AN INDEPENDENT VOICE FOR NURSING

Clinical Trial Nurse’s Role in

Safety Reporting nuf_248 18..26

Christina Catania, RN, BSN

Christina Catania, RN, BSN, is a Drug Safety Associate, Drexel University, Philadelphia, Pennsylvania, USA.

Keywords
Adverse event, clinical research
nurse, clinical trial nurse, expedited
reporting, safety reporting, serious
adverse event, unexpected adverse
drug reaction
Correspondence
Christina Catania, RN, BSN, Drexel
University, 3141 Chestnut Street,
Philadelphia, PA, 19104, USA.
E-mail: cmc326@drexel.edu
The clinical trial nurse (CTN) can have a substantial amount of respon-
sibility for clinical trials and can perform many roles in the management
of clinical trials. Although new opportunities for the registered nurse in
clinical trials have emerged in recent years, there remains to be a dearth
of literature surrounding the important roles of the CTN in clinical trials.
The CTN is a specialty-nursing role that is unfamiliar to many, including
some nurses. Therefore, it is important to address this gap in the literature
and enlighten the nursing profession and others about the roles of the
nurse in clinical trials. This article aims to explore and provide an over-
view of the CTN’s role in safety reporting. Safety reporting is a significant
component of clinical trials by protecting the rights, safety, and welfare of
subjects. The CTN integrates and utilizes his or her knowledge, experi-
ence, skills, and sound ethical principles when performing the duties of
this role. This allows the CTN to be a vital member in the safety-reporting
process and in the protection of subjects.

A clinical trial is defined as a research study involving
human participants that is intended to answer specific
health questions about how to improve health and
control or cure disease. Clinical trials are conducted in
order to determine the safety of the investigational
agent and to understand adverse events (AEs) associ-
ated with the intervention (Fowler & Stack, 2007). A
multidisciplinary clinical research team is involved in
the conduct of clinical trials that includes determining
the safety of an investigational drug or device (Poston
& Buescher, 2010).
One important member of the multidisciplinary
research team is the clinical trial nurse (CTN) (Poston
& Buescher, 2010). The CTN performs many duties,
one of which includes gathering information and
reporting serious adverse events (SAEs; Fowler &
Stack, 2007). This paper aims to explore and examine
the CTN’s function in AE monitoring and reporting.
AE monitoring and reporting is critical to protecting
the rights and welfare of subjects (Rosenbaum,
2009a). Although risks in clinical trials are inevitable,
safety reporting allows for risks to be minimized and
for unanticipated harms to be rapidly detected and
contained (Califf et al., 2003). It is the efforts and
collaboration of the CTN and the principal investigator
(PI) in the assessment and reporting of AEs that allow
the subject’s rights and well-being to be protected
(Oncology Nursing Society [ONS], 2010).
Unfortunately, the relatively new role of the CTN
has received limited attention in the current literature
with few rigorous investigations performed (Rickard &
Roberts, 2008). Despite this, the CTN’s unique contri-
butions and skills allow him or her to be an integral
component to the safety-reporting process. It is for this
reason that it is beneficial to increase awareness and
insight into the role of the CTN in safety reporting
and the processes in place to maintain safety (Green,
2011).
Before the role of CTNs and their contribution to
safety reporting are examined, it is beneficial to
provide a general overview of the nature of the CTN
role and of CTNs’ recognition in the literature. This
helps to provide justification as to why it is important
to examine one of the CTN’s roles in clinical trials.

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Background
CTN
The role of the nurse in clinical trials is defined by
the ONS (2010) as a specialty-nursing practice that
involves a distinct framework of knowledge for work-
ing with subjects involved in clinical drug trials. The
CTN performs various duties that are essential to the
successful management of clinical trials (Fowler &
Stack, 2007). Some of these duties include obtaining
informed consent, determining participant eligibility,
gathering information on SAEs, and monitoring sub-
jects (Fowler & Stack, 2007). Although all study activi-
ties at the site are ultimately the responsibility of the
PI, the CTN coordinates the day-to-day management
of the trial. This includes a collegial relationship
between the CTN and the PI when implementing and
managing the trial protocol and its success (Poston &
Buescher, 2010). However, the CTN is permitted to
assume a leadership role in pharmaceutical clinical
trials when she or he is appropriately prepared and
partnered with a physician. This includes the nurse
assuming the role of the PI with a physician listed as
the coinvestigator (Rosenzweig, Bender, & Brufsky,
2005). Otherwise, the nurse may function as a study
coordinator, research coordinator, or CTN (Grady &
Edgerly, 2009).
The CTN, who may be a registered nurse with an
advanced degree, has become an essential member of
the research team (Fowler & Stack, 2007). Raybuck
(1997) states that the nurse as a research coordinator
should be prepared at the master’s level. The CTN
prepared at the advanced level possesses many neces-
sary skills for this role, including clinical, leadership,
and research skills (Raybuck, 1997). Despite this sug-
gestion by Raybuck, the educational preparation of
the CTN varies and has not received much attention in
the literature.
Title of CTN
The actual title given to the nurse who works in
clinical trials can vary greatly (Fowler & Stack, 2007).
The inconsistent titles and terms used for the CTN role
is an obvious factor limiting CTNs’ visibility (Rickard
& Roberts, 2008). This inconsistent terminology was
evident during a survey of Australasian intensive care
units. Although the most common title was research
coordinator, in total, 49 respondents reported 21 dif-
ferent job titles (Rickard & Roberts, 2008). This incon-
© 2012 Wiley Periodicals, Inc.
Nursing Forum Volume 47, No. 1, January-March 2012
Clinical Trial Nurse’s Role in Safety Reporting
sistent terminology is problematic because there is still
the question as to whether or not to embrace this term
and use it internationally. Although most research
coordinators are nurses, there are still other profes-
sions like medical doctors and pharmacists who fulfill
this role without difficulty (Rickard & Roberts, 2008).
Despite this inconsistency, a generic title given to
the nurse involved in clinical trials by The Royal
College of Nursing is the “clinical research nurse”
(Gordon, 2008). Additional titles include research
nurse, clinical trials coordinator, and clinical research
coordinator (Fowler & Stack, 2007). This inconsis-
tency is only one challenge the CTN faces in being
recognized in the healthcare community (Rickard &
Roberts, 2008). This lack of recognition and under-
standing of the CTN role is evident when reviewing
the literature.
Review of Literature
CTN
The number of clinical trials being performed in
many specialties has increased in the last decade
(Green, 2011). This is due to an increased interest and
demand for evidence-based practice by healthcare
providers (Rosenzweig et al., 2005). The demand for
evidence-based practice has resulted in a growing
number of nurses in the CTN-type positions world-
wide (Rickard & Roberts, 2008). Despite the large
number of nurses in this position, the role has received
little attention (Rickard & Roberts, 2008). A review of
the literature using Cumulative Index to Nursing and
Allied Health Literature (CINAHL), Proquest, and
Ovid found that there was little written about the
experiences of CTNs (Gordon, 2008). Stephens-Lloyd
(as cited in Gordon, 2008) supported this by finding
that there is a lack of evidence on this group (CTN)
despite their widespread existence. The literature that
is available on the CTN is predominately anecdotal
reports and few rigorous investigations (Rickard &
Roberts, 2008).
In addition, commentaries revealed a gap in under-
standing the CTN’s potential contributions to clinical
trials, role, and scope of practice (Spilsbury et al.,
2007). The literature also revealed that clinical nursing
colleagues often do not understand the role of the CTN
(Gordon, 2008). Nursing colleagues perceive the CTN
role as being defined by paper work and protocols that
are removed from hands-on clinical care (Gordon,
2008). Instead, the CTN should be viewed as a special-
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Table 1. Search History on Clinical Trial Nurse and Safety Reporting

Search ID# Search terms Search options Results

S1 “Clinical research nurse” Search modes—Boolean/phrase 28

S2 “Clinical trial nurse” Search modes—Boolean/phrase 6
S3 “Clinical trials coordinator” Search modes—Boolean/phrase 2
S4 “Research nurse” Search modes—Boolean/phrase 234
S5 “Adverse event” Search modes—Boolean/phrase 1,646
S6 “Serious adverse event” Search modes—Boolean/phrase 114
S7 “Unanticipated problem” Search modes—Boolean/phrase 1
S8 “Adverse event reporting” Search modes—Boolean/phrase 137
S9 (MH “clinical trials”+) Search modes—Boolean/phrase 92,038
S10 S1 or S2 or S3 or S4 Search modes—Boolean/phrase 242
S11 S5 or S6 or S7 or S8 Search modes—Boolean/phrase 1,646
S12 S10 and S13 Search modes—Boolean/phrase 0
S13 S9 and S11 Search modes—Boolean/phrase 661

ist who can participate in every level of a clinical trial,
from giving direct subject care to coordinating and
managing a trial (Snyder, 1994).
It is evident from the review of the literature that
the CTN is underrepresented and misunderstood
despite bringing traditional nursing skills to the clinical
trial role (Gordon, 2008). In addition, much of the
current literature pertaining to the CTN originates
from more than 5 years ago. In fact, much derives
from the literature of the 1990s and early 2000s. For
example, Spilsbury et al. (2007) found two papers
reporting on the clinical research nurse role and their
contributions to clinical trials, which involve inter-
views conducted between 1992 and 1999. In order to
gain insight into the evolving role of the CTN, it is
important to increase the literature to include more
recent publications. This is especially true considering
the large number of nurses specializing in the coordi-
nation of complex clinical trials over the last decade
(Rickard & Roberts, 2008).
CTN in Safety Reporting
study. Considering safety reporting is such a critical
component of clinical trials in the protection of sub-
jects, it is important to address this dearth of literature
and increase the awareness and knowledge of the CTN
in this role by exploring this topic further. This
involved reviewing the results of the literature search
for S10 and S13 separately, and then incorporating the
two as needed.
The roles and responsibilities of the CTN in safety
reporting are critical to the conduct of clinical trials.
One of the principles established in the International
Conference on Harmonization (ICH) Good Clinical
Practice guideline includes the reporting of all AEs to
the institutional review board (IRB). This principle,
along with the others in this guideline, provides assur-
ance that the rights, safety, and well-being of subjects
are protected (ICH, 1996). Therefore, it is important to
examine this topic and understand its importance in
greater detail.
Importance of Examining the CTN’s Role in
Safety Reporting

A recent search of the literature (February 2011) on
the CTN’s role in AE reporting was performed in
CINAHL. The search of the literature is presented in
Table 1.
The results of this particular literature search were
also limiting. Although the search yielded results on
the CTN and safety reporting separately, when the two
search terms were combined using AND, it yielded
zero results. It is clear from the review of the literature
that the CTN role in safety reporting requires further
According to the Declaration of Helsinki, the well-
being of research subjects must take precedence over
all other interests (World Medical Association, n.d.).
AE monitoring and reporting is one process in place
that serves to protect the subject’s safety, welfare,
or rights (Office for Human Research Protections
[OHRP], 2007).
The goal of safety reporting is to better protect sub-
jects from avoidable harms and decrease unnecessary
burdens (OHRP, 2007). Although risks in clinical

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research are inevitable, it is essential to minimize these
risks and to rapidly detect and contain unanticipated
harms (Califf et al., 2003). According to the OHRP,
subjects are protected through the assessment and
reporting of unexpected, serious, and possibly related
AEs. These events suggest that research subjects are at
a greater risk for physical or psychological harm than
what was previously known (OHRP, 2007).
When unexpected, serious, and possibly related
events occur in clinical trials, corrective actions are
necessary (OHRP, 2007). These corrective actions
protect subjects and include changes to the protocol,
modifications of inclusion or exclusion criteria, sus-
pension of enrollment of new subjects, and additional
procedures for monitoring subjects (Rosenbaum,
2009b). When changes are warranted to the research
protocol, this also includes changes to the informed
consent process or document (OHRP, 2007). This new
consent allows subjects to be aware of the AEs and to
decide if they wish to remain in the study (Rosenzweig
et al., 2005).
Safety reporting also enables the sponsor to amend
the Investigator’s Brochure to reflect changes in safety
information (ICH E2A, 1994). The Investigator’s Bro-
chure makes risks discovered in clinical trials readily
available for investigators, IRBs, and Data Monitoring
Committees to review so that study participants are
better protected (Califf et al., 2003).
Not only does safety reporting allow for the amend-
ment of the Investigator’s Brochure, but it also pro-
vides the Food and Drug Administration (FDA) and
the IRB the information needed to stop a study if it is
dangerous or reveals that it does not show beneficence
(Dimsdale, 2006). In addition, the sponsor and the IRB
are always questioning whether or not it is safe to
continue the trial based on the event experienced
(Rosenbaum, 2009b).
Overall, the reporting of unanticipated problems
and SAEs to the IRB and the FDA allows for the
protection of the rights and welfare of human subjects.
This is important because AEs can change the risks of
study participation (Rosenbaum, 2009b). In the end,
the mechanisms for reporting need to be optimized in
order to protect study participants (National Institutes
of Health, 1999).
It is beneficial for nurses and other healthcare pro-
fessionals to have awareness and insight into the role
of the CTN in safety reporting and the processes in
place to maintain safety because it serves to protect
subjects (Green, 2011). The CTN can positively con-
tribute to this role in various ways. These contribu-
© 2012 Wiley Periodicals, Inc.
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Clinical Trial Nurse’s Role in Safety Reporting
tions are evident when the advanced role of the CTN
is integrated with safety reporting.
Connecting the Advanced Role of the CTN to
Safety Reporting
The CTN is an integral part of the safety reporting
process and is well suited for this role for many
reasons. For example, the CTN is well suited for the
development of AEs and/or serious events because of
his or her nursing background and his or her knowl-
edge in disease processes (Lenoble, 2000). The CTN is
also well suited for this role because he or she receives
research-specific training (Gordon, 2008). This
includes having an adequate understanding of clinical
research, research ethics, and the components of Good
Clinical Practices (Califf et al., 2003). This understand-
ing allows the CTN to ensure the probity and safety of
the research process (Gordon, 2008). This is particu-
larly true for the CTN who is familiar with the Good
Clinical Practice guidelines, which cover all aspects of
clinical trials including AE reporting (Green, 2011).
The CTN acquires knowledge relating to clinical trials,
regulations, and guidance by participating in educa-
tional opportunities (ONS, 2010). The CTN is able to
utilize this knowledge and experience and integrate it
with the roles of safety reporting.
Roles and Responsibilities
Although regulatory documents do not refer to the
CTN in the safety reporting process, they still have a
significant part to play in this role by assisting and
collaborating with the investigator. However, as men-
tioned previously, the nurse can serve as the PI if he or
she is appropriately prepared at the doctoral level and
paired with a physician for pharmaceutical clinical
trials. In this case, the nurse as the PI is permitted to
assume the leadership role (Rosenzweig et al., 2005).
Regardless of the role, the CTN is involved and con-
tributes to the assessment, documentation, and
reporting of AEs.
Detection/gathering of AEs. The first step in AE
reporting is detecting and gathering AEs. This is
accomplished through physical assessments, reporting
of symptoms by subjects, clinical laboratory results,
and diagnostic tests (Rosenbaum, 2009a). The foun-
dation for determining an AE is based on a thorough
physical examination and medical history (Fowler &
Stack, 2007). Although the PI is often responsible for
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Table 2. Definitions for Basic Terms Associated With Clinical Safety Experience (ICH E2A, 1994,
Definition Section)

Basic terms Definitions

Adverse event
Serious adverse event
Unexpected adverse event
Severity
Any unfavorable and unintended sign, symptoms, or disease temporally associated with the
use of a medicinal product, whether or not considered related to the medicinal product.
Any untoward medical occurrence at any dose that results in death, is life threatening,
requires inpatient hospitalization or prolongation of existing hospitalizations, results in
persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Includes those that may jeopardize the patient or require intervention to prevent one of
these outcomes.
The nature of severity of that is not consistent with the information in the relevant source
documents (e.g., Investigator’s Brochure for an unapproved investigational medicinal
product).
Describes intensity (severity) of specific event

this baseline information, the CTN in the coordinator
role assists with gathering this information (Fowler &
Stack, 2007). The CTN is very capable of assisting with
this duty. According to the American Nurses Associa-
tion (ANA, 2010), the nurse is able to collect compre-
hensive data relevant to the subject’s health and/or
situation. The CTN is also well equipped to assist in
this duty because of his or her nursing education,
skills, and expertise that emphasize patient assessment
(Lenoble, 2000). Specifically, the nurse in the
advanced role is able to initiate and interpret diagnos-
tic tests and procedures that are pertinent to the sub-
ject’s current status (ANA, 2010). This information
provides the necessary information to determine an
AE (Fowler & Stack, 2007).
Assessment of AE. Once this background informa-
tion is collected, the CTN and the PI can then deter-
mine if an AE or an SAE occurred. The CTN is capable
of assisting with this function because he or she has
the knowledge and expertise to assist study team
members with interpreting these situations (Fowler &
Stack, 2007). A deviation or worsening of the partici-
pant’s baseline since enrollment is considered an AE
(Fowler & Stack, 2007). Once an AE is determined,
the PI and the CTN assess the AEs for certain criteria
(Ness, 2007). These include severity of event(s), seri-
ousness, and expectedness of events(s) (ICH E2A,
1994). Table 2 provides the definitions of these terms.
Another criterion to be assessed includes the CTN
assisting the PI in determining the causality of each AE
or relationship to the protocol treatment (Fowler &
Stack, 2007). Relatedness of the event to the protocol
treatment is defined by determining whether or not
there is a reasonable possibility that the procedures
involved in the study caused the AE (OHRP, 2007).
The relationship of the event to the protocol treat-
ment can be classified as definite, probable, possible,
unlikely, or unrelated (Rosenbaum, 2009a). The CTN
is able to contribute to this process by effectively col-
laborating with the PI. The nurse in the advanced role
leads in establishing, improving, and sustaining col-
laborative relationships, which allows for safe, quality
healthcare consumer care (ANA, 2010). This collabo-
rative relationship also allows for the assessment of
AEs to be correctly reported to the FDA and the IRB
(ONS, 2010). The CTN can also utilize his or her criti-
cal thinking skills and background of scientific knowl-
edge when performing the assessment of AEs (ONS,
2010).
Documentation and recording of AEs. Once the
CTN assists the PI in assessing the AEs, he or she can
then document his or her findings according to the
protocol, FDA, sponsor, and IRB policies (ONS, 2010).
According to Rosenbaum (2009a), all AEs must be
recorded in source documents and case report forms
(CRFs). Typically, the development of clinical trial
documents is the responsibility of the CTN (Poston &
Buescher, 2010).
The CTN abstracts relevant data from source docu-
ments (e.g., clinical chart, hospital chart, medical
record) and records them to the CRF that is reliant on
the protocol (Ness, 2007). The CTN is valuable to this
function because as a nurse, he or she is experienced
with documentation and medical records (Lenoble,
2000). The abstracted information gathered from the
source documents to the CRFs includes the severity or

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grade of the event, the relatedness of the event to the
study medication, treatment for the event, and the
dates of the onset and resolution of the event (Ness,
2007). In many instances, electronic CRFs will be used
to gather data during clinical trials (Ene-Iordache
et al., 2009). The CTN’s ability to utilize computers
and basic computer programs can allow the CTN to
perform this task with ease (ONS, 2010). Once the
necessary information is recorded, the next step
involves reporting the AE.
AE reporting. The CTN is responsible for reporting all
SAEs to the investigator, sponsor, and research/ethic
committees (Lenoble, 2000). Although all AEs are to be
reported in a clinical study, there are some that require
immediate reporting (Fowler & Stack, 2007). This
immediate reporting is referred to as expedited report-
ing, which includes AEs that are serious, related or
possibly related to participation in research, and unex-
pected (OHRP, 2007). It is the seriousness and not the
severity that determines regulatory reporting obliga-
tions (ICH E2A, 1994). When this task is completed, the
CTN and the PI can then determine the time lines for
reporting the events to the IRB, sponsor, and other
regulatory groups (Ness, 2007). Again, this process
involves collaboration between the PI and the CTN. The
strong verbal and written communication skills of the
CTN and his or her ability to work in teams can be vital
to this collaboration (ONS, 2010).
Types of expedited reports. There are two types of expe-
dited reports. These include a 7-day report and a
15-day report (ICH E2A, 1994). Seven-day reports
include any unexpected fatal or life-threatening
adverse drug reactions that may cause the study to
be suspended or require other limitations (ICH E2A,
1994). These events require regulatory agencies to be
notified as soon as possible but no later than 7 cal-
endar days after first knowledge of the event (ICH
E2A, 1994). All other serious unexpected AEs must
be reported to the FDA and the IRB no later than 15
calendar days from when the event was first identi-
fied and the minimum criteria for reporting are met
(ICH E2A, 1994). However, SAEs that are identified
as not being related to the study product are not
expedited (ICH E2A, 1994). This also includes events
that may initially appear to meet expedited reporting
requirements but are excluded from this as per the
protocol (Ness, 2007). The CTN has the ability to set
priorities and reprioritize quickly (ONS, 2010). The
CTN can apply this ability during the expedited
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Clinical Trial Nurse’s Role in Safety Reporting
process, which enables the CTN to prioritize the
reporting of AEs in order to adhere to regulatory
reporting requirements.
Reporting of all other serious events. In addition to expe-
dited reporting, the CTN is also responsible for report-
ing all SAEs despite their relationship to the study
intervention (Fowler & Stack, 2007). For example, the
CTN would report an SAE of a broken leg that
involved hospitalization for surgical intervention
immediately to the sponsor regardless of its relation-
ship to the study intervention (Fowler & Stack, 2007).
Method of reporting. The next step after determining
the reporting time lines includes reporting the events.
The reporting of expedited events includes filing an
Investigational New Drug Safety Report (ISR). This
safety report is written when there is a serious unex-
pected AE that is associated with the use of the drug
(FDA, n.d.). The time line for filing an ISR is based on
the 7- and 15-day reporting requirements (Ness,
2007). The FDA is to be notified no later than 7 cal-
endar days after the sponsor’s initial receipt of the
information for any unexpected fatal or life-
threatening experiences that are associated with the
drug. The FDA is to be notified of these experiences
either by telephone or by facsimile transmission (FDA,
n.d.). The CTN reports this subset of events using an
expedited report form (Ness, 2007). The commonly
accepted standard for expedited AE reporting is the
Council for International Organizations of Medical
Sciences form (ICH E2A, 1994). Even though some
report forms may be different, they all have the same
key components (Ness, 2007).
Components of safety reporting form. The key compo-
nents of the reporting form include reporter informa-
tion, subject demographics, study agent, event,
attribution, narrative summary, and investigator sig-
nature (Ness, 2007). The most important part of the
report is the narrative. This is especially true consid-
ering the recipient of the form will most likely not
know anything about the subject or their history
(Ness, 2007). Therefore, the CTN makes sure that they
provide enough background information in the narra-
tive to support the attribution and grade of the event
(Ness, 2007). Again, the CTN’s inherent skills of atten-
tion to detail and strong written communication skills
can be utilized when performing this role (ONS,
2010). These skills can be extremely useful when com-
pleting expedited report forms.
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Clinical Trial Nurse’s Role in Safety Reporting
Who is informed. Once the form is complete, the report
is sent to the FDA and to the required regulators or
other official parties in countries where the drug is also
under study (ICH E2A, 1994). The CTN is responsible
not only for informing the FDA and the IRB but also
for currently enrolled subjects of serious unexpected
AEs that are associated with the use of the investiga-
tional agent (Ness, 2007). It is important to inform
subjects immediately when new SAEs occur (Rosen-
baum, 2009a). This is important because the risk
profile that the subject was initially “informed” of in
the consent process will change if there is a causal
relationship with the investigational agent (Rosen-
baum, 2009a). This requires a revised consent form
with all new and continuing subjects having to review
and sign the new form (Rosenbaum, 2009a).
The CTN is an excellent member of the research
team for informing subjects of new risks and discussing
their options. The CTN is the key individual for this
process because he or she is able to integrate ethical
provisions in all areas of practice (ANA, 2010). For
example, the CTN recognizes the right to self-
determination by allowing the individual to make his
or her own decisions (Twomey, 2008). The CTN pro-
vides the means to do this by informing them of the
new risks so they can make the decision as to whether
or not they want to continue or withdraw from the
study (Ness, 2007). The CTN also brings his or her
ability to assess the subject’s understanding of new risks
and to advocate for subject safety (Twomey, 2008). The
nurse is a key participant in the ongoing consent
process and is often the one who has an ongoing
relationship with the patient as a research subject.
Therefore, the nurse has the responsibility of assessing
the subject’s understanding of the consent form when
it changes. This is in contrast to other members of the
research team who often spend little time with the
subject (Twomey, 2008). In addition, the CTN commu-
nicates effectively by conveying information to subjects
in communication formats that promote accuracy
(ANA, 2010).
It is evident that the CTN is well prepared for the
role in AE monitoring and reporting. The CTN has the
required skills needed to collect all data related to an
SAE and complete the required paper work and
reporting (Fowler & Stack, 2007). The nurse is ideally
suited for this role because he or she has the knowl-
edge and expertise to understand an SAE, to collect
pertinent data, and to assist the research team with
interpretation (Fowler & Stack, 2007). In addition, the
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clinical nurse specialist, as a research coordinator, pos-
sesses sound ethical principles upon which to practice
nursing (Raybuck, 1997). This allows the CTN the
opportunity to incorporate the code of ethics for
nurses with the role of safety reporting. This includes
provision three from the ANA’s code of ethics for
nurses.
Integrating the Code of Ethics for Nurses with
Safety Reporting
Provision Three
Provision three from the ANA’s code of ethics for
nurses states that “the nurse promotes, advocates for
and strives to protect the health, safety and rights of
the patient” (Twomey, 2008, p. 23). Interpretive state-
ment 3.3 of provision three, the protection of partici-
pants in research, states that the nurse’s primary role
in research includes making sure that subjects are
aware of potential risks and that they are protected to
the greatest extent possible by reducing these risks to
their lowest level (Twomey, 2008). This provision
directly correlates with the ethical principles seen with
safety reporting. This includes better protecting sub-
jects from avoidable harms and decreasing unneces-
sary burdens (OHRP, 2007).
Integration
Interpretive statement 3.3, protection of partici-
pants in research, is included in the ANA’s code of
ethics for nurses because of the increased activity of
nurses as nurse researchers or as members of research
teams. The inclusion of this interpretive statement
under provision three focuses on the primary role of
the nurse involved in any part of research. It states
that the primary role of the nurse is to ensure that
subjects are aware of potential risks and that they are
protected from these risks to the greatest extent pos-
sible (Twomey, 2008). The nurse is also advocating for
subjects during this process by ensuring that they are
well informed of risks (Twomey, 2008).
Interpretive statement 3.3 mirrors the goals of safety
reporting, which allows the CTN to integrate this inter-
pretive statement with his or her role in safety report-
ing. The CTN makes subjects aware of potential risks
and protects them by reducing these risks to their
lowest level possible by gathering, assessing, docu-
menting, and reporting AEs. More specifically, this
C. Catania
occurs when SAEs are evaluated, identified, and
reported in a timely fashion to the IRB, FDA, and
sponsors (OHRP, 2007). This is important as this may
have an immediate implication for all volunteers par-
ticipating in the trial (Rosenbaum, 2009a). The correc-
tive actions that stem from SAEs also reflect the
statements of this provision. These corrective actions
protect the rights, safety, or welfare of subjects by
preventing further harm to subjects (OHRP, 2007).
Conclusion
Although the current literature available on the
CTN’s role in safety reporting is limited, nurses are
well equipped for this role because of their skills,
education, and expertise. These abilities allow the
CTN to assess, document, and report AEs accurately
and appropriately. In addition, the nurse is typically
the one entrusted to perform these duties as the PI
can be overextended with his or her responsibilities.
The process of safety reporting proves to be an
important component in the implementation and
management of clinical trials. Safety reporting
mirrors the ANA’s provision three of the code of
ethics for nurses by ensuring that risks are minimized
and study participants are better protected from
avoidable harms. Without the nurse’s abilities and
role in safety reporting, the subject’s welfare, safety,
and rights may be jeopardized. It is for this reason
that the role of the CTN in safety reporting should be
better recognized in the literature and understood by
the nursing profession and society as a whole.
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