Request INTERMACS Standardized
De-identified Data for Research
Purposes
The Transfer of INTERMACS Deidentified Data to Researchers:
Policies/Standard Operating Procedures
and Data Request Form
 Process
 De-identified Data (forms)
 Policies
 Data Request form
Please note: Analyses will not be performed by the INTERMACS
Data Coordinating Center
Approved by NHLBI:
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I. Introduction
INTERMACS is a national resource for researchers in the area of mechanically assisted circulatory
support devices. This document contains the policies and standard operating procedures for transferring
INTERMACS patient level data to researchers. Researchers are defined as those individuals who are
interested in conducting studies that advance one or more of the stated goals of INTERMACS (see table
1). For the purpose of this document, “researchers” do not include representatives from industry, federal
agencies, commercial entities, insurance companies, other clinical databases, administrative databases and
hospital consortia. Request for data from these entities should be directed to the INTERMACS DCC.
The policies in this document follow the NIH policies for data sharing
(http://grants.nih.gov/grants/policy/data_sharing/).
II. Process
A. Submit Request
Attached to this document is a data request form for a researcher to request patient level data that
is de-identified (see glossary). (This form is for requesting data and is not for requesting analyses
or data summaries to be performed by the INTERMACS DCC.) This form will be submitted to
the INTERMACS DCC.
B. Review of the Request by the DAAP Committee
The DAAP Committee will meet monthly to review and approve or disapprove the request.
The DAAP Committee may ask the researcher for more specific details of the request. The
general guidelines for review will be:
1. Does the request have scientific/clinical merit?
2. Is there sufficient data in INTERMACS to answer the research question?
3. Has the research question been recently addressed in an INTERMACS study or is one
of the ongoing research projects in INTERMACS?
4. Does the researcher have the necessary resources (statistical and data management
support) to conduct the research requested?
If the research question submitted is similar for two or more requests then priority will be given
to the researcher at an INTERMACS hospital.
C. Notification to the Researcher
The INTERMACS DCC will notify the researcher of the DAAP Committee’s decision. If the
request is approved, then the researcher will be asked to submit a detailed statistical analysis plan
(SAP – see glossary).
D. Evaluation of the Statistical Analysis Plan (SAP)
The INTERMACS DCC will review the statistical analysis plan (SAP) and will evaluate the plan
according to its ability to provide the statistical analysis necessary to answer the research
question. Statistical analysis plans that are deemed to be insufficient will be referred back to the
researcher. We strongly recommend that the researcher collaborate with a statistician to create
the statistical analysis plan (SAP).
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E. De-identified Data to the Researcher
The INTERMACS DCC will transmit the de-identified data according to the information security
protocol. The next section (III.) contains a description of the data that will be submitted.
F. Data Management
The researcher will be responsible for the data management of the de-identified data that he/she
receives. Data management include linking of the datasets, file management, re-coding of
variables for statistical analyses, sub-grouping of the data, calculation of derived variables, etc.
A SAS programmer is required to manage this data.
G. Statistical Analysis of the Data
The researcher will conduct the statistical analyses of the data based on the statistical analysis
plan (SAP). Again, we recommend that the researcher collaborate with a statistician to conduct
the analyses.
H. Results of the Analyses: abstracts, presentations, papers
The researcher is to submit final abstracts, presentations and papers to the DAAP Committee (via
the INTERMACS DCC) for final review. The INTERMACS DCC must have at least 4 weeks to
review these materials before they are submitted to a journal or presented at a scientific meeting.
If the DAAP Committee provides a favorable review then the INTERMACS DCC will notify the
researcher. If the DAAP Committee provides an unfavorable review of the final abstract,
presentation or paper, then the DAAP Committee will contact the researcher and DAAP
Committee Chairman will serve as final arbiter of the identified issues. The researcher is to use
the following sentence for acknowledgement of INTERMACS data: “The data for this study
came from the Interagency Registry for Mechanically Assisted Circulatory Support
(INTERMACS), National Heart Lung and Blood Institute, Contract number
HHSN268200548198C, 2010”
I. Time limitation on approval of a data request
Once the researcher receives the data from INTERMACS, then the researcher has 1 year to
complete the analyses and any resultant manuscript. At the end of 1 year of receipt of data the
researcher should return the data to INTERMACS DCC and destroy any copies that may reside at
the researcher’s location. If the researcher has not completed the research project within 1 year,
then the researcher must submit a new data request go through the process stated above.
III. De-Identified Data
A. Form of the datasets:
The INTERMACS web-based data entry system creates a complex series of relational
databases. The DCC has linked and merged these databases into 4 research datasets.
Patient dataset:
 1 record per patient
 Patient demographics including race
 Patient outcomes including transplant, explant due to recovery, device exchange and
death for each operation per patient
 Patient pre-implant information including hemodynamics, NYHA and INTERMACS
patient profile level
Device dataset:
 1 record per implant operation
 Demographics including race
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

Outcome including transplant, explant due to recovery, device exchange and death
Pre-implant information including hemodynamics, NYHA and INTERMACS patient
profile level
Follow-up dataset:
 1 record per follow-up visit per implant operation
 Includes pre-implant information for each implant operation
 Includes implant discharge information
Events dataset:
 1 record for each adverse event episode per implant operation
 Includes each rehospitalization per implant operation
B. De-identification of data:
All data that are sent to a researcher will be de-identified in 3 specific ways:
 Patient data: no patient identifiers will be included. This includes all PHI as defined by
HIPAA. Therefore, the data will have no dates
 Hospital data: no hospital identifiers will be included.
 Device brand data: no device brand identifiers will be included. However, broad device
descriptors such as pulsatile or continuous flow will be included.
 These 4 datasets will be SAS datasets. The major statistical packages (applications) have
utility programs to translate a SAS dataset.
C. Time Windows
The INTERMACS data is adjudicated bi-annually and frozen datasets are produced after specific
data cleaning processes have been implemented. The data time windows will be March 31st and
September 30th of each year. The datasets will actually be ready for distribution 4 months after
each data time window specified above.
D. Data Acquisition and Quality Procedures
These datasets will consist of data that have been collected according to the Manual of Operations
(MOO) and will follow the protocol specified within the MOO. This includes a process for
adjudication, completeness of data and data monitoring,
IV. Required Policies for transferring and utilizing de-identified data
requested by Researchers
1. INTERMACS will only consider 1 request at a time from a researcher.
2. The researcher has 1 year to complete their analyses based on this request.
3. The researcher may not attempt to merge INTERMACS data with any other database.
4. The researcher may not attempt to identify a patient within the datasets.
5. The researcher may not attempt to identify a hospital within the datasets.
6. The researcher may use the INTERMACS data for only the purpose stated in his/her request.
7. The researcher may not use the INTERMACS data for a public comparison of his/her
institution’s data to the INTERMACS data.
8. The research may not disclose, print, copy or distribute the data he/she receives to any other
entity.
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Table 1:
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Glossary
Anonymized dataset - Previously identifiable data that have been de-identified and for
which a code or other link no longer exists. An investigator would not be able to link
anonymized information back to a specific individual.
DAAP Committee – This is the INTERMACS Data Access, Analysis, and Publications
Committee.
Data Coordinating Center (DCC) – The DCC for INTERMACS is located in the
Division of Cardiothoracic Surgery at the University of Alabama at Birmingham.
A DCC provides support for large studies and focuses on central training in research
methods, statistical leadership, data collection and management. Also known as a
Coordinating Center or Biostatistical Center.
Data Dictionary - A data dictionary, or metadata repository, as defined in the IBM
Dictionary of Computing, is a "centralized repository of information about data such as
meaning, relationships to other data, origin, usage, and format." The term may have one
of several closely related meanings pertaining to databases and database management
systems (DBMS): A document describing a database or collection of databases.
Dataset - is a collection of data, usually presented in tabular form. Each column
represents a particular variable. Each row corresponds to a given member of the data set
in question. Its values for each of the variables, such as height and weight of an object or
values of random numbers. Each value is known as a datum. The data set may comprise
data for one or more members, corresponding to the number of rows.
De-identified data - Under the HIPAA Privacy Rule, data are de-identified if either (1)
an experienced expert determines that the risk that certain information could be used to
identify an individual is "very small" and documents and justifies the determination, or
(2) the data do not include any of the following eighteen identifiers (of the individual or
his/her relatives, household members, or employers) which could be used alone or in
combination with other information to identify the subject: names, geographic
subdivisions smaller than a state (including zip code), all elements of dates except year
(unless the subject is greater than 89 years old), telephone numbers, FAX numbers, email
address, Social Security numbers, medical record numbers, health plan beneficiary
numbers, account numbers, certificate/license numbers, vehicle identifiers including
license plates, device identifiers and serial numbers, URLs, internet protocol addresses,
biometric identifiers, full face photos and comparable images, and any unique identifying
number, characteristic or code; note that even if these identifiers are removed, the Privacy
Rule states that information will be considered identifiable if the covered entity knows
that the identity of the person may still be determined.
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HIPAA elements - The following individually identifiable data elements, when
combined with health information about that individual, make such information protected
health information (PHI):
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Names
All geographic subdivisions smaller than a State
All elements of dates (except year) for dates directly related to an individual
including birth date, admission date, discharge date, date of death
Telephone numbers
Fax numbers
Electronic mail addresses
Social security numbers
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/License numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images; and
Any other unique identifying number, characteristic, code, or combination that allows
identification of an individual.
Limited access dataset – A limited access dataset is protected health information that
excludes certain identifiers but permits the use and disclosure of more identifiers than in a
de-identified dataset. In particular, the limited access dataset allows the inclusion of
dates, 5 digit zip codes, and the city as indirect identifiers.
Relational Database - A database that maintains a set of separate, related files (tables),
but combines data elements from the files for queries and reports when required. The
concept was developed in 1970 by Edgar Codd, whose objective was to accommodate a
user's ad hoc request for selected data. Most every business database management system
(DBMS), including Oracle, DB2, SQL Server, MySQL, etc., is a relational DBMS
(RDBMS).
SAS - A programmable integrated system of software published by SAS Institute Inc. for
accessing, managing, analyzing, and reporting data.
SAS Transport File - SAS XPORT transport format, also called Version 5 SAS
transport format, is an open format published by the SAS Institute. The description of this
SAS transport file format is in the public domain. Data can be translated to and from this
SAS transport format to other commonly used formats without the use of programs from
SAS Institute or any specific vendor.
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Statistical Analysis Plan (SAP) - a document that contains a more technical and detailed
elaboration of the principal features of the analysis described in the protocol, and includes
detailed procedures for executing the statistical analysis of the primary and secondary
variables and other data. The components of a SAP include, but are not limited to,
specific inclusion/exclusion criteria to define the patient cohort, specification of the
primary and secondary endpoints, patient groups to be compared, statistical methods for
group comparisons and methods to provide statistically adjusted comparisons, methods
for time-related endpoints which includes a precise description of censoring mechanisms,
methods for addressing missing data and a description of the expected power or
necessary sample size for the primary statistical analyses.
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INTERMACS Data Request Form for Researchers
Please fax the completed form to 205.975.0085 or
Email completed form to Grant Studdard at gkst@uab.edu
MOO v3.0
03/31/2011
Appendix Ja: DRFR
Requestor (Name/Position)_________________________________ Date: __________
Requesting Hospital: ________________________________________
Contact information: email: _________________________ phone: _______________
Relationship to INTERMACS:
[ ] Operations Committee member
[ ] Clinical site Local PI
[ ] Steering Committee member
[ ] Clinical site - other: _____________________________
[ ] Subcommittee member
[ ] Outside investigator
[ ] Manufacturer representative company ___________________________________________________
Data Request for Researchers: Policy and Procedures
Please read and sign and date this document in order to receive your data package requested. Your data package will
contain the following information and will be transferred according to the following policy and procedures:
I.
II.
Purpose of the Research Request: The de-identified data that I will receive will accomplish the following
research (please attach your research purpose as follows):
 Specific Aims
 Background significance
 Study Design and Method
 Analytic Methods
 Anticipated findings
Expected Dissemination of the Research Results (list organization / date)
 Abstract
_____________________ / ________
 Presentation
_____________________ / ________
 Publication
_____________________ / ________
 Internal Use
_____________________ / ________
 Other
_____________________ / ________
4 De-identified (SAS) datasets: these datasets will contain de-indentified INTERMACS Registry data within the
specified time window listed in this SOP (see section III.C above)
a.
Patient dataset:
 1 record per patient
 Patient demographics including race
 Patient outcomes including transplant, explant due to recovery, device exchange and
death for each operation per patient
 Patient pre-implant information including hemodynamics, NYHA and INTERMACS
patient profile level
b.
Device dataset:
 1 record per implant operation
 Demographics including race
 Outcome including transplant, explant due to recovery, device exchange and death
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INTERMACS Data Request Form for Researchers

III.
IV.
V.
MOO v3.0
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Appendix Ja: DRFR
Pre-implant information including hemodynamics, NYHA and INTERMACS patient
profile level
c.
Follow-up dataset:
 1 record per follow-up visit per implant operation
 Includes pre-implant information for each implant operation
 Includes implant discharge information
d.
Events dataset:
 1 record for each adverse event episode per implant operation
 Includes each rehospitalization per implant operation
You will also be provided with a SAS transport file containing all 4 de-identified listed above. This SAS
transport file will facilitate the importing of your SAS datasets onto any SAS platform that you are running at
your organization (i.e. PC, UNIX, etc).
Data Dictionaries: You will receive a data dictionary for each of the de-identified described above. These data
dictionaries will provide a technical data management tool for your data manager. All data elements within these
4 datasets will be described according to its SAS specifications. This data management tool will allow your data
manager to do all work necessary to fully manage and analyze this INTERMACS data.
Data Transfer: You will receive the above listed files (#I and #II) via a secure data transfer system (UAB DropBox). This system will require a single point of contact to receive the data and instructions will be given to your
point of contact to download your data and additional documentation. The SAS datasets and SAS Transport file
will be password protected for security according to INTERMACS protocol. Your point of contact to receive the
data will be required to call Grant Studdard at (205-934-1193) to obtain this password and to complete your
download and access to your data.
Data Consultation: Once we have completed the data transfer listed above you will then be responsible for all
data management and analyses with your requested INTERMACS data. If you require any support with data
management or statistical analyses consultation with the INTERMACS DCC can provide this support for an
additional charge per hour (up to a total of 10 hours max) which will be invoiced to your organization. There is
no charge for receiving the de-identified datasets.
Agreements required to process this request
In order to process this request you must sign all agreements below and fax to the number listed or
provide an electronic signature and email to the email address listed above.
Data Request Researchers: Policies and Procedures Agreement
I have read, understand and agree to the entire above policy “The Transfer of INTERMACS De-identified Data to Researchers:
Policies and Standard Operating Procedures” . I will also adhere to the NIH data sharing policies listed at
http://grants2.nih.gov/grants/policy/data_sharing
____________________________________
Signature
________________________
date
Confidentiality Agreement
I agree to use the data that I receive based on this request only for the purposes explicitly stated in this request. I also agree
not to disclose, print, copy or distribute the data that I receive based on this request without appropriate permission from the
INTERMACS DCC.
____________________________________
Signature
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Statistical Support
The following personnel will provide statistical support for this research project.
____________________________________
Signature
________________________
date
____________________________________
Email address
________________________
work phone number
Data Management Support
The following personnel will provide data management support (SAS) for this research project.
____________________________________
Signature
________________________
date
____________________________________
Email address
________________________
work phone number
Current Conflict of Interest disclosure form:
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Included ( )
on file at DCC ( )
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