Use Case and Application Requirements for a Protocol Lifecycle Tracking
Tool, with a Focus on the Trial Initiation Phase
Jack W. London, PhD1, Sharon A. Elcombe, MA2, Alma Villasin, RN, BSN, MBA1, Corey
Sagenich1, Paul Davis3
1Thomas Jefferson University, Philadelphia, PA; 2Mayo Clinic, Rochester, MN; 3Essex
Management
Abstract have undertaken the development of use cases and
system requirements for a computer Protocol
The time required to initiate clinical trials, from
Lifecycle Tracking tool, which would not only
declaration of the investigator’s intent to opening of
provide the capability to manage the process flow
the study for participant accrual, is cited as often
and monitor the progress of trial initiation in real
being so long that clinical research is seriously
time, but also deconstruct the complex work flow and
impeded. Efforts to improve operational efficiency of
provide institution and study-type specific data on the
trial initiation are confounded by the work flow
contributing factors to initiation delays.
complexity and the variations encountered with
different types of trials and institutional Background
environments. A computer Protocol Lifecycle
The National Cancer Institute’s cancer Biomedical
Tracking (PLT) tool would enable study initiation ®) program, begun in 2004,Informatics Grid (caBIG
staff to manage the process, and the various clinical
includes clinical trials research informatics among its
research stakeholders to monitor the progress of a ®primary domains for investigation. The caBIG
study’s initiation, as well as obtain data on the work
Clinical Trials Management System (CTMS) work
flow to identify those activities that are in need of
space has created a Business Architecture Model
operational efficiency improvement. The objective
(BAM) of the clinical trials research work flow, from
of our work was to develop use cases and system
study initiation, through study conduct, to study
requirements for a PLT tool. The result of our study 4 The BAM describes the activities, goals,closure.
is a use case document that can serve as the
people, and organizational needs involved in clinical
specifications for developing a PLT application.
trials. The almost 400 pages of use cases developed
Introduction for the BAM informed CTMS participants of the
variability and complexity of the clinical trials work
A 2005 report on restructuring the cancer clinical
flow: the activities involved in planning, initiating,
trials enterprise stipulated the reduction of
and conducting trials varies according to the sponsor
operational barriers to trial initiation among its
primary goals.1 Supporting the significance of trial (industry, government agency, cooperative group, or
institutional investigator initiated) and whether the
initiation delay, Dilts and his colleagues, who have
sponsor (e.g., cooperative group) or performance site
uniquely studied these processes involved in opening
(e.g., cancer center) perspective is being considered;
trials, concluded that in some situations “The steps
whether the trial is interventional or non-
required to develop and activate a clinical trial may
interventional; and the specifics of the trial itself
require as much or more time than the actual
completion of a trial.”2 Another Dilts study, which (e.g., pharmaceuticals or device involved?).
evaluated the trial initiation processes at a major With this comprehensive BAM to draw upon, we
academic medical center, noted that while decided to develop the use cases and requirements for
administrative barriers to opening trials is often a Protocol Lifecycle Tracking computer tool that
criticized by researchers, the process has in general could accommodate the inherently variable work
not been formally documented or evaluated.3 flow of initiating clinical trials research. So while the
caBIG® BAM describes the clinical trial processes,
The sometimes long delays in activating clinical
this PLT use case project describes the requirements
trials, as well as the conflicting anecdotal attributions
for a tool which can manage these processes.
for these delays, are well known to those involved in ®Furthermore, while this study arose from the caBIG
clinical trials research. Correspondingly,
program, non-oncology clinical trials expertise was
comprehensive means for monitoring the work flow
also included for these specifications, to minimize
of study initiation by the various stakeholders –
disease-specific applicability.
principal investigators, clinical research associates,
administrators – are not available. To address this, we
29
Use Case and Application Requirements for a Protocol Lifecycle Tracking
Tool, with a Focus on the Trial Initiation Phase
Jack W. London, PhD1, Sharon A. Elcombe, MA2, Alma Villasin, RN, BSN, MBA1, Corey
Sagenich1, Paul Davis3
1Thomas Jefferson University, Philadelphia, PA; 2Mayo Clinic, Rochester, MN; 3Essex
Management
Abstract have undertaken the development of use cases and
system requirements for a computer Protocol
The time required to initiate clinical trials, from
Lifecycle Tracking tool, which would not only
declaration of the investigator’s intent to opening of
provide the capability to manage the process flow
the study for participant accrual, is cited as often
and monitor the progress of trial initiation in real
being so long that clinical research is seriously
time, but also deconstruct the complex work flow and
impeded. Efforts to improve operational efficiency of
provide institution and study-type specific data on the
trial initiation are confounded by the work flow
contributing factors to initiation delays.
complexity and the variations encountered with
different types of trials and institutional Background
environments. A computer Protocol Lifecycle
The National Cancer Institute’s cancer Biomedical
Tracking (PLT) tool would enable study initiation ®) program, begun in 2004,Informatics Grid (caBIG
staff to manage the process, and the various clinical
includes clinical trials research informatics among its
research stakeholders to monitor the progress of a ®primary domains for investigation. The caBIG
study’s initiation, as well as obtain data on the work
Clinical Trials Management System (CTMS) work
flow to identify those activities that are in need of
space has created a Business Architecture Model
operational efficiency improvement. The objective
(BAM) of the clinical trials research work flow, from
of our work was to develop use cases and system
study initiation, through study conduct, to study
requirements for a PLT tool. The result of our study 4 The BAM describes the activities, goals,closure.
is a use case document that can serve as the
people, and organizational needs involved in clinical
specifications for developing a PLT application.
trials. The almost 400 pages of use cases developed
Introduction for the BAM informed CTMS participants of the
variability and complexity of the clinical trials work
A 2005 report on restructuring the cancer clinical
flow: the activities involved in planning, initiating,
trials enterprise stipulated the reduction of
and conducting trials varies according to the sponsor
operational barriers to trial initiation among its
primary goals.1 Supporting the significance of trial (industry, government agency, cooperative group, or
institutional investigator initiated) and whether the
initiation delay, Dilts and his colleagues, who have
sponsor (e.g., cooperative group) or performance site
uniquely studied these processes involved in opening
(e.g., cancer center) perspective is being considered;
trials, concluded that in some situations “The steps
whether the trial is interventional or non-
required to develop and activate a clinical trial may
interventional; and the specifics of the trial itself
require as much or more time than the actual
completion of a trial.”2 Another Dilts study, which (e.g., pharmaceuticals or device involved?).
evaluated the trial initiation processes at a major With this comprehensive BAM to draw upon, we
academic medical center, noted that while decided to develop the use cases and requirements for
administrative barriers to opening trials is often a Protocol Lifecycle Tracking computer tool that
criticized by researchers, the process has in general could accommodate the inherently variable work
not been formally documented or evaluated.3 flow of initiating clinical trials research. So while the
caBIG® BAM describes the clinical trial processes,
The sometimes long delays in activating clinical
this PLT use case project describes the requirements
trials, as well as the conflicting anecdotal attributions
for a tool which can manage these processes.
for these delays, are well known to those involved in ®Furthermore, while this study arose from the caBIG
clinical trials research. Correspondingly,
program, non-oncology clinical trials expertise was
comprehensive means for monitoring the work flow
also included for these specifications, to minimize
of study initiation by the various stakeholders –
disease-specific applicability.
principal investigators, clinical research associates,
administrators – are not available. To address this, we
29
