About CAEP Research Consortium

CAEP Research Consortium Advantage

The CAEP RC is a network of over 45 Canadian emergency medicine investigators, teachers and clinicians!!

The CAEP Research Consortium (CAEP RC) is Canada's first national Emergency Medicine Investigator (EMI) network of academic and community based emergency medicine (EM) physicians. We are a member owned and operated alliance committed to the pursuit of evidence-based management for pediatric and adult disease presentations assessed in emergency departments. Our initiatives can yield additional valuable information regarding epidemiology, demographics, quality of life assessments, patient accrual rates, and pharmaco-economics of EM practice.

With new opportunities emerging in the research & development landscape the CAEP RC is poised to tackle exciting new frontiers in the EM-based clinical research arena. Through its streamlined, professional business infrastructure, the CAEP RC provides a united, specialised investigator network to work more effectively and efficiently with Industry. The Consortium provides leadership in the design, evaluation, budgeting, quality control, and conduct of clinical studies to ensure that Canada plays a leading role in EM-based research. EMIs can provide the critical link for accessing patients and collecting data. CAEP RC investigators work collaboratively with pharmaceutical companies, global contract research organizations, and the technological industry to investigate the role of new drug therapies and technological innovations in EM settings.

About CAEP RC

The CAEP Research Consortium (CAEP RC) was established in 1998 as a division of the Canadian Association of Emergency Physicians (CAEP).

The CAEP Research Consortium is a coordinated research network that promotes excellence in disease management encountered in Canadian emergency departments.

From our Edmonton headquarters, the CAEP RC offers an ethical professional approach to satisfying the demands of multi-centered EM clinical research. By streamlining the research infrastructure and executing timely resolution of regulatory, budgetary and contractual issues, the CAEP RC can engineer prompt trial implementation and generate valid research outcomes in a cost-effective manner. The Consortium enables emergency medicine investigators to partner effectively with industry to conduct large-scale multi-centre studies that are not achievable by any single centre.

Many of our members are world opinion leaders in emergency medical practice and therefore offer a resource that can provide an excellent setting for research and development in EM related topics across a spectrum of research initiatives here in Canada. The Consortium brings the collective expertise of this national collaboration of EM investigators, teachers and clinicians, with their large diverse patient pools, together with our sponsors, the pharmaceutical companies, technological industries, government, and peer-review organizations, to conduct research that influences the practice of medicine in the ED setting.

Principle Goal

To develop and promote multi-centre emergency medicine based research projects in Canada.

Principle Aims

  • To understand the variation in and complexity of pediatric and adult health presentations to emergency departments in Canada;
  • To understand current practice patterns in Canadian emergency departments;
  • To promote emergency department-based research locally, nationally and internationally;
  • To disseminate knowledge of diagnosis and treatment of health conditions that present to emergency departments in Canada;
  • To work in cooperation with industry and other professional colleagues toward providing sound evidence to guide clinical practice;
  • To provide sound evidence for policy decision makers.

CAEP RC Operations

Edmonton based CAEP RC headquarters regularly receives queries channeled from members, from industry, and from other interested parties. The Consortium is equipped to quickly provide centralized communications for: feasibility surveys, capabilities of research sites, expedited reviews of clinical trials, or suggest membership on advisory boards.

CAEP RC Economic Structure is streamlined, effective and efficient...

CAEP RC Corporate Agreement:

Potential study sponsors deal directly with the Consortium instead of contacting each individual site. The full membership is continuously informed of the projects proposed to the Consortium and of what stage of development they may be in.

Once a project or clinical trial has successfully undergone a CAEP RC expedited review and there is full agreement between the CAEP RC and the Sponsor to move forward and enter into the project or clinical trial phase, then the CAEP RC executes a performance-based corporate agreement with the Sponsor.

In brief, the Sponsor is required to pay CAEP RC a pre-determined amount for every patient entering the project or clinical trial across all CAEP RC participating sites. The full value of the agreement is estimated based on the number of expected subjects required. Only 25% (of the estimated value of the agreement) is applied as a non-refundable deposit upon signing and is held in credit on account until CAEP RC recruitment equals the value of the deposit. Once this occurs, CAEP RC will invoice the sponsor quarterly for ongoing performance until completion of the project or study.

The CAEP RC directs revenues generated from Sponsor Agreements to fund the collective academic, research, corporate and administrative objectives of the Consortium.

Services

The CAEP RC directs revenues generated from Sponsor agreements to fund the collective academic, research, and administrative objectives of the Consortium. In return the CAEP RC offers the following value-added services which are of shared benefit to the medical community and industry world wide...

CAEP RC investigators have the skills and knowledge to provide Sponsors with high quality research and services across a spectrum of initiatives...

  • headquarter data-base of CAEP RC site and investigator profiles
  • fast track communications to member sites and investigators
  • site selection
  • centralized negotiations and study budgets
  • protocol development
  • Expedited Reviews of clinical trials
  • executing clinical trials
  • manuscript / abstract preparation
  • clinical practice guideline development
  • patient registries
  • conducting surveys
  • systematic reviews
  • feasibility studies

Expedited Reviews

In brief the expedited review process follows the following steps:

Step 1

Prior to their participation in clinical trials, the CAEP RC requires pharmaceutical sponsors or other interested parties to request an in-depth Expedited Review (critical assessment process) of their protocols, drugs and projects. The CAEP RC will sign a blanket confidentiality agreement on behalf of Consortium members and employees. All relevant information stemming from the Expedited Review will be centrally disseminated to all of its members.

Step 2

CAEP RC headquarters arranges the Expedited Review after a mutually agreeable date has been set and develops the agenda in collaboration with the Sponsor. The requesting Sponsor will bear all expenses relating to the Review at cost. Charges incurred may involve: transportation, parking, accommodation, reviewer honoraria, room rental, food and beverage, teleconferencing, audio-visual, administrative on-site fee, and 15% corporate surcharge. The CAEP RC makes every effort to keep these costs to a minimum.

Step 3

The Consortium provides presentation guidelines to assist Sponsors in structuring the presentation and content of their Review. As Sponsors present their protocols, the CAEP RC review team under the direction of a head reviewer prepares a draft assessment report which includes: project summary, comments, recommendations, budget details, and a priority ranking. Final assessment reports are forwarded to the Sponsor within approximately two weeks of the presentation.

Step 4

The CAEP RC requests that the Sponsor submit a written response to the assessment report. The CAEP RC then distributes a copy of both the CAEP RC assessment report and Sponsor's response to all members of the Consortium informing them of the details and status of the given project.

Step 5

A positive assessment report and company response and a high priority ranking will likely result in a 'call for sites' - the go ahead signal - which signifies that the clinical trial or project has been satisfactorily reviewed, all negotiations have been completed, and the project is ready for participation. A call for sites, is issued to all CAEP RC members.

Step 6

Investigators wishing to participate in the study are required to communicate their interest to CAEP RC headquarters within 5-7 business days. The CAEP RC then forwards the "short-list" of interested investigators directly to the Sponsor. The final selection of sites is entirely at the Sponsor's discretion.