What is the “philosophy” of the BCCR project? |
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In
1999, a community-driven project was initiated by a group of experts
in genetics, surgical pathology, epidemiology, nutrition, medical oncology,
gastroenterology and computer science, working on pancreatic cancer -
the Pancreatic Cancer Collaborative Registry (PCCR) project. This community
involved a panel of 21 experts representing
Creighton
University, Evanston Northwestern
Healthcare,
Johns
Hopkins
University, Mayo Clinic,
New
York
Medical
College, University of Nebraska Medical
Center,
University of
Pittsburgh,
University of
Washington, and the NCI.
By January
of 2006, the project was adapted to several other types of cancer and
chronic diseases including thyroid, HIV/neuro,
head and neck, lung cancer screening, lymphoma and breast cancer.
The BCCR
uses a confederation model. This model provides an essential standardized
approach to data collection and reporting, allows centers to maintain
autonomy, and provides opportunities to integrate selected sites for
different research projects based on a site’s resources and expertise.
It is the center’s decision and responsibility to collect and follow-up
data that they choose to submit to the registry. Using this “Confederation”
concept, the community team described above has agreed upon a Core Data
Set of information that all participating centers must agree to provide
into and share with the BCCR community. The additional data and detailed
information that make up the Complete Data Set is at each center's discretion.
The BCCR Core Data Set includes the following patient socio-demographic,
environmental, clinical and family history data elements:
- Date of birth
- Date of study
- Age at diagnosis/ age at study
- Birth country
- Gender
- Marital status
- Race/ethnic
- Current Ht. & Wt.
- Usual Wt. at age 20, prior to
illness
- Education – highest level completed
- Tobacco/smoking
- Alcohol – current & past
- Dietary habits
- Environmental exposure
- Reason for seeking care
- Gynecologic History
- Medical History
- Summary of family history
- Physical activity level
- Breast cancer therapy
- Surgical history
- Procedure history
- Quality of Life survey
- Sleep survey
The Core
Data set also includes the following administrative data elements:
- Date report submitted
- Current status of the report
- Registering institution code
- Person completing the report
(Name, contact information telephone, email, fax)
- Code
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How were the standardized forms developed? |
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The
matter of standardization and categorization of the collected data has
been taken very seriously from the inception of the BCCR. For this purpose,
four committees (Pathology/Specimen, Epidemiology/ Instrument, Imaging
Collection, and IRB) were organized from the group of 21 aforementioned
experts. Questionnaires already in use at the participating institutions,
as well as established forms for the socio-demographic, environmental,
clinical and family history data of individuals and family members with
a history of pancreatic cancer, were analyzed and agreed upon by these
groups. Existing standards, such as Health Level 7 (HL7), International
Classification of Diseases (ICD-9), Systematized Nomenclature of Medicine
(SNOMED), Common Data Elements (CDE), etc., were also utilized in the
development of the forms.
Questionnaires well recognized in the cancer research community, such
as the FACT-hepatobiliary /pancreas symptom
index version 2.0 and the NCI Quick Food Scan Percent Fat Screener questionnaires
are also implemented. When creating the physical activity page, the
American Cancer Society’s (ACS) examples of moderate versus vigorous
physical activity guidelines for cancer prevention (Byers, CA 2002 52:2)
were used. |
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Where is the data we enter physically located? |
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The
Web-based BCCR is housed in the University of Nebraska Medical Center
(UNMC) Data Center. |
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Will the system be functioning all the time once in place? |
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Yes,
registered users will have around-the-clock access to the system from
anywhere in the world. Technically, the system will be available 24
hours a day, 7 days a week with the exception of 2 hours of downtime
a week for maintenance. |
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What happens if the system fails? |
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There
are four situations when the system could be inaccessible:
1. The Internet connection on your side is down – of course there
is nothing we can do in this case. You should contact your IT support
and wait until the connection is restored.
2. If you are able to connect to other websites and are not able
to connect with the BCCR, there is a connectivity problem on the UNMC
side. In this case, you should call or e-mail to our support. In most
cases, this type of problem can be resolved with in one hour.
3. If you are able to connect to the BCCR, but receive an error
message right away – the application server is down either due to maintenance
or hardware failure. Maintenance should take no longer than 1 hour.
If it is hardware problem, it could take up to 3-4 hours to fully restore
the server.
4. If you receive an error or empty page after you logged in – your
Internet connection could be dropped for some reason, or there may be
a problem in the application itself. First, try to close your Internet
browser and log in again. If the problem persists, call or e-mail our
technical support. Some problems can be fixed immediately; others could
take longer.
We constantly
mirror all of the data to another hard drive as well as backup all of
the data nightly. In the worst scenario, only current changes on the
form you have been working with, could be lost if the system fails.
Everything else is saved in the database, backed up and could be retrieved
after the problem is rectified. |
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Can we edit the template of information entry later on? |
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If
there is a need to change a form or add additional information, it can
be done. Some changes can be made very quickly and some could take several
weeks: it all depends on the difficulty of the change. In any case,
none of the changes have to be made at the user site: everything is
completed on the server at UNMC. |
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Should we enter only patients with breast cancer? |
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No,
The BCCR allows clinicians and researchers to better organize and analyze
information in clinical, epidemiological, nutritional, pharmaceutical,
and genetic studies of familial and/or sporadic cases of breast cancer as well as, individuals at high risk
of developing this disease (unaffected individuals). |
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We have several patients on our local breast cancer database
- do we load these up? |
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Yes,
if you already know the list of fields you would like to export, a program
developed in the UNMC Bioinformatics laboratory could do it. (Perhaps,
some adjustments will be needed to take care on specific fields in your
database). We are currently helping
Creighton
University to convert their MS Access database
into the BCCR. |
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Please confirm that only our center
can access our own data. |
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Through
secure log-on and password-protection, clinicians and researchers at
participating centers will be able to retrieve only the patient data
entered from its site. There will be five types of users of the BCCR
(patient, coordinator, clinician, center manager, and BCCR systems coordinator)
defined below. Each will be assigned an appropriate level of access
to clinical data and will have a particular type of authority. All patient
identifiers defined by HIPAA standards will be encrypted at the registry
level such that no one, including the BCCR System Coordinator at UNMC
who tracks the accuracy of all site data, can identify an individual
patient. The registry will assign a site, family and individual ID for
each patient entry. The users will receive a password according to their
particular type of authority. A user is able to access only the particular
resource that has been granted to the user.
Access levels |
User |
Authority |
Patient |
To
enter personal, demographic, and family history data. |
Coordinator |
Assigned
to represent a clinician. All of the above + Enter medical data,
submit the case for the review of the system coordinator, retrieve
and edit existing cases of his/her assigned clinicians patients. |
Clinician |
All
of the above + Enter medical data, submit the case for the review
of the system coordinator, retrieve and edit existing cases of
his/her patients. |
Center
Manager |
All
of the above + Retrieve and edit cases of the patients of the
center/institution, return cases to the clinicians of the center
for revision. |
BCCR
Systems Coordinator |
All
of the above + Retrieve and edit all cases, return cases to the
clinicians for revision, activate/suspend users, assign the user
authorities, etc. |
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If only the individual groups can access their own data,
how do we get an overview to see how the joint databases might be used
for collaborative projects? |
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Levels
of access for the investigators and collaborators depend on the agreement
between the collaborators. Each center can decide that its data is not
accessible for anyone else or otherwise; all data accessible to all
collaborators, or only part of the data should be accessible and everything
else is secured. In either case, you need to make this decision.
An overview of the joint databases can be done in two ways. The first
way is to use simple prebuilt queries. Several
tools are already in place to produce simple reports from the registry.
Right now, in principle, we can generate a number of simple
reports at the requests of users.
The second way is to use technology of data warehousing (DW). In order
to do this, data collected in the BCCR will be transferred into the
data warehouse. A data warehouse is a separate, database,
designed specifically for mining large volumes of data for
analysis and decision-making purposes. The DW is not a static data repository;
it provides easy access to large amounts of data by means of a dynamic
querying system. Once the data is loaded into the DW, users have a chance
to see what data is available to them. The purpose of data mining is
to discover hidden or unexpected relationships in the data that may
direct researchers to interesting trends and leads that can be followed
up with other models of analyses. The pilot DW for the BCCR data is
completed and we are currently working on implementing the production
version of the DW. |
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What types of security measures are in place to protect unauthorized
users from accessing the registry? |
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The
BCCR servers located in secure state-of-the-art data center and are protected
by the UNMC firewall.
Security issues are addressed using recommendations of the Computer-based
Patient Record Institute (CPRI) and the electronic information security
standards mandated by the Federal Health Insurance Portability and Accountability
Act (HIPAA). According to the CPRI, a complete security solution that
maximizes the benefits of networked data communications must contain
the following elements: User authentication,
Access control, Encryption, Physical protection, and Management.
Computer-based Patient Record Institute
(CPRI) Security Elements |
User |
Authority |
User
authentication and Levels of access |
The
systems are oriented on several types of end-users, each with
the corresponding level of access to data. Initially, when a user
attempts to gain access to computing resources, the user is prompted
to enter his/her ID and password, which will be preliminarily
assigned to each user. |
Access
control |
A
user is able to access only the particular resource that has been
granted to the user. |
Encryption |
We
utilize secure Web server communication and support 128bit SSL
and HTTPS authentication. All patient personal data to be collected
in the BCCR is encrypted. Only the users with the corresponding
level of access are able to work with this information. |
Physical
protection |
Servers
are placed in secured location (room) and kept under locked doors
with a restricted access. |
Management |
No
direct access to the data from the outside is available. Only
the application server has access to the data. Servers are protected
by firewall. Passwords are complex and difficult to break. Adherence
to institutional Confidentiality, Privacy and Information Security
Agreement Policies. All personnel have signed a Computer Access
(security) Agreement. |
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On a day-to-day basis is there funding to help with data
input as we already have three/four separate databases that we input
into? |
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Currently
there is no funding for data entry. For the BCCR, the majority of the
data is to be obtained from and submitted by the subject and the medical
data required should be collected and submitted by the clinicians involved
in the subject’s care.
We believe that BCCR will help its users to apply for federal funding.
There is no fee for use of the BCCR. However, if and when you submit
a new grant application with provision of the use of the BCCR, it would
be reasonable to secure a portion of funding for data entry and support
maintenance of the BCCR. Dr. Sherman at UNMC would be glad to help you
with writing the bioinformatics portion of your grant applications. |
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Once installed into the BCCR, is there a fee for its continuation? |
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There
will be no fee for continuation of the BCCR. Again, if and when you
submit a new grant application with provision of the use of the BCCR,
funding support for the BCCR should be secured in the grant application.
We would be glad to help you with writing the bioinformatics portion
of a grant. |
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Could you provide information about HIPAA, IRB, and sharing
data? |
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The
BCCR operates under an IRB-approved protocol for data collection, storage,
and sharing at UNMC. Written consent from participants for research
will need to be obtained. Each participating center will need to have
all of the research activities and consent forms approved by their own
Institutional Review Boards.
As a participating center you will have access to templates of the wording
that is in use for centers participating in the Breast Cancer Collaborative
Registry (BCCR) that may be useful for an IRB application and patient
informed consent form. These templates address the HIPAA, IRB and data
sharing concerns, of course individual centers applications for the
BCCR will have to be appropriately adapted. |
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Will the Certificate of Confidentiality mentioned in the
Informed consent apply to us? |
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UNMC
holds a multi-site ‘Certificate
of Confidentiality’ (COC) from the National Cancer Institute
on behalf of the Secretary of the Department of Health and Human Services
to prevent a court of law from being able to subpoena Registry records.
The COC will apply to all institutions participating in this Registry.
A Certificate of Confidentiality will not be issued to an applicant
conducting research involving human subjects unless the project has
IRB approval. The approving IRB must be in compliance with applicable
Federal requirements. Therefore we will need your IRB approval letter
in order to add your center to the COC.
We will also need documentation of your IRB qualifications. The
University of
Nebraska Medical Center OHRP Assurance Number is FWA00002939 and
is active 6/2/2011. As the lead site of this multi-site project, we
will maintain a copy of the OHRP assurance number for the all of the
reviewing IRB's, which we have to make available
to the NIH upon request. For additional information on OHRP and IRB
assurances, see
http://www.hhs.gov/ohrp/assurances/. |
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How would you sort out authorship for future 'joint' publications? |
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The
Principal Investigator will discuss authorship with each center at the
time of the initiation of a collaborative study. Suggested guidelines
include:
1. Preparing
a detailed study protocol to include a background section, specific
aims, study design and projected patient, financial and manpower requirements,
and estimated time to completion based on enrollment rates.
2. Preparing
an informed consent form.
3. Revisions
to either the study protocol or the informed consent form.
4. Timely
completion of the project.
5. Preparation
of abstracts and manuscripts reporting preliminary and final data. Each
author included in such work should receive a copy of said abstract
or manuscript for review prior to submission for consideration of presentation/publication.
The Principal Investigator should make a good faith effort to incorporate
alterations suggested by co-authors.
6. The Principal
Investigator will designate the first, second, and last author of each
abstract and manuscript.
The sequence of co-authorship
on each abstract/manuscript will be determined by the Principal Investigator.
A formed subcommittee made up of uninvolved members of the advisory
and prioritization committee will arbitrate any disagreements. If the
BCCR will be used in the study, proper acknowledgement of this should
be made. |
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What are the BCCR technical requirements? |
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