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FAQ for Members
The RTOG is governed by the Executive Committee, the Full Member Principal Investigators, and an organization of standing committees. The scientific work of the Group is performed by the Disease Site Committees and coordinated by the Research Strategy Committee. The RTOG Constitution and Bylaws dictate the membership of the Executive, Research Strategy and Steering Committees. Membership in the individual Disease Site, Standing, and Administrative Committees is determined by the committee chair and dictated by the resources and expertise required to carry out the objectives of the committee. If an individual is interested in participation in a Committee he/she should contact the Committee Chair in writing through the RTOG Clinical Trials Administration Office at Headquarters. The roster for each committee along with the chair and co-chair is listed on the RTOG Web site and in the RTOG Semi-Annual Meeting book. How do I submit a concept for a new protocol? A complete discussion of the protocol development process and a copy of the Protocol Guidelines and the Protocol Concept Template can be found in the RTOG Procedure Manual. A brief description of the process is given below. Prior to activation, all protocols must be reviewed and approved both by the Group, through the committee system, and by the NCI. A procedure has been designed by Headquarters (HQ) to assist RTOG investigators in the development, review, and activation of an approved protocol. This procedure consists of five phases: (1) concept approval, (2) review and approval of the protocol among the Group members, (3) Headquarters review, (4) NCI review, and (5) protocol activation. The Director of Protocol Development and Regulatory Compliance, Linda Kish, and the HQ protocol development staff ensure that all RTOG protocols undergo the proper review procedures and that the final document adheres to the Group's Protocol Guidelines. Investigators who wish to have a protocol idea considered by the Group should first contact the responsible disease site committee chair and, if applicable, the appropriate scientific core committee chair (IMRT, Medical Oncology, Outcomes, Surgery, TRP, etc.). This is necessary to make sure that the concept and target patient population is not already assigned. If the idea is approved for consideration, the investigator then should complete a Protocol Concept Sheet and submit it to the HQ Protocol Development Department. The concept is assigned a study number and sent to the appropriate committees, the Statistical Department, and to other HQ staff (Data Management, RT Quality Assurance, and Regulatory Compliance) for review. An accrual survey is also sent to all of the RTOG Principal Investigators to help judge participation. The concept will also be reviewed and discussed by the appropriate committees at the RTOG Semi-annual meeting and during the disease site committee conference calls. If the responsible committee approves the concept, the committee chair presents it to the Research Strategy Committee for approval and prioritization. At this point the investigator, the study statistician and other HQ staff will begin working on developing a complete protocol and the necessary documents needed for submission to NCI by the RTOG Director of Protocol Development. It is also at this time that any contractual arrangements with protocol sponsors are finalized by HQ staff, and the data collection forms and procedures are developed. Once the study chairs, committee chairs, statistics, and other HQ staff approve the completed protocol document, it is submitted to NCI for approval. Phase III protocols must also be submitted to the NCI Central Institutional Review Board (CIRB) for approval. All protocols are submitted to the ACR Institutional Review Board for approval. The NCI reviewers frequently reply to submitted protocols with questions and concerns that must be addressed by study/committee chairs and HQ staff before formal approval is given. All correspondence to and from NCI is through the RTOG Protocol Development Department. Once NCI approval is granted, study chairs and HQ staff complete the final preparations for protocol activation. Who can attend the semi-annual meetings? The RTOG semi-annual meetings are open to all RTOG investigators and research associates. Registration materials for the meeting are available three months prior to the meeting on the RTOG Web site. Attendees are responsible for their own travel funding. Non-members who wish to attend should contact the RTOG Clinical Trials Administrator at RTOG Headquarters. What is the current reimbursement schedule for members placing cases on an RTOG study? Institutions are reimbursed for each patient placed on study to help defray the costs of the institution’s participation in clinical trials. This funding may be used to support data collection and reporting, patient management, and other clinic costs. Payments are processed monthly for all eligible cases. The current reimbursement schedule is:
What are the criteria for continuing to be a member in good standing? To maintain membership in RTOG an institution must submit the required patient data in a timely fashion, treat patients according to the protocol and RTOG published guidelines, and each year enroll the number of patients required by the institution’s membership category. The specific membership requirements are on the Web site and listed summarized below. The complete Evaluation Procedures are found in the RTOG Procedure Manual. Summary of Evaluation Procedures for RTOG Members The accrual and data quality scores of all RTOG members are reviewed twice yearly. The RTOG Membership Evaluation Committee reviews the Full and Provisional members, The CCOP Membership Evaluation Committee reviews the CCOP members and Headquarters reviews the Affiliate members according to the guidelines below. Following the review, the institutional Principal Investigator receives a copy of the evaluation and the review reports. Minimum Patient Accession Requirements If patient entry falls below the acceptable level the institution will be given a Warning Letter. If at the next six-month review accrual is still deficient the institution will be placed on probation. An institution can remain on probation for one year, but if it continues to have unacceptable accrual it will be asked to resign.
The overall Score of the following categories must be greater than 80% or a Warning Letter will be issued. If at the next six-month review the score is still below 80% the institution will be placed on probation. If at the time of the next evaluation, the problem is still not corrected the institution will be asked to resign. A Minor Deficiency warning is given if an institution falls below 80% in a particular category. 1. Patients entered on study found eligible & evaluable What is the difference between “cases” and “credits”? In general each patient placed on an RTOG treatment study earns one case credit. There are, however, exceptions to this rule. Some high priority or complicated studies may earn more than one case credit. Some cancer control or ancillary studies earn less than one credit. For a complete listing of the credits awarded per protocol contact RTOG Clinical Trials Administration at 215-574-4173. Where do I submit notice of IRB approvals and reapprovals? Beginning on January 6, 2003 all institutions must submit their IRB approval notices to the NCI Cancer Trials Support Unit (CTSU) – and not to RTOG Headquarters. The CTSU has developed the Regulatory Support System (RSS) database as a central repository for Cooperative Group regulatory submissions. This centralization will help the Cooperative Groups focus their efforts on the science of clinical trial development, and should alleviate much of the redundancy imposed on investigators and groups alike. The submission of data to the central regulatory office will streamline the process across all Cooperative Groups and will aid staff at member sites who currently submit regulatory documentation to several addresses, depending on their Group affiliations. The regulatory documentation to be collected and maintained by the central office will include all regulatory documentation currently submitted to the RTOG, including the following:
These regulatory materials should be mailed to: CTSU Regulatory Office The CTSU has developed an IRB Certification Form for use in submitting regulatory documentation. The form is available on the CTSU member web site http://members.ctsu.org/. The IRB Certification Form contains all the required data points necessary to process an IRB approval. The CTSU recommends that sites utilize this tool for their submissions. The Central Regulatory Office will accept other documentation (such as the HHS 310 form or IRB approval letter) only if it includes the following information: Institutional IRB assurance number The omission of any of these data points will delay the verification of site IRB approval in the RSS 2.0 database and may delay the enrollment of patients from your site. If I resign from RTOG, what are the expectations regarding patients enrolled in RTOG studies? Although you have resigned your membership in RTOG, both the Group and the NCI expect information to be submitted on study subjects. Furthermore, having consented to participate, study subjects will also expect that information continue. RTOG will continue to pay you for follow-up data on your patients. If your site reapplies for membership and there is a record of outstanding data, this information will be considered in your reapplication and will affect membership approval.
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