Start with the study in plain terms

• Tell me briefly which therapeutic area this study is in and the enrollment target set at launch
• How many active sites are open to enrollment today Options: 1-5, 6-15, 16-30, 31+
• Describe where enrollment stands against the projected timeline and which milestone slipped first
• Who on your team owns day-to-day recruitment operations and who makes the final vendor decision Options: Clinical operations director, Enrollment strategy lead, Study manager, Head of site operations, Other
• How urgent is recovery, in your view, measured by when leadership expects visible progress Options: Immediately, within 2 weeks, Within 4 weeks, Within 8 weeks, This quarter, No firm deadline

Where the current plan leaves the most room for improvement

• What single enrollment miss from the past six months would have changed how you allocated resources
• Describe the common characteristics of underperforming sites, including geography, specialty, and previous recruitment history
• How many sites have achieved less than 50 percent of their committed enrollment Options: None, 1-3, 4-10, More than 10
• When sites report low patient volume, which causes do they cite most often Options: Narrow eligibility, Competing trials, Low patient awareness, Limited staff time, Other
• Which site-level risk would cause you to pause a vendor rollout immediately

How patients are slipping through the funnels you're using

• How much pressure from competing trials do your priority sites face, and has that pressure grown recently Options: Significantly increased, Moderately increased, About the same, Decreased
• Which patient sources have historically driven the most eligible referrals for you Options: Site outreach, Digital advertising, Physician referrals, Patient advocacy partners, EHR screening
• Walk me through a recent week where referrals converted well, from channel to pre-screen to randomization, and what went right
• Which eligibility criteria in the protocol do you believe are excluding otherwise reachable patients
• If a channel produced 30 percent more eligible referrals but sites struggled to convert them, what would need to change internally to realize the gain

Where execution tends to stall in trials like this

• Which single operational constraint has blocked launch or scale on previous enrollment efforts
• Describe any IRB or ethics committee delays you have experienced and which step took the longest
• How many weeks of delay do IRB holds or site approvals typically introduce in your trials Options: 0-2 weeks, 3-6 weeks, 7-12 weeks, More than 12 weeks
• Who must sign off on patient-facing outreach materials at the sponsor and site levels
• If data sharing approval for patient matching is denied at a site, what fallback options would you consider Options: Manual chart review, Broaden digital outreach, Use only physician referrals, Pause that site, Other

The alternatives you are actively weighing

• Who are you actively considering instead of bringing in an external recruitment partner, and what attracts you to those options
• List the types of solutions on your shortlist, for example incumbent vendor, in-house program, or different agency model Options: Incumbent vendor, Build in-house, New external vendor, CRO-provided recruitment, Hybrid model
• What would have to be true about your current approach for you to justify staying with it rather than switching
• Has anyone on your team proposed solving recruitment without an outside partner, and if so which approach did they propose Options: Yes, expand site outreach, Yes, increase PI incentives, Yes, internal digital campaign, No internal proposal, Other
• Which competitive or internal option would make you delay a vendor decision until after a protocol amendment or budget reforecast

How referrals actually convert in your workflow

• If a channel doubled referral-to-randomization, what internal change would block you from accepting those referrals immediately
• Walk me through a successful referral that became a randomization at a single site last quarter, including timing and who touched the patient
• Which channels have historically delivered the highest conversion rates at your sites Options: Physician referral, Site outreach, Search ads, Social media, EHR-driven outreach, Patient advocacy
• How do you currently attribute a randomization back to a specific referral source Options: Unique referral ID, Manual reconciliation, Site report, No consistent method
• What referral-to-randomization rate by channel would make you consider scaling that channel aggressively Options: >30%, 20-30%, 10-19%, <10%

What has to be ready before we press the green button

• Which single technical or compliance blocker would prevent a campaign from starting on your target date
• List the systems we would need to integrate with at site and sponsor level, for example EHR, CTMS, CRM, and who owns each Options: Site EHR, Sponsor CTMS, Recruitment CRM, Call center telephony, Other
• Do you have API access to site systems or only scheduled exports such as HL7 or CSV Options: API access available, Scheduled exports only, Depends by site, Not sure
• How queryable is site-level patient data for the key inclusion criteria, on a scale from 1 to 5 Options: 1 - Not queryable, 2, 3, 4, 5 - Fully queryable
• How many dedicated sponsor or site staff hours per week can be allocated to onboarding and running recruitment activities Options: <5 hours, 5-10 hours, 11-20 hours, 21-40 hours, 40+ hours

Measures that decide whether we move forward

• If a short pilot hits your target referral-to-randomization and timeline, what organizational approval would still be required to sign a full program Options: Procurement signoff, Legal/Privacy signoff, Budget owner approval, Executive sponsor approval, No further approval
• Define the measurable success criteria you will use for a pilot, including target referral-to-randomization, timeline, and acceptable cost per randomized patient
• Which single missed metric would be decisive enough for you to stop the pilot
• How quickly could you approve a pilot contract if the terms matched your commercial and privacy requirements Options: Immediately, Within 2 weeks, Within 4 weeks, Longer than 4 weeks
• Who in procurement and legal needs to be involved before launch, and are they already aware of this initiative

A practical path to decision and next steps

• If we proposed a two-site pilot with clear go no-go gates, what would make you greenlight it this quarter
• Which artifacts would you like to see next to move toward an internal approval, for example protocol summary, site feasibility, data handling terms, or draft budget Options: Protocol summary, Site feasibility, Data handling agreement, Draft budget, IRB-ready materials, Other
• What is your preferred decision timeline for selecting a recruitment partner Options: This week, Within 2 weeks, Within 4 weeks, This quarter
• Who should be invited to the next meeting to resolve technical, legal, and site readiness questions Options: Clinical operations lead, Site operations manager, IT/integration owner, Legal/privacy counsel, Other
• What immediate blocker would stop scheduling a pilot within the next two weeks

• Recruitment Strategy Walkthrough

• Confirm the current state and its cost
• You confirm the current state and the quantified cost statement matches your operational reality.
• Provide site-level enrollment data for the last six months including screen-fail rates, recent referral sources, and site capacity constraints.
• You agree that the proposed channel-specific referral flows address the primary leak points in your current pipeline.
• Map expected referral flows by channel and site
• Run a trial-specific referral-to-randomization forecast using the provided site data and deliver the model within five business days.
• Walk through pre-screening and site handoff
• You validate the referral-to-randomization conversion assumptions or identify specific inputs that must be changed for your sites.
• Confirm the list of 3 to 5 pilot sites and the channels you want prioritized in the pilot.
• Show referral-to-randomization conversion model and sensitivity
• Provide protocol eligibility constraints and any recent amendments or known site-specific interpretation issues that impact screening.
• You agree on a pilot scope and the evidence needed to proceed to a commercial proposal.
• Validate alignment

• Recruitment Strategy Walkthrough
• Recruitment Strategy Walkthrough Deck
• Recruitment Strategy Solution Brief

• meeting
• slides
• document

• Produce IRB‑Approved Advertising Materials
• Launch Condition‑Specific Search Advertising Campaign
• Deploy Social Media Patient Recruitment Campaign
• Run Targeted Display and Video Advertising
• Mine Patient Database and Outreach Matches
• Activate Physician Referral Network Outreach
• Implement EHR‑Based Patient Identification at Sites
• Operate Study Landing Page and Patient Intake Forms
• Run Call Center Pre‑Screening and Patient Intake
• Conduct Digital Pre‑Screening and Eligibility Triage
• Manage Referral Tracking via Recruitment Portal
• Deliver Referral‑to‑Randomization Performance Reports
• Provide Site‑Level Recruitment Support Materials
• Assist Patient Consent Navigation at Participating Sites

Produce IRB‑Approved Advertising Materials

• Describe the IRB submission packet we should prepare for recruitment advertising (list specific documents such as ad copy versions, call scripts, translations, and consent language).
• List the patient‑facing material types that must be IRB reviewed for this study (display ads, social posts, landing page copy, call center script, printed flyers). Options: Display ads, Social posts, Landing page copy, Call center scripts, Printed flyers, Translations
• Which IRB review pathway will govern advertising at participating sites (central IRB, local/site IRB, single IRB with site reliance agreements)? Options: Central IRB, Local/site IRB per site, Single IRB with reliance, Not yet decided
• How many site‑specific ad amendments do you anticipate across participating sites during the campaign? Options: None, 1-3, 4-10, More than 10
• Identify the IRB artifacts required as deliverables (example: stamped approval letter, versioned ad PDFs, translation certificate) and the owner for each.
• Confirm the acceptance evidence we must collect to proceed with live ads (for example: dated approval letters for each site, approved ad version IDs or IRB stamp). Options: Dated approval letters per site, Approved ad version IDs with IRB stamp, Both of the above, Other - describe

Launch Condition‑Specific Search Advertising Campaign

• Name the prioritized condition‑specific search keywords, phrases, and common synonyms you want targeted (include any negative keywords to exclude).
• Specify the geographic targeting for search ads by site ZIP codes, metropolitan statistical areas, or national scope. Options: By site ZIP codes, By MSA / city regions, National coverage, Custom list (upload)
• Provide the landing page URL(s) or domain structure that search traffic should resolve to for patient intake and pre‑screening.
• Estimate the target referral‑to‑pre‑screen conversion range you expect from search traffic (choose a range to set pacing expectations). Options: <1%, 1-3%, 3-5%, >5%
• Who will own keyword bid strategy, daily budget pacing, and negative keyword list maintenance during the live campaign (role or team)? Options: We will manage bids, You will manage bids, Shared management - specify cadence
• When will search campaigns be scheduled to start relative to site activation or IRB approval (select best fit and provide days if 'Other'). Options: After central IRB approval, After first site activation, Simultaneous with site activation, Other (specify days)

Deploy Social Media Patient Recruitment Campaign

• List the social platforms and audience targeting segments you want to use (for example: condition interest groups, caregiver demographics, age bands). Options: Condition interest, Caregiver targeting, Age bands, Behavioral segments, Look‑alike audiences
• Describe the approved creative formats for social (single image, carousel, short video, story) including maximum video length and file specs.
• Indicate required IRB‑approved disclaimers or privacy language that must appear verbatim on social ad copy.
• Will you provide final creatives and copy or do you require creative production services and asset localization? Options: We will provide final assets, We require production services, Shared responsibilities
• Identify any patient advocacy groups or community pages authorized for amplification and the contact for partnership coordination.
• Specify frequency caps, daily spend limits, or per‑site budget allocation rules for social spend. Options: Frequency cap per user, Daily spend per region, Per‑site budget allocation, No caps - let us recommend

Run Targeted Display and Video Advertising

• Name the publisher categories or content placements preferred for display/video (condition education sites, patient portals, streaming video). Options: Condition education sites, Patient portals, Streaming video, Health news sites, Custom placements
• Provide the tracking endpoints, pixel or SDK IDs and UTM parameter scheme required for display and video creatives.
• Detail creative technical specs required for display and video (VAST version, aspect ratios, max file size).
• Explain the attribution window and rules you want applied for view‑through and click‑through attribution that map referrals to sites.
• Identify the owner for programmatic buys and whether private marketplace (PMP) deals are permitted. Options: We handle programmatic, You handle programmatic, PMP allowed with preapproval
• Estimate the monthly impressions and expected click volumes by display and video channel to help with pacing. Options: <50k impressions, 50k-250k, 250k-1M, >1M

Mine Patient Database and Outreach Matches

• State which patient registries or databases we are authorized to query and the legal basis for outreach (consent on file, opt‑in, de‑identified match).
• Which matching identifiers are available for outreach (medical record number, hashed email, phone number, combination) and do you permit hashed identifier matching? Options: MRN, Hashed email, Phone number, Combination
• Indicate the data fields you require returned with each match for pre‑screening (last visit date, diagnosis code, relevant lab values, contact phone).
• Are there PHI handling constraints or a required Business Associate Agreement for mining each database or registry? Options: Yes - BAA required, No, Depends on site - specify
• Assign the approver for outreach scripts and cadence for matches (role that must sign off before outreach).
• Limit the maximum outreach frequency per matched patient and specify any do‑not‑contact triggers (days between contacts, opt‑out handling). Options: One outreach only, Up to 3 attempts over 30 days, Custom cadence - describe

Activate Physician Referral Network Outreach

• Outline the referral network types to be activated (specialist clinics, community PCPs, clinical research networks) and target specialties by name (e.g., neurology, rheumatology).
• Detail the physician‑facing materials required (referral kit, pocket cards, quick eligibility checklist) and whether those materials require IRB review. Options: Referral kit, Pocket cards, Eligibility checklist, Educational slide deck
• Explain any permitted compensation or fee‑for‑service arrangements for referring clinicians and compliance documentation needed.
• Assign the outreach owner for physician engagement and the preferred channel for scheduling educational webinars or office visits. Options: Study outreach team, Site CRA, Joint owner
• Select the channels you authorize for physician outreach (secure EHR message, fax, direct mail, field rep call). Options: Secure EHR message, Fax, Direct mail, Field rep visit
• Project expected referral volume per site from physician outreach during the first 90 days. Options: 0-5 referrals/site, 6-15 referrals/site, 16-30 referrals/site, 30+ referrals/site

Implement EHR‑Based Patient Identification at Sites

• Supply the list of EHR systems used at participating sites and the local IT/informatics contact for query implementation.
• Encode the protocol inclusion and exclusion criteria that must be translated into the EHR query (for example: ICD‑10 codes, lab thresholds, medication exclusions, date windows).
• Indicate allowable data fields to return for pre‑screen (encounter date, diagnosis codes, lab values, medications) and any PHI gating rules.
• Confirm the local sign‑off owner for EHR query deployment at each site (site IT lead, informatics contact, PI) and the expected approver contact info format.
• When will EHR queries be scheduled relative to site activation and IRB approvals (provide a target day offset)? Options: After central IRB approval, After each site IRB approval, After site activation, Other (specify days)
• Specify the accuracy threshold for EHR match lists that you require for acceptance (for example: spot check match accuracy >= 90% across test patients). Options: >=90%, >=95%, Custom threshold

Operate Study Landing Page and Patient Intake Forms

• Indicate whether landing pages and intake forms will be hosted by your team or hosted by us and the domain/URL structure to use. Options: Hosted by you, Hosted by us, Co‑hosted (we provide path)
• List the intake form fields required for protocol pre‑screening (age, diagnosis date, current medications, recent labs, contact details).
• Clarify whether full PHI collection is permitted on the landing page and where PHI will be stored (secure recruitment portal, site EHR, other). Options: Recruitment portal, Site EHR, Secure CRM, Other
• Assign who will approve landing page UX, copy and form flow, and state expected revision turnaround time in business days.
• Describe the consent path on the landing page (eConsent, referral to site for consent, phone‑assisted consent) and any language translation requirements. Options: eConsent, Redirect to site, Phone‑assisted, Translations needed
• Estimate expected daily traffic and peak hour windows for the landing page to determine hosting and handoff capacity. Options: <100 visits/day, 100-500, 500-2,000, >2,000

Run Call Center Pre‑Screening and Patient Intake

• Describe required call center hours of operation, languages supported, and SLA for initial call pickup. Options: Business hours only, Extended hours, 24/7, Languages: English only / Multilingual
• List the mandatory pre‑screen questions call agents must ask (protocol eligibility checkpoints, medication checks, recent lab values) and whether audio recording is permitted.
• Report which CRM or recruitment portal agents will use to log calls and create referrals and whether SSO or API integration is required. Options: Recruitment portal, Your CRM, Other
• State whether agents require protocol‑specific training and manager sign‑off before handling live patient calls. Options: Yes - training required, No - we will handle
• Confirm the acceptance criteria to validate call center readiness (for example: QA pass rate on test calls >= 90%, roster of trained agents with signed training logs). Options: QA pass rate >=90%, Trained agent roster with signed logs, Both conditions
• Assign ownership for inbound versus outbound call responsibilities and provide the escalation path for clinical eligibility questions.

Conduct Digital Pre‑Screening and Eligibility Triage

• Describe the exact digital pre‑screen rules to implement on the intake form (minimum age, specific lab thresholds, medication exclusions).
• Choose the redirect action for partially eligible candidates (immediate phone handoff, queued site scheduling, educational content) when a pre‑screen returns partial match. Options: Phone handoff, Queued scheduling, Educational content, Decline
• Indicate the data elements that must be captured for attribution and regulatory traceability (timestamp, consent flag, referral source UTM, agent ID).
• Designate the automated triage thresholds that trigger immediate site notification versus queueing for call center follow‑up. Options: Immediate notification, Queue for call center, Manual review required
• Specify who will maintain pre‑screen logic if protocol eligibility changes (sponsor, vendor, shared) and the expected turnaround for updates. Options: Sponsor, Vendor, Shared
• Estimate the expected digital pre‑screen completion rate and average time to complete the pre‑screen form. Options: <30% completion, 30-60%, 60-80%, >80%

• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Pricing & Payment Schedule
• Performance Addendum
• Data Processing Agreement (DPA)
• HIPAA Business Associate Addendum (BAA)
• Data Use Agreement (DUA) for Site/EHR Data
• Launch Milestone & Acceptance Schedule
• Change Order Agreement
• Confidentiality Agreement (Mutual)

• First Measurement Review (weeks 4-10)
• Acceptance Gate Review (around day 90)
• Monthly Operational Review
• Quarterly Performance and Optimization Review

• Reconfirm numeric targets
• Publish the acceptance decision and underlying data package to the shared workspace within 24 hours.
• If remediation is required, create a remediation tracker with milestones and target recheck date.
• Archive the supporting data snapshots used for the acceptance decision for auditability.
• Quick status and dashboard highlights
• Ensure the top three underperforming sites or channels have defined corrective actions and target completion dates.
• Agree prioritization and target dates for the top three enhancement requests impacting conversion rate or time-to-randomization.
• Close or assign owners to all open operational blockers and record expected resolution dates.
• Update the open-issue tracker with resolution dates and evidence required for closure.
• Schedule and execute agreed channel optimizations and record performance impact after implementation.
• Publish the prioritized enhancement backlog with target delivery windows.
• Quarter outcomes versus targets
• Agree the prioritized optimization roadmap with target impact estimates and delivery timelines.
• Confirm any channel or site budget reallocations and document expected performance changes.
• Establish the measurement plan and reporting cadence for the next quarter.
• Produce the quarterly performance report comparing outcomes to Agreement & Commit stage targets and distribute to stakeholders.
• Implement the top-priority optimizations and set success criteria for post-implementation measurement.
• Schedule the next quarterly review and publish the measurement windows and datasets to be used.
• Validate whether referral-to-randomization conversion rate and referrals per channel are on trajectory against targets recorded in the Agreement & Commit stage.
• Document three priority corrective actions with completion dates and acceptance criteria.
• Confirm data sources and reporting cadence for ongoing measurement.
• Publish the measurement dataset and dashboard links for async review within 48 hours.
• Implement the agreed channel targeting or creative adjustments and record expected impact and completion date.
• Update the referral tracking portal to capture any missing pre-screen failure reasons identified during diagnosis.
• Produce a documented acceptance decision with pass/fail recorded for each numeric criterion from the Agreement & Commit stage.
• Restate acceptance criteria and targets
• When conditional, agree a remediation plan with milestone dates and a recheck window.
• Ensure acceptance evidence and the decision record are published to the shared workspace.
• Present first measurement data
• Channel performance detailed review
• Trend analysis and root causes
• Present 90-day outcome data
• Enhancement roadmap and impact assessment
• Root-cause diagnosis for gaps
• Site-level issues and blocker burn-down
• Document pass or fail per criterion
• Resource and allocation decisions
• Agree corrective actions and dates
• Enhancement requests backlog review
• Agree remediation plan if conditional
• Action register and next steps
• Identify risks and blockers
• Close acceptance evidence and next steps
• Confirm next quarter measurement plan
• Confirm next checkpoint