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Biostatistics Office Hours on Tuesdays in One Brigham Circle:
Tuesday, May 15 from 1 - 2p.m.
One Brigham Circle, CCI Conference Room 3-014B
BWH Center for Clinical Investigation Biostatistics Core and the Harvard Catalyst Biostatistical Consulting Program are providing Biostatisticians for consultation and guidance on Tuesdays. No reservation required, and it is free. Biostatisticians will answer your statistical questions, guide you to more in-depth support, and will be available for both short and long-term collaborations. Please come to One Brigham Circle, follow the signs for the Center for Clinical Investigation Conference Room 3-014B on the 3rd floor (pass the lunch room, turn right through double doors).
Upcoming Office Hours: 1-2p.m. in OBC, Room 3-014B
Office hour times may vary, so please make a note of the exact time of the office hour you plan to attend.
May 15, 22 & 29
IRB/QI Roundtable Series
These lectures are designed for all researchers and study staff who are submitting materials to the IRB. One lecture in each session will elucidate ethical and regulatory aspects of human subjects research and provide guidance on what information the IRB needs for review. The other lecture of each session will be presented by the QI Program to provide additional guidance, tools and practical tips on how to follow and apply these regulations in your research.
Attendees may choose to attend all sessions or can attend whichever sessions are pertinent to their learning needs. Please register for each session you wish to attend separately. Lecture descriptions and learning objectives can be found at the links below.
IRB/QI Roundtable Series Schedule: (Thursday afternoons)
Session 1:
New Submissions for Full Board Review 4/5 @ 2:30p.m.
Study Start-up 4/12 @ 2:30p.m.
Session 2:
Continuing Review & Amendments 4/26 @ 2:30p.m.
Source Documentation 5/3 @ 2:30p.m.
Session 3:
Protocol Adherence & Reporting Requirements 5/10 @ 1p.m.
Amendments & Reporting 5/17 @ 1p.m.
Session 4:
Informed Consent Process 6/5 @ 2:30p.m.
Consent Form Writing 6/26 @ 2:30p.m.
Sponsored by the Center for Clinical Investigation in collaboration with the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI)
Phlebotomy Training
Thursday, May 17, 2012 in One Brigham Circle, 4th Floor, Center for Nursing Excellence, Room 4-004D
Lecture from 8:30a.m. - 10:30a.m.
Hands-on Training will be divided into two 90-minute workshops (10:45a.m. - 12:15p.m. and 1:15p.m - 2:45p.m.)
Phlebotomy Training is available for research coordinators, assistants and study staff at BWH who draw blood on research subjects in clinical research studies. This training consists of a lecture on phlebotomy and observed phlebotomy on a simulation device and practice venipuncture on a simulation device.
Participants will be required to complete his/her clinical experience and validate competency under the supervision of qualified staff members within his/her own research settings.
Please note: practice draws on the simulation mannequin arm will not count towards the number of successful blood draws required to complete the phlebotomy competency assessment at their own research setting. .
More info about this program:
This training does not certify you to perform these tasks for your research study. If approved by the IRB in the protocol, the PI can delegate who can do what in the research setting. However these delegations should be consistent with state law and hospital policy. If the study is FDA regulated then the FDA has its own guidance relating to the delegation of authority in research studies.
Visit the Partners Human Research Office website for guidance on PI delegation of responsibilities. The Partners Human Research Quality Improvement (QI) Program is also able to assist and make sure that the delegations look reasonable.
Please contact Lisa Horton with any questions.
Sponsored by the BWH Center for Clinical Investigation (CCI) and the BWH Department of Nursing Center for Nursing Excellence.
Research Connection Live Lunch
Monday, May 21 from noon - 1p.m.
Carrie Hall, 15 Francis Street, BWH
Lunch will be served.
RC LIVE Lunches are open to all researchers at BWH and are connected to the RC email series. Each month, come by and listen to the latest news from BWH research community leaders, ask your questions and stay for a free lunch. Please RSVP online.
Hosted by the Biomedical Research Institute, Center for Clinical Investigation, Center for Faculty Development and Diversity, and Research Administration.
REDCap (Research Electronic Data Capture) Programming Training:
Next session: Tuesday, May 22 from 2 - 4p.m.
One Brigham Circle, Computer Room 4-014
In collaboration with the Harvard Catalyst | The Harvard Clinical and Translational Science Center, REDCap and REDCap Survey are free, secure, web-based applications hosted by the ERIS Team and designed to support data capture for research studies.
To learn more about REDCap visit: http://rc.partners.org/edcredcap. The Programming Trainings are two hour hands-on computer sessions to help REDCap users design databases and surveys. Learn about project life cycles, data management, and how to program data fields, branching logic, and calculations. Users should bring their forms and design questions.
Learning Objectives: Learn the different types of projects REDCap can support and how to program data collection instruments, code branching logic and calculated fields.
Target audience: Researchers that have evaluated and decided to use REDCap and/or have started a REDCap project.
Register on the BWH Events Calendar; there is limited space in these sessions. Capacity = 8.
Upcoming Sessions:
4th Tuesdays 2-4pm: 5/22, 6/26, 7/24, 8/28
2nd Tuesdays 9-11am : 7/10, 8/14
These trainings are co-sponsored by BWH Center for Clinical Investigation, Harvard Catalyst, and ERIS.
AE/SAE Notification Tool for Clinical Researchers
Thursday, May 31 from 3:00p.m. - 3:45p.m.
One Brigham Circle, Room 4-002B, BWH
The AE/SAE Notification Tool can be set up to automatically notify you if your research subjects come in to many of the PHS Emergency Departments or are directly admitted to a hospital. The system covers PHS affiliated hospitals and reduces the amount of time to gather information about adverse events and reinforces subject safety. Designated study staff can be notified by email, page or phone 24/7.
Keith Jennings, MBA, Chief Information Officer, MGH/MGPO, will explain how this system works and how you get started.
Please note that research subjects must be told you are using this system; there is a standard blurb to include in the consent form, if you elect to use this optional service. See a related memo from the Partners Human Research Office.
Registration is required. Please contact Lisa Horton if you have any questions or concerns.
eIRB Training: A Hands-On Introduction to eIRB
Wednesday, June 6 from 10:00a.m. - noon
One Brigham Circle, 4th Floor Computer Training Rooms, BWH
This training is a hands-on workshop for users that need to submit to the Partners IRB. The workshop will focus on the basics of how to navigate, track, and submit common submission types using eIRB.
The eIRB/Humans module within the Insight Research Portal allows users to electronically prepare, submit, sign and track their human-research protocol submissions to the Partners Intuitional Review Board (MGH, BWH, and Faulkner). Sessions led by Daniel G. Connor, IRB Systems Analyst II, Partner Human Research Office/Committee.
Learning Objectives:
-Provide an Insight Overview
-Learn to successfully navigate the Humans/eIRB module
-Learn how to prepare and submit common submission types to the IRB
-Learn how to track submitted eIRB applications
Upcoming Workshops:
Registration is required. Capacity = 8. All sessions are from 10a.m. - noon.
- 6/6 REGISTER
- 6/15 REGISTER
- 8/7 REGISTER
- 8/15 REGISTER
- 12/5 REGISTER
- 12/11 REGISTER
Contact Lisa Horton if you have any questions or concerns.
Sponsored by the BWH Center for Clinical Investigation (CCI) in partnership with the Partners Human Research Office.
BWH Clinical Trials Billing Fundamentals
Wednesday, July 11, 2012 from 2:00p.m. - 3:30p.m. - REGISTER
One Brigham Circle, Room 4-002B, BWH
In this session, Terry Stone, Research Billing Compliance Auditor for Brigham and Women's Hospital, will present a comprehensive overview of the research billing process at BWH. This will also include explanation of the proper use of the Medicare Coverage Analysis (MCA) grid to appropriately direct patient charges.
Although this lecture is geared toward research nurses, study coordinators, and research assistants, all study staff are encouraged to attend this lecture.
Key learning objectives for this session:
1. To gain a common understanding of the definition/nature of clinical trials.
2. To understand the CMS requirements for billing of services in a clinical trial.
3. To obtain information and resources related to the budgeting/charging of clinical services.
4. To convey the value and importance of validating and reconciling research study funds.
The BWH Clinical Trials Billing Fundamentals training is held quarterly.
Upcoming Sessions:
- July 11, 2012
Please contact Lisa Horton if you have any questions or concerns.
CCI All User Meeting
Thursday, September 20 from 9:00a.m. - 10:00a.m.
Shapiro Breakout Room, BWH
The Center for Clinical Investigation (CCI) is holding the next all user communication meeting for the clinical research community. CCI All User Meetings are for all clinical researchers, study staff and administrators who are involved with the conduct of clinical research at Brigham and Women's Hospital. Each meeting highlights clinical research resources and scientific highlights from the community, with ample time for discussion of questions and concerns.
Register online to receive reminders and information directly. Visit the CCI Research Community SharePoint Site to see slides from past meetings.
CCI Announcements
We'd like to hear from you! Are all of your clinical research education needs being served? We are polling the community for feedback and new ideas for future courses with the CCI Education Program. Please complete this brief online feedback form. Your opinion is important to us!
HCCRC Ancillary Policy Change
The CCI previously notified all investigators about a change in the policy for the funding of routine ancillary laboratory tests from HCCRC which will become effective on September 1, 2011. If you missed the announcement, or need further information, please click here for the full policy information.
CCI Research Service Support Core FY12 User Fees:
In accordance with Partners Core Policies and Procedures, the new FY12 CCI Core user fees, effective 10/1/2011, have been announced. The CCI has notified all current users of the updated fees directly and these prices will be posted online in mid September. To obtain additional information, please contact Mary Schneider.
Maintaining Research Subject Privacy and Information Security: What Clinical Researchers Must Know
This talk is available for viewing online from a Partners PC at the link above. Please note the system requirements to view the program. View video recording at this link.
Presenters: Elizabeth Hohmann, MD, Physician Director, Partners IRB
Roisin Hopkins, RN, JD, HIPAA Compliance Project Manager, BWH Health Information Services
Kevin Littlefield, BWH Information Security Officer
With federal and state agencies holding all covered entities to new standards for securing personal and protected information, Roisin Hopkins, BWH's HIPAA Project Manager, will discuss the importance of applying these regulations within the clinical research setting. This presentation will include real life examples, ways to prevent potentially damaging privacy and security breaches from occurring, and IRB actions and mandatory reporting requirements for research privacy breaches.
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This page was last modified on 5/11/2012