Project Initiation
Anyone may request that the ASTRO ETC assess a device or procedure related to radiation oncology.  The ETC will review proposals, from any stakeholder or at its own initiative, and select technology for ETC assessment. 

• Any stakeholder interested in initiating an ETC project may communicate with the ASTRO staff contact to request an application. Completed applications will be forwarded to the ETC Monitoring Subcommittee (MSC) Co-chairs for review and recommendation to the ETC. A decision by the ETC regarding initiation of a project will be made and communicated to the applicant within 60 days of application submission [link to application]
• Projects may be initiated directly by the ETC.
• Initiation of new projects will be at the sole discretion of the ETC, unless the ASTRO Board of Directors requests that the ETC initiate a project.
• Board of Directors will be notified of all projects as they are undertaken.
• When considering a project, the ETC may consider questions such as but not limited to the following in making its decision:

• What is the device or procedure and the issue in question?
• Does the prevalence or anticipated prevalence of the device or procedure warrant the development of a technology report?
• Are there existing documents or studies on the technology of the proposed device of procedure?
• Is there uncertainty /controversy about the relative effectiveness of the device?
• The ETC will meet monthly to review all proposals submitted to the ETC and approve or reject any proposals. The ETC may determine to assess a specific device or procedure individually or to batch a functionally similar group of devices or procedures together for evaluation. An initial decision not to initiate an evaluation project at a specific time may be revisited by the ETC at a later date at its discretion.
• Individual devices or devices within “families” that have been previously reviewed, with reports issued, will not be revisited for full review for a minimum of two years, except in extenuating circumstances, to be determined by the ETC or the Board.

Project Implementation

1. All approved projects will be directed by the ETC with delegation to the ETC Evaluation Subcommittee (ESC). Timelines for individual projects will be determined by the ETC.
2. Project Task Groups will be convened by the ESC Co-chairs who will be responsible for appointing Task Group members and Task Group Leader(s) (TGLs). When considering potential Task Group members, Chairs will seek to identify a team that will be able to provide a balanced, objective, accurate, comprehensive and timely report.
3. The Task Group will typically consist of five to 10 members. Task Group members may include:
   • Experts familiar with the medical device or procedure in question.
   • At least one non-academic based physician.
   • Additional experts as needed.
   • Consideration should be given to including a resident/fellow.
4. All ETC committee and subcommittee members will fill out ASTRO’s standard Conflict of Interest Disclosure Form which are reviewed by the ETC Committee Chairs. ETC Committee Chair forms, like all ASTRO Committee Chair forms, are reviewed by the ASTRO Conflict of Interest Committee. In addition, prior to project commencement, each Task Group member, and each ETC member will receive a Conflict of Interest Disclosure Form on which they must indicate any and all real or potential conflicts related to the particular device or procedure as a supplement to the standard ASTRO Conflict of Interest form. Copies of the signed forms are reviewed by a designated ETC Conflict of Interest Primary Reviewer who will determine whether any real or perceived conflicts exist and if so, whether an individual should be excluded or other measures taken to address any potential conflict. Typically, the Primary Reviewer will be one of the ETC Committee Co-chairs, however, if in any instance, both ETC Co-chairs are recused from a particular project, a Primary Reviewer shall be appointed by the ASTRO Board or by the Chair of the ASTRO Conflict of Interest Review Committee.
5. The ETC, in consultation with individual TGLs will determine anticipated project completion dates. These dates represent only potential targets and ultimate project completion will be at the discretion of the ETC.

Report Development

1. Project Scope and Objectives:  The Task Group’s objective will be to produce an objective, comprehensive, balanced, accurate and timely assessment of the new or emerging technology. Within that overall framework, it shall define the project’s specific scope and objectives. In determining these, the Task Group may consider the following:
   • What is the health technology?
   • What is the purpose of the device or procedure?
   • Who are the intended users of the device or procedure?
   • What are potential benefits and risks for patients who use the device or procedure?
   • What other studies have previously been made concerning the device or procedure?
   • Is the device or procedure safe and efficacious?
2. Data Collection:  Based on the project scope and objectives, the Task Group will define key search terms and conduct an independent and comprehensive data search concerning the device or procedure at issue. The data search will include, but is not exclusive to literature review. The Task Group may also collect and consider any general product information concerning the device.
   • Task Groups will have the ability to request input, assistance or data from ASTRO membership or from outside of the Society (including vendors and/or developers) as appropriate and necessary for satisfactory completion of their assignments. Appropriate disclosures shall be made with respect to any sources utilized in the assessment.
   • The ETC, in consultation with the Co-chairs of the ESC and individual TGLs may determine target dates after which no additional new data will be reviewed and after which no newly developed devices or procedures in that category will be considered. The ETC may incorporate relevant publicly published materials into the assessment after such target date if practicable. Target dates will be posted on the ETC page of the ASTRO Web site.
3. Interpreting and Synthesizing Data:  The Task Group will review, summarize and evaluate the compiled data.
   
   
4. Analysis and Findings:  Based on its data assessment, the Task Group will analyze the device or procedure and make findings regarding technology development, application, safety and efficacy, and utility of the device or procedure. 
   
   
5. Document Drafting:  A primary drafter(s) will be chosen by the Task Group. The primary drafter will be responsible for drafting and revising the document for ETC review and comment. All reports in various stages of preparation will carry the statement: This document is a work in progress and is not approved for circulation, citation, or submission.
   
   
6. Report Section Headings:  Unless otherwise directed for a specific project, the Task Group will prepare and present reports using the general section headings:
   1. Use of Technology
   2. Description of Technology
   3. Summary of Existing Evaluations on Device or Procedure
   4. Assessment of Existing Evaluations
   5. Description of Patient Benefits from Technology Use
   6. Description of Patient Risks from Technology Use
   7. Analysis and Technology Assessment Findings
If appropriate, the report may also include an executive summary.

7. Document Review, Revision and Approval:  Each Task Group member will review the initial draft and submit his or her suggestions to the full Task Group. The full Task Group will then convene to discuss the draft, re-examine the original goals regarding the scope of the report, and make any recommended revisions. After the Task Group completes its initial draft review, the Task Group will present the revised draft to the ETC. The ETC will then review the draft and make comments and recommendations to be addressed by the Task Group which will then prepare a revised version for ETC consideration.
     
8. Legal Review:  Upon completion of its review, the ETC will distribute the report to in-house and/or external legal counsel for legal review. Counsel will review the report for any legal concerns.
   
   
9. Final Approval and Dissemination:  Following receipt and incorporation of various comments, the ETC will meet to consider formal approval of the report for presentation to the Board for review and approval. Until and unless the Board determines otherwise and makes appropriate delegation, all reports must receive final approval from the Board before publication or any other dissemination of the report. If operating on an expedited timeframe, reports can be approved by the Executive Committee.