Clinical Research Coordination Simulation

Welcome to Your Clinical Research Assignment

Review the trial materials and prepare to coordinate this important pediatric study

Your Role

Position: Clinical Research Coordinator Intern

Principal Investigator: Dr. Sarah Martinez, MD, PhD

Trial Duration: 6-month recruitment period (target: 75 participants)

Your Mission: Support all aspects of the trial from patient screening to data management while ensuring regulatory compliance and participant safety.

Trial Overview: BREATHE-EASY Phase II Study

Protocol ID: MCHR-2026-RESP-001

Study Design: Randomized, double-blind, placebo-controlled trial evaluating efficacy of investigational inhaled biologic (BioBreath-200) for moderate-to-severe pediatric asthma

Target Enrollment 75 participants

Age Range 6-17 years

Study Duration 24 weeks per participant

Trial Phase Phase II

IRB Approval Date January 15, 2026

Enrollment Deadline July 15, 2026

Trial Materials & Documentation

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Protocol Summary

Primary Objective: Evaluate the efficacy of BioBreath-200 in reducing asthma exacerbation rates in children with moderate-to-severe asthma compared to placebo.

Secondary Objectives:

Assess improvements in lung function (FEV1% predicted)
Evaluate quality of life using Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Monitor safety and tolerability of BioBreath-200
Measure reduction in rescue inhaler use

Inclusion Criteria

Age 6-17 years (inclusive)
Physician-diagnosed asthma for ≥12 months
≥2 exacerbations requiring oral corticosteroids in past 12 months
FEV1 40-80% predicted at screening
Currently on moderate-dose inhaled corticosteroids (ICS) ± long-acting beta-agonist (LABA)
Parent/guardian able to provide informed consent; assent from participants ≥7 years

Exclusion Criteria

Other chronic lung diseases (cystic fibrosis, bronchiectasis)
Smoking history or household exposure to >10 cigarettes/day
Use of biologics (omalizumab, mepolizumab) within 6 months
Severe asthma exacerbation requiring hospitalization within 4 weeks
Known allergy to study drug components
Pregnancy (for post-menarchal females)

Study Schedule

Visit	Week	Procedures	Duration
Screening	-2	Consent, medical history, spirometry, bloodwork	90 min
Baseline	0	Randomization, first dose, PAQLQ, safety labs	120 min
Week 4	4	Spirometry, adverse events, study drug accountability	60 min
Week 12	12	Spirometry, PAQLQ, safety labs, adverse events	90 min
Week 24 (End)	24	Final spirometry, PAQLQ, safety labs, study closeout	120 min

Patient Database Overview

Our hospital's asthma clinic has 428 active pediatric patients. Here's the current database breakdown:

Age Group	Total Patients	Moderate-Severe Asthma	On ICS+LABA	≥2 Exacerbations/Year
6-8 years	98	42	28	18
9-12 years	156	72	54	38
13-17 years	174	86	62	44
TOTAL	428	200	144	100

Regulatory Requirements

IRB Reporting: All serious adverse events (SAEs) must be reported to IRB within 24 hours
Data Management: Case Report Forms (CRFs) must be completed within 48 hours of each visit
Monitoring Visits: Sponsor monitors will audit 100% of consent forms and 25% of source documents quarterly
Drug Accountability: Study drug logs must be reconciled monthly
Protocol Deviations: All deviations must be documented and reported to PI within 24 hours

Recruitment Challenges

Current Status (Week 8 of recruitment):

Patients screened: 32
Screen failures: 14 (44% failure rate)
Enrolled: 18 participants
Target enrollment pace: 3.1 patients/week needed to reach 75 by deadline
Current pace: 2.3 patients/week (25% behind target)

Common Screen Failure Reasons:

FEV1 >80% (too well-controlled): 5 patients
Recent biologic use: 3 patients
Only 1 exacerbation in past year: 4 patients
Parent declined participation: 2 patients

Budget & Compensation

Per-Patient Payment: $1,200 from sponsor (covers all visits)

Participant Compensation:

Screening visit: $50 gift card
Each study visit: $75 gift card
Completion bonus: $100 gift card
Total per participant: $525
Parking validation provided for all visits

Safety Monitoring

Data Safety Monitoring Board (DSMB) Stopping Rules:

≥2 anaphylactic reactions → immediate trial suspension
>15% treatment-related SAEs → trial review
Exacerbation rate in treatment arm >1.5x placebo → futility analysis

Adverse Events to Monitor:

Injection site reactions (expected in ~40%)
Upper respiratory tract infections
Headaches
Nausea/vomiting
Worsening asthma symptoms (requires immediate PI notification)

Section 1: Patient Screening & Recruitment Strategy

Analyze the patient database and develop an effective recruitment plan

Current Challenge: You're 8 weeks into recruitment with only 18 enrolled (need 75 total by Week 26). Screen failure rate is 44%. Dr. Martinez has asked you to develop a strategy to accelerate enrollment.

Q1: How many potentially eligible patients exist in your database?

Q2: At the current enrollment pace of 2.3 patients/week, how many total participants will you enroll by the deadline (Week 26)?

Q3: What minimum screening rate (patients screened per week) do you need to achieve your enrollment goal of 75 participants?

Q4: Recruitment Strategy - Describe your plan to accelerate enrollment (150+ words)

Section 2: Informed Consent & Regulatory Compliance

Navigate the consent process and ensure protocol adherence

Scenario: You have a family (Martinez family) scheduled for a screening visit tomorrow. The patient is Sofia Martinez, age 9, diagnosed with asthma 2 years ago. She meets all inclusion criteria based on chart review.

Complication: Sofia's parents are divorced. Her mother has sole legal custody, but her father wants to be present at the consent visit and is asking detailed questions about the study.

Q5: Who must legally sign the informed consent form for Sofia's participation?

Q6: What additional document must Sofia provide given her age?

Protocol Deviation Scenario: You've just reviewed visit data for Participant #012. The Week 4 visit was conducted on Day 32 instead of Day 28 (±3-day visit window). The spirometry was completed, but the safety labs were accidentally skipped. The participant is scheduled to return for Week 12 visit next month.

Q7: Is the late visit (Day 32 instead of Day 28 ±3) considered a protocol deviation?

Q8: Action Plan - How would you handle the missed safety labs? (100+ words)

Section 3: Adverse Event Management & Safety Monitoring

Assess and respond to adverse events appropriately

Active Safety Event: You receive a call at 2:45 PM on Thursday. Parent of Participant #024 (Marcus, age 14) reports that Marcus developed hives, facial swelling, and difficulty breathing 15 minutes after receiving his Week 4 study drug dose this morning at 10:00 AM. They called 911. Marcus was taken to the emergency department and treated with epinephrine, antihistamines, and steroids. He's now stable and being observed in the ED.

Q9: How would you classify this adverse event?

Q10: What is your immediate reporting timeline to the IRB for this event?

Q11: Should Marcus continue in the trial?

Q12: Complete Adverse Event Report - Document this incident (150+ words)

Section 4: Data Management & Study Outcomes Analysis

Analyze trial data and prepare for study closeout

Scenario: The trial has completed enrollment (75 participants). You're preparing for the Week 12 interim analysis. Here's the current data:

Treatment Arm: 38 participants (3 discontinued due to AEs, 2 lost to follow-up)
Placebo Arm: 37 participants (1 discontinued due to AE, 3 lost to follow-up)
Exacerbations - Treatment: 12 total events among 33 active participants
Exacerbations - Placebo: 24 total events among 33 active participants

Q13: What is the retention rate for the treatment arm at Week 12?

Q14: What is the exacerbation rate per participant in the treatment arm?

Q15: Based on the interim data, what percentage reduction in exacerbations does the treatment arm show compared to placebo?

Data Quality Issue: The sponsor's monitor has identified discrepancies during their quarterly audit:

12 CRFs missing spirometry data
8 consent forms missing participant signatures (parent signed only)
Source documents for 5 participants show different FEV1 values than CRFs

Q16: Query Resolution Plan - How would you address these findings? (150+ words)

Q17: Study Closeout Preparation - What are your top priorities for successful trial completion? (150+ words)

Your Clinical Research Coordination Results

--

out of 100 points

--

Section 1

Patient Screening

--/25

Section 2

Regulatory Compliance

--/20

Section 3

Adverse Events