- What is the IECRN?
The IECRN is the Inventory and Evaluation of Clinical Research Networks. It is a project funded by the National Institutes of Health (NIH). The first phase of the project was conducted from September 2004 to July 2006 to develop an inventory of clinical research networks and to conduct an assessment of networks with efficient and effective practices. The second phase of the project which will be conducted from August 2006 through July 2009 is to continue to develop and maintain the inventory of clinical research networks. The inventory of clinical research networks is available on this web site from .
During the first phase of the project there were four components of the IECRN: the Core Survey, the Descriptive Survey, the Best Practices Study, and the National Leadership Forum. The Core Survey verified that the network was an active clinical research network and included brief background questions, such as types of studies being conducted and any focus on special populations. The Descriptive Survey included questions in seven modules (see "What was the Descriptive Survey?" for a list of the modules). The Best Practices Study sought to identify clinical research network practices that contributed to a network's demonstrated success in several areas. A National Leadership Forum was convened on May 31 and June 1, 2006 to summarize the findings of the Descriptive Survey and Best Practices Study and discuss next steps. During the second phase of the project, the Core Survey will continue to be used to collect information on clinical research networks in order to add them to the Inventory.
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- What is a clinical research network (CRN)?
For the purposes of this project, a clinical research network (CRN) is defined as an organization of clinical sites and investigators that conducts or intends to conduct multiple collaborative research protocols. A CRN must conduct research on human subjects or use data from human subjects that is relevant to improving the quality of human health. Types of studies may include clinical trials as well as epidemiologic, behavior modification, health communication, patient care, medical practice, clinical quality and process improvement research. A CRN must have scientific leadership that either develops or evaluates the concepts or protocols that are brought before it and must include at least three independent participating entities.
For a more detailed explanation of a clinical research network, read the definition of a Clinical Research Network using Adobe Acrobat.
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- How does the IECRN fit into the NIH Roadmap?
The IECRN is related to Reengineering the Clinical Research Enterprise, a part of the NIH Roadmap initiative aimed at enhancing the efficiency and productivity of clinical research by promoting clinical research networks that can rapidly conduct high quality studies capable of addressing multiple research questions. More information is about the NIH Roadmap is available on their web site. (Visit www.nihroadmap.nih.gov.)
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- What is the Core Survey?
All identified, eligible networks receive the "Core" Survey. This brief survey verifies that the network is an active clinical research network and asks a few questions about the network such as age of network, participating entities, types of studies being conducted, and any focus on special populations. The survey, which should take no more than 15 minutes to answer, can be returned via mail or fax. Information from the Core Survey is displayed in responding networks' profiles on this IECRN Inventory web site.
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- What was the Descriptive Survey?
The Descriptive Survey was a series of survey modules designed to elicit information about the organization and functioning of a random sample of CRNs. The modules covered network management and governance; operations; training and professional development; information technology; data management; recruitment and retention; and financial practices. Parts of the modules were completed in hard copy or online and other parts were administered by telephone to identified network representatives.
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- What was the Best Practices Study?
The IECRN project sought nominations for clinical research network (CRN) best practices from fall 2005 through January 2006. Each CRN had the opportunity to nominate itself or another network as a candidate for exemplifying a best practice or best practices in meeting one or more specified outcomes. The Westat team invited representatives from government agencies such as the NIH Institutes, the Centers for Disease Control, and the Veterans Administration to submit nominations as well.
The nominations were reviewed by a team of clinical research network experts and evaluation specialists who scored the nominees on the basis of demonstrated success in achieving one or more of the stated outcomes. A subset of the networks studied had their practices showcased at the National Leadership Forum.
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- What was the National Leadership Forum?
The National Leadership Forum was held on May 31 and June 1, 2006. The Forum served as a venue to present selected findings from the Descriptive Survey and the Best Practices Study. It was an important vehicle for disseminating information about network characteristics and best practices and for formulating recommendations for next steps to take in promoting CRNs. To view the presentations, web casts, and reports from the Forum, go to the pages of this web site.
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- How will my CRN benefit by participating in this project?
CRNs are invaluable in advancing clinical, behavioral, and epidemiological research and are key to building future research capacity. One of the benefits to you is contributing to an important element of the NIH Roadmap and having your CRN information available on a public web site so that others can learn about your research efforts.
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- How can I find out if my CRN qualifies as a network and if it is already in the inventory?
To find out if your CRN satisfies the project's definition of a CRN and is included in the inventory, please visit the page. Enter the information requested on the one-page form and submit it to us. Also, you may call the toll free number: 1-877-885-1122. If your network meets the project definition of a CRN, we will send you a Core Survey to complete.
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- How will my CRN be contacted?
Networks that satisfy the project definition of a clinical research network (see "What is a clinical research network (CRN)?" for the project definition of a CRN) will receive the Core Survey to complete. If you believe that your network satisfies the definition and has not received a survey, please visit the page and submit the form.
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- If I provide my CRN name and address, what information will become public and what information will remain confidential?
CRNs will be asked for consent to have information about their CRN posted on this web site. CRNs will be able to review the information prior to it appearing on the web site. Networks can also update information using the "Request Update" function on the profile. Personal email addresses and private phone numbers will not be posted.
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- Who is coordinating the Project?
The first phase of the IECRN project was coordinated by Westat with support from Lockheed Martin Aspen Systems, Social & Scientific Systems, and Borland. An Advisory Panel of 12 clinical research network experts also provided consultation to the project team. Westat is coordinating the second phase of the project to continue to maintain and update the inventory of clinical research networks.
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- What is a "Network Profile"?
A Network Profile is a summary of the information that a network provides in response to the Core Survey. The topics included are: year network established, funding sources, geographic location, types of studies, conditions studied, and target population. Most networks also include their web site and contact information.
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- What is the "Inventory"?
The Inventory is the list of over 200 clinical research networks. This inventory is a searchable data base which may be searched by browsing the list of networks, searching on key words, and searching the Core data on multiple variables. If you want to search for a specific type of network and you need help, you may complete the form in the section of this web site.
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- What is the source of the data for the Inventory?
The Inventory is based on the information that each participating clinical research network has provided in the Core Survey and agreed to have displayed online.
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- How does the inventory information relate to ClinicalTrials.gov?
If the clinical research network reported that they conduct clinical trials, the web site for ClinicalTrials.gov appears next to the network's title. When you click the link to ClinicalTrials.gov you leave the IECRN web site and enter in the topic area for the same search topic that you entered in the previous IECRN web site.
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- How can I update my CRN's profile with new information?
Updated information can be submitted using the "Provide Update" button in the Profile. This selection shows the current information for each item and provides space to update the profile. After completing the update, you can select "Request Update" and the changes will be sent to the web site manager for updating the data base. Changes will usually be available in 48 hours from the receipt of the update.
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- Are there other ways I can get involved in reengineering the clinical research enterprise?
The National Heart, Lung, and Blood Institute (NHLBI) is currently developing a Clinical Research Guide to assist current and potential investigators in specific areas:
- Organizing a human subjects application
- Conducting a study
- Maintaining an award
As a result of the recent IECRN National Leadership Forum, a tool kit to include templates and samples for protocols, consent forms, COI policies, report cards and other useful items will be developed. To obtain more information, feel free to contact Victoria Pemberton at pembertonv@nhlbi.nih.gov
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