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REDCap (Research Electronic Data Capture) Programming Training:
Next session: Tuesday, February 14, 2012 - REGISTER
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:
2nd Tuesdays 9-11am :   2/14, 3/13, 5/8, 7/10, 8/14 
4th Tuesdays 2-4pm:     2/28, 3/27, 4/24, 5/22, 6/26, 7/24, 8/28
These trainings are co-sponsored by BWH Center for Clinical Investigation, Harvard Catalyst, and ERIS.

Biostatistics Office Hours on Tuesdays in One Brigham Circle:
Tuesday, February 14 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: All 1-2p.m. in OBC, Room 3-014B
     February 14, 21, 28
     March  6, 13, 20, 27
 
BWH Clinical Trials Billing Fundamentals
Wednesday, February 15, 2012 from 1:00p.m. - 2:30p.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: 
      - April 11, 2012
     - July 11, 2012
Please contact Lisa Horton if you have any questions or concerns.
 
Welcome to the Genetic Code: An Overview of Basic Genetics
Thursday, February 16 from 1:30 - 6:00p.m.
Bornstein Amphitheatre, BWH
This introductory course will review fundamental language and concepts including DNA anatomy and genome organization; genotype-phenotype correlations; basic population genetics; and genotyping.
Learning Objectives:
     1. Develop a working knowledge of the organization of the genome and an understanding of the basic processes of gene and protein expression.
     2. Understand the major patterns of Mendelian and non-Mendelian inheritance, and how mutations cause these patterns.
     3. Learn the basic principles of population genetics as they pertain to complex trait genetics
     4. Become familiar with the locally-available genotyping resources
This course is strongly recommended for both new and experienced clinicians, clinical investigators, nurses, and other clinical research staff who wish to further expand their knowledge of modern concepts in genetics and genomics.
This program will consist of a series of four lectures presented over a half-day period by Benjamin Raby, MD, MPH and Augusto Litonjua, MD, MPH.
Lectures Topics:
     1. How our genome works
     2. From genotype to phenotype: how mutations cause disease
     3. Populations and genes
     4. High-throughput Genotyping for gene mapping
CME Credit will be available:
The Harvard Medical School is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The Harvard Medical School designates this live activity for a maximum of 4 AMA PRA Category 1 Credits™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Upon completion of this activity, participants will be able to:
     1. Enhance the physician's knowledge of the correct conduct and practices of clinical research, as well as keeping the physician up to date on policies, practices, etc.
     2. Understand the various roles and responsibilities of the research team in the conduct of clinical research.
     3. Learn about clinical research resources available within the hospital and greater research community.
Course Director: Gordon Williams, MD, CCI Program Director
Registration is required. Please contact Lisa Horton if you have any questions or concerns.
This lecture is sponsored by the Center for Clinical Investigation (CCI) and Harvard Catalyst.
 
CCI All User Meeting
Thursday, February 16 from 9:00a.m. - 10:00a.m.
Shapiro Breakout Room, Shapiro Cardiovascular Center, BWH
The Center for Clinical Investigation (CCI) is holding its next All-User Communication Meeting for the clinical research community. The agenda includes:
    1. CCI Clinical Research Resources
              a. Research Coordinator Network
              b. Clinical Trials Center (CTC)
    2. Scientific Highlights from the Community
These sessions are open to all clinical researchers and study staff who are currently using, or are interested in starting to use, the clinical research resources available through the CCI.
The slides previous meetings are posted online:
     - September 29, 2011 slides
     - December 1, 2011 slides 
You may register online to receive reminders and information directly. Please email cci@partners.org if you have any questions or concerns. 

Research Connection Live Lunch
Monday, February 27 from noon - 1p.m.
Carrie Hall, 15 Francis Street, BWH 
Please register, 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. Hosted by the Biomedical Research Institute, Center for Clinical Investigation, Center for Faculty Development and Diversity, and Research Administration.
 
IRB Lecture: Human Subjects Research, Exemptions, and Expedited Minimal Risk Research Determinations
Tuesday, March 6 from 2:30p.m. - 3:30p.m.
Carrie Hall, 15 Francis Street, BWH
Join Judy Scheer, SM, RN, IRB Chair in a discussion of how the Partners Human Research Committee (IRB) makes review determinations. This lecture will provide an overview of the criteria used by the IRB to determine whether a study is not human subject research, exempt research, "engaged" in human subject research, minimal risk research that is eligible for expedited review, or research requiring full review.
Lecture Objectives:
1. Recognize the regulatory definitions of IRB classifications of human research
2. Gain a basic knowledge of the IRB process used to determine research classifications
3. Understand the types of information the IRB needs from investigators in order to make these determinations
Please register online.

RCR Rounds: ClinicalTrials.gov Results Reporting
Thursday, March 8 from 2:30p.m. - 3:30p.m.
Carrie Hall, 15 Francis Street, BWH
The FDA Amendment Act of 2007 (FDAAA) requires aggregate results and adverse event reporting of any Phase 2 – 4 FDA regulated study using an approved (for any use) drug, biologic, or device. Does this apply to you?
Do you know what results reporting entails and how to get started in the ClinicalTrials.gov database? This presentation will provide an introduction to results and adverse event reporting in the ClinicalTrials.gov database. We will review: 
   • The key elements for the four results modules:
       • Participant Flow
       • Baseline Characteristics
       • Outcome Measures & Statistical Analyses
       • Adverse Events
   • The basic mechanics of entering results
   • Common errors in results reporting
   • Resources for further guidance
This course is geared towards investigators, research nurses, study coordinators and all other study staff that is assisting in the clinical trial registration and results reporting process.
Learning Objectives:
1. To understand what FDAAA requires for results and adverse event reporting.
2. To become familiar with the key data elements for the 4 results/adverse event reporting modules.
3. To become oriented with the basic mechanics of entering results and adverse events into the database.
Speakers:
Emily Ouellette, JD, QA/QI Specialist, Partners Human Research Quality Improvement Program
Sarah White, MPH, Assistant Director, Partners Human Research Quality Improvement Program
Pearl O’Rourke, MD, Director, Partners Research Affairs
Responsible Conduct of Research (RCR) credit will be available.
More about "RCR Rounds:" Responsible Conduct of Research Rounds, or “RCR Rounds,” are open to the entire BWH research community and are sponsored by either the Center for Clinical Investigation (CCI) and/or the Center for Faculty Development and Diversity Office for Research Careers (ORC).  Some topics may be applicable to all research, while others are designed for either clinical or basic researchers; please see the specific lecture details to know if the course fits your specific research education needs.  
Please note: Responsible conduct of research (RCR) training is required of students, trainees, and investigators with career development awards who are supported by National Institutes of Health (NIH) funds.  Visit the Partners Research Compliance Office website for information on how to claim credits from these lectures and meet requirements.  Completion of each RCR Rounds will fulfill one RCR lecture/discussion requirement unless otherwise indicated.
Please register online for RCR Rounds: ClinicalTrials.gov Results Reporting.
This lecture is co-sponsored by the Center for Clinical Investigation (CCI) and the Office for Research Careers (ORC) - CFDD .

Study Coordinator Orientation 
March 13, 14, 20, 21  & 27 from ~ 1p.m. - 4p.m. 
Who: For study coordinators, research nurses and research assistants working on clinical research studies at BWH. Although not mandatory, it is recommended that all clinical research staff at BWH, who haven’t previously attended, participate in this program.
What:  This program consists of four afternoons of classroom sessions that combine lecture with case study activities to provide valuable information about navigating the BWH research system.  The fifth afternoon is comprised of a review session and exam.  There is also a four-hour Clinical Skills Training component*.
During the classroom sessions, activities and case studies will guide you through the regulations that govern clinical research, the roles and responsibilities of clinical research staff as well as best practice and study management advice.  Participants will learn from members of the Partners IRB, the QI Program, BWH Office for Research Compliance, as well as the CCI.  Additional speakers include an experienced clinical research project manager with recruitment advice from the trenches, as well as BWH Senior Vice President for Research, Dr. Barbara Bierer, who will lead a lively discussion of ethical considerations in clinical research.
Where:  One Brigham Circle, Room 4-002B, BWH
When:  March 13, 14, 20, 21 & 27.  Classroom activities go from 1 - 4p.m.
Clinical Skills Training (need only attend ONE of the following sessions):
- May 4, 2012 from 8a.m. - noon
- May 11, 2012 from 8a.m. - noon
How: Complete the online registration form. Please contact Lisa Horton if you have any questions or concerns.
Notes:   As this program is designed to be taken in its entirety, participants are expected to make every effort to attend all sessions. All sections must be completed in order to receive a certificate. Please read the CCI Certificate Policy. 
*Clinical Skills Training is led by the BWH Department of Nursing Center for Nursing Excellence and is a required part of Study Coordinator Orientation if you haven't had previous clinical training. Clinical Skills Training covers:
        - Heights/Weights 
        - Temp/ Pulse / Respiration
        - Blood Pressure
        - EKG 
Study Coordinator Orientation is sponsored by the BWH Center for Clinical Investigation (CCI).
 
RCR Rounds: Who Tells the IRB What To Do? The Effect of Case Law
Thursday, March 22 from 2:30p.m. - 4:00p.m. 
Carrie Hall, 15 Francis Street,  BWH
Who tells the IRB what to do and where did these regulations and systems come from anyway? In this lively presentation Pearl O'Rourke, MD will provide a historical review of challenges to research regulations and guidelines and will describe how case law has informed the current system of research oversight. Additionally, Dr. O'Rourke will discuss current challenges to regulations and the regulatory process.
This lecture is strongly recommended for both new and experienced clinical investigators, research nurses, and study coordinators.
Learning Objectives:
1. Understand the specifics of the Tuskegee Syphilis Trial and the effect on human subjects protections.
2. Understand the history of the federal regulations re: the protection of human subjects.
3. Understand the recent reports re: research in Guatemala.
CME and Responsible Conduct of Research (RCR) credit will be available. Completion of this course will fulfill one RCR lecture/discussion requirement.
More about "RCR Rounds:" Responsible Conduct of Research Rounds, or “RCR Rounds,” are open to the entire BWH research community and are sponsored by either the Center for Clinical Investigation (CCI) and/or the Center for Faculty Development and Diversity Office for Research Careers (ORC).  Some topics may be applicable to all research, while others are designed for either clinical or basic researchers; please see the specific lecture details to know if the course fits your specific research education needs.  
Please note: Responsible conduct of research (RCR) training is required of students, trainees, and investigators with career development awards who are supported by National Institutes of Health (NIH) funds.  Visit the Partners Research Compliance Office website for information on how to claim credits from these lectures and meet requirements.  Completion of each RCR Rounds will fulfill one RCR lecture/discussion requirement unless otherwise indicated.
CME Credit will be available:
The Harvard Medical School is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The Harvard Medical School designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credits™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Upon completion of this activity, participants will be able to:
     1. Enhance the physician's knowledge of the correct conduct and practices of clinical research, as well as keeping the physician up to date on policies, practices, etc.
     2. Understand the various roles and responsibilities of the research team in the conduct of clinical research.
     3. Learn about clinical research resources available within the hospital and greater research community.
Course Director: Gordon Williams, MD, CCI Program Director
Registration is required. Contact Lisa Horton with questions.
This lecture is co-sponsored by BWH Center for Clinical Investigation and the Partners Research Affairs.
 
Genetic Literacy: An Intermediate Guide to Understanding the Language and Concepts of Modern Genetic Research
Thursday, March 29 from 12:30 - 5:00p.m.
Bornstein Amphitheatre, BWH
What's a SNP? What's the HapMap? What is a microarray and is it used for genotyping or gene expression analysis? What's an association study (and why do they do it)? If you find yourself asking similar questions, come to this course designed to briefly describe the terminology, technologies, and methodologies of modern genetics.
Learning Objectives:
     1. Develop an understanding of the concepts of genetic association, including how variants are associated with each other (linkage disequilibrium) and with disease.
     2. Learn the fundamental principles of genetic association studies
     3. Understand how to conduct and analyze a genome-wide association study, and recognize the strengths and limitations of this powerful genetic mapping technique.
This second module of the series is intended for individuals with basic knowledge of modern concepts of genetics and genomics or who have taken Welcome to the Genetic Code: An Overview of Basic Genetics.
This program will consist of a series of lectures presented over a half-day period by Benjamin Raby, MD, MPH and Augusto Litonjua, MD, MPH.
Lectures Topics:
     1. Genetic association: SNPs, haplotypes and more
     2. Association studies: case-control and family-based designs
     3. Genome-Wide Association Studies
CME Credit will be available:
The Harvard Medical School is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The Harvard Medical School designates this live activity for a maximum of 4 AMA PRA Category 1 Credits™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Upon completion of this activity, participants will be able to:
     1. Enhance the physician's knowledge of the correct conduct and practices of clinical research, as well as keeping the physician up to date on policies, practices, etc.
     2. Understand the various roles and responsibilities of the research team in the conduct of clinical research.
     3. Learn about clinical research resources available within the hospital and greater research community.
Course Director: Gordon Williams, MD, CCI Program Director
Registration is required. Please contact Lisa Horton if you have any questions or concerns.
This lecture is sponsored by the Center for Clinical Investigation (CCI) and Harvard Catalyst.
 
eIRB Training: A Hands-On Introduction to eIRB
Thursday, April 5 from 10:00a.m. - noon
One Brigham Circle, Computer Training Room 4-014, 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.
     - 4/5    REGISTER
     - 4/10  REGISTER
     - 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.

CCI Announcements

 6th Annual Research Nurse/Study Coordinator Networking Breakfast
If you missed last month’s breakfast, download the slides at the link above.  You may also read the recap of the Question and Answer Session on the CCI Research Community SharePoint site here: http://sharepoint.partners.org/bwh/cciresearchcommunity/default.aspx
This document is housed in a SharePoint site that anyone with a Partners User ID can view and print.   If you visit the Team Discussion section you'll see that a couple of the questions are posted in a discussion forum and we welcome you to comment and contribute. 
In order to post a comment, you need to request to join the group.  By opting in you can post questions, comments or share events with your peers.  Join the group by emailing us at BWHCCIed@partners.org and we will grant you access.  
The CCI Research Community SharePoint Site is created for the Center for Clinical Investigation to share information with the Brigham and Women’s Hospital clinical research community, and to foster engagement within the community.
 
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.

Other Courses & Events 

ClinicalTrials.gov: An Introduction to Results Reporting
Wednesday, February 8, 12:00pm - 1:00pm
185 Cambridge Street, Simches Building, Room 3.110
Speakers:
     Emily Ouellette, Quality Assurance/Improvement Specialist
     Sarah White, Director, Partners Human Research Quality Improvement Program.
The FDA Amendment Act of 2007 (FDAAA) requires aggregate results and adverse event reporting of any Phase 2 – 4 FDA regulated study using an approved (for any use) drug, biologic, or device. Does this apply to you?
Do you know what results reporting entails and how to get started in the ClinicalTrials.gov database?  This presentation will provide an introduction to results and adverse event reporting in the ClinicalTrials.gov database.
We will review:
     - The key elements for the four results modules:
     - Participant Flow
     - Baseline Characteristics
     - Outcome Measures & Statistical Analyses
     - Adverse Events
     - The basic mechanics of entering results
     - Common errors in results reporting
     - Resources for further guidance
Please feel free to bring your lunch.
*This course is geared towards investigators, research nurses, study coordinators and all other study staff that is assisting in the clinical trial registration and results reporting process.
*RCR Eligibility: Completion of this program will fulfill one lecture/discussion requirement.
Registration is required. Contact Lauren Michaels with further questions about this session.
Sponsored by the MGH Clinical Research Program and the Partners Human Research Quality Improvement Program

Applied Biostatistics for Clinical Trials 
Tuesdays, February 28, March 6, 13 & 20, 3:00pm - 4:30pm
185 Cambridge Street, Simches Building, Room 3.110
In this series, Dr. Halpern will review the statistical approach to problems commonly encountered in research. Each of the four sessions will focus on a different theme using concrete and realistic examples. This course is intended for investigators who are interested in clinical research.
Registration is required. Please contact Suzanne Powell with any questions.
Sponsored by the MGH Clinical Research Program and the MGH Biostatistics Center

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