UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE OFFICE OF FACULTY AFFAIRS AND PROFESSIONAL DEVELOPMENT ONSITE MONITOR GUIDELINES FOR CONTINUING MEDICAL EDUCATION ACTIVITIES
GENERAL The following synopsis details certain University of Maryland School of Medicine (UMSOM) Office of Faculty Affairs and Professional Development positions and requirements. It seeks to insure UMSOM’s compliance with current ACCME and AMA guidelines as well as internal policy. The reason for the accompanying questionnaire is to be certain that the reviewed activity adheres to these guidelines as well as providing helpful information for planning future events. CME MEETING ROOM A meeting area should be exclusively reserved for the educational activity. If necessary, this space can include meeting coordination needs such as registration, evaluation, certificate awarding, and required record keeping/transmittal duties. However, ideally these functions should be outside the meeting room. No commercial displays, signs, logos, banners, or other forms of commercial presence should be in the meeting room itself. CME REGISTRATION DESK AREA The registration desk should be free of commercial ambiance (personnel and/or materials). It is reserved solely for education support endeavors. Under no circumstances should commercial representatives be involved in any of the registration, evaluation, certificate granting, or other educational implementation procedures. As noted above, the registration area, if possible, should be outside the meeting room. When authorized by the UMSOM Office of Faculty Affairs and Professional Development, third party organizers, convention staff, or other designated individuals may conduct the onsite educational management of the course. The registration process should consist of the participant signing or initialing his/her name on the typed list of pre registrants. An Attendance Roster should include the preregistered participant’s name, degree, degree year, specialty, address (including city, state, and zip code), are code, telephone number, and social security number (for record keeping purposes only). Onsite registrants whose names are not on the preregistered list should print their name and the above information legibly on an onsite signin sheet and sign or initial after their name. Name tags, registrant packets, modest pens, notepads, agenda, evaluation forms, outlines, syllabi, information on modest meals and social events, etc., are the only items that should be provided at the registration desk unless preapproved by the UMSOM Office of Faculty Affairs and Professional Development. COMMERCIAL EXHIBITS, DISPLAYS, AND PUBLIC RELATIONS These should be conducted in another room or in a distinctly different area. At the very least, there should be a separate table away from the registration site for the commercial support personnel. No question should arise in the registrant’s mind that the educational component is completely autonomous. REFRESHMENTS, BREAKS, MEALS The refreshments, breaks, meals and social events should not overshadow the educational purpose of the activity. No alcoholic beverages may be served prior to or during a CME activity. No commercial displays, signs, logos, banners, or other forms of commercials presence should be in the dining area itself. AMBIANCE, AMENITIES, AND SOCIAL EVENTS These, including gifts to registrants, should follow established AMA and ACCME guidelines and standards. So called “social events” should be minimal and limited to the attending doctor and their spouse (or other companion). All social events or similar activities should be reasonable in cost and impact. Any variations in these stipulations must be preapproved by the UMSOM Office of Faculty Affairs and Professional Development.
UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE OFFICE OF FACULTY AFFAIRS AND PROFESSIONAL DEVELOPMENT ONSITE MONITOR GUIDELINES FOR CONTINUING MEDICAL EDUCATION ACTIVITIES
TARGET AUDIENCE Target audience should be identified on any posters set up in the hotel.
UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE OFFICE OF FACULTY AFFAIRS AND PROFESSIONAL DEVELOPMENT ONSITE MONITOR GUIDELINES FOR CONTINUING MEDICAL EDUCATION ACTIVITIES
RECORDS The onsite meeting coordinator(s), the designated Activity Director (i.e. UMSOM faculty), or the UMSOM OnSite Monitor should be responsible for collecting and transmitting the required records (registrations, evaluations, etc.) directly to the UMSOM Office of Faculty Affairs and Professional Development. These materials should not be processed or transmitted by commercial support persons or their designees. This includes third party organizers unless prior approval is obtained from the UMSOM Office of Faculty Affairs and Professional Development. EDUCATIONAL AND SPEAKER’S QUALITY VISÀVIS COMMERCIAL INFLUENCES The course should be monitored for educational excellence in the same manner as any UMSOM CME event (i.e. in terms of needs, goals, meeting objectives, method(s) of teaching, including audiovisual/printed materials, adequate evaluations, record keeping, etc.). Particular emphasis should be placed on evaluating whether any real or perceived bias occurs from the commercial support, onsite activities, speaker’s presentations, or in any other way. The absence or existence of speakers’ commercial affiliations or relationships should be disclosed in an appropriate manner. Speaker adherence to guidelines and standards for using drug names and/or equipment should be noted as well as his or her success in meeting the stated objectives. • Generic and Trade Names Presentations must give a balanced view of therapeutic options. Faculty use of generic names will contribute to this impartiality. If trade names are used, those of several companies should be used rather than only that of a single supporting company. • Reporting Scientific Research Objective rigorous, scientific research conducted by commercial companies is an essential part of the process of developing new pharmaceutical or other medical products or devised. It is desirable that direct reports of such research be communicated to the medical community. An offer by a commercial entity to provide a presentation reporting the results of scientific research shall be accompanied by a detailed outline of the presentation, which shall be used by the accredited sponsor to confirm the scientific objectivity of the presentation. Such information must conform to the generally accepted standards of experimental design, data collection, and analysis. • Unlabeled Uses of Products When an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose is discussed during an educational activity, the accredited sponsor shall require the speaker to disclose that the product is not labeled for the use under discussion or that the product is still investigational.