The Bronchiolitis Follow-up Intervention Trial
Phase: NA
Conditions: Bronchiolitis
Sponsor: University of Utah

The Bronchiolitis Follow-up Intervention Trial (BeneFIT) 
 
Principal Investigator:  
Stanford PI: 
Intermountain PI: 
Alan R. Schroeder, MD 
Associate Chief for Research 
Division of Hospital Medicine 
Associate Clinical Professor (Hospital Med and 
Critical Care) 
Department of Pediatrics 
Stanford University School of Medicine 
aschroe@stanford.edu, 650-725-0551 
Eric R. Coon, MD, MS 
Assistant Professor 
Division of Hospital Medicine 
Department of Pediatrics 
Primary Children’s Hospital 
Eric.Coon@hsc.utah.edu 
801-980-6181 
 
 
Sub-Investigators: Lauren A. Destino, MD, Department of Pediatrics, Stanford; Tom H. Greene, PhD, 
Department of Population Health Sciences, University of Utah 
 
 
 
 
Version Number:  v.1 
November 1, 2017  
 
 
 
 
 
 
Historical Versions: 

  
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Table of Contents 
1 
INTRODUCTION ............................................................................................................................................ 1 
1.1 
Study Rationale and Background ...................................................................................................... 1 
1.2 
Pilot data ............................................................................................................................................... 1 
2 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 2 
2.1 
Primary Objective and Endpoint ........................................................................................................ 2 
2.2 
Secondary Objectives and Endpoints ............................................................................................... 2 
3 
STUDY DESIGN ............................................................................................................................................. 3 
3.1 
End of Study Definition ....................................................................................................................... 3 
4 
STUDY POPULATION .................................................................................................................................. 4 
4.1 
Inclusion Criteria .................................................................................................................................. 4 
4.2 
Exclusion Criteria ................................................................................................................................. 4 
4.3 
Strategies for Recruitment and Retention ........................................................................................ 4 
5 
PARTICIPANT DISCONTINUATION/WITHDRAWAL .............................................................................. 4 
5.1 
Participant Discontinuation/Withdrawal from the Study ................................................................. 4 
5.2 
Lost to Follow-Up ................................................................................................................................. 4 
6 
STUDY ASSESSMENTS AND PROCEDURES ....................................................................................... 5 
6.1 
Study Intervention ................................................................................................................................ 5 
6.2 
Study PRocedures ............................................................................................................................... 5 
6.3 
Measures to Minimize Bias: Randomization and Blinding ............................................................. 6 
7 
STATISTICAL Methods ................................................................................................................................. 7 
7.1 
Sample Size Determination ................................................................................................................ 7 
7.2 
Statistical Analyses.............................................................................................................................. 7 
7.2.1 
Analysis of the Primary and secondary Endpoint(s) ................................................... 7 
8 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ................................ 8 
8.1 
Regulatory, Ethical, and Study Oversight Considerations ............................................................. 8 
8.1.1 
Statement of Compliance................................................................................................ 8 
8.1.2 
Informed Consent Process ............................................................................................. 9 
8.1.3 
Confidentiality and Privacy ............................................................................................. 9 
8.1.4 
Quality Assurance and Quality Control ......................................................................... 9 
8.1.5 
Data Handling and Record Keeping  ............................................................................. 9 
8.1.6 
Protocol Deviations ........................................................................................................ 10 
8.2 
Abbreviations ...................................................................................................................................... 11 
9 
REFERENCES ............................................................................................................................................. 12 
 

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INTRODUCTION 
 
1.1 
STUDY RATIONALE AND BACKGROUND 
 
Bronchiolitis is the leading cause of hospitalization in infants and the fourth leading cause of 
hospitalization overall in children.1  The condition is self-limited with few therapeutic interventions 
demonstrating meaningful benefit.2  As such, hospitalization generally consists of supportive care with 
hydration, oxygen, and other forms of respiratory support as needed.  
 
Given the current unsustainable pace of US healthcare spending, close examination of costly but 
unproven practices is essential.3 Because of the high prevalence of bronchiolitis and the abundant 
evidence of overuse of unnecessary tests and treatments,4-8 bronchiolitis care has been the focus of 
numerous recent high-value care improvement efforts.5,6,8-11 However, none of these efforts have 
addressed routine outpatient follow-up after hospital discharge, a common but understudied 
intervention.  
 
While routine follow-up after hospitalization is often recommended, regardless of the condition, the 
benefits, harms, and overall value of this core component of healthcare delivery are only just starting to 
be evaluated critically.12-14  Potential benefits include increasing parental reassurance, strengthening the 
relationship between a family and the child’s primary care provider (PCP), and modifying treatment to 
speed disease resolution or prevent disease exacerbation.  On the other hand, routine follow up visits 
cost money, may be burdensome for families, and may precipitate additional, unnecessary medical care.  
For example, a recent randomized trial involving 1,500 patients discharged from Cincinnati Children’s 
Hospital demonstrated that the intervention (a nurse-led home visit after discharge) was unexpectedly 
associated with an increased risk of acute healthcare reutilization (including readmission and emergency 
department visits) compared with no home visit.15 Overdiagnosis (the detection of conditions where 
such detection does not benefit patients16) may be one explanation for these findings. In other words, 
exposure to a medical encounter may uncover abnormalities that otherwise would have gone 
undetected and not caused harm had such a visit not occurred.  In bronchiolitis particularly, 
overdiagnosis of hypoxemia detected by routine pulse oximetry is a well-described phenomenon.7,17-20   
 
Our study will assess the relative benefits, risks, and costs of two different follow up strategies for 
children with bronchiolitis who are discharged from the hospital.  Our findings will impact management 
of over 100,000 hospitalizations per year nationally.21  Furthermore, results from this study can be used 
to inform follow up practices for other common, self-limited pediatric conditions.  
 
 
1.2 
PILOT DATA 
 
To prepare for BeneFIT, we conducted an observational pilot study22 of children hospitalized for 
bronchiolitis during the winter of 2016-17.  All five BeneFIT medical centers (listed in section 3) 
participated.  Among 199 enrolled subjects, a routine follow-up visit was either recommended or 
scheduled by the primary team in 84% of cases.  Two-thirds of patients who completed the study 
attended a routine follow-up visit, including 87% of those who had a follow up appointment scheduled 
prior to hospital discharge and 33% of those for whom as needed follow up was recommended.  

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“Reassurance provided” (70%) and “education provided” (15%) were cited by parents as the most useful 
aspect of the follow-up visit.  Hospital re-visits were uncommon (2%). 
 
 
2 
OBJECTIVES AND ENDPOINTS 
 
 
2.1 
PRIMARY OBJECTIVE AND ENDPOINT 
 
The primary objective of the study is to determine whether as needed Primary Care Physician (PCP) 
follow-up is non-inferior to scheduled PCP follow-up in terms of reduction in parental anxiety. 
Primary Outcome 
Parental anxiety, as measured by the anxiety portion of the Hospital Anxiety and Depression Scale 
(HADS),23 a validated tool used in a previous trial among parents whose children had been hospitalized 
for bronchiolitis.19  Parental anxiety will be measured by research coordinators at before hospital 
discharge (baseline) and at the first data collection phone call (5-9 days following discharge).  The same 
parent will be interviewed for both the baseline and the follow up HADS.  If the length of time between 
baseline HADS and actual discharge exceeds 2 days, the HADS will be repeated, such that each subject 
has a baseline HADS within 2 days of hospital discharge. 
 
Justification of Primary Outcome     
Our primary outcome was selected based on feedback from primary care providers and parents of 
children hospitalized for bronchiolitis.  Among parents surveyed in our pilot study, “reassurance” was 
most commonly selected (70%) as the most valuable aspect of the follow up visit.22  Parental 
reassurance was also mentioned repeatedly by primary care providers from Stanford, Intermountain, 
and elsewhere via informal discussions with the investigators.      
 
2.2 
SECONDARY OBJECTIVES AND ENDPOINTS 
 
Secondary objectives of the study include determining whether as needed PCP follow-up, compared to 
scheduled PCP follow-up: 
 
Does not adversely impact satisfaction with care? 
 
Does not adversely impact the relationship between the child’s primary caregiver and the child’s 
PCP? 
 
Does not prolong time to resolution of symptoms? 
 
Does not increase risk of hospital re-admissions and emergency department visits? 
 
Results in a fewer number of post-discharge ambulatory visits? 
 
Results in less ambulatory testing (pulse oximetry, chest x-ray) and fewer prescriptions 
(albuterol, antibiotics, steroids)? 
 
Results in fewer missed days from daycare and work? 
 
Results in lower medical costs? 

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Secondary Outcomes 
Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 
days after discharge, whichever occurs first:  
 
Time from hospital discharge to cough resolution 
 
Time from hospital discharge to child reported back to normal 
 
Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 
days after discharge, whichever occurs first:  
 
Number of hospital re-admissions and emergency visits  
 
Number of ambulatory visits  
 
Number of missed daycare and work days 
 
Ambulatory prescriptions (albuterol, antibiotics, steroids) 
 
Ambulatory testing (i.e. pulse oximetry, chest x-ray)- only measured at first ambulatory visit   
 
Measured by parent report via research coordinator phone call at 1 month from discharge: 
 
Relationship with PCP measured by the Patient-Doctor Depth-of-Relationship Scale24 
 
Satisfaction with care, measured by applicable questions from the Patient Satisfaction 
Questionnaire Short Form (PSQ-18)25 
 
Immunizations received 
 
Measured among patients cared for at Intermountain clinics and those who have Select Health 
insurance: 
 
Total charges for ambulatory medical care from discharge until: 
o 14 days after discharge 
o 
symptom resolution      
 
Measured at the time of discharge and during the first follow up phone call:  
 
 
Perceptions about pulse oximetry monitoring  
    
 
3 
STUDY DESIGN  
 
The BeneFIT trial will be a multicenter, unblinded randomized trial.  The study will take place within the 
inpatient units at 2 tertiary children’s hospitals (Primary Children’s Hospital, Lucille Packard Children’s 
Hospital- Palo Alto, CA) and 3 affiliated community hospitals (Riverton Hospital, UT; John Muir Hospital, 
CA; Packard El Camino Hospital, CA).  Data will also be collected via phone calls from the research team 
after patients have been discharged from the hospital. 
 
 
3.1 
END OF STUDY DEFINITION 
 

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The participant is considered to have completed the study after the final follow-up phone call has been 
conducted or at the time they withdraw from continued study participation. 
 
4 
STUDY POPULATION 
 
4.1 
INCLUSION CRITERIA 
 
Children less than two years of age who are hospitalized with an attending physician diagnosis of 
bronchiolitis will be considered for enrollment. 
 
4.2 
EXCLUSION CRITERIA 
 
- Chronic lung disease (any baseline supplemental oxygen need or on diuretics, including CF or other 
bronchiectasis) 
- Complex or hemodynamically significant heart disease (planned surgery, medications) 
- Immunodeficiency  
- Neuromuscular disease 
- Discharged home with medication for withdrawal (narcotic or benzodiazepine) 
- Inpatient team believes the child should follow up with their PCP 
- Patient enrolled during previous hospitalization (does not need to be re-enrolled) 
 
4.3 
SUB-POPULATION 
Patients discharged home with supplemental oxygen will not be randomized and will not be 
included in the main analyses.  However, a separate analysis of these patients will be conducted 
(section 7.2.2). 
 
 
4.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Research coordinators will identify eligible patients.  Families will be approached by a research 
coordinator for consent and enrollment, within 2 days of anticipated discharge.  Families will receive a 
$25 gift card for enrollment and a $325gift card for study completion.  These incentives will also be 
provided to families of children who are enrolled and then discharged home with supplemental oxygen. 
 
 
5 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
5.1 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request.  The 
investigator may also choose to discontinue or withdraw a participant from the study.  The reason for 
participant discontinuation or withdrawal from the study will be recorded in the research chart. 
 
5.2 
LOSS TO FOLLOW-UP 

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A participant will be considered lost to follow-up if the study staff are unable to contact the parent or 
legal guardian for the follow-up phone calls.  In an effort to decrease loss to follow up, study 
coordinators will ask parents at enrollment the best days and times of the week to reach them for follow 
up phone calls.  Parents will be provided with the phone number from which they should expect 
research coordinator phone calls.  Where possible, three messages will be left before considering the 
participant lost to follow-up.  The coordinator will document the failed attempts to contact the parent in 
the research chart. 
 
6 
STUDY ASSESSMENTS AND PROCEDURES 
 
6.1 
STUDY INTERVENTION 
Scheduled follow up   
At the time of hospital discharge, parents will be instructed to have their child follow up with their PCP 
within 4 days of discharge regardless of improvement and/or symptom resolution.  Research 
coordinators will verify that the child has a scheduled follow up appointment prior to discharge and will 
help with scheduling if necessary.   
 
As needed follow up 
At the time of hospital discharge, parents will be instructed that the child does not need to 
automatically follow up with his/her primary care physician. Rather, the child should follow up on an as 
needed basis: if the child does not improve or if new concerns arise. 
 
 
6.2 
STUDY PROCEDURES 
 
Consent, screening and study enrollment will occur while the participant is hospitalized for bronchiolitis.  
Eligibility confirmation will be obtained from the electronic medical record along with parent interview 
as applicable.  Prior to randomizing the eligible patient, the child’s parent will be asked to complete the 
anxiety portion of the HADS, administered verbally by research coordinators.  When a RedCap 
enrollment checklist has been completed, RedCap will supply the local research coordinator with the 
patient’s randomization assignment.  The parents will be notified of their randomization group and 
instructed on the study plan for follow-up as discussed in section 6.1.  Patients discharged home with 
supplemental oxygen will not be randomized, with follow up plans determined by the child’s medical 
team.   
 
Prior to hospital discharge, a research coordinator will call the child’s PCP to notify them of the child’s 
enrollment in the trial and their randomization assignment.  The research coordinator will fax a one 
page summary of the trial to the PCP.  PCPs will be notified at the time of the call and in the one-page 
summary that the protocol allows for and encourages PCPs to check-in over the phone with families 
enrolled in the trial. 
 
Demographic and hospitalization details will be obtained via electronic medical record review.  Data for 
the primary endpoint will be collected by administering the anxiety portion of the HADS survey prior to 
randomization and at the first post discharge follow-up phone call (5-9 days after discharge).  Data for 
the secondary endpoints will be collected via phone calls from a research coordinator and will occur 
weekly until symptom resolution or 50 days after discharge, whichever comes first.  Research 

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coordinators will follow a script for all data collection phone calls.  Electronic medical record review will 
supplement information collected by phone calls for patients who re-visit the emergency department or 
are re-admitted to the hospital.  In addition, a one month post discharge phone call will be made to 
administer the Patient-Doctor Depth-of-Relationship Scale questionnaire.  Study participation will 
conclude with the final discharge phone follow up call. 
 
Table 1: Schema of study procedures 
 
 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Randomization 
After consent and enrollment, a research coordinator at the site will obtain a site-specific computer-
generated randomization assignment for each patient.  Patients will be randomized with equal (1:1) 
allocation to either the scheduled PCP follow up group or to the as-needed PCP follow up group, using 
randomly permuted blocks of random sizes.  Randomization sequences will be stratified by site but not 
by any additional baseline factors.  The research coordinator will inform the patient’s family, inpatient 
Within 2 days of anticipated hospital discharge
Screening/Enrollment
•Screen potential participants by inclusion and exclusion criteria
•Obtain informed consent and enroll
•Obtain demographics and relevant medical history
•After consent and eligibilty verification, but before randomization, parent or legal guardian will 
complete anxiety portion of HADS
Day of discharge (patients discharged on oxygen will not be randomized)
Randomization
•Coordinator will obtain patient randomization assignment
•Coordinator will notify child's PCP of child's enrollment in study and randomization assignment
•Scheduled follow up:  Family instructed to follow-up with PCP (appointment made prior to discharge)
•As needed follow up:  Family will be instructed to follow-up with PCP on as needed basis
Follow-up assessments of study endpoints 
7 day phone call
•Parent will complete anxiety portion of the Hospital Anxiety and Deptression Scale (HADS)
•Parent assessment for secondary outcomes collected via phone interview (see script)
Follow-up assessment of study endpoints
Subsequent weekly 
phone calls
•Parent will be contacted weekly to collect secondary endpoint data until symptom resolution or 50 
days after discharge whichever comes first (see script)
Follow-up Telephone Call
1 month follow-up
•Patient-Doctor Depth-of-Relationship Scale will be administered
•Participant considered off study at this timepoint or when final weekly phone call occurs (if needed 
beyond 4 weeks)

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medical team, and PCP of the patient’s assignment.   
 
Blinding 
BeneFIT will be an unblinded trial because it will not be feasible to blind parents or research 
coordinators to intervention assignment, as the reason for any follow-up visit (i.e. routine vs new 
concern) that occurs needs to be documented.  However, investigators responsible for analyses will be 
blinded to individual patient intervention assignments.    
 
7 
STATISTICAL METHODS 
 
 
7.1 
SAMPLE SIZE DETERMINATION 
 
A previous bronchiolitis trial of 615 patients19 found a standard deviation for HADS scores of 4.1 and a 
serial correlation of the HADS score between an admission and 7-day assessment that exceeded 0.80 (S. 
Cunningham, personal communication, October 18, 2017).  To provide as conservative assessment of 
statistical power, we assume that the serial correlation over 7 days will equal or exceed 0.65 in the 
present study.  We designated a non-inferiority margin on the anxiety portion of the HADS of 2 points, 
the smallest clinically meaningful change.  Based on the non-adherence to recommended follow-up 
encountered in our pilot study,22 we estimated that up to 33% of patients randomized to as needed 
follow up would still follow up and that 13% of patients randomized to scheduled follow up would not 
attend follow up appointments. Hence, the non-inferiority margin for the ITT analysis of all randomized 
patients was adjusted to be 2 × (1-0.33-0.13) = 1.08.  We also assumed that the follow-up anxiety 
assessment would be obtained for at least 90% of subjects. Under these assumptions, a total sample 
size of 294 patients (147 patients in each group) will provide 80% power with 1-sided α=0.025 for the 
analysis of covariance planned for the primary analysis to demonstrate non-inferiority of as needed 
follow up if in fact as needed follow up and scheduled follow up lead to equal levels of anxiety.  Because 
children discharged home with supplemental oxygen are not being randomized and are not being 
analyzed in the main analysis, these patients are not included in the power calculation. 
 
 
7.2 
STATISTICAL ANALYSES 
 
 
7.2.1 ANALYSIS OF THE PRIMARY AND SECONDARY ENDPOINT(S) 
 
Intent-to-treat analysis for primary outcome  
 
The primary non-inferiority analysis will be an analysis of covariance comparing HADS scores 
approximately 7 days after discharge between patients randomized to scheduled PCP follow up or as 
needed PCP follow up, controlling for baseline HADS scores. A 1-sided upper 97.5% confidence bound 
for the difference in mean HADS score between the intervention and control groups will be constructed, 
and non-inferiority will be inferred if the upper confidence limit excludes the intent-to-treat non-
inferiority (ITT) bound of 1.08 points. 
 
ITT comparisons for secondary outcomes 

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A log-rank test will be used to compare the time from discharge to the first report of symptom 
resolution between the randomized treatment groups. Follow-up for symptom resolution will be right-
censored at 50 days after discharge or at the time of loss-to-follow-up.  Charges will be compared 
between the two intervention groups using two-part models, given that charge data will likely be semi-
continuous.  Other secondary outcomes will be compared between the randomized groups using 
Poisson or negative binomial models with robust standard errors for statistical inference.   
 
Instrumental variable analysis of the effect of the routine follow-up visit 
 
The primary ITT analyses evaluate the effect of a recommendation for scheduled PCP follow up or as 
needed follow up, irrespective of whether the PCP visit actually occurs. We will supplement the ITT 
analyses with an instrumental variable analysis, using randomization as the instrument, which will 
approximate the average causal effect on parental anxiety of actually receiving routine PCP follow up.  
The goal of this analysis is to estimate the local average causal effect of the treatment among the 
subgroup of patients who would attend the PCP visit if randomized to the scheduled follow up group but 
not if randomized to as needed follow up.26  The validity of instrumental variable analysis depends on an 
“exclusion” assumption which requires that the randomized intervention affects parental anxiety only 
through the occurrence or nonoccurrence of the PCP visit and not by other pathways.  It also depends 
on a monotonicity assumption that requires that randomization to the as needed follow up intervention 
could not cause any subjects to attend a PCP visit when they would not have attended a PCP visit if 
randomized to the scheduled follow up intervention. Because these assumptions are not fully testable, 
the instrumental variables analysis will be exploratory. 
 
 
7.2.2 ANALYSIS OF CHILDREN DISCHARGED HOME WITH SUPPLEMENTAL OXYGEN 
 
All of the same outcomes discussed above will be measured among the subpopulation of un-randomized 
children discharged home with supplemental oxygen.  We will describe parental anxiety and resource 
utilization among this subpopulation and compare them to patients who are not discharged home on 
oxygen, using the same statistical tests used for the main analysis.     
 
8 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
8.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
 
8.1.1 STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the applicable United States Code of Federal Regulations 
(CFR) and the International Conference on Harmonization Good Clinical Practice (ICH GCP).  The Principal 
Investigator will assure that the protocol, informed consent form(s), and all participant questionnaires 
will be submitted to the IRB for review and approval.  Approval of the study materials will be obtained 
before any participant is enrolled.  No deviation from or amendment to the protocol will take place 
without prior approval from the Institutional Review Board (IRB), except where necessary to eliminate 
an immediate hazard(s) to the trial participants. All changes to the consent form will be IRB approved. 
 

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8.1.2 INFORMED CONSENT PROCESS 
 
This study involves children as a vulnerable population and therefore adequate measures will be taken 
to ensure that the parent or legal guardian of the child is adequately informed of the study and an  
Informed Consent Form (ICF) is appropriately signed prior to enrolling the child in the trial.  The parent 
or legal guardian will be given adequate time to read the ICF and ask questions prior to signing.  A copy 
of the ICF will be given to the parent once signed.  Assent from the child will not be sought due to the 
age of the participant population. 
 
 
8.1.3 CONFIDENTIALITY AND PRIVACY  
The Institutional Review Board (IRB) or regulatory agencies or other Quality Assurance monitors may 
request to inspect all documents and records pertaining to the trial, including medical records (office, 
clinic, or hospital).  The clinical study sites will permit access to such records. 
 
Study participant’s contact information, necessary for phone call data collection, and study participant 
research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to 
and stored at Stanford University via the RedCap data system. The study data entry and study 
management systems used by clinical sites will be secured and password protected.  
 
 
 
8.1.4 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks that will be run on the database will be generated by the Principal Investigator or Clinical 
Research Coordinator at Stanford University. Any missing data or data inconsistencies will be 
communicated to the site(s) for clarification/resolution. 
 
When requested, the investigational site will provide direct access to all trial related source 
data/documents, and reports for the purpose of monitoring and auditing by the sponsor, or inspection 
by local and regulatory authorities. 
 
A Data Safety and Monitoring Board will not be utilized for the trial as this is a minimal risk, non-
therapeutic trial.     
 
 
 
8.1.5 DATA HANDLING AND RECORD KEEPING  
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
Principal Investigator. Aside from electronic medical review, all data will be collected via verbal 
interview of parents by research coordinators, adhering to a pre-specified script.  All of the validated 
questionnaires will be read aloud to the parent or legal guardian by research coordinators.  The anxiety 
portion of the HADS, for example, will be read aloud both at baseline and phone follow up, to maintain 
consistency.  Research coordinators will record responses in RedCap.  The investigator is responsible for 
ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 

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8.1.5.1 STUDY RECORDS RETENTION  
 
At the end of the study, all records will continue to be kept in a secure location for as long a period as 
dictated by the reviewing IRB or Institutional policies.  
 
8.1.6 PROTOCOL DEVIATIONS  
 
A protocol deviation is any departure from the defined procedures as outlined in the protocol version 
submitted and previously approved by the IRB.  Protocol deviations have the potential to place 
participants at risk and can also undermine the scientific integrity of the study thus jeopardizing the 
justification of the research.  
It is the responsibility of the site investigator to use continuous vigilance to identify and document 
deviations in the research records.  Protocol deviations must be sent to the reviewing Institutional 
Review Board (IRB) per their policies.  
 

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8.2 
ABBREVIATIONS 
 
CRF 
Case Report Form 
CTO 
Clinical Trials Office 
eCRF 
Electronic Case Report Forms 
GCP 
Good Clinical Practice 
HADS 
Hospital Anxiety and Depression Scale 
HIPAA 
Health Insurance Portability and Accountability Act  
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation  
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
OHRP 
Office for Human Research Protections 
PCP 
Primary Care Physician 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
 
 
 

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Parikh K, Hall M, Teach SJ. Bronchiolitis Management Before and After the AAP Guidelines. 
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Ralston SL, Garber MD, Rice-Conboy E, et al. A Multicenter Collaborative to Reduce Unnecessary 
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Schroeder AR, Marmor AK, Pantell RH, Newman TB. Impact of pulse oximetry and oxygen 
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The Bronchiolitis Follow-up Intervention Trial (BeneFIT) 
Version 1 
 
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