Clinical research* is critical to the advancement of medical science, and conducting such research is a complex, information intensive endeavor. Informatics solutions have long been applied to the work of clinical research, and work at the interface of clinical research and biomedical informatics is proceeding at a rapid pace through various public and private efforts. A new sub-domain of biomedical informatics, clinical research informatics (CRI), has emerged at this interface.

In 2007, AMIA identified CRI as a focus area for the organization and established the Clinical Research Informatics Steering Task Force (CRIS-TF) to guide the organization's strategy and plans for advancement of CRI efforts. The following is a progress report from this group that highlights initial efforts either underway or planned for the coming 12 month period. These efforts are intended to result in the positioning of AMIA as the leading professional home for those who study and practice CRI.

The CRIS-TF intends to chart the course by which AMIA can become the preferred professional home for CRI innovators, researchers and practitioners. Our recommendations to accomplish this will involve a combination of support for and enhancement of some ongoing AMIA activities (e.g. those occurring in the Clinical Research Informatics Working Group [CRI-WG]), as well as the development of new activities and initiatives. In order to inform these recommendations, we will work closely with the CRI-WG to build upon and broaden their ongoing efforts to produce an inventory of the challenges and opportunities facing CRI.

CRIS-TF objectives are to:

• Understand the needs of the CRI community, including those of current and potential members of AMIA.
• Encourage AMIA to develop and participate in initiatives that will allow it to serve as a focus of communication and collaboration among members of the CRI community. This community is envisioned to include individuals from both within and outside of AMIA.
• Guide and encourage the development of new CRI educational offerings to be sponsored by AMIA
• Identify and support venues, resources, and policies that will serve to encourage the scientific study and advancement of CRI.
• Support the CRI-WG to engage in efforts that maximize value for current and potential members of AMIA

• The ultimate goal of CRIS-TF is to elevate CRI as a major emphasis of AMIA and make AMIA a professional home for professionals working in the CRI domain.
• The CRIS-TF will be successful if the AMIA membership is able to represent a broad spectrum of individuals who perform research in or practice CRI, and who had not previously belonged to the association. We expect this to occur via the growth of the existing CRI-WG, and in particular through engagement and dialogue with other organizations that focus on CRI.

AMIA currently serves as a professional home for many of the professional’s who lead or participate in public and private CRI research and development efforts at multiple levels (e.g., from organizational efforts to large-scale consortia). In recent years, these members have brought their knowledge and collaborative opportunities to AMIA through involvement at events and working group activities. In addition, there are many groups that have interacted with AMIA on issues related to CRI, though these relationships have not been formalized at an organizational level. As we proceed, we will work closely with internal and external groups to align AMIA with the right organizations and establish new interactions and relationships. We will specifically stratify such engagement into two categories, as defined below:

The CRIS-TF recognizes that engagement and dialogue with current AMIA groups that may be affected by task force activities and initiatives is essential to our success. Specifically:

1. CRI-WG: The CRIS-TF recognizes that its role is to recommend strategy for AMIA and to support the CRI-WG as the "home" within AMIA for members with an interest in CRI. The CRI-WG has hosted many CRI-related academic and collaborative activities and we expect that it will continue to do so in the future. The CRI-WG is the group through which several organizations in the CRI space interact and as such, we will work closely with the CRI-WG to understand this domain, leverage relationships, and to make possible an expanded range of CRI-related activities and inter-organizational collaborations.
2. Other AMIA Working Groups: Several other WGs have a focus that overlaps with that of CRI. The CRIS-TF will therefore work to identify such groups, engage their leadership, and determine an optimal plan to ensure ongoing and constructive interaction.

Engagement with external groups is crucial for the CRIS-TF to properly identify community trends and needs. By collaboration and engagement with external groups, we will also assist AMIA to position itself as the leading professional organization in the CRI domain. To achieve such outcomes, the CRIS-TF has identified 2 key groups to be targeted for immediate communication and dialogue:

1. BRIA (Biomedical Research Informatics Association): the association of General Clinical Research Center (GCRC) informatics professionals.
2. CTSA Biomedical Informatics Steering Committee: This group represents the leaders of biomedical informatics of the NIH funded CTSA sites.

The CRIS-TF will continue to identify similar, external groups and determine proper engagement approaches on a case by case basis.

Based upon the initial and ongoing discussions of the task force, we anticipate engaging in the following activities over the next 12 months:

• In coordination with the CRI-WG, the CRIS-TF will co-sponsor a "Clinical Research Informatics Reception" at the AMIA 2007 Annual Symposium. The reception will be held in conjunction with current CRI-WG activities. Members of the CRIS-TF and CRI-WG are currently soliciting industry sponsors for this event
• The CRIS-TF will undertake an environmental survey of current CRI relevant professional organizations and meetings. The goal of this survey will be to: 1) identify potential communities of CRI professional who may not be members of AMIA, 2) determine what types of activities generate value for those communities, thus informing AMIA's efforts to demonstrate the value of AMIA membership, and 3) determine which of these outside groups already have active AMIA members.
• Based upon the results of item 3, the CRIS-TF will work in coordination with AMIA to promote opportunities for members to present CRI related work or become involved with relevant non-AMIA meetings. The goal will be to increase visibility of AMIA and to promote our vision for CRI at such venues and events.
• In addition to item 4, the CRIS-TF intends to engage in communication with both the GCRC and CTSA informatics communities, with the express purpose of engaging those communities in a dialogue that will help us define areas where AMIA can provide value. As an initial step, we intend to develop a mechanism by which these constituencies will have an opportunity to comment upon the proposed activities of the CRIS-TF, as embodied in an executive summary of this progress report.
• The CRIS-TF, with additional ad-hoc members as needed, will prepare a longer-range (2-3 year) work plan for AMIA that will include strategy and milestones for increasing AMIA's prominence in the CRI domain. The CRIS-TF will also prepare a specific proposal for AMIA on how to increase the visibility of CRI at existing AMIA meetings. We anticipate that this proposal will include in the near-term, the promotion of CRI specific themes and tracks at the Annual Symposium and Spring Congress, and in the longer term (2-3 years) the creation of a CRI-specific meeting.
• The CRIS-TF will help craft a press release, outlining our planned activities for the coming year, with the goal of increasing the visibility of AMIA's efforts in the CRI domain. The CRIS-TF will coordinate with AMIA to determine appropriate mechanisms of increasing the scope and quality of CRI related content on the AMIA Web site, with a particular emphasis on promoting CRIS-TF and CRI-WG activities and achievements.