Committee Minutes - Research Associates   RESEARCH ASSOCIATES COMMITTEE (January 2008) Theresa Thomas, M.S., CCRC, Chair Announcements New Chair: Roseann Bonanni introduced Research Associate's Committee New Chair: Terry Thomas. Terry Thomas presented a plaque and bracelet to Roseann for her contributions to the growth of Research Associate's Committee. Research Associate's Reception will be from 6-7 pm in Room 3152. Drive for new committee members. Contact Terry or subcommittee chairs if interested. Committee Reports Education: Norissa Honea Need Research Associate's to join Education Committee. Only two members at this time. Scientific Session "Symptoms Clusters: Concepts, Measurement and Opportunities for Research" at 1 pm today. Membership: Bonnie Sauder New members please fill out enrollment forms and send to Bonnie. Membership form is available in Research Associate's Reporter. Working on updating Research Associate's database and email addres Research Strategy: Heather Tharpe Mr. Martin Pellinat, the CEO of Vision Tree Software, Inc., will discuss a pilot ancillary study using an electronic Quality of Life data Collection tool for the top enrollers for RTOG 0415. The top 5 enrollers on RTOG 0525 are invited to participate in a Leap of Faith Pilot Study. This study is to improve pill compliance and AE reporting. Working on a new study of rash for patients receiving RT and cetuximab. Need new members and welcome ideas or concept for new studies. Disease Discipline: Joanne Ciconte Gayle Mallon was introduced as the Co-Chair. Need new members to review protocols and provide feedback during protocol development phase. Also need updated current member list. Working on new guidelines to better define protocol reviewing process. Quality Control: Joyce Neading There were 134 audits performed in 2007. There were 24 of them which were not acceptable. Most major deficiencies were data delinquent greater than 6 months. RTOG needs paper copies of source documents for audit. Poster Contest: Julie Jester is replacing Deb Olsen as the Chair. Poster Contest Travel Award in honor of Joanne Stetz will be presented in summer meeting. The contest guidelines will be broadcasted. Mentor Program: Darlene Johnson Continue to recruit experienced Research Associate's as mentors. Qualifications include more than 5 years experiences as a Research Associate and association with a full member institution or an affiliated institution which enrolled more than 5 cases per year. Contact Darlene for more information. Headquarters: Stephen Dorian Need Research Associate's to assist in CaBIG™ initiatives. CaBIG™ stands for the Cancer Biomedical Informatics Grid™. It is an information network enabling all constituencies in the cancer community - researchers, physicians, and patients - to share data and knowledge. Committee members will need to attend teleconferences. Please let Stephen know if you are interested. There were 34 RTOG studies have one or more web base forms at this time. RTOG uses front-end edit check to reduce queries. Pre-populated labels are available for Research Associate's to print out on site. Web based forms are linked to CTCAE Version 3 metric system for AE reporting. Research Associate's need to enter AE terms, not 8 digit codes. It will be populated to metric version. Headquarters is working on deleting others-specify. Headquarters will send updated information through RTOG broadcast list, not mailing to Principal Investigator or Research Associate. Study sites need to use Ops Tools to review CRFs status. 90 days overdue is a minor deviation and 6 months overdue is a major deviation. Research Associate's need to document why the CRFs are late. The Research Associate's training in January had 18 participants from 11 states, Korea, and Canada. Next training session is in April. Communication: No report Guest Speaker: Mr. Martin Pellinat, the CEO of Vision Tree Software, Inc., presented a pilot ancillary study using an electronic Quality of Life data Collection tool for the top enrollers for RTOG 0415. Heather Tharpe is representing Research Associate's Committee in this study. Participating sites will attend a training session 2-4 pm today. RESEARCH ASSOCIATES COMMITTEE (June 2007) Roseann Bonanni CTR, CCRP, Chair Call to Order: Meeting called to order by Roseann Bonanni CTR, CCRP, Chair at 12:00 pm. Announcements: Pass the Hat: RA committee is taking collections during business meeting to support RTOG Foundation in the name of RA committee. RA seminar cancelled. RA reception at 6:30 pm. Committee Reports: Membership: No report Research Strategy: Heather Tharpe Julie Jester is replacing Lisa as the co-chair. Heather provided an update on the study "The Use of Acidophilus. Supplements for the Treatment of Oral Thrush in Head & Neck Cancer Patients Receiving Radiation Therapy. Ginger study for Radiation- Induced Emesis in Patients Receiving Large Abdominal Field Radiation Therapy: Haven't heard any updates on the status of the study. Will take this study off the committee list. Committee is looking into studies related to a cream to prevent Cetuximab rash, massage therapy, and relaxation. Contact committee members for concepts or ideas. Communication: Roseann announced the last RA Reporter is posted in RA Corner on the website. Poster Contest: Deb Olsen RTOG has approved of the Poster Contest Travel Award in honor of Joanne Stetz. Joanne was the Director of Data Management at RTOG. She was instrumental for many senior RAs. Will have the contest next summer. $800.00 will be awarded for attending educational meeting. Deb has developed a guideline for the poster contest. Look for the next RA Reporter for more information. Headquarters: Stephen Dorian RA training: There will be four in house RA trainings through 2008 (Oct 2007, Jan 2008, April 2008, and Oct 2008). The ones held in October 2006 and April 2007 had positive feedbacks. Data management: New version of calendar was announced via RTOG broadcast in May. Update user's guide V2 is available. Need feedbacks or ideas for improvement. Web forms: RTOG now has designated IT staff to develop web forms. All newly activated studies after July will be 100% web data entry. Forms are linked to the proper dictionaries for specific studies. It's required to use web data entry for those available web forms. Will continue to get queries from RTOG. For the audit, need to print forms or fill them. It was suggested to expand comment field. Steve will follow up with this request. Contact ACRIN for concerns or questions related to ACRIN forms. RAs could attend ACRIN round table discussion. Disease Discipline: Joanne Ciconte Larry Korman presented the results of the Acuity/Complexity Analysis Project. The presentation will be posted at the RA Corner on the website. The Acuity tool is not finalized. Education: Norissea Honea Norissea announced the symposium for H&N cancer. RTOG 435 will be reviewed during the meeting. The RA panel attendance is down and the committee is looking for ideas to increase the attendance. The Executive Committee has asked to move the RA Panel to Thursday so RAs could attend the symposium. It was recommended to move the panel back to Friday. Roseann will discuss these issues with the Executive Committee and headquarters. The committee is looking for committee members, ideas, or suggestions. AD HOC Committee Reports: Quality Control: Joyce Neading Joyce reported RTOG audit results: 7 acceptable, 24 acceptable but need follow-up, and 11 unacceptable. Most problems with IRB issues or late form submission. Study sites using EMR are required to print out paper copies as source documentation. If the audited institution is an affiliate of a full member institution or CCOP, all new patient registrations will be suspended from both the full member/CCOP and the affiliate/CCOP component. Mentor Program: Darlene Johnson Contact Darlene as needed. Will connect new RAs with senior RAs. New Business: PI/Study Chair workshop: RTOG provides in house two-day training for PIs and study chairs. Three senior PIs from Jefferson attended the training and highly recommend other PIs to attend the training. RESEARCH ASSOCIATES COMMITTEE (February 2007) Roseann Bonanni, Chair Committee Reports Headquarters: Stephen Dorian Case registration; RA's were reminded to only press "submit" icon once when registering a new case to protocol. A confirmatory email will be sent from HQ. Web data collection/remote data entry; 18 studies now have partial web data collection tools in place. RTOG 0525 has complete data collection via web in North America. Initial Evaluation On-Study Form (I1) is next form slated for web entry. RA's were reminded to print confirmatory email of submission. Data revisions should be submitted via data form or query form as applicable. Patient status: The F1 form should be utilized to submit survival data i.e. alive or death status. If status is unknown, a general Communication form should be submitted documenting attempts to contact. Resend General Communication Form after 3 year period to request form suppression. AdEERS; a reminder was made to submit form within 24 hours of SAE. AE CRF should be reconciled with AdEERS. The CTEP may be contacted for content related or technical support. A new edition of CTCAE MedDra 9.0 is available. Withdrawal of Consent; form applies to patients who withdraw consent to every portion of study, including follow-up. This form has no influence on data previously collected. Calendar; a new and improved OPS tool will be available as of January 31, 2007. A broadcast to general membership after the winter 2007 meeting. RA's will be able to request patient calendar by study number, specific study and case number, or due date. RA Training at HQ; first in-house sessions were held October 26-27, 2006. The next session that can accommodate up to 25 RA's will be held April 12-13, 2007. Interested parties may contact Steve Dorian, Wendy Bergantz, or Mary Gramkowski, via email for additional information. Cancer Biomedical Information Grid (caBIG); availability of high level overview for current, new or prospective participants is available at www.cabig.nci.nih.gov Roseann Bonanni announced addition of other reports in written format only via minutes or RA Reporter due to time limitations posed by request for presentations by two physicians related to their respective RTOG studies. Research Strategy: Heather Tharpe Heather provided the status of proposed RA based studies. Heather and Joyce Neading are continuing their study efforts involving "The Use of Acidophilus Supplements for the Treatment of Oral Thrush in Head & Neck Cancer Patients Receiving Radiation Therapy. To date one patient has been enrolled to the study. The status of study; Ginger for Radiation-Induced Emesis in Patients Receiving Large Abdominal Field Radiation Therapy, designed by Susan Provins is withdrawn. Attempts to reach Susan have been unsuccessful. Research Associates Research Strategy meeting, February 2, 2007 will feature presentation by Clement K. Gwede, Ph.D, M.P.H., R.N., on supportive care protocol development. Membership: Bonnie Sauder No report. Communication: Jane Gardener Jane announced the last RA Reporter did not get posted in RA Corner on the website. She has not heard back from email communication with Sharon Hartson-Stine. A copy of the newsletter will be forwarded to Roseann Bonanni. She will contact Tom Wudarski regarding issue. Steve Dorian requested copy of RA Reporter also be forwarded to him. Disease Discipline: Joanne Ciconte Joanne announced the final draft of the Acuity/Complexity Analysis Project is complete. Larry Korman, Project Coordinator, plans to attend Summer Meeting to present results. AD HOC Committee Reports: Quality Control/Education: Joyce Neading Joyce reiterated that Dr. Curran requests that all RA's attend Friday, February 2, 2007, Symposium; Benchmarking Your RTOG Accrual: Where Your Institution Stands and Strategies for Improvement. Research Associates Seminar will feature presentation on RTOG Audit Program. Mentor Program: Darlene Johnson Darlene introduced new CTMB guidelines to be discussed in depth at RTOG Audit Program on February 2, 2007. <\li> a.     two unsatisfactory institutional audits will result in that respective facility being assigned a mentor. RA Resource Manual is undergoing revision by Jane Gardener. Call for RA membership to submit appropriate materials to her as soon as possible Elaine Boyle will forward template for Action Plan, in response to unsatisfactory audit, for inclusion in manual.<\li> Poster Contest: Deb Olsen No report. New Business: Introduction of Paul T. Sperduto, M.D., RTOG 0320 Study PI, to RA Committee Business Meeting attendees. a.     Dr. Sperduto reviewed schema of RTOG 0320 and highlighted most recent amendment for the group. He encouraged members to assist in recruitment activities. Introduction of Hak Choy, M.D., RTOG Lung Committee Chair, to RA Committee Business Meeting attendees. a.     Dr. Choy provided overview of locally advanced NSCLC and use of RT alone versus combined modality therapy. b.     review of clinical research issues including optimizing chemoradiation therapy; comparison of sequential and concurrent treatment, optimizing radiotherapy; STDF versus IF, integration of molecular imaging via RTOG 0235 & RTOG 0515, and follow- up study considerations involving recruitment to RTOG 0214, SWOG 0424 (RTOG endorsed). c.     introduction of soon to be activated RTOG 0617 Announcements by Roseann Bonanni a.     Resignation of Sharon Byrne, RA Committee Secretary, announced. A call was made for interested individuals to contact Roseann Bonanni. b.     RTOG Foundation collection will be held at summer meeting. c.     Members were reminded of the RA Reception this evening. RESEARCH ASSOCIATES COMMITTEE (June 2006) Roseann Bonanni, CCRP, Chair Meeting called to order by Roseann Bonanni, CCRP, at 12:00 pm. Joyce Neading requested to give her report first due to a conflicting meeting. Committee Reports Quality Control: Joyce Neading Joyce gave the following report from the meeting. 8/49 audits were acceptable 30/49 were accepted with follow-up 11/49 unacceptable Headquarters has a decrease in auditors. Physicians from Quality Control Committee have volunteered to go out on audits. Audits packets are being sent out by email. CTSU is having an impact on audits. CTSU is developing an audit manual to assure GCP’s are being followed and written SOP’s data collection and data management are in place. Cooperative Groups are establishing guidelines for data delinquency. Any data >6mos will be considered a major deficiency; 3-6mos a minor deficiency. ITC reports that RTQA office will be responsible for chairs to review contours remotely. RPC is asking RA’s to encourage their Physics department to return TLD’s in a timely manner. The Medical Oncology Committee is recommending the RTOG QC Committee form a Pharmacology Committee. Steve Dorian stated CaBig has a SOP template on their web site Education: Norissa Honea Norissa announced the Panel Discussion was well attended and encourage everyone to attend the Scientific Sessions. This session would be on RTOG#0421. Each of the study chairs will give a presentation. Membership: Bonnie Sauder Bonnie had no report. Research Strategy: Heather Tharpe Heather announced that Liz Elliott’s Biafine study was published in the May, 2006 edition of JCO. She stated her study the Use of Acidophilus Supplements for the Treatment of Oral Thrush in Head & Neck Cancer Patients has IRB approval. She does not know the status of the ginger study at McGill since Susan Provins relocated. Roseann stated she spoke with Dr. Souhami from McGill and he stated unless someone at his institution has an interest in the study it would be dropped. Heather made call for RA ideas for future protocol concepts and invited new member participation on RA Research Strategy Committee. Disease Discipline: Joanne Ciconte Joanne announced the pilot phase of the acuity scoring should be completed by August, 2006. She asked any RA interested in serving on the committee to contact her. Communication: Jane Gardener Jane stated they are still attempting to resolve the RA Reporter issues. Roseann stated she is hoping to meet with Tom Wudarski and Sharon Hartson at this meeting to address these issues. Mentor Programs: Darlene Johnson Darlene had a conflicting meeting. Roseann asked RA’s who have an interest in serving on the Mentor committee to send their resume’ to Darlene. Interested RA’s need to have 5 years or more of experience Headquarters: Stephen Dorian Steve presented the following: 11 studies now have data collection forms on the web. RTOG 0525-all forms will be on the web Web forms-print off your confirmatory email; there are 2 data forms-one is only a summary data form-make revisions on the “data form” only. Use the F1 when you know the patient is alive or deceased with no other information. Complete the remainder of the questions with “unknown” Use the general communication form when the patient status is unknown. Document all attempts to locate the patient. The K3 form is being phased out. Remember to initiate the AdEERS within 24 hours. Withdrawal of consent-form has been revised. Submit form only if the patient withdrawals from all parts of the study including follow-up. Calendar-soon sites will be able to print off their forms due calendar. Cooperative Groups have a CRA panel in development to standardize data entry system for all Groups. Poster Contest: Deb Olsen There are 3 poster entries at the meeting from Princess Margaret, Moffitt Cancer Center and Summa Health Systems. New Business Roseann introduced Eleanor Walker, MD, Co-Chair of the Clinical Trials Education and Recruitment Working Group. Dr. Walker stated the purpose of the committee is to assist with recruitment. She asked for volunteers to serve on this committee and stressed this is truly a working group. There is a great deal of work involved. RESEARCH ASSOCIATES COMMITTEE (January 2006) Rosanne Bonanni, CTR, CCRP, Chair Call to Order The meeting was called to order by Roseann Bonanni CTR, CCRP, Chair at 12:00 pm. She announced the RA Committee would once again support the RTOG Foundation by asking members to make a nominal donation. Joyce Neading, RA Steering Committee member will collect funds during this session. Roseann extended thanks on behalf of Dr. Wally Curran and the Foundation. Committee Reports Roseann announced the resignations of Sharon Prokop and Susan Provins as co-chairs of the Education Committee. She thanked both for hard work and commitment. Education: Susan Provins In turn, Susan thanked her entire committee for their dedication. She announced Terry Thomas and Narissa Honea would assume co-chair positions for the committee. The membership was informed the Research Associates Panel Presentation speakers would include Jeannette Y. Wick R. Ph, MBA from CTEP/NCI and Dani Zajac RN BSN OCN, H. Lee Moffit Cancer Center & Research Institute. The topic for the session is "Managing Oral Investigational Agents. Susan also announced the RA Scientific Session, "RTOG 0412: Everything You Need to Know" would be presented by Maria Werner-Wasik, MD and Benjamin Movas, MD. Susan announced a $500.00 donation to the RA Committee from Dr. Souhami, from McGill University. The donation will be added Foundation monies collected during the 2006 RA Business Meeting. Membership: Bonnie Sauder It was reported the CRA database is available as a resource to members. They should contact Bonnie as they need a contact number or have a revision in contact information. A question arose from the membership about the database being available on the RTOG web site. This will be explored, in the meantime, Bonnie will bring hard copy of database to summer 2006 meeting. Research Strategy: Heather Tharpe Heather introduced herself to membership as new RA Research Strategy Chair. She shared information about committee activities including: Biafine Study completion and study results currently in publication process. (Elliot, L.) Ginger for Radiation-Induced Emesis in Patients Receiving Large Abdominal Field Radiation Therapy (Provins, S). Pilot to be conducted at McGill. Ginger supply is procured. Study will then be turned over to Research Associates Committee to present to RTOG for consideration. The Use of Acidophilus Supplements for the Treatment of Oral Thrush in Head & Neck Cancer Patients Receiving Radiation Therapy (Neading, J & Tharpe, H.) The study will be presented to their respective IRB in February 2006. They will propose RTOG study consideration, during this meeting, to Dr. Larry Berk at the Research Strategy Committee meeting. Heather made call for RA ideas for future protocol concepts and invited new member participation on RA Research Strategy Committee. Disease Discipline: Joanne Ciconte Joanne announced the continuation of work of the Acuity/Complexity Research Protocol Scoring Tool. A second test run of revised tool is forthcoming. She asked for seasoned RA's volunteers to assist in review. It was asked if members have concerns or questions related to opening new trials, to contact Joanne or Roseann Bonanni. Communication: Jane Gardener Jane apologized to membership the last issue of the RA Reporter did not go out due to technical difficulties. She is working on resolution to problems so an edition will come out prior/post summer 2006 meeting. Members may contact her to request archived copies of newsletter. Quality Control: Joyce Neading Joyce shared key points shared from the Quality Control Committee meeting; Protocol amendments need to be submitted and approved within 90 days. There is currently a 12% rate of non-compliance identified from RTOG audit activities. Unacceptable audits have decreased 50% in the last period. Pharmacies need to be reminded to return NCI supply drug at study closure. Source documents to support eligibility need to be available to auditors. Related to survival eligibility, the PI can document and sign a statement that patient meets criteria. Physics departments should follow-up with ITC/ATC re: digital submission of pre/post treatment plans. There has been 0% error in plans for NSABP B-39/RTOG 413 thus far. The Quality Control Committee requests a general session for all RTOG related personnel including PI's and RA's at future meeting. Mentor Programs: Darlene Johnson Darlene informed the group she is receiving notification of institutions scheduled for upcoming audits so Mentors can offer a prospective assistance Program. The group is also available to address low accrual and low quality score issues with members. Please email her with requests. Headquarters: Stephen Dorian Stephen Dorian was introduced to the group at large. He welcomed ideas from the Research Associates Committee related to improving data management policies and procedure. Stephen presented a CD program highlighting issues from Headquarters. These included; Pilot testing a combination AO/ I1 registration form Follow-up forms (F1) in production for 6 prostate studies, F1 in development for 7 additional studies, two F1 forms are in the testing phase. RTOG 0525 has entirely web-based entry The General Communication Form is in revision. They are streamlining instructions and providing more space for documentation. There is a motion to have all Intergroup studies utilize standardized forms. He is included in the committee working on this. Membership is reminded there are both a technical and content related Help Desk available at Headquarters for questions or concerns. It is asked that RA's minimize coding of AE's as "other, specify" on the ADEERS reporting. They should refer to various resources available to choose best term for reporting. He also informed membership as of April 2006, all grades 5 AE's will identically categorized. Stephen took questions from the audience related to CIRB/CTSU issues and timeliness of posting information to coincide with RTOG broadcasts. Poster Contest: Deb Olsen Deb announced posters will once again be accepted 4-6 weeks prior to the summer 2006 meeting. A grant of $800.00 toward travel/educational expenses will be awarded. The next issue of the RA Reporter will provide a review of poster presentation. New Business Roseann asked members to please complete a hard copy of the Protocol Recruitment. Survey prior to leaving this afternoons meeting if they have not yet done one on-line. Members were also reminded of the RA Reception this evening. RESEARCH ASSOCIATES COMMITTEE (January, 2005) RESEARCH ASSOCIATES COMMITTEE (June 2005) Roseann Bonanni CTR, CCRP, Chair Call to Order Roseann Bonanni, Chair, called the meeting to order at 12:00 pm. She welcomed attendees and announced the RA Reception would take place following conclusion of the day’s events on the 33rd Floor of host hotel. Tickets, which are required for entry to reception, were disseminated to the group. Roseann announced the resignation of Jackie Fisher from the Research Associates Steering Committee. On behalf of the committee and the entire RA membership, she expressed thanks to Jackie and recognized her enduring commitment and dedication to RTOG and the Research Associates Committee. Committee and Ad-hoc Committee Reports Education: Susan Provins Susan recognized and extended thanks to speakers who participated in these sessions Research Associates Panel Presentation; “Drug Development: Use in a Cooperative Group Setting.” A total of 97 RA’s were in attendance. She announced the afternoon’s RA Scientific Session, “Collecting Adverse Events for Head and Neck,” would be presented by Andy Trotti, MD and Bonnie Sauder RN, BS, CCRP. Susan also extended thanks to members of the Research Associates Education Committee who worked hard planning and coordinating events. Membership: Bonnie Sauder Bonnie announced there are 485 members in the RA Database. She asked members to update their status on the on-line membership form in the RA Reporter. Research Strategy: Lisa Chin The status of current and proposed RA based studies was provided by Lisa who announced the committee met on 6/24/2005. Elizabeth Elliot’s, MRT, A Phase III Comparison of Biafine to Declared Institutional Preference for Radiation Induced Skin Toxicity in Patients Undergoing Radiation Therapy for Advanced Squamous Cell Carcinomas of the Head and Neck, RTOG 9913, has completed data analysis. A review will be forthcoming. Jackie Fisher’s Ginseng Study for Fatigue did not receive financial support for drug procurement and distribution. It is no longer considered for RTOG backing. Susan Provins is conducting a Phase I Study using Ginger for Radiation-Induced Nausea at her institution. She will present a concept and data to RTOG Gastrointestinal Cancer Committee for consideration in future. Joyce Neading announced Heather Thorpe, RA is presenting new protocol concept to the Symptom Management Committee at June 2005 meeting. The study involves use of Acidophilus Supplements for the Treatment of Oral Thrush in Head & Neck Cancer Patients Receiving Radiation Therapy. Disease Discipline: Joanne Ciconte Joanne announced that Larry Korman presented a slide presentation at the Disease Discipline Committee meeting on the status of Acuity/Complexity Analysis Tool developed by the committee. Larry explained the tool was developed to determine the level of expertise and staffing needed to manage specific protocols. Larry disseminated copy of the scoring sheet to the group which included the following sections; 1. Trial Details 2. Study Activation 3. Patient Enrollment 4. On-Study Procedures 5. Follow-up 6. Miscellaneous Activities The total score on the tool can range from 14-65 and will assign one of three complexity levels to a study. The next step in tool development is validation. Joanne and Larry are seeking experienced RA’s with expertise in all areas of protocol development to assist in efforts to test validity of tool. Interested parties are asked to contact Joanne or Larry. The aim is to have the tool validated by the January 2006 meeting and present the finished product at the June 2006 conference. Roseann announced the resignation of Larry Korman from the Research Associates Committee and RA Reporter effective post-June 2005 meeting. He will continue to assist with the above Acuity/Complexity Scoring Tool project until completion. Jane Gardener reiterated how much Larry will be missed and asked that submissions to the RA Reporter be forwarded to her attention. Roseann thanked Larry for dedication and hard work on the Reporter and assistance with the acuity scoring project. Quality Control: Joyce Neading Joyce reported 58 audits were conducted in the past 6 months by RTOG. A total of 14 were deemed unacceptable. Areas of concern were shared with the group at large. They include: 1. IRB Amendments- please make sure all amendments are submitted are submitted to respective IRB within 90 days. 2. Pharmacy Review- unacceptable variations included missing data on drug logs and return of study drugs upon protocol closure. 3. Study Drugs- Guidelines for Study Agents can be found on RTOG Website and are part of audit manual. Please review. 4. Radiologic Physics Center (RPC)- return of radiated TLD’s has been untimely. Please communicate with respective Physics Department. Joyce announced a Multi-disciplinary Training Session to address Quality Control is being planned for fall 2005. Announcements will be forthcoming. Mentor Program: Joanne Ciconte Joanne questioned audience members regarding their awareness of committee, its purpose and contact information. Based on response, Joanne updated participants on above and announced requests for mentoring services should be referred to Roseann Bonanni, c/o Thomas Jefferson University Hospital for the next few months. Poster Contest: Deb Olsen Deb announced to the group the receipt of the June 2005 poster contest award is Joanne Ciconte from the Radiation Oncology Department at Thomas Jefferson University Hospital in Philadelphia. The poster on display at the Registration Desk Area addressed the Annual IRB Renewal Process. Joanne was congratulated by the group on receipt of $800.00 in travel funds toward the upcoming Winter 2006 RTOG Semi-Annual Meeting. Headquarters: Elaine Motyka-Welsh Elaine provided an RTOG Headquarters Update that addressed Web Registration, Data Collection, Web-based Tools, the RA Corner, Notification of Discontinuation of Participation Form, updated Adverse Event Guidelines 2005, and the new General Communication Form. She provided an informative Power-Point presentation outlining each of the topic areas in more detail. 1. Web Registration- Institutions should receive an e-mail confirmation of patient registration with an AO attached upon randomization. Please contact Tech Support if assistance is needed or no confirmation is received. 2. Web-data Collection- Two prostate F/U forms are available via web. These include the F1 for RTOG 0126 and 9910. Additional study forms are being retrofitted and should be available in the future including F1 for RTOG 9601, 9406, 9408 and 9413. Elaine reminded the group patient calendars are available on website, as well as, institutional and study accrual reports. 3. RA Corner- A variety of materials from several sources are available in this location i.e. Audit Manual, RA Reporter, Investigator Brochures, Label Template, and link to CTSU. 4. Updated AE Guidelines- CTEP revised guidelines 2/1/2005. Group was reminded AdEERS is now used for all serious adverse event reporting. Report must be filed in 5 versus 10 days. 5. Notification for Discontinuation of Participation Form- Instruction Sheet and form (CW) can be found on website under Miscellaneous Forms category. 6. General Communication Memo- A new form is available on our website. It includes a space for a patient label. All are reminded this form is not to be used to communicate about dosimetry or pathology items, nor for missing QOL tools. RESEARCH ASSOCIATES COMMITTEE (January, 2005) Roseann Bonanni, Chair Call to Order Roseann Bonanni, Chair, called the meeting to order at 12:00 pm. She introduced a guest speaker, Andy Trotti MD, who would be sharing information and asking for groups input regarding Toxicity Reporting. Guest Presentation Toxicity Reporting: Andy Trotti MD Dr. Trotti, H. Lee Moffet Cancer Center, introduced the membership to a study constructed by Clement Gwede RN, Ph.D and himself entitled; “Proposal to Improve Safety Data Collection & Reporting in Clinical Trials.” The AREO Committee Proposal will be submitted to RTOG in the future. Dr. Trotti presented a detailed overview of the study; it’s purpose and design to date. He then asked the RA members for suggestions to assist in developing a more consistent and standardized approach to safety data collection and toxicity reporting. Suggestions made by group members included; a. delete pre-coding and include a section in the protocol to highlight what adverse events/toxicities should be monitored. b. utilize study consent form and construct individualized institutional based “working” form prior to transcribing events to study specific data collection form. c. utilize layman friendly self-reporting questionnaire on SAE’s. d. continue to provide hard copy data collection forms with both direct and open combination adverse event recording. Dr. Trotti ended presentation by asking the RA’s to give consideration to the issue and forward comments via email to Roseann Bonanni or himself. Committee and Ad-hoc Committee Reports Mentor Program: Darlene Johnson Darlene asked that members contact her, via email, if they are available to assist new or seasoned RA’s with audit preparation or any other issues. She also stated the RA Support Manual would be revised and asked for assistance from interested members. Education: Susan Provins Susan announced excellent multidisciplinary attendance for the RA Panel Presentation; “Current Modalities for Treatment of Primary Brain Tumors.” She requested any members interested in assisting in the planning process for the June 2005 Scientific Session and Panel Presentation contact her ASAP. Membership: Bonnie Sauder It was announced the RA Database has 445 members. New RA’s were asked to complete the registration form in the back of the RA Reporter. Bonnie provided a review of the top five states as far as RA membership. They are as follows; Florida- 44, Canada-43 (from 16 institutions), Pennsylvania- 39, New York-37, and California-35. Research Strategy: Jackie Fisher Jackie announced the committee met this morning. She reviewed the goal of the committee is to focus on RA based research questions, proposed on a day-to-day basis, and assist in the construction of proposals to answer these questions. The status of current and proposed RA based studies was provided. Jackie’s Ginseng Study for fatigue is still viable and seeking funding for distribution. Susan Provins will be conducting a pilot study of her Ginger Study for Nausea at her institution and presenting it to the RTOG for consideration at the June meeting. A research question under consideration for protocol development was presented to the group. It addressed Acidophilus supplemental for treatment of oral thrush in Head & Neck Cancer Patients. It will be discussed in more detail by potential investigator at next session. The committee will provide small working groups at the June 2005 meeting on Thursday afternoon. All RA’s with ideas for study are invited to attend. Disease Discipline: Joanne Ciconte An increase in the number of RA’s in attendance at last meeting was noted. Joanne shared current objectives of the committee. They include; review of developing trials by RA’s, sharing of information with the membership through the RA Reporter and continued development of the acuity-scoring project. She asked anyone interested in participating to contact her. Communication: Larry Korman Larry reviewed the publication schedule for the RA Reporter and announced that February 24, 2005 is the deadline for submission for the next publication. He reiterated Primary RA’s are responsible for submission of reviews from the Disease Discipline sessions. Otherwise, all members are invited to submit information, they feel is helpful or beneficial to the membership as a whole, via E-mail to either Jane Gardener or himself. Quality Control: Claire Brooks Claire cited the large number of unacceptable audits in 2004, which were discussed at the Quality Control Committee Meeting. She reviewed two frequent areas of deviations were IRB related; annual renewals not being submitted on time and amendments received over the 90 days cut off period. It was asked that RA’s be more attentive to these issues. New Investigators: Joyce Neading Joyce announced attendance at this group is recommended for all new physician investigators. Andy Trotti MD, spoke at the last session about his opportunities as an investigator in RTOG and how he became actively involved. Mitchell Machtay MD, outlined the role of new investigators and answered questions from the audience. Poster Contest: Deb Olsen Deb announced to the group the call for poster presentations for the June 2005 meeting and an award for educational travel funds is provided to the winner. A reprint of the article on guidelines for constructing a poster presentation will be published in the next RA Reporter. Headquarters: Elaine Motyka-Welsh Elaine provided an RTOG Headquarters Update that addressed web registration, data collection and web-based tools. She reminded members to utilize Technical Support for questions/concerns. Contact information can be found on the website. Web-based data collection was started in November 2004 for F1 collection on RTOG 0126. Institutional and Study-Specific accrual tools are available via web. Brenda Young, ACR, gave an update on Web-based initiatives this morning. It was noted by Elaine bar codes have been removed form patient submission labels. A template is available on-line for creation of labels rather than waiting for mail requests to be processed. Patient Identification information cannot be altered from existing format i.e. change from existing full name to patient initials. Any request from member institutions to do so requires a written request from the institution specific Regulatory Office (IRB). It must be on institutional letterhead and be submitted with reason to Brenda Young at the ACR. A broadcast regarding the process is forthcoming. Effective February 1, 2005, the CTEP will provide revised AE Guidelines. In summary, reports must be filed within five (5) calendar days, as opposed to working days. Headquarters is attempting to get a representative from the NCI to come and address this and other guidelines at the June 2005 RTOG Semi-annual Conference. A new development being constructed by Headquarters is a withdrawal from Study Consent Form. It should appear as a miscellaneous form on website and will attempt to clarify if study participant is having follow-up from other source or entirely withdrawing from study. The latter will cause data to become null and void. RTOG Foundation Joyce Neading announced a collection for contributions to the RTOG Foundation would be taken up at this and future winter RA Committee Business Meetings. Participation is voluntary and all funds will be donated to the Foundation from the Research Associates Committee membership at large. RESEARCH ASSOCIATES COMMITTEE (June, 2004) Roseann Bonanni, Chair Chair’s Report-Roseann Bonanni, CTR, CCRP Roseann reported that the RA’s collected $150 for the RTOG Foundation at the January meeting. Dr. Curran sent her a thank you letter on behalf of the Foundation. She stated Kristine Symes has resigned as secretary of the RA Committee. Roseann asked for volunteers to contact her. Membership–Bonnie Sauder has been on medical leave and just returned to work last week. No Report. Disease Discipline-Joanne Ciconte Joanne stated she had an excellent working meeting. The committee worked on developing the acuity complexing score tool. They worked on two existing protocols. Research Strategy–Lisa Chin for Jackie Fisher Lisa reported RTOG 0319 currently has 29 patients enrolled, expected enrollment is 226. Jackie Fisher is still trying to obtain financial support for her Ginseng trial for fatigue. Susan Provins is developing a ginger trial for nausea in patients receiving radiation therapy. Communications–Jane Gardner/Larry Korman Jane and Larry are solicitating for articles, ideas and questions for the Reporter. The deadline for article submission for the next edition is July 31, 2004. The Reporter will continue to profile individual institutions. Send updates to Jane or Larry. Education–Sharon Prokop/Susan Provins The RA Panel discussion was on adverse event reporting for NCI trials and pharmaceutical trials. The scientific session was on breast cancer. Quality Control–Elaine Motyka-Welsh for Claire Brooks Compliance for dosimetry is stable. Auditors are finding deficiencies with institutional pharmacies in the inventory records. Looking to develop a pharmacy committee. New Investigators–Joyce Neading Elaine Motyka-Welsh stated the New Investigators Committee meeting had 12 attendees with presentations from statistics and Joanne Ley from Headquarters. Headquarters–Elaine Motyka-Welsh Elaine reported the move is taking place soon. There will be a skeleton staff on July 9th and the computer system will be off-line on July 11, 2004. All studies activated from now on will have mandatory web registration. Pre-existing studies will be mandatory by January 2005. Fax data pilot is now ready. Five sites will be targeted. Adeers has a new version, which allows adverse event reporting for commercial drugs, radiation therapy and surgery on newly activated studies. RTOG will adopt this as the only AE reporting system. Poster Contest–Deb Olsen Deb stated no posters where submitted for this meeting. She will place a reminder in every issue of the RA Reporter. Mentor Program-Darlene Johnson Darlene explained the Mentor Program exists of experienced RA’s who are available to go out and assist institutions who have low data quality scores and are experiencing problems in general. The Research Associates Committee had developed a RA resource book that was funded by an educational grant from Bristol Myers Squibb Oncology. The Mentor Program has been given the charge to update this book. The book contains sections from Headquarters as well as tools developed by field CRA’s. Darlene stated she will include information on obtaining various degrees and certifications in the book. The RA steering committee suggested placing this resource book on the web site. RESEARCH ASSOCIATES COMMITTEE (January, 2004) Roseann Bonanni, CTR, CCRP, Chair Membership – No Report Disease Discipline - Joanne Ciconte Committee members continue to be active in the protocol review process for developing trials. Interested CRAs are welcome to join the committee and are encouraged to do so. Roseann Bonanni stated that Dr. Curran supports Research Associates input in the protocol development process. Research Strategy – Lisa Chin New concepts for CRA generated trials are encouraged. Communications – Jane Gardner/Larry Korman Roseann Bonanni complimented Larry Korman and Jane Gardner on the recent RA Reporter. A call for articles for the RA Reporter was made. The new format is designed to increase the shared information among the members. Appreciation to Sharon from Headquarters for formatting the publication. Education – Sharon Prokop/Susan Provins New members of this committee were introduced: Terry Thomas and Lisa Chin Clinical Research Associates are encouraged to attend the educational sessions. Quality Control – Claire Brooks IRB renewal notices will not be coming from Headquarters in the future. All sites must take responsibility for keeping current with an internal system. New Investigators – Joyce Neading Members are urged to have their new PIs attend this informative meeting. This is an opportunity to become involved in RTOG. Seed money is available for laboratory research and PIs are encouraged to apply for consideration. Headquarters – Elaine Motyka-Welsh As Director of Data Management, Elaine now reports to the Statistics Senior Director. Presentation of news and updates included review of rules for withdrawal from study, case status designation changes, web registration issues, and on-line access to patient calendars. There is to be a Data Fax Pilot initiated in five test sites. Emphasis on reporting of AE/SAE information was stressed. There is a 24 hour telephone reporting availability by calling 215 717-2762. MedWatch forms can be faxed to (215) 717-0990. Marie D’Amico is the new regulatory officer. RTOG Headquarters offices are relocating to 18th and Market Streets in Philadelphia in July 2004. Concerns were addressed regarding the accountability of CTSU for timely processing of regulatory documents. This area will be further explored with RTOG management. CTCAE 3.0 effective with implementation of new studies started 10/1/04. RTOG 0118 was the only study that needed to be amended to the CTCAE 3.0. Poster Contest – Deb Olsen There will be a poster contest in June 2004 at the meeting in Washington DC. New guidelines will be published in the RA Reporter and CRAs are invited to participate in this event. RESEARCH ASSOCIATES COMMITTEE (June, 2003) Joyce Neading, Co-Chair for Roseann Bonanni, Chair Education - Sharon Prokop Co-Chair There are CEU's available for the Panel Presentation and Scientific Sessions. Topics of discussion are Cox 2 Inhibitors and Iressa, both of which should be excellent. Membership - Joyce Neading for Bonnie Sauder A reminder for the RA's to fill out the membership form in the RA Reporter. Research Strategy - Lisa Chin Co-Chair Liz Elliot's study of Biafine ®, for Head and Neck has gone to statistical analysis. Clement Gwede's Sandostatin study is at the NCI for final review. It may be open by the next meeting. Jackie Fisher's Ginseng study had a few changes; it was submitted in April. Sue Provins presented a concept for a protocol using Ginger to prevent nausea and had good feedback from the group. Dr. Berk invited the committee to attend his meeting on Integrated Oncology. Disease Discipline - Joanne Ciconte Attendance was good. If anyone is interested in becoming a member of the committee, contact Joanne or Larry Korman. The committee is in the final stages of the development of the "Acuity Complexity Scoring System." Communication - Larry Korman Articles are due at the end of July for the RA Reporter. The next issue will have pictures taken by Larry. New information is posted on the web pre and post meetings. Your comments or suggestions can be submitted to Larry. Ad Hoc - Joyce Neading The Ad Hoc/Executive Committee, formerly Corporate Relations, is no longer including a RA representative in the meeting. Joyce will be talking with Steven King about the RA's purpose on that committee. In the past, the RA committee obtained support from this committee to help provide lunches and support the functions of the RA committee. New Investigators - Joyce Neading Joyce was unable to meet with Dr. White in the morning. At the Steering Committee, Joyce planned to discuss with Dr. White ways of assisting new investigators in using RA's more cost effectively to help them enroll patients, rather than perform other functions that a secretary or clerical person could do. Headquarters - Joyce Neading for JoAnn Stetz JoAnn has stepped down from her position and will be working internally at RTOG on developing training programs. We wish her all the best and a special thanks to her for all her dedication and hard work. Poster - Deb Olsen There are four posters, three contestants. The posters are outside the meeting rooms. The next poster contest will be at the meeting in Washington, DC. Patient Advocacy - Joyce Neading for Roseann Bonanni At the Steering Committee, Roseann discussed the best area for patient advocacy to be involved would be at Disease Discipline and the Outcomes Committees. She plans to discuss this further with Hank Porterfield the restructuring of this committee. New Business - Dr. Elizabeth Gore, is the new Principal Investigator for the Lung studies and has obtained backing from all the CCOP groups for RTOG 0214. Maryanne Dzibela from John F. Kennedy Hospital in Edison, NJ asked for volunteers in completing a survey being developed by ONS. RESEARCH ASSOCIATES COMMITTEE (June, 2002) Roseann Bonanni, Chair Education: Sharon Prokop Reported that there was good attendance for the morning panel discussion. The Scientific Session will be discussing "Human Subjects Ethical Concerns" and "International Guidelines to Clinical Practice." The committee is asking for topics for discussion or suggestions for speakers. Membership: Bonnie Sauder New RA's needed to submit their contact information. The form is available in the RA reporter. The database now has a list of 391 members. The top 5 states for RA membership are the following: FL-38, NY-36, CA & PA- 35 each, Canada-27, NC-24. Since the last meeting 10 new RA's registered. Research Strategy: Lisa Chin (for Jackie Fisher) The following studies are in the developing stages at HQ awaiting statistical review: H/N Biafine ® study, the Ginseng study for fatigue and the Sandostatin study for GI sequelae. Jackie Fisher could not be present. Some good ideas were discussed in the meeting for potential studies with Ginger and Music Therapy. Dr. Berk is encouraging any CRA to develop any ideas and that the CCOP PI Committee would be willing to support new concepts. Disease Discipline: Joanne Ciconte The committee is looking at ways of evaluating the complexity of developing studies and how to grade or score it in relation to time involved, compensation, logical, and adequate case credit compensation. The committee asked if any RA who may have been tracking time at their own institution to share their thoughts or concerns. This information may be helpful in developing a tool that may facilitate ways to evaluate future studies. Contact Joanne Ciconte by phone or e-mail. Communications: Kathy Drotar The committee is trying to develop a network for RA's who can be contacted with specific problems. Their goals are to have problems sent via email and use the network of individuals to help problem solve. Questions can also be submitted in the RA reporter. Mentoring: Darlene Johnson (unable to report) The RA committee does have a resource book and they are presently looking at revamping it. RA Reporter: Larry Korman The reporter will now be on the new RTOG website. By using it as an educational and communication tool, the RA Reporter can be used as a good resource to seek out or offer advice. Anything you would like to contribute or see in the reporter can be submitted to Larry Korman. The deadline for the next report is July 31st. Corporate Relations: Joyce Neading At the last meeting, a request was made for funds and a suggestion was made for the committee to write a grant and submit it to RTOG. The exhibitors provide funds to support the meeting, such as the lunch supplied at today's meeting. At the next meeting, 50/50 raffle tickets will be sold in an effort to help assist the needs for funds to support the RTOG Foundation. New Investigators: Joyce Neading Dr. Gore presented and discussed how studies develop. The committee teaches RA's and MD's how to write protocols and how to get involved in the research process. They also reviewed the roles of particular individuals. Quality Control: Clare Brooks The committee is developing guidelines from the NCI for institutions that do not pass audits. Headquarters: Roseann Bonanni (for Joanne Stetz) RTOG 98-01 needs all forms due for the analysis being conducted. Forms are due by September 1st. The Data Quality Scores are in: for Full Members and Affiliates heading the list is Medical Center of Wisconsin with 96% and 2182 forms submitted and Dartmouth scored 97% with 1138 forms. Gulf Coast led the CCOP with a score of 99% and 121 forms submitted. Other Business: Lisa Chin was recognized as the winner of the poster contest. She received a $750 educational award to be used to attend an educational meeting. So, start working on those poster ideas for the next meeting. Susan Provins from Montreal announced that she was able to convince the physicians at her institution to donate $500 to the RTOG foundation in the name of RA committee. RESEARCH ASSOCIATES COMMITTEE (January, 2002) Rosanne Bonanni, Chair General Updates: Linda Vocila moved to Phoenix AZ. Joyce Neading new representative of the New Investigators Committee. Clare Brooks resigned as chair of the Mentoring Committee. Darlene Johnson has taken over as the Mentoring Committee Chair. Committee Meeting Updates: Membership - Bonnie Sauder She is collecting names of new members to add to the member list. Currently there are approximately 400 members. A membership form can be found in the RA Reporter. Be sure information on the form is clear and in large print. Forms can be mailed or faxed. Disease Discipline - Joanne Ciconte RA's interested in reviewing developing studies can contact Joanne. The critiquing response to these studies has improved and these efforts are greatly appreciated. It is important to submit these reviews promptly to Headquarters. Liz Elliott is in Africa and Jean Bremnick has moved to Saudi Arabia. Education - Dani Zajac and Sharon Prokop The committee is interested in any ideas for future speakers as well as suggestions for obtaining speakers that are willing to volunteer because honorariums are not available. The committee welcomes your feedback regarding the panel presentations from the meeting and any suggestions for future topics of discussion. Communications - Kathy Drotar Round tables from last session went well. All of the RTOG resource manuals have been distributed. If anyone is willing to donate his or her manual to a new research associate can contact Kathy. If you have any new information for the next manual submit it to Kathy. News Letter - Larry Korman The deadline for articles for submission in the next RA Reporter is March 1st. As always, articles, tidbits, websites, pictures, helpful hints, jokes, experiences, etc. are encouraged. The RA Reporter would like to expand on its ideas and purpose. Research Strategy - Jackie Fischer RTOG 99-13 will reach it target accrual probably by April of this year. There was discussion of the Metamucil for GI toxicity study, which has undergone changes made by the NCI. It is now using Octriotide (Sandostatin) for the prevention of Chemo-induced diarrhea in patients with Rectal and Anal Cancer. This study will be presented for further discussion at the Chemoprevention Meeting. Lisa Chin presented a concept for a new QOL study examining the needs of patients and their caregivers, which was well received. She was encouraged to present the concept as a new developing study. The Ginseng study is pending statistical analysis from the NCI. Corporate Relations - Joyce Neading They are trying to be more creative in its' attempts to raise money for educational funds. If anyone has any suggestions contact Joyce. There is a planned discussion at the New Investigators meeting regarding the Mentoring Committee and ways to utilize this committee more effectively. Mentoring Program - Darlene Johnson The new chair is Darlene, who is in the process of re-organizing the program to assist institutions with improving data quality. Support groups are available to new RA's and encouraged. Contact Darlene with and questions or suggestions. Quality Control - Clare Brooks No updates. New Investigators Committee - No updates. Headquarters (from Joann Stetz) There are 33 full members with 20 institutions have data quality scores above 90% The Medical College of Wisconsin was recognized for its efforts with 2349 forms due and a data quality score of 96%. The Cross Cancer Institute had the highest overall data quality score of 97%. The CCOP institutions recognized Gulf Coast and New Bryant with 97% DQ scores and Christiana Care Health System with 543 forms due and a score of 96%. Other Business: The Research Associate Committee collected donations in an effort to support the RTOG foundation and its' activities of the group. Moneys collected help to provide funding for travel for RA's to attend conferences, towards training programs, funding for the website, and projects that are not supported by the NCI. A special thanks to RTOG for providing the wonderful lunch at the Research Associate’s Committee Meeting. Thank you, Headquarters and Dr. Curran. RESEARCH ASSOCIATES COMMITTEE (November, 2001) Roseann Bonanni, Chair Kathy Drotar Communications: Round Table Presentation was well received It was pointed out that there was no space for a signature on the attendance sheets. A handout was distributed soliciting input, questions, and articles for the RA Reporter. RAR - possibly will be distributed via e-mail in the future. Please complete a membership form if you have not been receiving the Reporter. Work is underway to develop a system to enhance communication among all RA members. *** July 31, 2001 *** Deadline for RA Reporter submissions. Lisa Chin Research Strategy: Lisa covering for Jackie who could not attend this RTOG meeting. RTOG 99-13 is doing well with accrual. Ginseng study is "in the wings" - be watching for more information. Metamucil study has been submitted to NCI and some modifications are pending. The Vitamin study presented by Darlene may be revived. Dani Zajac Education: Panel Presentations were well attended. Everyone encouraged to attend the afternoon presentations. Joanne Ciconte Disease Discipline: Has a vacancy to cover the Soft Tissue Sarcoma meeting. Any interested RAs should contact Joanne or Larry. Submission of articles to the Reporter noted to be excellent for the recent edition. Roseann Bonanni Membership: Hozefa has resigned from his position at Moffitt. A new Membership Chair will be appointed. Joyce Neading Corporate Relations: Concerns regarding prescription coverage and drugs not being provided for trials was discussed. Canadian issues were raised as being unique in this area. Jane will provide Joyce with a list of pharmaceutical issues for the Canadian members. Linda Vocila New Investigators: Reminder that all new investigators are on this committee for 18 months. The information shared with these physicians has been recently updated. Roseann Bonanni Headquarters: No one from HQ in attendance at this meeting. One announcement that was made concerning the resignation of Elaine Pakuris from her position as the Director of Development and Regulatory Affairs. General Announcements *Grant renewal feedback - looks good for the next six years. *Thanks to Dr. Walter Curran and Tom Wudarski for the lunch at today's meeting. *Panel Presentation at 5:30 for Research Associates Seminar today. *RA Reception begins at 6:30 - all are invited to attend. *Sandy Leonard is no longer with ACR as our meeting coordinator. *QA Physics concerns with communication between MD Anderson and Institutional Physics will be addressed at the Medical Physics meeting today. *Poster Competition has been approved to award an educational fund award. This competition will be at the summer sessions. Kathy Drotar is this meeting's winner. RESEARCH ASSOCIATES COMMITTEE (June, 2000) Roseann Bonanni, Chair Education – (1) Presentations to be held at this meeting: Cancer Clinical Trials: A National Perspective, presented by Andrea M. Denicoff, and Orientation to the Clinical Trials Support Unit (CTSU) presented by Detra Robinson. SoCRA credits available and CEU’s applied for. (2) Frederick Schmitt, Ph.D. from University of Kentucky will be conducting a training/certification course for Neurocognitive Assessment Tests. This will be a mandatory prestudy assessments of patients being considered for RTOG BR-0018, A Feasibility Study of Neuroconginitve Evaluation in Patients Treated for Brain Metastases. All participating institutions will be required to have a Certified Test Administrator prior to the registration of any patients to the study. Future workshops to be conducted at RTOG annual meetings. Membership-Clement Gwede: There are currently 330-registered research associates in the membership database. Clement announced that he would be relinquishing his position as Chair effective immediately. The new Chair will be Hozefa Divan. This should be a very smooth transition since Hozefa and Clement work together at Moffitt Cancer Center. Research Strategy-Jackie Fischer: (1) Ginseng study vs placebo for lung/breast/prostate has a developing number. (2) Clement Gwede is assisting with a new study utilizing Metamucil for radiation enteritis in patients receiving pelvic radiation. (3) Liz Elliott’s Biafine study for head and neck should be opening in the Fall. Disease/Discipline – Joanne Ciconte: There have been numerous changes, mostly all new members. (1) Letters were sent to all Chairs to have RAs introduce themselves at the committee meetings and utilize their expertise. (2) Developing protocols are being sent to RAs for review and critiquing. Guidelines about how to critique a developing protocol are available. It’s very important to return the review comments promptly to Elaine Pakuris at Headquarters. Newsletter – Larry Korman: The RA Reporter will have plenty of pictures in the next copy. Deadlines for data submission are August 15th and November. All are being encouraged to submit articles, stories, photos, news, tidbits, jokes, etc. Communication – Darlene Johnson: Letters will be distributed to all new principal investigators to obtain the name of the research associate at their site. Encouragement to complete a registration form to get on the mailing list. Kathleen Drotar plans to update the support list to assist new RAs on disease sites. Quality Control – Clare Brooks: The RA mentoring Committee met for the second time prior to this meeting. In the past six months, no requests for assistance have come. Discussions held regarding how to proceed when an affiliate asks for assistance. Full members should be approached first; then if unavailable, a request could be made to the mentoring committee. Some current issues that need to be addressed: cost issues, long distance relationships between affiliates and full member, and no limit to number of affiliates under the direction of a full member. To increase awareness among all institutions, plans for the next RTOG meeting will include; round tables for RAs, presentation at all orientations to new RAs. New Investigators – Linda Vocila the new Chair, will be doing presentations at the new investigators meeting. Headquarters – Joanne Stetz: (1) reviewing data forms to make them more similar across studies. (2) Many new faces at headquarters. (3) Discussion on the program that does the quality scores. Scores were lower among many institutions. Roseanne sent a letter to Dr. Cooper regarding this matter. Data Quality scoring is based on year-to-year. (One year Jan-Dec 1999) (4) Forms request is back in existence. Thank you Headquarters. New Business Canadian Institutions seem to have some unique problems dealing with protocols, lab value conversions, customs, and inability receiving NCI pamphlets (CTC version 2.0) and drug shipments. There are 14 institutions involved. Need to find liaisons to address these concerns. Poster Contest – Debbie Chavarriaga: A presentation to be done at the round table; to spark some interest. An award of $750.00 will be given to the prizewinner. Discussion how the money could be utilized as to travel expense for education vs paying for RTOG meeting attendance. RA Membership Committee – Roseann Bonanni: Attempting to have this meeting moved to a working lunch meeting with box lunches.