ARC Site Archives

Periodically, dated information that is deemed to be still of importance will be removed from other areas on the site and posted here. Please refer to this page whenever you need to find information which has been removed from other areas of the site.

• ARC Meeting Minutes
• IRB Task Force Meeting Minutes

Minutes

Tuesday 11 November 2003

Minutes:

Soo Bang, Director of the Office of Clinical Trials discussed some of the new initiatives that are being offered to PI’s and Coordinators

1. The staff of OCTD can assist with regulatory documents  for free to the investigator. Monies to do this can be negotiated up front from Industry. In addition the staff can assist with reviewing the regulatory binder, complete the `1572 form and help with consents. The PI must be responsible for the AE’s
2. The OCTD can provide outpatient space to conduct studies, space for the monitor and supply SOP’s if necessary. The office has some standard SOP’s in place.
3. The OCTD has created on the intranet a Research Tool Box that can offer information about budgets, pt services, regulatory and training.
4. In January, the OCTD will devise a study group for those who are interested in taking the CCRC exam. The test is in March 2004. In February 2004, there will be an initiative regarding recruitment.

Elan Czeisler, Director of IRB, reviewed some of the new projects for this year.

1.  To date new templates.have been posted on the website such as: Consents, registries, specimen banking. The 2004 schedules of IRB meeting is there too.
2. 2004 brings new challenges regarding the electronic submission process to which IRB is working very hard with the IT department and the new program called INFO ED. Till the we need to submit 13 copies 1copy for BH and 1 copy for GCRC. All cancer protocols must be reviewed by PRMC before going to IRB for approval.

Sharda and Ellie discussed with the group about the possibility of having a Central Office. There seems to be a need for this as our roles are becoming harder and more demands are place on coordinators. Our concern is standard of care for our patients and we need time to provide this. We also need to approach our research patients with GCP techniques, and have these policies in place across the board. The group voiced their opinions about this. We think we will have another meeting if possible in December to capture a larger group of coordinators.

Friday 21 February 2003

Minutes:

1. Elan Ceizler, Director of the IRB, came to meet the members of ARC and to discuss the new HIPPA (Health Insurance and Portability Act) compliant consent forms. The more common buzzword is PHI or Protected Health Information which must be in effect by April 14th, 2003. The new consent forms contain a paragraph that addresses the compliance of HIPPA, which requires permission from the subject to use their health information for research purposes. For chart review, you have to sign a release form before you can obtain anyone's health record. Training sessions will be set up for all personnel in research starting on March 3rd.2003. Future workshops will be scheduled for those who cannot make the March 3rd session
2. There will also be a new application form that should be on the web in the next few weeks, so watch for this. The IRB Website will have all the necessary forms for each hospital process, a glossary of medical terminology, and procedural terminology. If you need help you can call the IRB for assistance for consent forms and other issues. Please attend these sessions and remember you must use the HIPPA compliant consent forms by April 14th 2003.
3. Sharda Mc Guire, Chair of ARC, talked about trying to set up a round table. or "talk to the experts" session. A topic will be chosen and questions will be asked concerning the topic at hand. These kinds of questions would relate to issues in research that are not clearly defined or written and hopefully the experts would help answer them.
4. Ellie DeCandia, Chair of ARC, gave the group an update of job descriptions, which are not final in Human Resources. A flow sheet created by the educational task force has been accepted by Human Resources as a flyer to be handed out during orientation. In addition, the task force is discussing how to establish formalized training of coordinators. A piece about ARC was advertised in the Medical Affairs bulletin distributed in Tisch. A request was made for new members to join committees and we did add some.
   

Minutes:

1. Report Findings From The Educational Task Force: Rosemary Wein, RN. Three objectives were looked at by the group as a feasible plan to work on. The three are: job descriptions, mentoring program and tutorial. In the area of job descriptions, Ellie Decandia is working with Human Resources to look at the current descriptions available and to work with the group and HR to improve these. Through Nancy Sanchez, Director of HR, suggestion the educational task force will write a piece about ARC to be a part of New beginnings (all new hires must participate). To date we have not tackled the tutorial.
2. The IRB task force is waiting to meet the new director who has been recently hired.
3. The resource development/finance task force is steady now and keeping up with the new developments of the finance sub committee.
4. Research Oversight Committee Progression: Soo Bang, Director of Office of Clinical Trials Development (OCTD) gave us an overview of the clinical research oversight committee, which is hospital wide. Currently there is an 18 month plan to have certain issues operational. The issues at hand are numerous in terms of finance and accounts. Each subcommittee is addressing clinical trials issues, contacts compliance and billing. ARC members are involved in all the committees.
   • Finance sub-committee: Beau Gostomsky, RN
   • Compliance sub-committee: Pat Rentas
   • Administration sub-committee: Sharda McGuire, RN
   • Clinical Trials sub-committee: Soo Bang
5. Orientation To The Grants Office: Rise Schwab, Acting Director of OGARS gave us an overview of the grants office, its role and how they can help investigations. She showed us how to use their web site to find potential grant opportunities and hints on how to apply.
6. Data Safety Monitoring Plans and the Role of the RSA: Andrea Downey, RN talked about her role as the Research Subject Advocate in the GCRC. This role has been funded by NIH with the purpose to protect patients/clients on research protocols. To apply to the GCRC an investigator must have a data safety monitoring plan for the enrolled subjects that would include the various aspects of protecting patients rights/safety. For example how/who to report adverse events.

Minutes:

1. Sharda McGuire, chair of ARC,presented an overview of the events that took place since ARC began in July 2001. (handout) She also pointed out that our mission statement of a goal towards excellence in clinical trials seems to have evolved. Now more approiately to move towards excellence in clinical research.
2. Ronnie Landis, leader of the IRB task force, discussed the relationship between ARC and IRB and the focus of the IRB task force this past year.
3. Ellie DeCandia, chair of ARC discussed how Anton Saarimaki, systems manager for the GCRC, revised the ARC webpage, that included the face sheet and a separate section for IRB issues and updates. All the approved site- specific forms are on the IRB section our page. Ellie discussed the need to establish an education task force both for new and existing clinical research employees of NYU .An orientation program and job descriptions are two areas that need to be looked at.
4. Maureen Gomez and Meredith Anthony came to present the Mt. Sinai/NYUMC Website to us. Maureen reviewed the handout pointing out specific disease categories and the requirements to post and renew.Some issues of concerns were that the form was not interactive and could not be emailed to vernette owens. It was noted that it's difficult to locate the form on the webpage. Maureen was asked to investigate a clearer identification of the process.
5. Soo Bang, Director of Clinical Trials Development, was introduced to the ARC members for the first time. She presented slides that included her overall direction in this area and her strong support for education and development. She was encouraged to see that a forum such as ARC was in place, and plans on taking an active role in working with us to achieve our goals.
6. The group, by majority rule, responded to a directory list on the webpage as well as a employment page.
7. We asked for volunteers to sign up for the continuing IRB Task Force, the Education Task Force and the Resource Development and Finance Task Force. A separate page involving the activity of these task forces will be created.

Handouts:

ARC Yearly Review

Mt. Sinai/NYUMC webpage

Principles of ICH GCP

Training programs from Environmental Services

Copies can be obtained through Ellie DeCandia

Friday 1 March 2002

Minutes: Agenda items:

1. Recruitment Techniques by Maura Laverty RN ACTG Site Coordinator, was cancelled for this meeting and hopefully will be rescheduled for the next meeting.
2. Patti Gottdiener from IRB spoke about the results of 50 audits completed by the IRB quality assurance specialists. The protocols were randomly selected NIH and departmental studies. The results found issues of missing consents forms, missing adverse events recording and a host of protocol deviations. Some investigators welcome these internal audits and some do not. But it has been encouraged as a positive tool rather than a negative one. One interesting point was that the majority of investigators feel that their study coordinators are fully responsible for the study and that themselves and their co-investigators have minimum responsibility.
3. IRB is currently testing a new web program that will attempt to improve communications among study personnel and investigations.
4. Consent form language and translation is still being worked on by the IRB.
5. Ronnie Landis presented information from the IRB Task Force with the primary goal to open up communications so that both sides can clear and work out issues and concerns. We all agreed that the task force must continue in light of all the upcoming changes at the IRB. New members have been added, Rosemary Wein, Mary Soeding and Shirley Irons. They will be notified of their next meeting by Ronnie Landis.

1. The ARC members attending the meeting decided to introduce themselves in an attempt to get to know one another and try to make this group more personal.
2. Claudia Kaplan, Web Content Manager for the Mount Sinai NYU Health website spoke a little about how to put the studies and IRB approved advertisements online (www.msnyuhealth.org) for free. She will look into linking the Mount Sinai NYU Health website with the NYU SOM website (www.med.nyu.edu).

Friday 9 November 2001

Minutes: Agenda items:

1. Feedback about ARC email list and web site: Most members felt that the email list and web site was a positive approach in communication among coordinators. Anton Saarimaki, the GCRC's system manager, who also manages the ARC email list and web site was in attendance. He answered questions some group members had regarding the email list and web site.
2. Feedback about the IRB training course, Introduction to Coordinating a Clinical Study, held on 11/6/01: Some members felt that the course may have been too overwhelming for the novice. Others felt the material presented was information they already knew. The group agreed that it's probably not fair to judge until after the second course to be held on 11/20/01.
3. Results of questionaires complete at the first meeting: Sharda McGuire reviewed in depth the results of the questionnaires and some of the results were very interesting. The overall issues from the majority of the coordinators concerned IRB and recruitment. Contact Sharda for details.
4. Development of an IRB task Force. We asked for 5 volunteers from the group who would work with Patricia Gottdiener from the IRB to discuss issues related to the IRB review process. This group could either meet or communicate via email and report back to our group in February's meeting. The members can rotate after 3 months if they wished. Sharda McGuire created an outline to start the group going.
5. The next ARC group meeting will be in February 2002 (see the agenda above for details). Eleanor DeCandia will email the group in advance of the meeting as well as checking if Friday's are still good for all.

1. Christine Lema Foley, Environmental Services, talked briefly about IATA training for shipment of both diagnostic and infectious substances. If interested you can contact her at 263-5161. Environmental Services also offers a self-learning course on the web at www.med.nyu.edu/envservices/training/ship_training.html where you can become certified.
2. Vernette Owens told the group about the IRB's plans to purchase a new database system to manage the protcol review process that can better communicate information to both the investigators and the coordinators. Also a glossary of terms of language will be organized for consent purposes. She also talked briefly about the IRB's new web site www.med.nyu.edu/irb and email address ibra@med.nyu.edu.
3. Beau Gostomsky felt that a list of phone numbers of key personnel involved in clinical research be given to new coordinators as well as posted on the web site to help people navigate the NYU system. Eleanor DeCandia agreed to talk to Kathy Ames regarding new research hires.
4. Some members asked if they can post job opportunities on the ARC web site. It was agreed to initially try posting these directly to the ARC email list.

Friday 27 July 2001 (the first meeting)

Minutes:

1. Introduction to the group.
2. Needs assessment.
3. Institutional Board of Research Associates (IBRA) updates.
4. Mt. Sinai NYU Health Clinical Trials web site.
5. Review of General Clinical Research Center (GCRC).
6. Questionnaire and discussion.

IRB Taskforce
A subcommittee of ARC has been created to deal with issues realated to the IRB. It meets regularly with representatives of IBRA to discuss solutions to issues raised by ARC members. Below are the minutes of the first formal meeting. If you are interested in participating contact Ellie DeCandia.

Meeting Minutes Tuesday 30 April 2002

Attendees: Beau Gostomsky, Patti Gottdiener, Shirley Irons, Tracey Knibbs, Ronnie Landis, Lois Mannon, Pat Rentas, Mary Soeding, Rosemary Wein

The following is a compilation of items discussed at this meeting:

• Patti Gottdiener explained how the IRB's letters of communication are generated; created on Monday and Tuesday; posted by Thursday or Friday after the scheduled meeting.
• The group reviewed the new on-line tool for IRB correspondence.
• It was noted that "old and closed" trials be are still in the IRB database.
• Response for expedited reviews should be received within 2 weeks.
• Reiteration that a letter of Approval is necessary before any action, i.e., enrollment or advertising.
• Discussion about standardization of language especially concerning "genetic testing" ensued. Patti acknowledged the group's frustration and suggested contacting the respective board project managers concerning individual concerns or problems. There is no catch-all solution to the problem at this time.
• Due to the current climate of the FDA and legal action, with regard to clinical research, the Board is reviewing all items submitted, very carefully. It is the Board's responsibility to ask for changes on amendments, renewals, consents.
• During audits conducted by our IRB, the most common factor of non-compliance is "failure of Principal Investigator's to supervise".
• A complaint was registered that calls to the IRB staff, were not returned in a timely fashion. Patti suggested e-mail, with an explanation that an effort to reach someone numerous times was not acknowledged.
• The IRB will be conducting more workshops and will make them smaller and more interactive.

Requests for the ARC Membership

• It is believed that communication between the IRB and our organization has greatly improved. Please make every effort to implement this pathway.
• Known "old " or "closed" trials should be sent to the IRB so they can update their database.
• Coordinators should pass on to their Principal Investigators that it is the responsibility of the IRB to carefully scrutinize all items submitted.
• The taskforce finds a need for Principal Investigators to become more involved with regulatory issues involved with clinical trials. Our organization needs to find a way to communicate this and gain more support from them.
• The IRB welcomes all of your suggestions and invites anyone interested to participate in seminars given to coordinators.

Below you will find a call for abstracts listing with deadlines in
December, January, February and March. These are not all research
calls, many are looking for creative and innovative solutions to
practice problems and discussions of evidence based practice. If you or
any of your staff have an idea for an abstract submission, I would be
happy to help put it together.

Cheryl Holly
Director of Nursing Research
Cheryl.Holly@NYUMC.ORG

Month	Association	Deadline	Title	Focus	Comments
December	STT	12/15/04	Renewing Nursing through Scholarship	Evidence Based Preconference	Can be a protocol, standard, or ROL ---does not have to be a research study
	Pediatric Endocrine Nurses Society	12/10/04	Annual Meeting	Endocrine	Research or case presentations
	ONS	12/3/04	Annual Meeting	Palliative Care and End of Life Care	Sponsored by the Center for Palliative Care,Hospice and End of Life Studies
	New Jersey State Nurses Association	12/10/04 Deadline Extended	Annual Meeting	Nurses Working Together	Papers, posters, clinical issues, case presentations
	National League for Nursing	12/10/04	Annual Conference	Education	Clinical teaching and evaluation Evidence based teaching Evaluating Learning
January	MNRS	1/15/05	Advancing Clinical Research	Translation and dissemination of research findings to patients, staff, and policy makers
	Teachers College	1/15/05	Stewart Conference	Globalization of Nursing Practice and Healthcare Practice	Research and project presentations
	Association of Pediatric Oncology Nurses	1/2/05	Annual Meeting	Pediatric oncology	Can be research or educational session
	National Association of Clinical Nurse Specialists	1/14/05	Annual Conference	For master’s students in a CNS track	Clinical projects and innovations Clinical issues analysis
	STT	1/15/04	Scientific Assembly	Injury Prevention	Can be a workshop, educational session or research
	STT	1/19/05	Annual Convention	Clinical, Leadership, Scientific abstracts	Can be any of the above, a creative solution to a problem or a research study
	Amer Assoc for the History of Nursing	1/15/05	Annual Meeting	Nursing History	Must be research
	Emergency Nurses Association	1/15/05	Annual Convention	Scientific and Clinical Assembly	Can be research, clinical projects or injury prevention programs
	University of Arkansas College of Nursing	1/28/05	Annual Research Conference	Evidence for Practice	Paper and poster research presentations
	Association of Spinal Cord Injury Nurses	1/14/05	Annual Meeting	Advancement for Nursing Care	Research, use of technology, pediatric and geriatric SCI, Competency based practice End of Life issues Conflict/stress management programs for staff Clinical Pathways
February	Canadian Conference on Advanced Practice	2/28/05	Annual Conference	Advanced practice	Can be educational programs, research or practice guidelines
March	Emergency Nurses Association	3/28/04	Annual Conference	Leadership Challenges	New ideas, research, strategies for management, budget, staffing, etc

10/18/04

Sharda McGuire, co-chair of ARC talked about redirecting the focus away from the existing administrative issues to issues that concern the members . Some of the topics discussed include education, orientation, job opportunities, a central office, access to HIS. etc Sharda suggests that we should share information about what we do so that we can enhance our efforts towards group projects and spark interest in greater participation in ARC. The future format will ask volunteers to talk about a protocol or project they are working on that would be of interest to the group. A suggestion from a member alerted us to the fact many coordinators do not have access to the HIS system at Tisch. We will try to meet about this and get feed back to you.

Ronnie Landis, RN ; our first and gracious volunteer talked about a new procedure involving endographs for abdominal aneurysms. This procedure is less invasive for the patients and has less side effects.. As a research coordinator, Ronnie explained that she had to write a letter to Medicare as this new procedure did not have a CPT code or a way to bill. Ronnie would be a good resource for coordinators with similar problems.

Steven Aponte, Systems Manager for the GCRC, reviewed with the group some of the recent changes to the ARC website. You can now self-subscribe.. The ARC website will be adjusted to reflect the new format of the NYU website. Steven showed us a new feature of ARC called PHP Blackboard. This will allow the members of ARC to post job opportunities, educational displays, articles for discussion to name a few. We will have moderators to stimulate discussion openly or anonymously. Sounds like fun!

Elan Czeisler, Director of IRB, gave us a update of the new happenings at the IRB. They are piloting a new screening project that would allow the coordinator/PI to correct issues before the study gets reviewed. This must be done in a timely manner and the PI has to approve the corrections. This would greatly enhance the turn around time for some of the protocols submitted. There has been staffing changes in IRB as it seems that a new hire would be someone responsible for this above process. He informed us about the Bellevue committee. Ernesto Marrero, Director of Research at Bellevue is in the process of revamping the Bellevue approval process. There will be no more face to face meetings with investigators an electronic submission and hopefully a quicker turn around of the approval process. He is working with Elan and sending his employees to the IRB.

Ellie DeCandia co- chair of ARC talked about resurrecting a program that was worked on a year ago through the ARC educational Committee. This committee is meeting regularly to review the modules, thinking about mentorship program and should have this ready for ARC in a few months. It is aimed at new employees but with the capacity to build on modules to the program. We are searching the available grants in addition to meeting with the new Director of Nursing Research Cheryl Holley.

6/30/04
Attendance: 33 members

Agenda:

Sharda McGuire, FNP: Introduction to the meeting
Kathy Gallagher, Vice Dean of Administration
Steve Abramson, MD Associate Dean for Clinical Research
Jane Tsambis, MBA, Associate Dean for Sponsored Programs/Research Operations
Ellen-Hyman-Browne, JD, MPH, Director of Research Compliance
Ellie DeCandia, RN MA: Discussion and Conclusion

This meeting was an important step, one of many to follow, about informing the clinical coordinators of the School of Medicine’s New Clinical Research Initiative. This initiative involves a process of centralizing all research, that being NIH, departmental, bench, and clinical trials under one domain. It focuses on the team approach, by gathering the team, PI, Coordinator, Finance with OCT for a feasibility meeting up front prior to acceptance of conducting a clinical trial. Roles and responsibilities are defined and billing issues are addressed. (Satisfying: What is Standard of Care VS Research)

Ms Gallagher was very interested in the ARC group and was told previously that is was created out of a need to share information and to help one another. She was made aware that a formalized training and education program was non-existent. Ms Gallagher shared with the group her desire to change how we work in clinical research today and to make things better. She valued our input and was amazed as to how we managed to get things done with little or no assistance. One of the reasons for change is a direct result of billing compliance issues. Again, what is SOC vs Research?

Dr. Abramson discussed the idea of performing more translational research: bench to clinical. The central concept is to incorporate all research and to be excellent in all research projects. One of the ways to do so is by a mentoring program for young investigators, a clinical Masters program for research, training and educational programs and assistance with grants, awards etc.

Jane Tsambis, discussed briefly the process from beginning to end in the life cycle of a protocol. The focus was on the CTMS system in place. This is a research data base that the coordinators would use to input their studies and capture patient data/ schedules of events, etc. Moving forward this program would have billing codes on line, streamlined submissions, clinical research forms for inpatient/outpatient and much more. Education on this system will be forthcoming. The plan is to help investigators /coordinators make their work effort more efficient by having a central process.

Ellen Hyman-Browne introduced herself as the new Director of Compliance. She is a lawyer and has had past experience with research. She has made herself accessible to all who may have questions about any area in research. Some specific questions addressed included conflict of interest as well as human subjects, ethical considerations, and consent requirements.

Conclusion: The group remained for questions and some were asked of them. I wanted to bring to your attention the clinical research forms for inpatient/outpatient at Tisch. These forms have been used in the past and it alerts registration that the patient is a research subject. If you want to look at these forms they are on the OCT webpage under tools. I have used the inpatient tool and it seems to work well.

We will give all of you further information regarding training of CTMS and updates. We encourage dialogue between the coordinators and other key offices, departments, and persons involved in the research process. Please do your best to stay in the loop during this transitional period. Thank-you and please share this information with others.