Corrona Study Proposal Guidelines

These guidelines are intended to provide a description of the role of the Publications, Presentations, & Peer-Reviewed Proposals and the policies involving the use of data from the Corrona Research Foundation in publications, presentations and ancillary study proposals.

Application Approval and Priority
Because of the need to efficiently use important finite resource, priority will be assigned to all proposals based on the following criteria (all equally important):
Scientific merit including, significance, innovation, and appropriate methodology
Collaboration with investigators experienced with the Corrona datasets
Resource requirements (e.g. biostatistical resources) needed to complete proposed scope of work

The use of non-CRF statistical resources
Degree of additional burden imposed on participating clinicians and patients for “add on’ studies in relation to the value of the information to be gained.

Formal Application Process

For all proposed studies, a structured application form must be submitted to the CRF. This form includes a precis that must be submitted with the following sections:
• Background
• Research hypotheses and specific aims
• Data elements
• Statistical analysis
• Need (or lack of need) for CRF statistical resources

An ordered list of authors/investigators must be provided, including the designation of a corresponding author and sponsoring Corrona investigator. If time allows, the author/investigators may collaborate with the CRF statistical team in writing the Statistical Analysis section to assess preliminary feasibility. This section may be revised/updated by the CRF statistical team after submission. All investigators listed on any application should have appropriate certified training in protection of human subjects. IRB approval may fall within the purview of Corrona’s registry operations although will be discussed in the context of the review by the CRF.

Manuscripts and Abstracts
Once an analysis has progressed to the stage where it is ready to be considered for presentation and publication, the following principles apply:

Manuscript Process
The formal approval process for a new analysis begins with submission of a structured application to the CRF. The lead author is responsible for convening a writing group for the analysis and anticipated manuscript. The lead author has the responsibility of conducting the analysis and writing the paper according to the timeline outlined in this document. If the paper is delayed (e.g. beyond 12 months from completion of the analysis), the CRF chair has the option to reassign lead authorship. The lead author will be responsible for obtaining the appropriate review by their local Institutional Review Board and assuring appropriate ethics training for authors.

We suggest investigators NOT propose analyses focused on safety outcomes. Additionally, direct comparisons of individual drugs should not be proposed. Rather, classes of drugs may be compared: TNF inhibitors, non-TNF biologic agents, conventional DMARDs, etc. as long as the most frequently used drug in a class comprises no more than 70% of the total sample (this is to avoid cases where the class is predominantly composed of a single drug).

Manuscripts must be submitted to the CRF for approval 30 days before anticipated submission to a peer-­‐reviewed journal or public release. The CRF will review progress on manuscripts quarterly. Manuscripts should be completed within 12 months of CRF approval and receipt by the CRF statistical staff with available CRF statistical services (except under special circumstances); after12months the manuscript will be considered ‘dormant’ and the CRF will remove author and re-assign first authorship.
The CRF should be regularly apprised of manuscript status, including editorial decisions. The CRF should be provided with revised versions of the manuscript resulting from the peer review process. Authors may assume that manuscript revisions in response to peer review have the implicit approval of the CRF, unless there is explicit communication to the contrary.

A final copy of the manuscript submitted should be sent to the CRF. To “convert” an abstract into a manuscript, a separate proposal must be filed. The manuscript proposal should indicate the source abstracts to which it is linked.

Authorship for Manuscripts and Abstracts
All authors must meet criteria as established in the latest guidelines from the International Committee of Medical Journal Editors (www.icmje.org). Anyone with the appropriate scientific credentials may submit an abstract proposal or manuscript, but first priority will be given to those investigators who have worked closely with observational data including the Corrona registry data. This priority is to expedite the process ;alternatively, the proposer can work directly with a member of the CRF or the CRF board to help.

All abstract proposals will be submitted on the Corrona Research Foundation proposal form that specifies the primary question, data required, suggested analyses/sample. Approved proposals will be circulated to the Corrona Research Foundation to invite collaboration if their expertise is needed.

Related Information

PEER REVIEWED FUNDING
These are content elements that propose to expand upon existing data elements. Anyone with the appropriate scientific credentials, appropriate access to required scientific and logistical expertise, and appropriate institutional support may submit an ancillary proposal. An ancillary study typically entails collection of additional data, typically supported by external funding. First priority will be given to Corrona Research Foundation investigators (those who have worked with Corrona data previously).

Peer-reviewed proposals will include support for co-investigators from the core team at Corrona Research Foundation who will collaborate on the development and analysis of the grant (see details in Budget section). All peer-reviewed studies must be initially approved through the process described above.

Study Types
Analysis proposals: Studies using existing Corrona Research Foundation patients and data.
• Select patient sample (e.g., years, locations)
• Identify existing variables from Corrona Research Foundation data elements*
• Define hypotheses and analyses
• Budget – personnel for data management, statistical analyses, and infrastructure maintenance fees.

Peer-reviewed Proposals: Studies requiring additional investigations on existing patients
• Select patient sample
• Define additional investigators and time interval for assessment(s)
• Example: Performing indepth interviews with participants in the T2T trial. Budget will include incremental research staff to facilitate/manage additional  data collection; plus cost of data management and analyses as applicable; and infrastructure maintenance fees

Corrona Research Foundation Budget for peer-reviewed submissions
Proposed peer-reviewed and funded studies are expected to provide the appropriate resources to the Corrona Research Foundation team to carry out the proposed analytic work. Budgets should include Corrona Research Foundation research staff and investigators as appropriate from funding agencies as a subcontract or in a consultant role.

Research Support Staff
The Corrona Research Foundation may request funding for research coordinators, analysts and senior statistician based on the nature of the proposed study. Budgeting for ancillary studies will include:
Data analysis-­‐ for studies using existing Corrona Research Foundation personnel, effort will be needed for data base management, statistical analyses and interpretation within the Corrona Research Foundation team
Data collection-­‐ for studies proposing additional data collection/metrics.
% effort for database management and statistical analyses as necessary
% effort for research coordinator within the Corrona Research Foundation team to facilitate the collection of incremental data
Budget for administration of any new tools, surveys etc.

Corrona Research Foundation co-investigators may be needed for consultantations or co-investigators:
• Study design and results interpretation
• Epidemiologic consultation
• Data management and statistical analyses
• Others as appropriate to the topic proposed

Indirect funds and infrastructure fees for Peer-Reviewed Proposals
Percentage to be negotiated with relevant funding sources (such as NIH).
Data Monitoring Board and IRB Modifications
Ancillary studies will maintain their own IRB approval at the initiating institution.

Database
The CRF will maintain a list of current publications, presentations and ancillary studies that will be available to general public through contacting the Corrona Research Foundation . Authors/investigators are responsible for updating the CRF on status of their publications, presentations and ancillary studies. The CRF is responsible for circulating updates regularly.