Pilot Evaluation of FAMCOPE-ICU
Phase: NA
Conditions: Emotion Regulation, Coping Skills
Sponsor: University Hospitals Cleveland Medical Center

 
 
Pilot EvaluaƟon of FAMCOPE-ICU (Family Coping and EmoƟon RegulaƟon Tool in the ICU) 
 
NCT05408468 
 
January 11, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ObjecƟves 
Aim 1: We will use probing qualitaƟve quesƟons and validated self-report scales to determine the 
acceptability of FAMCOPE-ICU. We hypothesize that family members of the criƟcally ill will ﬁnd 
FAMCOPE-ICU acceptable.  
 
Aim 2: We will conduct a pilot, before-and-aŌer clinical trial to generate evidence of FAMCOPE-ICU’s 
preliminary eﬃcacy. We hypothesize that recipients of FAMCOPE-ICU will report less severe 
psychological symptoms (i.e., post-traumaƟc stress disorder, anxiety, depression), higher saƟsfacƟon, and 
less sleep disturbance than non-recipients) 
 
Background 
Each year, more than 6 million American families will endure a loved one’s admission to an intensive care 
unit (ICU).1 Consequently, most of these family members will report distressing psychological symptoms 
(stress, anxiety, and depression), which can compromise their involvement in surrogate decision-making, 
impair social funcƟoning, and persist for months aŌer the paƟent’s ICU discharge.2 Over the last three 
decades, there have been varied aƩempts to support these family members; unfortunately, these 
supporƟve intervenƟons have largely been ineﬀecƟve in reducing the intensity of family member 
psychological symptoms. Notably, these intervenƟons have largely focused on enhancing knowledge and 
improving communicaƟon, with liƩle aƩenƟon given to empowering family members with the skills 
needed to cope during these stressful, and oŌen traumaƟc, circumstances.3 Consistent with models of 
family-centered criƟcal care endorsed by numerous mulƟdisciplinary professional socieƟes, there is a 
signiﬁcant need to develop novel and scalable intervenƟons that miƟgate distressing psychological 
symptoms reported by family members of the criƟcally ill.4 
 
Inclusion and Exclusion Criteria 
 
 
 
 
 

 
 
 
 
Number of Research ParƟcipants 
 
We will recruit 60 parƟcipants (30/group). 
 
Recruitment Methods 
 
Each day, a research assistant (RA) will screen the admission orders and nursing admission ﬂowsheet 
documentaƟon within the electronic medical records (EMR) of paƟents in the CTICU, NSU, MICU, and 
TSICU (SICU paƟents only ). Using this process, the RA will document the month, day of month, and Ɵme 
of the paƟent’s ICU admission in our electronic screening log. They will use this informaƟon to idenƟfy 
paƟents on day 1 or 2 of their ICU stay who meet paƟent inclusion criteria #1 (age). It is possible that we 
will screen paƟents who have been in the ICU for more than two days (e.g., weekend admissions), in that 
case, we will follow the same procedures described below. 
 
On ICU day 1 (0-24 hours). The RA will confer with the paƟent’s nurse and/or provider to idenƟfy the 
paƟent’s legally authorized representaƟve. If there is uncertainty, the RA will examine the paƟent’s 
bedside chart for a paƟent informaƟon sheet (i.e., face page), family informaƟon sheet (usually collected 
at admission), or signed consent document as means of idenƟfying the paƟent’s LAR. 
- If the LAR is at the bedside, a RA will introduce the study (see “pre-recruitment script” 
document), emphasizing that they may be eligible for our study in two days. If interested in 
learning more about the study upon eligibility, the research assistant will collect the LAR’s name 
and phone number, which will transferred directly into the screening log, and give them the 
recruitment leƩer. The RA will tell the LAR that if the paƟent eligibility criteria are met, our team 
will reach out to them to coordinate their possible enrollment in the study. 
- If the LAR is NOT at the bedside, the RA will leave the recruitment leƩer at the paƟent’s 
bedside or with the bedside nurse, who will be asked to give the leƩer to the LAR should they 
visit the paƟent. 
 
On ICU day 2 (24-48 hours) of the paƟent’s ICU stay, the RA will aƩempt the locate the LARs at the 
paƟent’s bedside if they were unable to establish contact with them on day 1. They will also confer with 
the bedside RN about if the LAR has visited since we ﬁrst tried to establish contact, and if the leƩer was 
given to the family member. (Family involvement is a key element of the ICU RN handoﬀ; therefore, this 
informaƟon should be easy to obtain given there will only have been 1 RN (nightshiŌ) that the RA would 

not be in contact with since their last bedside visit). - If the leƩer was NOT given to the family member 
and is sƟll at the bedside, the RA will once again ask the RN to give the leƩer to the family member 
should they visit.  
- If the leƩer was NOT given to the family member and is NOT at the bedside, the RA will leave 
another leƩer, following the same process used on ICU day 1.  
- If the family is at the bedside, the RA will give the family member the recruitment leƩer, 
following the process described for ICU day 1. 
 
On or AŌer ICU Day 3 (48-72 Hours), The RA will idenƟfy paƟents who meet PaƟent Inclusion Criterion 
#2 by comparing admission informaƟon in the screening log to the EMR documentaƟon screening 
process described on ICU day 1. PaƟent’s meeƟng this criterion will be screen for PaƟent Inclusion 
Criterion #3.  
 
If PaƟent Criterion #2 is met, the RA will confer with the nurse/provider to verify if the paƟent’s current 
plan of care involves discharge within the next 24 hours by asking “To your knowledge, does the 
paƟent’s plan of care involve discharging from the ICU by this Ɵme tomorrow?”  
 
If the nurse/provider answers Yes, the paƟent does not meet Criterion #3. The RA will reevaluate on the 
next screening day if the paƟent is not discharged.  
 
If the nurse/provider answers No, the paƟent meets Criterion #3. The RA will obtain permission from the 
RN/Provider to evaluate PaƟent Criterion #4.  
 
Consistent with recommendaƟons from the UH IRB InvesƟgator Manual, a RA will conduct a global 
cogniƟve assessment by assessing the paƟent with the following quesƟons:  
1) Is the paƟent alert and able to communicate?  
2) Is the paƟent comfortable enough to communicate?  
3) Is the paƟent medically stable enough to have an informed consent discussion? 
 
The RA will evaluate the potenƟal paƟent parƟcipant for eligibility and will confer with the CWRU PI 
(PignaƟello) if there is a quesƟon. This conversaƟon will be documented in the electronic screening log.  
 
If the LAR is not at the bedside, the RA will confer with the screening logs and/or nurse to confer the 
delivery status of the opt out leƩer:  
- If the leƩer has been delivered AND the opt out period has lapsed. The RA will call the LAR to 
ascertain interest (see phone script) and conﬁrm eligibility criteria. If criteria are met, the RA will 
aƩempt to schedule a face-to-face meeƟng to discuss their parƟcipaƟon (see recruitment script). 
- If the leƩer has delivered, BUT the opt out period has NOT lapsed. The RA will make a note in 
the screening log about the date that we can call the LAR, assuming the paƟent remains eligible. 
- If the leƩer has NOT been delivered and is at the bedside. The RA ask the nurse about their 
knowledge of the LAR’s visiƟng habits and request that the RN deliver the leƩer should the 
family visit.  

- If the leƩer has NOT been delivered and is NOT at the bedside. The RA will provide the RN with 
another leƩer to give to the LAR and update the screening log to reﬂect the new delivery 
aƩempt. 
 
If the LAR is at the bedside, the RA will conﬁrm the family inclusion criteria with the LAR face-toface. - If 
the family member is ineligible, the RA will thank the LAR for their Ɵme and document this ﬁnding in the 
screening log.  
- If the family member is eligible, the RA will iniƟate the recruitment discussion (See aƩached 
“Recruitment Script”). 
 
*RaƟonale for calling parƟcipants* - Due to COVID-19 related delays with the US mail, mailing an opt 
out leƩer/ﬂyer would likely reduce the opportunity the parƟcipant has to parƟcipate in this research 
study. Also, given our understanding of this populaƟon, it is very possible that parƟcipants may not be 
returning to home regularly to check their mail. Furthermore, it is very likely that, unless the LAR is the 
spouse/living with the paƟent, an address for the LAR will not available, further limiƟng the opportunity 
to parƟcipate in this study. In addiƟon, due to the contextual nature of this study and work of our prior 
team, the need to contact family members early on the paƟent’s ICU stay may potenƟate the potenƟal 
beneﬁt of being in this study, as their psychological response to the ﬁrst few days of their loved one’s 
criƟcal illness is a signiﬁcant predictor of their well-being throughout the rest of the paƟent’s hospital 
stay and post-discharge period. To reduce parƟcipant burden, we will only call parƟcipants during normal 
business hours (0900-1700), and will only call them a second Ɵme if they return our call or leave a 
voicemail expressing interest in the study. 
 
Seƫng 
 
1) We will be recruiƟng from UHCMC CTICU, NSU, and TSICU (SICU paƟents only)  
2) PaƟent inclusion criteria will be parƟally veriﬁed in the private oﬃce of the CWRU PI using remote 
EMR capacity. The remaining criteria will be veriﬁed in person at the bedside, or over the phone.  
3) We will conduct the interview in a private family conference room as designated by the respecƟve 
medical directors of each ICU, a private locaƟon approved by the parƟcipant (including the paƟent’s 
bedside), or the CWRU PI’s Oﬃce (Nursing Research HRC 302E). 
 
Consent Process 
 
Once in a locaƟon with the LAR’s desired privacy, the RA will formally iniƟate the informed consent 
process. The RA will provide a copy of the informed consent document to the LAR, giving them an opƟon 
to review it independently ﬁrst. Next, the RA will review each secƟon of the informed consent document 
with the LAR. Consistent with the 2018 Common Rule, the RA will emphasize: 
1) A statement that the study involves research, an explanaƟon of the purposes of the research 
and the expected duraƟon of the subject’s parƟcipaƟon, a descripƟon of the procedures to be 
followed, and idenƟﬁcaƟon of any procedures that are experimental  
2) A descripƟon of any reasonably foreseeable risks or discomforts to the subject;  
3) A descripƟon of any beneﬁts to the subject or to others that may reasonably be expected 
from the research;  

4) A disclosure of appropriate alternaƟve procedures or courses of treatment, if any, that might 
be advantageous to the subject;  
5) A statement describing the extent, if any, to which conﬁdenƟality of records idenƟfying the 
subject will be maintained;  
6) For research involving more than minimal risk, an explanaƟon as to whether any 
compensaƟon and an explanaƟon as to whether any medical treatments are available if injury 
occurs and, if so, what they consist of, or where further informaƟon may be obtained;  
7) An explanaƟon of whom to contact for answers to perƟnent quesƟons about the research and 
research subjects’ rights, and whom to contact in the event of a research-related injury to the 
subject;  
8) A statement that parƟcipaƟon is voluntary, refusal to parƟcipate will involve no penalty or loss 
of beneﬁts to which the subject is otherwise enƟtled, and the subject may disconƟnue 
parƟcipaƟon at any Ɵme without penalty or loss of beneﬁts to which the subject is otherwise 
enƟtled; and  
9) A statement that idenƟﬁers might be removed from the idenƟﬁable private informaƟon or 
idenƟﬁable biospecimens and that, aŌer such removal, the informaƟon or biospecimens could 
be used for future research studies or distributed to another invesƟgator for future research 
studies without addiƟonal informed consent from the subject or the legally authorized 
representaƟve, if this might be a possibility 
 
AŌer, the RA will give the LAR the opportunity to ask any addiƟonal quesƟons about the study. Then, the 
RA will conﬁrm their understanding with a post-consent quiz:  
1) In a few sentences, tell me what you think the purpose of our study is?  
2) Just to make sure you understand, can you tell me what we’re asking you to do?  
3) What are the risks of being a part of our study?  
4) If you decide not to parƟcipate, what other opƟons do you have?  
5) What else would you like to know? 
 
If the LAR is unsure or incorrect in their responses, the RA will re-review the relevant informaƟon in the 
consent document. The RA will then use a teach-back method to ensure understanding. 
 
Next, the RA will ask the LAR to sign and date the wriƩen informed consent document. AŌer which the 
RA will provide the LAR a copy of the consent document that they signed and dated. The RA will 
complete the aƩached “informed consent documentaƟon” form and proceed with the T1 interview. 
 
Reassessing the PaƟent for Decision-Making Capacity 
 
Consistent with recommendaƟons from the UH IRB, we will use the process described in the recruitment 
process to reassess the paƟent for decision-making capacity at the T4 interview (face-to-face) and T5 
interviews (unless the paƟent died in the period between T1 and T4, or T4 and T5). For the reassessment 
process, the RA will ask the LAR the global assessment quesƟons.  
- If the LAR answers NO to any of the quesƟons, the RA will NOT perform a telephone assent 
conversaƟon with the paƟent.  

- If the LAR’s answers are a combinaƟon of Yes and/or Unsure, the RA will seek permission to 
perform their own global assessment. If there is sƟll uncertainty, the RA will confer with the 
CWRU PI (PignaƟello) to determine the best course of acƟon. This conversaƟon and any ﬁrm 
determinaƟons of paƟent capacity will be documented in the electronic enrollment log.  
- If the LAR answers YES to any of the quesƟons, the RA will perform a telephone assent 
conversaƟon with the paƟent (see aƩached “Phone Assent”) 
 
When compleƟng the assent (either on the phone or in person), the RA will perform their own global 
assessment. If the paƟent passes the RA’s global assent, the RA will begin the formal assent process. At 
the end of the conversaƟon, the RA will ask the following as a post-assent quiz: 
1) In a few sentences, tell me what you think the purpose of our study is?  
2) Just to make sure you understand, can you tell me what we’re asking you to do?  
3) What are the risks of being a part of our study?  
4) If you decide not to parƟcipate, what other opƟons do you have?  
5) What else would you like to know? 
 
Based on the answers to these quesƟons, the RA will correct or expand upon informaƟon as needed 
using a teach-back method. If the RA:  
- Thinks the paƟent is able to provide assent, the RA will ask the quesƟon at the boƩom of the 
“Phone Assent” document: “Do we have your permission to use de-idenƟﬁed data from your 
medical record for our study?” The RA will thank the paƟent for their Ɵme, end the conversaƟon, 
ﬁll out the “Phone Assent” document, and document the outcome of the interview/assent 
conversaƟon in the enrollment log.  
- Thinks the paƟent is unable to provide assent, the RA will thank the paƟent for their Ɵme and 
request to speak to the LAR. They will then seek a verbal assent from the LAR on behalf of the 
paƟent.  
 
*If the paƟent parƟcipant regains capacity and refuses consent/assent to parƟcipaƟon, no paƟent 
data will not be used for research* 
 
Sharing of Results with Research ParƟcipants 
 
This study uses surveys to measure symptoms of anxiety, depression, and stress. As part of the 
FAMCOPE-ICU’s design, individuals will be made aware of the severity of their symptoms based on their 
responses. We have a miƟgaƟon plan, see “Study Procedures” 2b below and aƩached “Suicide Screening 
Script”.  
 
Study Design 
 
The study design is a pilot before and aŌer clinical trial of FAMCOPE-ICU, a tablet-based coping and 
emoƟon regulaƟon tool. The ﬁrst 20 parƟcipants will be enrolled in the control group, and the next 40 
parƟcipants will be included in the intervenƟon group. 
 
 

Study Procedures 
 
*These study procedures reﬂect the interview of the “family parƟcipant” (i.e., LAR).* 
 
1) This study has 5 interviews (T1-T5). The T1 (~35 minutes) will occur in person immediately aŌer 
informed consent. The T2-T4 interviews will occur 24-48 hours aŌer the compleƟon of the preceding 
interview, depending on the parƟcipants availability. T2-T4 (~15-20 minutes) will occur in person for 
parƟcipants in the FAMCOPE condiƟon; in the control condiƟon (usual clinical care) will have the opƟon 
of compleƟng the study in person or on the phone. For all parƟcipants, the T5 interview will occur over 
the phone one month aŌer their T1 interview. Following the T5 interview, an RA will complete the chart 
review instrument if they obtained assent. The ﬁrst 20 parƟcipants will be enrolled in the control group 
(UC), and the next 40 parƟcipants will be included in the intervenƟon group (FAMCOPE-ICU). 
- Study groups:  
o FAMCOPE-ICU: The FAMCOPE-ICU intervenƟon design is grounded in Gross’s Extended 
Process Model of EmoƟon RegulaƟon. Consistent with this model, there are three 
disƟnct doses, which will be administered at T2, T3, and T4. via a tablet device (See 
“FAMCOPE Modules” aƩachment). The content of the intervenƟon is tailored to 
parƟcipant responses to the T2-T4 surveys, which are built into the intervenƟonal 
interface. The informaƟonal content will be administered via pre-recorded audio with 
accompanying summary text and visuals. We anƟcipate each module will require 15-20 
minutes to complete. Notably, its design interface is rooted in CogniƟve Load Theory, 
which provides guidance on designing and delivering informaƟonal content in a way that 
reduces cogniƟve burden for the user.  
o Usual Care (UC): The UC condiƟon represents the standard support aﬀorded to all 
family members in the ICU. Idividuals in the UC group have the opƟon of compleƟng T2-
T4 over the phone because they are not assigned to the intervenƟonal group. 
- In the case of the paƟent’s death:  
o We will contact the family member on the day of their scheduled T5 oﬀer our 
condolences and see if they would be willing to complete the T5 interview. We will 
remind them their conƟnued parƟcipaƟon is completely voluntary. We will then seek 
their verbal assent to perform our chart review. We will document the outcome of this 
conversaƟon in our enrollment log and complete the chart-review if assent was 
obtained. 
- In the case of a missed  
o T2-T4 Interview, the RA will call the LAR to determine if the interview needs to be 
rescheduled. If the RA is unable to make contact, they will leave a brief voicemail staƟng 
the reason of the call and provide a call-back number. The next day, the RA will aƩempt 
to make contact in person with the family member and make one more phone call if 
unable to locate the LAR. If the LAR does not answer, the RA will not aƩempt to call the 
LAR again, unƟl face to face contact is made or the T5 interview, whichever comes ﬁrst. If 

the LAR does not answer, the RA will leave a voicemail. No further contact eﬀorts will be 
made.  
o T5 Interview, the RA will leave a brief voicemail staƟng the purpose of the call and 
provide a call-back number. If the family member does not call back within one week, 
we will make a ﬁnal aƩempt at phone contact and leave one ﬁnal voicemail if they do 
not answer. 
 
2) Procedures to monitor research parƟcipants for safety/minimize risk include:  
a. Breach of Privacy/ConﬁdenƟality (Very Low Risk): Other than informaƟon used for screening 
and coordinaƟon of study interviews (PaƟent Name, MRN, bedspace; ParƟcipant name, address, 
and phone number), our study aims require no addiƟonal PHI. PHI will be stored with the other 
screening/enrollment/refusal tracking sheets in the REDCap server. Data collected for research 
purposes will be linked to a deidenƟﬁed study ID # in REDCap. The REDCap mobile app will be 
used to collect baseline data for all T1 and T5 interviews, as well as the T2-T4 data for 
parƟcipants in the control group. T2-T4 research data (no PHI) will be collected by FAMCOPEICU 
for those in intervenƟon condiƟon. Upon compleƟon of the indicated module, a RA will export 
data from FAMCOPE-ICU and upload it immediately to the REDCap server. To protect 
parƟcipant’s privacy/conﬁdenƟality during the data collecƟon process, we will give the 
parƟcipant the opƟon of compleƟng the T1-T4 interviews in a private conference room at the 
hospital. For any phone interviews (T2-T5 for control & T5 for intervenƟon group), we will 
encourage parƟcipants to ensure they are in a locaƟon that they feel comfortable compleƟng 
the interview, and will accommodate reasonable requests to reschedule interviews to a 
convenient Ɵme for the parƟcipant.  
b. Psychological Well-Being (small risk): Given the populaƟon, we would expect the majority of 
parƟcipants to report mild or moderate symptoms of stress, anxiety, and/or depression. For 
parƟcipants who report severe levels of depression, anxiety, or stress (using previously validated 
and widely used PROMIS Instruments – see table below), The RA will follow the “Suicide 
Screening Script”.  
c. Risks from FAMCOPE-ICU (very low risk): While we anƟcipate the risks posed by delivery of 
FAMCOPE-ICU to be low, it is possible that the emoƟonal focus of the intervenƟon may in of 
itself be a subsequent trigger for psychological distress. However, the FAMCOPE-ICU intervenƟon 
will screen for symptoms of stress, anxiety, and depression in each of the three modules, and 
will automaƟcally provide resources discussed in 2b for those with severe symptoms. To this 
point, the purpose of the intervenƟon is to empower users with evidence-based strategies they 
can use to cope with stress and regulate symptoms of anxiety and depression. Furthermore, to 
our knowledge of the extant literature in this populaƟon, supporƟve intervenƟons have not 
been associated with deterioraƟons in psychological outcomes, except for the use proacƟve 
palliaƟve care services in one isolated study which evaluated symptoms of PTSD over a six-
month period. Furthermore, the intervenƟon was designed to be succinct and contain necessary 
informaƟon consistent with the underlying theoreƟcal framework and empirical evidence. 

3) We will be using standard tablet devices to collect study data and deliver the FAMCOPE-ICU 
intervenƟonal components. 
 
4) We will be collecƟng non-PHI source documentaƟon from the EMR (See “Chart Review” instrument) 
that will be examined as potenƟal covariates to include in the analysis for this study, as well as tailoring 
variables for future versions of FAMCOPE-ICU. 
 
Study Timeline 
 
 
Data to be Collected for your study 
 
 

Data Analysis Plan 
Aim 1: We will use themaƟc analysis to code qualitaƟve acceptability data, and interpret descripƟve 
staƟsƟcs for quanƟtaƟve data  
Aim 2: We will interpret associaƟons between T1 data and T5 data to idenƟfy relevant covariates to 
include in our main analysis. For our main analysis, we will use analysis of covariance to determine if 
there are staƟsƟcally signiﬁcant diﬀerences in T5 variables between the control and intervenƟon groups.  
An a priori sensiƟvity analysis was conducted using G*Power. With a signiﬁcance criterion (α) of .05 and 
power of .80, a sample of 120 will allow for staƟsƟcal detecƟon of medium eﬀects (d = .52). 
 
Risks to Research ParƟcipants 
Breach of ConﬁdenƟality/Privacy: Low risk, low magnitude, potenƟally reversible  
Physical Risks: n/a  
Psychological: Low risk, mild to moderate magnitude, reversible, variable duraƟon.  
Social Risks: Low risk (e.g., conﬂict caused between family members via parƟcipaƟng in study). Variable 
duraƟon.  
Legal: n/a  
Economic: n/a 
 
Provisions to Protect the Privacy Interests of Research ParƟcipants 
1) All data (except for that selected by FAMCOPE-ICU will be collected and/or stored directly into 
UH REDCap. Data collected by FAMCOPE-ICU will be temporarily stored on the device (no PHI), 
and transferred to REDCap following the study interview.  
2) We will have an available private space to conduct all in-person study procedures  
3) We will provide individuals in the FAMCOPE-ICU study condiƟon a headset to listen to the 
provided informaƟon  
4) All data will be deidenƟﬁed and referenced by only a study ID number 5) All phone interviews 
will be conducted in the CWRU PIs research oﬃce. 
 
PotenƟal Beneﬁt to Research ParƟcipants 
Consistent with our prior experience in this populaƟon, parƟcipants may experience catharsis by 
parƟcipaƟng and sharing of their experiences through the study’s course. Given the study’s purpose, it is 
possible that those in the intervenƟon group may beneﬁt from the FAMCOPE-ICU IntervenƟon, and 

report improvements in psychological symptoms. Should this occur, it is possible that this may also 
promote psychological well-being in the long term. 
 
Withdrawal of Research ParƟcipants 
Subjects can choose to withdraw from the study at any Ɵme. We anƟcipate the most common cause of 
study withdrawal to be due to the discomfort of sharing their experiences serving as a surrogate decision 
maker or related, the inconvenience of the study procedures, or if the paƟent is unexpectedly discharge 
(e.g., dies). If a parƟcipant decides to withdraw from the study, we will use any data already collected for 
analysis, but will not aƩempt to collect more data nor contact the parƟcipant. 
 
AlternaƟves to ParƟcipaƟon 
If an individual decides that they do not want to parƟcipate, their alternaƟve is to not parƟcipate in this 
study. 
 
Costs to Research ParƟcipants 
All tablet devices that are used for FAMCOPE-ICU will be provided by the research team. We will not 
provide compensaƟon for ensued costs related to transportaƟon or telephone bills. 
 
Research ParƟcipant CompensaƟon 
ParƟcipants who complete all ﬁve study interviews will be mailed a $25.00 Amazon giŌ card. 
 
Provisions to Monitor the Data to Ensure the Safety of Research ParƟcipants 
A data and safety monitoring plan will be put in place to ensure regulatory compliance of the research, 
address the ﬁdelity of the procedures, and idenƟfy emerging issues associated with recruitment or 
concerns about the study. All safety-related risks will be monitored rouƟnely by the PI. Informed consent 
forms and data collected during this study will be monitored for completeness and accuracy on a weekly 
basis by the PI. Adherence to the study protocol will be also assessed at every monthly team meeƟng 
and randomly monitored by the PI through direct observaƟon of the RA. Emerging issues associated with 
screening and recruitment or study concerns will be regularly discussed with the study team. The 
security of conﬁdenƟal informaƟon will be monitored regularly by the PI and the RA will report any 
breaches of conﬁdenƟality to the PI. The PI will also evaluate the data for any negaƟve outcomes that 
would require modiﬁcaƟon of the project or protocol. The PI will be responsible for regularly monitoring 
any adverse events or unanƟcipated problems. An adverse-event form will be developed detailing the 
incident, acƟons taken, supervisor notes, and follow-up steps. The PI will immediately report any serious 
or life-threatening incidents to the IRB. The research team will be also consulted as appropriate. The PI 

will take appropriate acƟon to stop the study, release a subject from the study, or modify procedures to 
reduce and/or eliminate the study-related risks if they occur. 
 
References 
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