Source
Journal for Clinical Research Excellence
Issue 82
A Publication of the Society of Clinical Research Associates
530 West Butler Avenue, Suite 109 Chalfont, PA 18914 USA
November 2014
ISSN 1536-9900
Highlights - In this issue...........
Self Study Opportunity - FDA Guidance for Industry:
Enrichment Strategies for Clinical Trials to Support
Approval of Human Drugs and Biological Products
Clinical Preparation and Defined Roles Increase Data
Collection Quality and Result Integrity in Metastatic
Thyroid Cancer Trials
Project Management: Introduction to Tools and
Templates
Preserving Integrity in Clinical Research: Avoiding
Research Misconduct
Effort and Complexity Tracking Metrics in Cancer
Clinical Research
Clinical Trials in the European Union: Regulatory
Legislative Framework
A Canadian Perspective on Standard Operating
Procedures
Quality Management Systems: The Site How-to Guide
to Creating a Sustainable Quality Management
System (QMS)
Electronic Data Capture in Clinical Trials: A Vendor
View of the Risks, Challenges, and Benefits
Moral Sensitivity in the SUPPORT Study
SOCRA SOURCE © - November 2014 - 1
Quality Education
Peer Recognition
PRESIDENT’S MESSAGE ................................................ 4
SOCRA INFORMATION BOARD OF DIRECTORS ................................................ 5
CHAPTER PROGRAM Chapter Contacts .................................. 79-80
TABLE OF CONTENTS
SELF-STUDY OPPORTUNITY
FDA Guidance for Industry:
Enrichment Strategies for Clinical Trials to Support Approval of Human
Drugs and Biological Products - Part 1 ................................................ 7
Self Study Questions ........................................................................ 12
Self Study Answers ........................................................................... 39
PEER-REVIEWED JOURNAL ARTICLES
Clinical Preparation and Defined Roles Increase Data
Collection Quality and Result Integrity in Metastatic Thyroid
Cancer Trials
Madonna Pool, RN, BSN, MSN, CCRP .................................. 13
JOURNAL ARTICLES
Project Management: Introduction to Tools and Templates
Melissa Harris, CCRP ............................................................. 22
Preserving Integrity in Clinical Research:
Avoiding Research Misconduct
Lauren Solberg, JD, MTS ........................................................ 29
Effort and Complexity Tracking Metrics in Cancer
Clinical Research
Patricia Bebee, RN, BA, CCRP ............................................... 36
Clinical Trials in the European Union:
Regulatory Legislative Framework
Anatoly Gorkun, MD, PhD ....................................................... 40
A Canadian Perspective on Standard Operating Procedures
Valerie Cronin, RN, SCM, BA (Hons), MA, CCRP .................. 44
Quality Management Systems: The Site How-to Guide to
Creating a Sustainable Quality Management System (QMS)
Christina R. Eberhart ............................................................... 55
Electronic Data Capture in Clinical Trials:
A Vendor View of the Risks, Challenges, and Benefits
Patricia M. Beers Block, BS, CCRP ........................................ 61
Moral Sensitivity in the SUPPORT Study
Mark Hochhauser, PhD ........................................................... 68
IN MEMORIUM - Patrick T. Garoutte ........................................ 6
2014 ANNUAL CONFERENCE IN REVIEW .................... 51-54
CERTIFICATION .................................. 82
Eligibility ......................................................... 82
Examination Dates ........................................ 83
Application ..................................................... 84
24th ANNUAL CONFERENCE ............... 84
Registration ................................................... 85
Call for Poster Abstracts ................................. 86
Exhibitor Registration ................................... 87
Call for Speakers (2016 Conference) ........... 67
CONFERENCES AND SEMINARS Clinical Science Course ............................... 88
Social Media in Clinical Research ..................89
Clinical Research Monitoring Workshop ...... 90
Project / Program Management ................... 91
Human Research Protections/Legal Issues ...92
Clinical Investigator Workshop ...................... 93
Conducting Clinical Trials in Canada .......... 94
Certification Prep & Review Course ............ 95
Site Coordinator / Manager Workshop .......... 96
Advanced Site Management Finance and
Productivity Workshop ................................. 97
FDA Clinical Trials Requirements .................. 98
SOP Workshop ........................................... 99
Pediatric Clinical Trials ............................... 100
Device Research and Regulations ..............101
ONLINE TRAINING OPPORTUNITIES cGMPs for INDs in Phase I Clinical Trials ...... 102
Steps Involved in FDA Inspections ........... 102
IND/ IDE Assistance ................................ 102
ADVERTISING OPPORTUNITIES Website Classified Advertising ........... 103
SOCRA Source Advertising ...................... 103
OPPORTUNITIES & SERVICES - INDEX University of Maryland ............................. 104
2013 Annual Conference Poster Abstracts - Begins on page 72
Clearer Nutritional Labeling May Improve Subject
Compliance in Weight Loss and Satiety Trials
The Clinical Trials Management Benefits of Implementing a
Global Materials Protocol
Implementation of Simple and Robust Systems to Provide
‘High Quality Trial Management’ Services for Phase I, II and III
Clinical Trials
Global Clinical Trials in Site Management in Japan from the
Viewpoint of Clinical Research Coordinators
SCTR Institute Research Coordination and Management
Program
Management of a Hospital-Integrated Biobank
in the Baylor Health Care System
Multicenter Clinical Trial Management
Can a Central IRB Improve Efficiency and Human Subject
Protection?
Ambulatory Monitoring of Pulse Wave Velocity and its
Application in Clinical Research
Operational and Data Quality Considerations
in the Transition of a Large Data Coordinating Center
Clinical Trials in Emerging and Developing Countries by Taking
the Example of India, Nigeria and South Africa
A Systematic Review of the Literature on the Use of Placebo
in Clinical Research Trials: An Ethical Dilemma
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Electronic Data Capture in Clinical
Trials: A Vendor View of the Risks,
Challenges, and Benefits
Patricia M. Beers Block, BS, CCRP
Adjunct Assistant Professor
Rutgers, The State University New Jersey
Abstract: Electronic data capture (EDC) in clinical trials offers many benefits. However, there are also risks and
challenges about which sponsors who choose and use EDC systems, and clinical research sites that use them must be
aware.. This article describes the benefits, risks, and challenges of using EDC for clinical trials, from a technology
provider’s perspective.
The views and opinions expressed in the article are those of the author and should not be attributed to the Society of
Clinical Research Associates or Rutgers, the State University of New Jersey.
Introduction to Vendor Applications
Software vendors offer a full suite of
applications that are useful in clinical
research. Some offerings include:
• applications that assist in the
development of an electronic
protocol;
• the electronic review and
signing of informed consent
documents;
• the collection of clinical data
at the clinical site;
• the assembly of data used to
manage the clinical trial ;
• applications that allow
subjects to record study
outcomes while participating
in a clinical trial;
• subject randomization
procedures and results;
• test article drug distribution
applications;
• the statistical analysis of data
to assess the progress of the
study;
• Medical coding that
standardizes information
about medical procedures and
adverse events;
• the preparation of this data
that meets standardized data
formats for submission to
regulatory authorities and
other interested stakeholders;
and
• applications that capture
pre-clinical data in electronic
health records, data that can
be integrated into clinical
data applications. (Table 1).
An application can be developed and
offered as an independent application,
in which case the application is
capable of running independently and
contains all of the modules needed
to complete its expected actions. An
example of an independent application
is one that performs statistical analysis
of clinical data. The data are uploaded
via a prescribed format, and the data
are processed by the application.
No other interaction with another
application is needed by the statistical
program to complete the data analysis.
Another program type commonly
offered by software vendors are
known as embedded programs.
These programs are designed to
perform a specific operation or set of
operations within a larger application
and/or system. An example of an
embedded program is the calling (e.g.,
implementation) of a set of commands
stored in a library file to perform
desired operations. When the library
file is called for use, the operations are
performed and the data are preserved
in a defined file. An embedded
program typically does not exist as a
SOCRA SOURCE © - November 2014 - 61
TABLE 1
EDC Offerings
• Full suite of applications:
oIntegrated EDC and EHR systems
oPatient-reported outcomes (e-diaries)
oStudy drug distribution and randomization (IXRS)
oSubmission applications
oStatistical applications (SAS)
• Delivery approaches:
oSoftware as a service (SAAS) (hosted)
oTechnology transfer (non-hosted)
separate application, but relies on the
functionality of the hosting program.
A final program type that is commonly
developed by software vendors are
integrated programs.
With regard to how programs are
offered to a client/customer, any of
these applications can be delivered
as software as a service (SAAS)
applications (e.g., applications that
are entirely hosted, and managed by
a technology provider ) or through a
technology transfer process (e.g., the
application(s) would be completely
installed on the customer’s hardware,
and the customer would be responsible
for the hosting and operation of the
application). As an aside note, there is
a move to offer applications as SAAS
products, where a vendor provides
access to a particular application via
a subscription service. The length
of time of an active subscription
could be as short as the length of
the clinical trial or as long as several
years beyond the close of the trial if a
sponsor or clinical research site wants
the technology provider to retain and
preserve its clinical data. With SAAS
products, vendors typically upgrade an
application and push the new version
to the customer for its use. Customers
may have a trial period during which
they can test the new features of the
upgrade, but customers usually have
no choice in deciding whether to
accept all of the new features; the new
version is pushed out to all users and
data are migrated to the new software
version.
Vendors are developing applications
that can run on a variety of operating
systems, browsers, and devices. It’s
becoming more common to find EDC
applications configured for a desktop
computer, a laptop, a notebook, or
a tablet device. Vendors also offer
applications that can run on smart
phones; and diagnostic devices. We
can expect to see this trend continue
where vendors develop applications
for use on new technologies that make
it easier to capture clinical data.
Data Collection and Integration
The EDC process starts with data
input, which can be manual or
automated. Laboratory information
is often automated. A subject entering
data into an e-diary or the study
coordinator entering information
into the EDC system are examples of
manual data input. Then the data are
processed, analyzed, and appropriately
manipulated.
The data may go through a transfer
process, moving, for example, from
the clinical research site to the
SOCRA SOURCE © - November 2014 - 62
sponsor or to the technology provider.
The output could be displayed on a
monitor or presented in reports.
The technology vendor can download
the EDC application to a system or
a device. Many E-PRO technology
providers download the application
to the device itself, although some
e-diaries are now offered as Webbased systems and subjects are using
iPads to collect data.
The information flows through all
of the interested parties: subject,
institutional review board (IRB)
or institutional ethics committee,
investigator, study coordinator,
sponsor, and laboratories. Ultimately,
the data are handled in such a way
that the sponsor does not have total
control over them. The sponsor
can never have data exclusively. A
technology provider is an independent
party that will preserve the data in a
way that complies with regulatory
requirements, especially those of the
European Medicines Agency and the
U.S. Food and Drug Administration,
which are very concerned about one
party having complete control over all
of the data.
Data integration refers to the data
moving into the EDC system (Table
2). Vendors must be very flexible
in the way they develop their
applications because no one knows
where the next system might come
from or which data systems will be
used to integrate data.
EHR is today’s current challenge.
Fortunately, organizations such
as the Clinical Data Interchange
Standards Consortium (CDISC) have
stepped in and are developing data
standards. Through the Reference
Forms Document, CDISC is helping
to develop a process by which
information from EHRs will be
successfully integrated into EDC
systems. The data that go into the
system and go back to EHRs will
TABLE 2
Data Integration
•
•
•
•
•
Flexibility and interest in total application integration
Utilize data standards
Need clear and complete system/application requirements
Independence of data structure
Understanding of and agreement on data retention
only be those data that the sponsor
or the subject wants returned to the
EHR. The International Standards
Organization is also working very
hard to standardize not only the data
format, but the way in which the data
are collected.
Utilizing data standards requires
clinical research sites, sponsors, and
IRBs to establish standards, which
may be called edit checks. The
standards would be things such as
ranges of acceptable laboratory
readings and broader organizational
standards.
CDISC’s C-Dash is an electronic
representation of case report forms.
CDISC is trying to determine how to
successfully create an electronic case
report form that will work across a
number of different product lines in
different therapeutic categories.
important to not affect legacy data
during migration.
It is important to have a very clear
understanding and agreement on
the responsibilities of the sponsor
and the technology provider. The
sponsor must thoroughly consider
the way in which all of the parties
will communicate. The European
Medicines Agency, in its Reflection
Paper on eSource, underscored the
need for a written contract between a
technology provider and the sponsor.
The sponsor must clearly understand
what the technology provider will do
and what it will provide to the sponsor
and all of the other relevant parties.
System and application requirements
must be very clear. Thus, the sponsor
must pay a great deal of attention to its
requirements for conducting a study.
Those requirements primarily come
from the protocol. The regulatory
agencies expect the protocol to
identify which electronic systems will
be used to capture data.
The agreement must also address
data retention and the archival
processes. Some technology providers
were offering unlimited archiving
of data. As they grew, however,
they realized that they could not
continue to do this and began to look
at ways to transfer the data back in
a controlled fashion to the clinical
research sites and the sponsors, only
transferring the appropriate data to the
sites. Therefore, it is important that
organizations thoroughly consider
what each party will contribute to the
data retention and archival processes.
The data structure must be somewhat
independent. Migrating data is very
challenging, as the new system will
have additional parameters and it is
Regulatory Expectations for EDC
It is very important to consider
regulatory expectations whenever
considering the use of any type of
electronic system. These expectations
are outlined in the European
Medicines Agency’s Reflection Paper
on eSource and the
FDA’s Guidance for Industry on
Electronic Data Source used for
Clinical Investigations.
The first regulatory expectation
is that the data be retained for the
appropriate period of time. Both the
FDA and the European Medicines
Agency have stressed that checks and
balances are still necessary with EDC,
that is, clinical research sites must
keep information about what they did
during the conduct of the research.
Sponsors must keep data that reflect
what the investigators, laboratories,
and any other parties involved,
delivered in the EDC system. No
one party can have exclusive control
over all data. Neither the clinical
investigator nor the sponsor can be
the sole owner of all of the data.
When selecting the EDC system, it is
important to ensure that it can provide
both parties with independent access
to the data.
The regulatory agencies expect
the sponsor to have a contractual
arrangement with the technology
provider. The European Medicines
Agency has stressed the need for a
signed contract. The FDA has not
explicitly stated this; however, it
expects the sponsor to understand
what the technology provider will be
providing. It is always important to
have this in writing.
Another regulatory expectation is
that the best practices from the paper
process will be preserved in the
electronic process. Thus, the data
must still be attributable, legible,
contemporaneous, original, and
accurate.
Benefits of EDC
EDC offers many benefits to subjects,
investigators, IRBs, and sponsors.
SOCRA SOURCE © - November 2014 - 63
TABLE 3
Benefits of EDC
• Benefits to subjects:
oOnline and remote access training and help
oElectronic reminders of data requirements
oMore accurate recording of data:
▫▫ Units and terminology are integrated into the
application
oTechnology improvements have increased portability
and ease of use
• Benefits to investigators:
oEnd-to-end applications are available
oUse standardized data/fields
oBuild edit check processes to improve data quality
oRemote monitoring and data review
oOnline and remote training and help access
oConsistent look/feel by system users
oPatient compliance and ease of use
• Benefits to IRBs:
oElectronic transfer and review of research proposals
oConsistency among proposals
oPotential for higher quality proposals
oElectronic informed consent software applications and
processes
oElectronic tracking of reviews, requests for changes,
and approvals/denials of research proposal
• Benefits to sponsors:
oImproved data quality and consistency
oRapid access to data
oRapid feedback to sites, contract research organizations,
and clinical research associates
oQuicker path to product approval (or decision to
discontinue research)
oElectronic submissions to regulators
This technology can be cost effective
in that it can speed up the process of
collecting data and submitting them to
regulatory authorities, thereby offering
significant benefits to primarily
investigators and sponsors. (Table 3)
For subjects, EDC facilitates
compliance, for example, with
e-diaries. It is easy for subjects to use.
Help is available if subjects have any
problems, often on the device itself or
in a manual that is easily accessible
electronically or in a paper form.
Through unique EDC features such
as electronic alarms and reminders,
subjects are reminded that data needs
to be entered into ePRO devices, This
SOCRA SOURCE © - November 2014 - 64
results in more accurate recording of
data, which facilitates data integrity
and data quality. Subjects can get
immediate help from the electronic
help modules that are embedded in
most devices. Additionally, subjects
who use electronic informed consent
document applications can review the
ICD and related educational material
for as long as they like, and only
electronically sign the ICD after all of
their questions have been addressed
by the software application, and the
attending clinical staff. Sponsors,
investigators and IRB members can
be assured that the subject has a good
understanding of the research into
which the subject has volunteered.
Behind the scenes, EDC systems
capture metadata so that clinical
research professionals know exactly
when the subject completed the
information. This eliminates the need
for paper diaries. Thus, improved
data can be sent to the regulatory
authorities. Technology improvements
occur continually, providing increased
portability and ease of use.
The benefits to the investigator
include the availability of end-to-end
applications. The EHR and EDC
systems capture clinical data that the
investigator can submit to the IRB.
Many universities have developed
electronic systems for the review of
clinical trials. The investigator submits
the protocol and all of the recruitment
information into the electronic
system and the IRB does the review
electronically. This is a real benefit
to the investigator, as he/she does
not have to deliver reams of paper
to the IRB’s office, ensure that it is
distributed, and provide paper updates.
EDC provides quick access to updated
information.
The investigator can create
edit checks, using the sandbox
environment that many technology
providers offer. The sandbox is a
weighted feature for user acceptance
testing. A person enters data to
determine whether the edit check
works in an environment that is not
live.
EDC allows remote monitoring
and data review with some types of
electronic data capture. Commercial
technology providers offer online
and remote training and help. If the
organization develops a system inhouse, it should definitely include
these features. EDC also facilitates
consistency and makes it easier for
clinical research professionals to
become comfortable using these
systems.
The IRBs at many universities
have developed great EDC systems
for review of clinical trials. As
mentioned, these systems allow
electronic transfer and review of
research proposals. Commercial
IRBs are also using EDC systems.
Information in these EDC systems
is easy to retrieve, update, and share
among IRB members. EDC systems
facilitate consistency among protocols,
enabling IRB members to easily
search for features that they expect to
be part of a submission. EDC systems
help IRBs comply with the rules that
govern their operations and meet their
regulatory requirements. They can also
be used to capture informed consent
and to track submissions.
The benefits of EDC systems to
the sponsor include improved data
quality and consistency and rapid
access to data at many levels.
The biostatistician and the data
management team can be looking
at data while the clinical research
sites are still collecting and inputting
data. The monitor can review
data electronically both remotely
and onsite. EDC systems provide
quick feedback to clinical research
associates through the query approach,
such as the need for an additional edit
check or additional training. Sponsors
can use EDC systems to make
electronic submissions to regulators.
TABLE 4
Challenges and Risks of EDC
•
•
•
•
•
•
•
•
Global environment
Technical, complex language translations
Rapid changes in technology
Rapid evolution of data storage practices
Lack of, or evolving, data and submission standards
Evolving regulatory policies and requirements
More complicated security and business continuity plans
Clear and understandable communications between all parties
CDISC has developed a submission
that the FDA has found acceptable,
the standard data tabular approach
module. Electronic submissions are
also easier for the FDA to review than
paper submissions.
Challenges and Risks of EDC
Table 4 outlines challenges and risks
of EDC for vendors and, to some
extent, for sponsors. The global
environment requires dealing with
different languages and having help
available 24/7. Technology changes
rapidly. Personal computers started
with desktops, then moved to laptops.
Floppy disks for storage were replaced
by flash drives. Now storage systems
are Web-based. Systems that were
used on desktops or laptops are now
used on Smartphones and other more
modular devices. Electronic tablets are
now being considered medical devices
when data are collected on them and
may, at some point, be regulated as
medical devices.
Sponsors that use EDC systems, as
well as the vendors that make them,
must keep up with the applicable
regulations. Sponsors must purchase
the right product to meet regulatory
requirements.
Data storage practices are evolving
rapidly, and moving to the cloud.
Sponsors that use technology
providers that use cloud storage must
ensure that they understand what this
means. Cloud storage does not have
all of the security features of Webbased systems, where the data are
stored at the technology provider’s
location on its own servers. With a
cloud storage system, the data can be
stored anywhere in the world, which
is both good and bad. Sponsors must
understand the standards that must be
met in clinical research. For example,
perhaps it is acceptable to have
information about the application,
such as the edit checks, stored in the
cloud but the actual data should not be
stored in the cloud.
Data and submission standards may
either be lacking or in an evolving
state. CDISC and other standardsetting bodies are engaged in trying
to set EDC standards. Technology
providers are trying to keep up with
this work. They, sponsors, and clinical
research sites are actively engaged
in discussions around building new
standards. Any organization that is
interested in EDC can be an active
participant in all these activities.
SOCRA SOURCE © - November 2014 - 65
Regulatory policies and requirements
are evolving. Users finally have
a good understanding of Part 11,
Electronic Records; Electronic
Signatures. The FDA is not changing
its rules or orientation on Part 11. The
FDA and the European Medicines
Agency have provided some
additional guidance on electronic
source data, which has been very
helpful. It is important for sponsors
and technology providers to keep
abreast of regulatory policies and
requirements. Sponsors must ensure
that the technology providers they use
are aware of the latest policies and
requirements.
Security and business continuity
plans are more complicated with EDC
systems. The European Community
expects data to be kept in the
European countries unless there is a
safe harbor agreement. Technology
providers must be aware of security
and data privacy issues and have
procedures in place to deal with these
issues.
Clear and understandable
communication between all parties
is necessary, including who will be
doing what, when, where, and why.
For example, if a system changes, who
will validate the revised system? If
a technology provider is hosting all
of the data, that technology provider
must validate the system. If the
system is being provided as a SAAS
application, the technology provider
may allow a clinical research site to
use the application for a month or two
before pushing it out.
Real-Life Application of EDC
Some interesting events related
to EDC are occurring. New data
requirements may necessitate software
modifications and upgrades. The FDA
has published a draft guidance on data
standards, which recommends that if
the standards change, EDC systems
should be upgraded to push those
standards.
Other organizations recommend that
this is not always necessary. There can
be caveats as to when EDC systems
need to be upgraded to new standards.
For example, in a long-term, multisite study, it would be disruptive to
change the EDC system every time
there is a small change in standards.
Clinical research sites would be using
different standards at different times
and integrating them at the end of the
study could be a nightmare. In those
cases, the sponsor should work with
the FDA or other relevant regulatory
authority to ensure that the regulatory
authority understands that the sponsor
will not be upgrading the EDC system
and why.
Data migration is a real challenge.
Sponsors and clinical data
management teams must thoroughly
consider the requirements before
employing an EDC system. It is
especially important to consider
anything that will be monitored
because any changes to the system for
monitoring will require data migration.
The sponsor, clinical research sites,
and technology providers will have
to spend time to ensure that data
migration works. Sometimes it does
not. A great deal of time may be
needed to check the data.
The best remedy for this is better
planning for implementation.
Sponsors should test the EDC system
and use the sandbox to test the edit
checks and the parameters to ensure
that they work. Anything that does not
work should be changed before going
into production. An implementation
checklist is always helpful in tracking
work. This should be a mindful
checklist that contains the basics but
grows and changes as the needs of a
particular study change.
One real-life event occurred when a
sponsor supplied laptops to a clinical
research site, collected the laptops
at the end of the study, and left the
site with no data from the study. In
the past, the site would have paper
data and records that were kept in the
medical file or other records. In this
case, the site had nothing to show its
TABLE 5
Suggestions for Success in Using EDC Systems
• Develop a detailed plan:
oWho, what, when, where, and why
• Document responsibilities and activities:
oIn the contract and in the protocol
• Assess vendors’ qualifications and applications
• Communicate regularly:
oAssess and mitigate risks
oTrain and retrain as applications change
• Stay tuned-in to regulatory discussions:
oUse recommended data standards
oUse recommended best practices
oThink globally
SOCRA SOURCE © - November 2014 - 66
work on the study. This is dangerous,
not only for the sponsor, but also
for the clinical investigator. If the
sponsor had a problem with a server
or the laptops crashed, there will be
no evidence of the work done by
that clinical investigator. Also, the
expectation that clinical research data
be independent has not been met.
The remedy to this is to ensure that
the contract covers data control and
retention, and states that each party
keeps its respective data in some
format. In this case, a simple remedy
would have been for the clinical
research site to have copied the data
from the study laptops onto one of
its computers before the sponsor
collected the laptops. The sponsor
could also have sent the site a copy of
the data, however, it is good practice
to back up any system so the site
should have had a back-up of the data,
on, for example, a flash drive or on
another hard drive. It may have been
possible to print out the data. Another
remedy is to create certified copies of
the data, an exact copy that includes
data and metadata, on a flash drive,
and retain this throughout the study.
Suggestions for Successful Use of
EDC Systems
Table 5 outlines suggestions for
successful use of EDC systems,
including developing a detailed plan
that covers who, what, when, where,
and why. The plan should include
which parties will be contributing
data, how they will be doing this,
how often the data will be put into
the system, and whether the system
will be used to collect e-source. It
is acceptable from a regulatory
perspective for a clinical research site
to put data into an EDC system and
never record it on paper. However, if
this is how the study will be operated,
this should be clearly noted in the
plan. The roles and responsibilities
related to EDC should be documented
in the contract and the protocol.
Vendors’ qualifications and
applications should be assessed.
Vendors might present a sophisticated
system with all of the bells and
whistles. However, all of those bells
and whistles may not be needed. It
is necessary to know that the vendor
is qualified and reliable, and that it
validates its application and offers
training and help. The vendor should
also have a process for developing
software and the application must be
reliable and trustworthy.
Staying tuned to regulatory
discussions is also important. Data
standards should be used, including
those of CDISC and other standardsetting bodies. Global thinking is
required. While many regulatory
authorities have harmonized their
regulations with the International
Conference on Harmonization E6
Good Clinical Practice, not all
countries do this. It is also important
to meet local regulatory requirements.
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September 30 to October 2, 2016
Montréal, QC Canada
Please consider contributing to this very important meeting through your participation in the speaker
program. There are a number of areas pertinent to clinical research professionals that will be emphasized
during our conference.
• Site Management - Informed Consent, Enrollment Process, Finance & Budgeting, GCP
• Your therapeutic area in research (i.e.: radiation therapy, etc.)
• Subject Enrollment and Follow-up
• Project / Program Management
• Data Technology and Collection
• Patient Compliance / Issues of Drug Interactions (patients on multiple studies) /
AE & SAE Reporting
• IRB/EC Guidelines, Informed Consent, & Records Management
• Auditing / Monitoring / Documenting
• Drugs / Devices / Biologics
• Quality Assurance - GCP / ICH / NIH - Guidelines and Regulations
SOCRA encourages responses to this call for papers from persons working at investigational sites and persons
working for SMOs, sponsor companies, CROs, and government; from those working for providers of technology
solutions, and other service providers. Presentations, however, must not promote specific products or services.
All speakers receive a fee-waived registration to the (main) conference.
Guidelines for submissions & other information may be found at www.socra.org/annual-conference
SOCRA SOURCE © - November 2014 - 67