Diabetic Retinopathy Clinical Research Network (DRCR.net)

Overview of Requirements for Visual FieldReading Center to Collaborate with the DRCR.net

  1. PURPOSE

The purpose of this document is to outline the specific requirements for collaboration between the Diabetic Retinopathy Clinical Research Network (DRCR.net)anda reading center whose objective will be to (1) train and certify DRCR.net technicians for obtaining visual field data and (2)provide feedback and guidance to technicians/sitesregardingquality issues.

An accompanying RFAwill invite interested Visual Field Reading Center (VFRC) applicants to submit proposals to aid in case report form design, perform training, certification, and quality feedbackas outlined in this document and in the RFA.

  1. PROJECT DESCRIPTION - DRCR.NET BACKGROUND

The Diabetic Retinopathy Clinical Research Network (DRCR.net) is a collaborative network dedicated to facilitating multicenter clinical research of diabetic retinopathy, diabetic macular edema and associated conditions. The DRCR.net supports the identification, design, and implementation of multicenter clinical research initiatives focused on diabetes-induced retinal disorders. Principal emphasis is placed on clinical trials, but epidemiologic outcomes and other research may be supported as well. The DRCR.net is funded by the National Eye Institute (NEI). The NEI is a part of the National Institutes of Health, which is the branch of government that funds medical research.

The DRCR.net was formed in September 2002 and currently includes over 100 participating sites (offices) with over 300 physicians throughout the United States. The Jaeb Center for Health Research in Tampa, FL is the Coordinating Center (CC) for the DRCR.net.

The DRCR.net will be conducting a Phase III randomized trial to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-VEGF therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy. An important secondary outcome will be comparing Humphrey visual field results in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP. Both 30-2 (central) and 60-4 (peripheral) test patterns will be required on each study eye using a size V target with the Fastpac test strategy. This will be the first DRCR.net protocol evaluating visual field data.It should be noted that these visual fields will be obtained at clinical sites that are retina specialists with staff who work with retinal specialists. While there may be some experience with Humphrey visual fields, it is likely that the experience will be less than if a clinical trial were being done among clinical sites of glaucoma or neuro-ophthalmology specialists. Therefore, standardized training, certification, and quality control, recognizing that these sites involve retina specialists, were deemed necessary. Reading center aid will also be solicited to determine what additional data should be collected that is relevant to Humphrey visual field data interpretation, although actual statistical analysis and interpretation of the results will be performed at the Coordinating Center.

  1. TRAINING OF TECHNICIANS

Humphrey visual field data will be obtained by using a standardized DRCR.net procedure. The DRCR.net procedure will need to be developed with input from the VFRC. Potential training methods will be discussed with the VFRC prior to implementation, but may include a training manual, training video, and/or training conference calls. It is unlikely that in-person training would be feasible for the Network.

The VFRC will be available as needed to answer technician questions and provide additional training and feedback to technicians.

  1. CERTIFICATION OF TECHNICIANS/SYSTEMS

Technicians will be certified to perform the specific DRCR.net procedure. Pending input from the VFRC, the Humphrey Visual Field system may also need to be certified prior to collecting study data.

Certification of technicians to perform Humphrey visual field testing will be performed by the VFRC according to standardized procedures which may involve submission of non-study certification visual fields. Any certification testsperformed by a technicianwill bedistributed to the VFRC to assess compliance with procedure and quality of the data. If the certification tests are sufficient, the VFRC will enter the approved certification on the DRCR.net website. If the technicianfails, the certification attempt, this will also be recorded on the DRCR.net website, with the reason for the failure. If a technicianis certified for another project with a similar procedure in which the similar procedure and the certification are documented and approved for grandfathering by the DRCR.net, then that certification for the similar procedure may be used to grandfather the technicianfor certification for the DRCR.net.

  1. QUALITY CONTROL
  1. DATA ACQUISITION

The VFRC will work with the CC to determine the best approach for data acquisition. It is expected that data will first be uploaded from the clinical site to the CC via a secure internet connection. The CC will then provide a subset of the data to the VFRC for quality control assessment. However, if the VFRC has experience with direct data upload and transfer, the data could be sent directly to the VFRC from the clinical site and then transferred to the CC. The VFRC will use its standard procedures to import the quality control data into its grading queue.

  1. QUALITY ASSESSMENT AND FEEDBACK

The VFRC will evaluate visual field data for quality assessment metrics that are agreed to by DRCR.net. Feedback on data quality issues will be provided to the site through the VFRC to promote high quality data acquisition. The need for technician contact may be initiated by the VFRC or by the CC. All contacts with technicians will be logged onto the DRCR.net website. The VFRC should follow astandard procedure, approved by DRCR.net, to determine when quality issues necessitate feedback. In addition, the CC will monitor data quality and may request that the VFRC contact a technician to provide data quality feedback.

As a function of ongoing quality control, the VFRC will also assist Clinical Sites via teleconference with repair and maintenance of their visual field equipment.

  1. DETERMINATION OF ADDITIONAL DATA RELEVANT TO HVF INTERPRETATION

The VFRC will work with the CC to identify additional variables that are most highly relevant for subsequent analysis of Humphrey visual field data (e.g. reliability indicies, pupil size, refractive error). The determination of additional variables to be collected will aid in designing prespecified analyses of the HVF data which will be performed at the CC once data collection is completed.

  1. ELIGIBILITY REQUIREMENTS

Proposals may be submitted by domestic public or private, for-profit or non-profit organizations.

The VFRCsenior investigator must be experienced in conducting multicenter clinical research with Humphrey visual field data. Experience in diabetes and/or in the area of diabetic complications is preferred, but not necessary. The VFRC must be able and willing to comply with all aspects of Parts C, D, E, and F above.

  1. LENGTH OF CONTRACT

At periodic time intervals, the DRCR.net Executive Committee will review the status of the VFRC awarded this contract. If the Committee does not believe that the VFRC is performing acceptably then the contract may be terminated. However, it is expected that the contract will span the duration of the DRCR.net protocol from 2011 – 2015.

  1. PUBLICATION RIGHTS

DRCR.net is free to publish and present the study data without restriction. The VFRC may not publish or present any study results that have not already been publicly disseminated by DRCR.net. When appropriate, the PI or other members of the VFRC may be asked to participate on DRCR.net Writing Committees. The VFRC is free to use the data for internal education but all data are the property of DRCR.net.

  1. LEGAL AGREEMENT

A legal agreement will be established between the VFRC and the CC which will detail the obligations of both parties and the agreed upon payment schedule.

  1. PAYMENT SCHEDULE

Payments will be based on a fee for service basis. As part of the response to the RFA, the VFRC applicant will be asked to provide a cost estimatefortraining, certification and quality monitoring based on the DRCR.net’s needs as outlined in the RFA.

  1. OWNERSHIP OF DATA

DRCR.net will have ownership of all collected data. At the completion of the study, the DRCR.net will place the final dataset in the public domain.

  1. CONFIDENTIALITY

Study data, protocols, and individual patient medical information obtained as a result of this project is considered confidential and disclosure to third parties other than those noted below is prohibited. Medical information may be given to the patient’s personal physician or to other appropriate medical personnel responsible for the patient’s welfare in accordance with an institution’s policies. Data generated as a result of this study are to be available for inspection upon request by the CC, the NIH, and auditors of regulatory agencies. All Network participants agree to take all reasonable care to maintain CONFIDENTIAL INFORMATION as secret and confidential, such efforts to be no less than the degree of care employed by the individual to preserve and safeguard his or her own confidential information. The CONFIDENTIAL INFORMATION shall not be disclosed or revealed to anyone except employees of the Network investigator or staff who have a need to know the CONFIDENTIAL INFORMATION for Network activities and who agree to be bound by the Network’s policies of confidentiality.

  1. FINANCIAL DISCLOSURES

All DRCR.net personnel, including VFRC investigators, will be required to disclose all financial interests and working relationships with any entity whose financial interests potentially could be affected by the conduct or outcome of DRCR.net research. This disclosure will be required based on DRCR.net financial disclosure reporting policy.

  1. ADHERENCE TO DRCR NETWORK POLICIES

The VFRC must agree to comply with the DRCR.net policies as outlined in the DRCR.net policy document. Failure to comply may result in termination of participation.

  1. HUMAN SUBJECT EVALUATION

This research project involves human subjects. The VFRC applicant’s proposal must address the involvement of human subjects and protections from research risk relating to the VFRC’s participation in the proposed research plan and indicate its plan for obtaining IRB coverage

  1. REVIEW CONSIDERATIONS

A panel will be developed to review the applications. The review panel will assess each applicant as outstanding, excellent, acceptable, or not acceptable on the components listed below. Proposals will be judged solely on completion of the application and the written material provided.

Selection of a VFRC for a contract award will be based on an evaluation of proposals with respect to technical approach andqualifications. For applicants that are considered acceptable,the cost of the proposal then will be considered. Although technical factors are of paramount consideration in the award of the contract, cost is also important to the overall contract award decision. The DRCR.net reserves the right to make an award to that applicant whose proposal provides the best overall value to the Network.

  1. TECHNICAL EVALUATION CRITERIA
  1. Understanding the Requirement and Technical Approach

The proposal must demonstrate a thorough understanding of the requirements of Parts C, D, E and F above and describe an approach that will demonstrate the ability to achieve the goals outlined in those sections. The proposal must present a comprehensive statement of the problem, scope, and purpose of the project to demonstrate an understanding of the requirements from a management and technical standpoint. Proposals must delineate an understanding of the requirements outlined by this RFA as well as the VFRC’s ability to address these issues with regard to:

(1)Training of technicians

(2)Certification of technicians

(3)Quality assurance and control

(4)Determining additional variables relevant to HVF interpretation

(5)Interaction with Coordinating Center

  1. Qualifications and Availability of Proposed Personnel and Equipment

The applicant must demonstrate evidence of the qualifications, experience, and availability of professional and technical personnel comprising the necessary project staff. In addition, the applicant must demonstrate how the staff will be equipped to handle the DRCR.net trainingand certification timelines described in the RFA. The applicant should indicate whether there are currently trained staff in-house that can accommodate the workload described in the RFA, or whether additional staff will need to be hired and trained.

It is anticipated that the success of this project will require a multidisciplinary team. This team should have extensive experience in clinical trials and preferably this team should have worked together on previous trials. The team will require a strong, experienced leader/director, preferably, although not necessarily, with a clinical background. There must also be strong expertise in study coordination, clinical operations, and in data management.

Applicants will describe the availability and proposed use of appropriate facilities and equipment required to successfully perform the work requirements.

  1. Cost Criteria

The applicant will complete the DRCR.net VFRC budget document enumerating all costs to be incurred by the DRCR.net. The budget will outline costs on a per testbasis including any other relevant overhead costs.

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