**Guidelines for Proposing a Research Study Using Data**

**from the Universal Data Collection (UDC) Project**

**Background**

The mission of the Centers for disease Control's (CDC) Division of Blood
Disorders (DBD) is to prevent and reduce complications experienced by
persons with certain hereditary blood disorders. In keeping with this
mission and in response to a request from the bleeding disorders
community to establish a blood safety surveillance system, the DBD has
worked with care providers in the Nation's federally supported
hemophilia treatment centers to develop a system of routine viral
testing and standardized clinical data collection known as the Universal
Data Collection (UDC) Project. Since its inception in May, 1998, testing
has been performed and data have been collected on over 18,000 people
with bleeding disorders during more than 50,000 comprehensive care
visits.

The data collected have been made available to the treatment centers and
regions as downloadable Microsoft Access database files. In addition,
CDC publishes routine surveillance reports, maintains daily updated
summary reports on its website, and has published several studies in
which UDC data have been used to address important prevention issues
related to blood safety and joint disease.

In order to make the best use of these important data, and further
enhance the mission, CDC in collaboration with the provider community
through its UDC Working Group is seeking proposals from investigators
with clinical research questions that may be addressed using data
collected as part of this project. Investigators from any discipline
(physician, nurse, social worker, physical therapist, etc.) who are
affiliated with a federally supported hemophilia treatment center are
invited to participate. This document provides a proposal template and
guidelines for proposal submission.

**Submission Details**

1\) Complete and submit ***via electronic mail*** the attached "UDC Data
Research Proposal Form." Please be brief but be sure to address all of
the questions on the form. Your proposal should be approximately 2 pages
in length.

2\) You will be sent via email an acknowledgement of proposal receipt
within 1 week.

3\) Your proposal will be reviewed by a member of the UDC project team
in DBD as well as by a primary and secondary reviewer from the UDC
Working Group. Their assessment of your proposal will then be discussed
with the full UDC Working Group. This review may take up to 2 months.

4\) There are several criteria by which your proposal will be assessed:

-   **Scientific Merit** - What is the relevance and importance of the
    proposed topic? Are the proposed methods scientifically sound?

-   **Feasibility** - Can the UDC data be reasonably expected to
    contribute knowledge about the topic? Are requirements for
    additional data collection to address the topic realistic?

-   **Time** - Is the time frame proposed for the study reasonable? Does
    the study require interventions and follow-up data collection? Will
    further IRB clearance be required?

-   **Resources** - How much data collection and data analysis support
    will be required? Is there any requirement for additional (e.g.
    laboratory) support from the DBD? Will the investigator have
    resources (e.g., grant) to support required activities, testing,
    etc?

5\) Within 2 weeks of review by the full UDC Working Group, you will
receive a written critique, together with a recommendation that falls
into one of the following categories:

\_\_ Accepted and may proceed

\_\_ Requires further work by author after discussion with CDC staff

\_\_ Additional information is needed

Questions:

\_\_ Not approved in current format

6\) Once your proposal has been accepted, you will be provided with a
contact list that consists of a CDC UDC staff member and/or
biostatistician at the DBD. You are also encouraged to include
investigators outside of your institution with interest in this area
and/or members of the UDC Working Group. The CDC contact will assist you
as needed with tasks such as the further development of the study plan,
collection of data, database assembly, data analysis, and manuscript
preparation. UDC Working Group members will collaborate with you on
tasks related to the study plan, potential IRB and other clinical
issues, interface with the centers for additional questions/data needs,
manuscript preparation and other issues as needed.

7\) Any publication (abstract/manuscript) resulting from this work must
be reviewed by the UDC working group and have CDC clearance prior to
submission. You must have "UDC Investigators" (or an appropriate subset)
and appropriate CDC personnel as authors. Adequate lead time (6 weeks
prior to the due date is recommended) must be provided to complete this
review.

8\) Authorship of publications resulting from this work will follow the
Uniform Requirements for Manuscripts Submitted to Biomedical Journals
published by the International Committee of Medical Journal Editors. In
brief, authorship credit should be based on 1) substantial contributions
to conception and design, or acquisition of data, or analysis and
interpretation of data; 2) drafting the article or revising it
critically for important intellectual content; and 3) final approval of
the version to be published. Authors should meet conditions 1, 2, and 3.
More information on these requirements can be found at
[www.icmje.org](http://www.icmje.org/). In addition, all submitted
manuscripts will be expected to appropriately acknowledge the UDC
Project.

**UDC DATA RESEARCH PROPOSAL FORM**

-   **Title**

-   **Principal Investigator**

> Name:
>
> Institution:
>
> Address:
>
> Phone #:
>
> Fax #:
>
> E-Mail Address:

-   **Co-Investigators and Collaborations**

-   **Background and Rationale** (Include any preliminary data)

-   **Specific Aims of the Study**

-   **Study Plan**

> Overall design (ie, cohort study, case-control, if known)
>
> Study population (inclusion/exclusion criteria)

Study outcomes or end points

> Study risk factors

Statistical considerations (sample size, special analyses)

-   **Data Requirements**

UDC data elements that will be used

Additional data not in UDC that will be required

If additional data are needed, how do you propose to obtain it?

-   **Resources**

What components can the investigator accomplish (i.e., data collection,
analysis)?

What components would require assistance from CDC?

Will funding be available to the investigator for work on this study
(e.g., K12

Career Development Award, grant)?

***Please address any questions and submit proposals via email to the
CDC contact listed below. You will receive acknowledgment of your
submission within one week.***

Rodney Presley, PhD\
Division of Blood Disorders\
National Center on Birth Defects and Developmental Disabilities\
Centers for Disease Control and Prevention\
1600 Clifton Road, MS E 64\
Atlanta, GA 30333\
Phone: 404-718-8630;  Fax: 404-718-8650\
Email: rpresley@cdc.gov