contacted about future studies.
Finder's fee	A payment to a person, other than the site's sponsor-funded study budget, for referring or enrolling a specific individual. Sponsor per-participant and milestone payments to the site under the clinical trial agreement are not finder's fees.
Recruitment vendor	A service provider engaged to advertise, collect leads, pre-screen or refer candidates.

5. Procedure

5.1 Recruitment planning

5.1.1

During feasibility (SOP-200), the PI and Site Director estimate the number of eligible participants the site can realistically enroll, using retrospective data such as the site's patient population, database counts and prior enrollment in similar studies (ICH E6(R3) Annex 1, 2.2.1). The estimate and its basis are recorded on F-200-01.

5.1.2

Before activation, the CRC or Recruitment Specialist drafts a written study recruitment plan, approved by the PI. The plan states:

the sources to be used (site patients, referring practices, research volunteer database, advertising, vendors, sponsor campaigns)
the materials needed and who produces them (site, sponsor or vendor)
the HIPAA pathway for each records-based source (section 5.3)
the pre-screening questions and who asks them
languages needed for materials and consent, and how non-English speakers will be consented (SOP-301)
the enrollment target, timeline and how progress will be reviewed

5.1.3

The plan is filed in the ISF or study recruitment file and updated when sources or materials change.

5.2 IRB approval of recruitment materials

5.2.1

Every recruitment material, whether written by the site, sponsor, CRO or vendor, must have IRB approval before first use (ICH E6(R3) Annex 1, 2.4.2; 21 CFR 56.111(a)(3) and FDA guidance Recruiting Study Subjects). This includes:

print ads, flyers, posters, brochures, and radio, TV and streaming scripts
web pages and landing pages describing a specific study, including pages on the site's own website
social media posts, paid social media ads, and their images, video and captions
emails, letters and text messages to potential participants, including the site's own patients and database members
phone and in-person pre-screening scripts and online pre-screening questionnaires
recruitment videos and digital "eligibility quiz" tools

5.2.2

The following generally do not need IRB review under FDA guidance, but the Regulatory Coordinator checks [CENTRAL IRB NAME] policy, because some IRBs require submission:

a listing of the study that gives only basic information (title, purpose, protocol summary, basic eligibility criteria, location and how to contact the site), for example ClinicalTrials.gov or a site "current studies" list in that format
communications directed to health care professionals, such as "Dear Doctor" letters and doctor-to-doctor letters, that are not intended for participants
news stories and publicity directed at audiences other than potential participants

5.2.3

Before submission, the PI reviews each site-written or site-modified material and confirms it:

does not state or imply that the investigational product is safe or effective, or equivalent or superior to other treatment
does not call the product a "new treatment", "new medication" or "new drug" without saying it is investigational
does not promise "free medical treatment" (it may say participants receive study-related care at no cost)
does not emphasize payment by larger or bold type, and states payment only as approved by the IRB
does not promise a certainty of cure or other benefit beyond what the protocol and consent form describe
is accurate, consistent with the protocol and consent form, and readable by the intended audience

5.2.4

The Regulatory Coordinator submits the material to the IRB per SOP-203 in the exact final form it will appear (final layout, images, audio or video). For social media and digital ads, the submission includes each ad variant, image and caption, and a description of where and how it will run. A material modified after IRB approval (text, images, placement that changes the message) is resubmitted before use. Changes to formatting only (font, size, color) are handled per IRB policy.

5.2.5

The Regulatory Coordinator logs each material on F-300-02 with version, IRB approval date, where it will be used, and the date it is retired. Approved files are stored in the ISF. Only materials on F-300-02 with a current approval may be used.

5.2.6

For social media, the site must also:

run posts and ads only from site-controlled accounts with access limited to named staff
disable public comments where the platform allows, or monitor comments at least [DEFAULT: each business day] and remove posts that disclose a person's health information
answer comments or messages only with IRB-approved text or a general invitation to contact the site privately; never give medical advice or discuss an individual's eligibility in public
never post photos, names or stories of participants without the participant's written authorization and IRB approval

5.2.7

When a study closes to enrollment, the Recruitment Specialist or CRC removes or takes down all its materials (web pages, ads, posters) and records the retirement date on F-300-02.

Network note: In Model N, the Network Office may run network-wide advertising, a shared website or a central recruitment call center (Appendix B, SOP-300 rows). Each material must have IRB approval for every member site it names or sends candidates to, and F-300-02 shows which sites each version is approved for. A network ad lists only sites with a current approval for that study. Staff who do protocol-specific tasks for a site's participants or candidates, including pre-screening against a study's criteria, are listed on that site's F-302-01 for the study (SOP-904); a service log under SOP-105 covers only tasks that are not protocol-specific (for example general lead intake or appointment scheduling). Central call center staff pre-screen for a site only when so delegated, use that site's IRB-approved script, and record each candidate on that site's F-300-01 or on a network log that shows the receiving site.

5.3 Identifying candidates from medical records

5.3.1

Before any staff member reviews medical records to find candidates, the PI confirms which HIPAA pathway applies and records it in the recruitment plan. Whether HIPAA applies depends on who holds the records. If [SITE NAME] or its affiliated practice is a covered entity, its records are PHI. If the site is research-only and not a covered entity, records it receives from outside practices are still governed by the HIPAA obligations of the practice that discloses them. The Site Director determines and documents the site's HIPAA status under SOP-400.

5.3.2

Use the pathway that fits the situation:

Patient's own provider. A treating clinician at a covered entity may discuss trial options with their own patient as part of care without HIPAA authorization or a waiver. The clinician may give the patient the IRB-approved study information and site contact, or, with the patient's agreement, refer the patient to the study team.
Preparatory to research. Workforce members of the covered entity that holds the records (including site staff when the site is part of that covered entity) may review records to identify potential participants, and may use the PHI to contact them to seek their authorization and consent, after documenting the representations required by 45 CFR 164.512(i)(1)(ii): the review is solely to prepare a protocol or identify participants, no PHI will be removed from the covered entity, and the PHI is necessary for the purpose (HHS OCR HIPAA FAQ 317). PHI may not be removed from the covered entity under this pathway. A researcher who is not a workforce member of that covered entity may not use this pathway to contact patients or to take PHI away; that requires a partial waiver or authorization.
Partial waiver of authorization. When records belong to a covered entity of which the study team is not a workforce member (for example a referring practice's patient list), or when PHI must leave the covered entity for recruitment, the IRB or a Privacy Board must approve a partial waiver of authorization for recruitment (45 CFR 164.512(i)(1)(i)) before the review or disclosure.
Authorization. The patient signs a HIPAA authorization permitting the disclosure for research recruitment.

5.3.3

The representations for preparatory-to-research review are documented on the covered entity's form, or on a site form approved by the Privacy Officer, and filed in the recruitment file before review begins. A preparatory-to-research representation is a HIPAA representation, not an IRB approval; it does not permit contact with a candidate about a study before the IRB has approved the recruitment materials (section 5.10).

5.3.4

Record reviewers use only the minimum necessary information. They record candidates on F-300-01 under a pre-screening ID (section 5.5) and do not copy records, take screenshots, or export lists outside the covered entity's systems.

5.3.5

Records of substance use disorder treatment from a federally assisted program are subject to 42 CFR Part 2. Staff do not use Part 2 records for recruitment unless the Privacy Officer confirms a permitted pathway.

5.3.6

Contact with patients identified by record review follows the IRB-approved method (letter, call or message from the treating provider or the study team). Where the IRB requires the treating provider to make first contact, the study team does not contact the patient until the provider has done so or the patient has asked to be contacted.

Network note: Whether central staff may review records under the preparatory-to-research pathway depends on which covered entity holds the records. N-Integrated: member sites that are one legal entity are one covered entity, so central recruitment staff who are its workforce members may review records across member sites under section 5.3.2, using the minimum necessary. N-Integrated defaults apply only where the member site and the network entity are the same legal entity. A separate subsidiary, or a professional corporation under a management services arrangement, follows the N-Affiliated rows for PHI, direction of staff, contract signature, records custody and payments unless counsel confirms otherwise (SOP-900, 5.2.1). Legally separate covered entities count as one only if they are under common ownership or control and have documented a designation as an affiliated covered entity (45 CFR 164.105(b)); the Privacy Officer confirms the designation is on file. N-Affiliated: Network Office staff are not workforce members of a member site's covered entity, so central review of that site's records, or a network patient database built from several sites' records, needs a partial waiver of authorization from the IRB or a Privacy Board, or the patient's authorization. Each cross-entity flow is recorded on F-905-01 (SOP-905; Appendix B, SOP-300 rows).

5.4 Research volunteer databases and registries

5.4.1

The site adds a person to its research volunteer database only with the person's written or electronic agreement to be contacted about future studies, and records the date of agreement. The agreement states what information is kept, how it is used, and how to be removed. The Site Director decides whether the database itself is submitted to an IRB.

5.4.2

Staff search the database only for studies with an approved recruitment plan, and contact database members only with IRB-approved materials.

5.4.3

Staff honor opt-out requests within [DEFAULT: 5 business days] and record the removal.

5.4.4

Outreach by phone or text follows the person's stated contact preferences. Automated calls and text messages to mobile numbers may require the person's prior express consent under the Telephone Consumer Protection Act (47 U.S.C. 227); the Site Director confirms the site's consent language and any vendor's compliance before a campaign starts.

5.4.5

When the site uses an external registry or referral platform, staff follow the platform's terms and the IRB-approved recruitment plan, and record the source on F-300-01.

5.5 Pre-screening and the pre-screening log

5.5.1

Only staff delegated pre-screening on F-302-01 and trained on the study's pre-screening criteria pre-screen candidates (SOP-302, SOP-103).

5.5.2

Pre-screening uses only the IRB-approved script or questionnaire. Staff do not add questions, perform tests, take measurements, collect specimens, or ask a candidate to stop or change any medication before consent. These are screening procedures and require consent (SOP-301, SOP-303).

5.5.3

Staff tell the candidate that pre-screening does not determine eligibility, that a full screening after consent is needed, and that participation is voluntary.

5.5.4

Staff record each pre-screened candidate on F-300-01. The log contains only what is needed to manage pre-screening and report recruitment metrics:

pre-screening ID (site-assigned, not derived from name, date of birth or medical record number)
date and staff initials
study
referral source (for example site patient, database, ad name and version, vendor)
outcome: referred for consent, not eligible, not interested, unable to contact, or other
reason category when not referred (for example a criterion number or "declined"), without clinical detail
screening number if the candidate later enters screening

5.5.5

Identifying information (name, phone, medical record number) needed to follow up with candidates is kept in a separate access-controlled key linked by pre-screening ID, not on F-300-01. Answers to pre-screening questions and the identifying key are kept only as long as the IRB approval and the site's retention schedule allow, and are then destroyed per SOP-402. F-300-01 itself is kept with the study records.

5.5.6

F-300-01 is kept in minimum necessary form: no names or medical record numbers, and each candidate is identified only by the pre-screening ID. It is not de-identified: dates linked to a person are PHI (45 CFR 164.514(b)(2)(i)(C)). When a sponsor requests pre-screening data, staff send aggregate counts (section 5.9.1). The log itself is sent only after the Privacy Officer confirms a HIPAA basis (for example a limited data set under a data use agreement, 45 CFR 164.514(e), or the candidate's authorization), and identifiable information only where the IRB has approved and the candidate has authorized the disclosure.

5.5.7

Candidates who appear eligible are offered an appointment for the consent discussion. Candidates who do not qualify are told they do not qualify for this study, without disclosing which answer excluded them unless the script permits, and may be offered other studies or, with their agreement, added to the database.

5.6 Incentives, payments and undue influence

5.6.1

Recruitment must not coerce or unduly influence. Recruitment materials state payment only as the IRB approved and do not emphasize it (section 5.2.3). Payment amounts and methods follow SOP-310.

5.6.2

Finder's fees at [SITE NAME]: [DEFAULT: prohibited]. The site's policy on finder's fees and enrollment incentives is recorded under SOP-104. Under the default, no staff member, clinician, practice, participant or other person may receive or offer a payment, gift or credit for referring a specific individual or for that individual's enrollment. Sponsor per-participant and milestone payments to the site under the clinical trial agreement are not finder's fees (section 5.6.5).

5.6.3

Participants are not offered payments or gifts for referring other people to a study unless the IRB has approved the specific incentive in advance.

5.6.4

Staff incentives tied to a specific individual's enrollment (for example a bonus per participant enrolled or randomized) are [DEFAULT: prohibited]. General performance pay not tied to individuals (for example pay linked to team quality measures or overall site results) is a Site decision. Any such program must be approved in writing by the Site Director and reviewed by the Quality Lead before use, and it must be disclosed to the IRB where IRB policy requires.

5.6.5

Sponsor-funded recruitment bonuses or enrollment milestone payments to the site are reviewed under SOP-201 and disclosed to the IRB where IRB policy requires.

5.7 Recruitment vendors

5.7.1

The site engages a recruitment vendor only after qualification and a written agreement per SOP-105, recorded on F-105-01. The agreement covers confidentiality, HIPAA status (including a business associate agreement where the vendor handles PHI on behalf of a covered entity), data security, data return or destruction, and use of IRB-approved materials only.

5.7.2

The Finance / Contracts Lead confirms the vendor's fee is for services (for example a flat fee or a fee per activity) and is not a payment to any person for referring a specific individual.

5.7.3

Vendor materials, landing pages and pre-screening questionnaires go through section 5.2 before use. The vendor's referral data are logged on F-300-01 under the vendor as the source.

5.7.4

Sponsor-contracted vendors that refer candidates to the site are overseen by the sponsor. The site still confirms that the materials the candidate saw are IRB-approved for the site and records the referral source.

5.7.5

The Recruitment Specialist or CRC reviews vendor performance and complaints at least [DEFAULT: monthly while the vendor is active] and reports problems to the Site Director.

5.8 Reaching the intended population

5.8.1

IRBs must find that selection of participants is equitable (21 CFR 56.111(a)(3)). The site supports this by recruiting from the full population the protocol allows and not narrowing it without a protocol reason.

5.8.2

In the recruitment plan, the PI and Site Director consider barriers that keep eligible people from enrolling, and plan practical measures where feasible:

outreach through practices and community organizations that serve the population affected by the condition
IRB-approved translated materials and a plan to consent non-English speakers (SOP-301)
visit hours, transport and reimbursement (SOP-310), and remote options where the protocol allows (SOP-313)
materials written in plain language and accessible formats

5.8.3

Staff do not exclude a candidate for language, literacy, disability or similar reasons unless the protocol requires it. When the site cannot support a candidate's language, the PI decides with the sponsor and IRB whether the candidate can be accommodated, and the outcome is recorded on F-300-01.

5.8.4

Staff collect demographic information during pre-screening only if the IRB-approved questionnaire includes it, and report it to sponsors only in aggregate unless the IRB approved otherwise.

5.9 Reviewing recruitment performance

5.9.1

The CRC or Recruitment Specialist summarizes F-300-01 for each enrolling study at least [DEFAULT: monthly]: candidates by source, referred for consent, screened, enrolled, and main reasons for not proceeding.

5.9.2

The PI and Site Director review the summary against the recruitment plan and decide on changes (new materials, new sources, closing a source). New or changed materials go through section 5.2.

5.9.3

Complaints about recruitment conduct (for example unwanted contact or misleading ads) are recorded and sent to the Quality Lead, who decides whether a deviation (SOP-308), a privacy incident (SOP-400, F-400-01) or a CAPA (SOP-703) is needed. Reportable events go to the IRB per its policy.

5.10 Pre-screening before IRB approval and activation

5.10.1

This section is the single rule for the library. SOP-200, SOP-203 and SOP-205 point to it and do not restate it.

5.10.2

Record review for feasibility under the HIPAA preparatory-to-research provision (section 5.3.2) may happen before activation, provided no PHI leaves the covered entity and no candidate is contacted. Results are recorded as counts on F-200-01 (SOP-200).

5.10.3

Any contact with a candidate about the study, and any use of recruitment materials, happens only after the IRB has approved those materials (section 5.2).

5.10.4

F-300-01 entries for a study start on or after the date of the IRB approval for that study. No candidate is logged for a study before that date.

5.10.5

Nothing that requires consent happens before the study is activated (SOP-205) and the participant has consented (SOP-301).

5.10.6

A preparatory-to-research representation is a HIPAA representation, not an IRB approval (section 5.3.3).

F-300-01 Pre-Screening Log
F-300-02 Recruitment Material Tracking Log
F-105-01 Service Provider Qualification and Oversight Record
F-200-01 Study Feasibility Assessment
F-302-01 Delegation of Authority Log
F-400-01 Privacy Incident Report
F-905-01 Cross-Entity Data Flow Register (Model N only)
SOP-103 Staff Qualification, Training and Training Records
SOP-105 Oversight of Service Providers and Vendors
SOP-200 Study Feasibility and Selection
SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets
SOP-203 IRB Submissions, Approval and Continuing Oversight
SOP-301 Informed Consent Process and Documentation
SOP-302 Delegation of Authority
SOP-303 Screening, Eligibility Verification and Enrollment
SOP-308 Protocol Deviations and Noncompliance
SOP-310 Participant Payments and Reimbursement
SOP-313 Decentralized Trial Elements (Remote Visits, Home Health, Direct-to-Participant IP)
SOP-400 Participant Privacy and HIPAA in Research
SOP-402 Record Retention, Archiving and Destruction
SOP-700 Internal Quality Control and Quality Assurance Audits
SOP-703 Corrective and Preventive Action (CAPA)
SOP-104 Conflict of Interest and Financial Disclosure
SOP-902 Network Study Feasibility, Allocation and Central Contracting (Model N only)
SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)
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 50	Protection of Human Subjects
21 CFR 56.111(a)(3)	IRB criteria for approval: equitable selection of subjects
45 CFR 160 and 164	HIPAA Privacy Rule
45 CFR 164.512(i)	Uses and disclosures for research purposes (waiver, preparatory to research)
45 CFR 164.508	Uses and disclosures for which an authorization is required
42 CFR Part 2	Confidentiality of Substance Use Disorder Patient Records
47 U.S.C. 227	Telephone Consumer Protection Act
ICH E6(R3) Annex 1, 2.2.1	Investigator resources: recruitment potential
ICH E6(R3) Annex 1, 2.4.2	IRB/IEC approval of participant recruitment procedures (e.g., advertisements)
ICH E6(R3) Appendix C	Essential Records (advertisement for participant recruitment; participant screening log)
FDA Guidance (1998)	Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators
FDA Guidance (1998)	Screening Tests Prior to Study Enrollment
FDA Guidance (Jan 2018)	Payment and Reimbursement to Research Subjects
HHS OCR HIPAA FAQ 317	Can the preparatory research provision be used to recruit individuals to a research study?
FD&C Act (as amended by FDORA 2022)	Diversity Action Plans (sponsor obligation)

Independent Site SOP Library. Licensed CC BY-NC 4.0 by the American Institute for Medical Research (AIMR), with added permission for any site's internal use (license terms). Not legal advice: each adopting site confirms state law, IRB and sponsor requirements with its own counsel and owns every step it approves.