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CLINICAL RESEARCH ALLIANCE (CRA)

CLINICAL RESEARCH ALLIANCE

A COMMITTEE OF THE NATIONAL SCIENTIFIC ADVISORY COMMITTEE OF THE CCFA

 

Preamble

In 1990 the National Scientific Advisory Committee (the “NSAC”) charged a working group to develop a “Research Agenda” which was updated in 1993.  In 1995 the NSAC requested a companion “Clinical Research Agenda”, in which a subcommittee on Clinical Networking was charged “to develop and implement the mechanism for performing future clinical trials including: establishment of networks of medical centers, private practitioners who are members of the CCFA and other organizations, and encouragement of clinical researchers to enter the field of inflammatory bowel disease.” To pursue the clinical research agenda in IBD in 1996 the Clinical Research Alliance (CRA) was instituted and a constitution and bylaws were established. The program of the CRA was based on the mission statement “to ask and answer clinically relevant questions that would not otherwise be studied with a goal of improving the quality of life for patients with IBD.”

 

Article I.         Definitions

CLINICAL RESEARCH ALLIANCE COMMITTEE (“Clinical Alliance”)- is a consortium of multiple centers working together on multiple research studies. All research studies to be conducted through the Alliance will be pre-approved by the Steering Committee and Oversight Committee.  Any number of the centers involved in the consortium may participate.

 

CROHN’S & COLITIS FOUNDATION OF AMERICA (CCFA)- a non-profit, volunteer-driven organization dedicated to finding the cure for Crohn’s disease and ulcerative colitis. It was founded in 1967 by Irwin M. and Suzanne Rosenthal, William D. and Shelby Modell, and Henry D. Janowitz, M.D.

Four decades ago, the Crohn’s & Colitis Foundation created the field of Crohn’s disease and ulcerative colitis research. Today, the Foundation funds cutting-edge studies at major medical institutions, nurtures investigators at the early stages of their careers, and finances underdeveloped areas of research. Educational workshops and symposia, together with the scientific journal, Inflammatory Bowel Diseases, enable medical professionals to keep pace with this rapidly growing field.

 

NATIONAL SCIENTIFIC ADVISORY COMMITTEE (NSAC)- CCFA NSAC membership consists of the chairs and Co-Chairs of all of the CCFA’s scientific committees.

 

DATABASE Management center (DMC) –supports the data management and analysis of research data for the various projects.  They will participate in the design of clinical protocols, management of the protocol and amendment approval process, in addition to providing the data management and analysis necessary to support them. They facilitate data entry by building and maintaining data entry forms. The center has developed and maintains the “Protocol Manager” clinical data management system used for the collection, storage and analysis of data for all clinical sites that participate in network studies. They are also responsible for generation of reports and analysis of data for CRA studies.

 

Article II.       Mission Statement

The CRA is a confederation of clinical research centers to ask and answer clinically relevant questions that would not otherwise be studied, with a goal of improving the quality of life for patients with IBD.

 

Article III.      Organization

SECTION 1.  Organizational Structure.

The Clinical Alliance is a standing committee of the NSAC comprised of a Clinical Alliance Chair, a Clinical Alliance Co-Chair, participating institutional and affiliate members, and the chairpersons of various subcommittees.  The Chairperson of the NSAC, the CCFA Director of Collaborative Research Projects, and Chair of the Board of Trustees shall be member’s ex‑officio of the Clinical Alliance without voting rights.

 

SECTION 2. Institutional Membership.

Institutional members are independently administered primary centers consisting of hospitals, medical centers or research institutes, or a group of such centers which have developed an IBD‑related research program approved by the Clinical Alliance and administered by a Principal Investigator (a “PI”).

Procedure for Membership

To become a member- a membership application must be completed and includes the following information:

  • PI CV (NIH style), and a letter of intent indicating a willingness to participate in the Alliance
  • An estimate of the number of IBD patients treated at the institution
  • The number of IBD trials in the last 2 years and the number of patients enrolled in each trial
  • A description of the IBD clinical trial support staff
  • A description of the institution’s Human Studies review board.
  • In the case of several PIs at a single institution, there must be one member identified as the voting member.

The Chair and Co-Chair will review applications and approve qualified centers.

Procedure for Continuing Membership Status

Each institutional member shall be re-evaluated in Clinical Alliance activities by the chair and Co-Chair every 2 years. The number of IBD clinical trials in the last 2 years (including the title of the clinical study), included patients in each trial, and number of patients treated in each center should be updated.  If the voting member changes, a new PI must be identified as the voting member.

Procedure for Funding

The Clinical Alliance Core, which is hosted at the site of Clinical Alliance Chair, will be provided a yearly stipend for administrative work.  Funding for projects will be developed by the Clinical Alliance Chair and Co-Chair with the input of CCFA.  Funded projects will be determined through competitive review of Clinical Alliance members.

 

SECTION 3. Clinical Alliance Chair

The Clinical Alliance Chair shall be elected by closed ballot by the Clinical Alliance for a three‑year term by a simple majority vote and approval of the CCFA NSAC.  Nominations are submitted by members of the Alliance.  Nominees will be approved by the NSAC.  A closed ballet election will be held.  The Clinical Alliance Chair may be elected for only one additional term but becomes eligible again following one term out of office.

The Clinical Alliance Chair’s responsibilities shall include the following:

  • The Clinical Alliance Chair is responsible for the conduct and quality of the scientific activities and efficient operation of the Clinical Alliance, and shall represent the Clinical Alliance in its business with the NSAC of the CCFA.
  • The Clinical Alliance Chair shall convene and conduct Clinical Alliance meetings.
  • Receive, monitor and supervise dispersal of all externally received funds; determine (with appropriate input) overhead for Clinical Alliance activities; and report regularly to the Clinical Alliance regarding the status of such funds.  Contributions should be channeled through the institution of the Clinical Alliance Chair, then to the Alliance, as appropriate.
  • Manage studies – RFPs
  • Monitor membership
  • The Clinical Alliance Chair’s institution will act as the Central Office for the Alliance

Should the Clinical Alliance Chair be vacated prior to expiration of the usual term of office by resignation, death, incapacity, or for any other reason, then the Clinical Alliance Co-Chair shall finish the term of office.

SECTION 4. Clinical Alliance Co- Chair

The Clinical Alliance Co-Chair shall be appointed by the Clinical Alliance Chair.  The role of the Clinical Alliance chair will be to work with the Chair on the development of a plan for the Alliance during their term.  Together they will work with primary PI on the projects funded by the Alliance to ensure the success of the studies.

 

SECTION 5. Oversight Committee

The Oversight Committee shall consist of the Clinical Alliance Chair, the Clinical Alliance Co- Chair, the Chair of the NSAC, the Chair of the CCFA Board of Trustees, and the Director of Collaborative Research Projects.  A member-at-large may be appointed at the Chair’s discretion.  The Oversight Committee can meet via conference call.

The Oversight Committee shall meet as often as necessary, usually but not necessarily in association with Clinical Alliance meetings, but at least twice a year.

The Oversight Committee shall be responsible for final approval of overall policy for the Clinical Alliance; it shall work with the CCFA Board of Trustees in the areas of policy and budget of the Clinical Alliance; it shall have the power to recall the Clinical Alliance Chair and revoke institutional membership; and it shall conduct other business as comes before it.

 

SECTION 6.  CRA – clinical trials scientific committees

Members will consist of Chair, Co-Chair, Director of Collaborative Research Projects, Primary PI of the study, and selected individuals from the Clinical Alliance membership.

Each funded project will have a scientific committee.  The role of committee will be to guide the project, make sure milestones and deadlines are met, and aid in the development of the project to obtain additional funding.

The committee will be in charge of:

  • Creating and reviewing protocol and protocol change- then presenting to oversight committee for final approval
  • Setting up milestones and flowcharts
  • Guide the PI on accomplishing milestones

 

SECTION 7. The Clinical Alliance Central Office.

The Clinical Alliance Central Office shall be directed by the Clinical Alliance Chair.

The Clinical Alliance Central Office shall keep the Constitution of the Clinical Alliance, records and minutes of all Clinical Alliance meetings, and other pertinent matters.  Official correspondence of the Clinical Alliance, including agenda, minutes, final copies of protocols, reports to the NSAC, CCFA and NIH, and similar documents and official correspondence which affect the Clinical Alliance function with outside organizations shall be conducted through the Clinical Alliance Central office.

An Administrative Officer appointed by the Clinical Alliance Chair shall be responsible for the day‑to‑day operation of the Clinical Alliance Central Office and of related fiscal matters.

 

SECTION 8.  The Data Management Center

The Data Management Center shall support and be involved in the statistical and scientific aspects of the planning of group‑wide protocols.  It shall develop and maintain an efficient and reliable data management and processing system.  It shall devise and implement randomization schedules when appropriate.  It shall carry out the final analysis of Clinical Alliance studies.  It shall issue interim reports describing the progress of all active studies and help monitor ongoing studies.

 Article IV.    Meeting

The Clinical Alliance shall meet as often as necessary, but at least twice a year, typically at Digestive Disease Week and at Advances in IBD.  In addition, the Clinical Alliance shall meet on the call of the Clinical Alliance Chair.  Such special meetings shall be convened within 4 weeks of the date of receipt of the request.

A quorum for Clinical Alliance or subcommittee meetings shall be defined as 50 percent of its membership.  A majority of members present and voting shall decide any issues on the agenda.