Prompt Details
Model
Chat - (gpt-6-luna)
Token size
402
Example input
[Study Protocol & Therapeutic Area]: Phase III Double-Blind Type 2 Diabetes Clinical Trial (Endocrinology / Investigational GLP-1/GIP Dual Agonist).
[Patient Demographics & Inclusion Criteria]: Adults aged 35–70, diagnosed with Type 2 Diabetes for at least 1 year, HbA1c between 7.5% and 10.5%, on stable Metformin therapy for at least 90 days. Excluded: Type 1 diabetes, history of pancreatitis, eGFR < 45 mL/min.
[Recruitment Channels & Site Setting]: Hospital-affiliated academic medical center in Chicago, IL; targeted social media ads, local primary care clinics, and community health fairs.
[IRB Guidelines & Study Guardrails]: FDA 21 CFR 312 compliance, zero claims of weight loss or guaranteed blood sugar reduction, clear statement that investigational medication may not provide direct health benefit, local IRB submission required.
Example output
# Clinical Trial Recruitment Protocol & Outreach Plan
## 1. Multi-Channel Patient Outreach Collateral
* **Digital Ad Headline:** Managing Type 2 Diabetes? Consider a Clinical Research Study.
* **Ad Body Copy:** Chicago-area researchers are evaluating an investigational study medication for adults with Type 2 Diabetes on stable Metformin. If you are 35 to 70 years old, you may qualify to participate. Qualified participants receive study-related health monitoring at no cost.
* **Mandatory Disclosure:** This is an investigational drug study. Participation is entirely voluntary. Health benefits are not guaranteed.
* **Community Poster Visual Brief:** Clean image of an adult reviewing a health journal at home, featuring bold tear-off contact tabs.
---
## 2. Telephone Pre-Screening & Eligibility Matrix
| Clinical Criteria | Patient-Friendly Screening Question | Qualifying Response | Routing Action |
| :--- | :--- | :--- | :--- |
| **Age 35–70** | "What is your date of birth?" | Age between 35 and 70 | Proceed to Question 2 |
| **Type 2 Diabetes** | "Have you been diagnosed with Type 2 Diabetes for at least one year?" | Yes | Proceed to Question 3 |
| **Metformin Use** | "Are you currently taking Metformin, and has your dose stayed the same for 3 months?" | Yes | Proceed to Question 4 |
| **Pancreatitis Exclusion** | "Have you ever had an inflamed pancreas (pancreatitis)?" | No | Schedule Site Visit 1 |
---
## 3. Physician Referral & Medical Network Kit
* **Subject:** Clinical Research Opportunity: Investigational GLP-1/GIP Study for Uncontrolled T2D Patients
* **Clinical Briefing:** Our Chicago site is enrolling for a Phase III randomized, double-blind evaluation of an investigational GLP-1/GIP dual agonist for patients with HbA1c between 7.5% and 10.5% despite stable Metformin regimens.
* **Practice Referral Action:** If you have eligible adult patients who may benefit from comprehensive metabolic monitoring, please share the attached study overview or contact our clinical research office directly.
---
## 4. Participant Retention & Study Navigation Protocol
* **Visit 1 (Baseline):** Provide dedicated study coordinator contact card and parking validation.
* **Visit Reminders:** Automated SMS sent 72 hours and 24 hours prior to scheduled fasting blood draws.
* **Travel Support:** Administrative travel reimbursement provided for study-related visits per IRB-approved schedules.
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GPT-6-LUNA
Design compliant clinical trial recruitment strategies, patient outreach collateral, and pre-screening workflows to accelerate study enrollment. Tailored for clinical research coordinators, principal investigators, and CRO recruitment managers managing Phase I–IV trials. Produces IRB-ready outreach copy, eligibility pre-screening matrices, physician referral kits, and multi-channel patient communication plans.
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Added 2 weeks ago
