October 2017 NEWSLETTER

CTSI Spotlight spotlight 
PRIME: Pathways to Research Independence and Mentoring Excellence 
CTSI launches new PRIME Program to support research environment, building a community and mentoring culture for the Medical Campus NIH K Funded Investigators.  The goal of  the new program PRIME is to improve the success rates of independent RO1 funding by BUMC NIH K funded career researchers. 

Seminars will occur every 1st and 3rd Tuesday of the month, 
12-1pm, starting October 17, 2017, ending in May, 2018. The 1st Tuesday of each month will feature interactive presentations of direct relevance to faculty research endeavors; the 3rd Tuesday of each month will provide an opportunity for  researchers to have their works-in-progress reviewed by PRIME peers and directors for constructive interdisciplinary feedback, including abstracts, papers, posters, presentations, and importantly, review of your grants' specific aims and other sections. Mock grant review panels will be held, scheduled at least six weeks before the intended NIH submission deadline, with insightful feedback by seasoned faculty. Each session will also have time built-in to provide a "safe space" for the researcher  to brainstorm and troubleshoot with the PRIME peer network about the challenges and issues facing faculty in their research trajectory.

Directed by: 
Tuhina Neogi, MD, PhD

Richard Wainford, PhD

 Research Resources resources 

Clinical Research Resources Offices (CRRO)
Offers Clinical/Human Research Training's, Seminars and Workshops 

Fundamentals in the Conduct of Human/Clinical Research Studies:BMC/BU Medical Campus Human Research Professional Staff Training

Part 1: Tuesday, October 17, 
9:00 am to 1:00 pm
Part 2: Tuesday, October 24, 
9:00 am to 1:00 pm
Part 1: Thursday, February 8,
9:00 am to 1:00 pm
Part 2: Thursday, February 15, 
9:00 am to 1:00 pm   

This 2 session training, each 4 hrs, is offered several times a year. It utilizes the International Conference on Harmonization Good Clinical Practice (ICH-GCP) as the gold standard for the conduct of clinical research and will cover key topics and concepts to ensure Clinical Research Professionals at BMC/BU Medical Campus are confidently and successfully able to conduct research study activities.

The Principal Investigator Role: What Every New and Seasoned PI Needs to Know about the Conduct and Oversight of Clinical Research

December 6th, 2017
8:30:am - 12:30pm

Room E- 720
The Principal Investigator (PI) holds ultimate responsibility for the design, conduct, and management of a research study which requires up-to-date skills and knowledge.  Using International Conference on Harmonization Good Clinical Practice (ICH-GCP) as the gold standard for the conduct of human research studies, this rigorous training for new and experienced clinical researchers who are interested in a refresher, will focus on providing information on:
  • responsibilities of an investigator and/or investigator-sponsor
  • adhering to the protocol and safety plan
  • best practices in consent and screening processes
  • why and how to best document your study
  • monitoring, evaluation and reporting of adverse events and unanticipated problems
  • navigating the IRB and the INSPIR application

Clinical Research Seminar

Seminars usually take place from 12 to 1 pm, on the second Wednesday of the month from September to June.

The purpose of the monthly seminar is to enhance attendees' knowledge regarding important ethical, regulatory, and operational clinical/human research topics. Come and enjoy lunch, earn some CMEs, and get updated on clinical research topics!

RPN Peer-led Clinical Research Learning Workshops

NEW this Fall! 

As part of the RPN (Research Professionals Network) mentoring and continuing educational offerings, interactive workshops will be developed focusing on topics identified by the RPN membership such as 'Best practices in study documentation' and 'Monitoring and auditing'.

Research Recruitment & Retention Program

The Research Recruitment and Retention Program welcomes
Dr. Christina Yarrington as the newest member of the team.
Dr. Yarrington joins us from  the Maternal Fetal Medicine division in Obstetrics and Gynecology.  Prior to medical school and residency at BU, her professional life centered on community service in Boston, including the American Red Cross Disaster Relief and program development at the South End Community Health Center.  She also has an advanced degree in theology, with work in Tibetan Buddhism and preventive health as well as Islam and breast health education.  She completed her MFM fellowship at Brigham and Women's Hospital and returned to BMC motivated by the population and the mission.  Here, she has spearheaded BMC's prenatal Zika screening program and is now investigating prenatal Chagas screening to reduce cardiac sequelae in addition to vertical transmission.  Her research interests include metabolic predictors of fetal macrosomia and implementation of mobile technology in obstetric care.  

Please contact project manager, Jill MacRae at jmacrae@bu.edu with your recruitment and retention questions and how the R3 program can help your study.
Services, Consults & Regulatory funding 
BERD: Biostatistics, Epidemiology & Research Design  
BERD program provides researchers with comprehensive support in designing and carrying out research at the design, implementation and analysis stages. As biostatistics assistance ranks among the top requests for CTSA services, BERD has generated a portfolio of solutions for the most common needs to ensure participation in the earliest stages of study development.
Offer input for BERD seminar topics HERE.

Boston University Profiles 
CTSI created BU Profiles, a software tool that supports research networking and expertise searches. It enables individuals (either internal or external to BU) to locate researchers by subject matter, name, institution, department, division, faculty, etc.   

Center for Regenerative Medicine 
Induced Pluripotent Stem Cells (iPSCs) generated by forced overexpression of defined transcription factors in somatic cells hold great promise for human disease research and personalized medicine. The Center for Regenerative Medicine (CReM) iPSC Core was created to expedite the use of iPSC technology by providing essential services and support to on-campus investigators and the broader scientific community. 
Clinical Research Resources Office
The CRRO provides regulatory consultations for PIs and research staff at any point during the life of a research study.  We can help with IRB applications before and after submission to the IRB and advise on FDA regulations and the IND and IDE applications.  We also provide a number of trainings on the conduct of human research.

Community Engagement
The BU CTSI Community Engagement program offers assistance and advice to researchers around 1) forming patient and community advisory groups; 2) communicating about science in everyday language; 3) hosting Science Caf├ęs, or small discussion events to deliver research results back to the community; and 4) consultation on a variety of community engagement topics. We also offer Connecting Community to Research trainings - one-time, 2-hour trainings that introduce community members and patients to opportunities to basic research concepts and opportunities to partner with researchers around community health. 

 Clinical Research Informatics & Technology Consults

The CRITIC consultations help BU/BMC researchers identify, develop, and implement the effective and efficient use of information technology and informatics in their clinical studies. For a free. One-on-One consultation contact: 

Christopher Shanahan, MD, MPH @ christopher.shanahan@bmc.org


General Clinic Research Unit 
The GCRU provides resources for protocol implementation across BUMC, BMC, BU and CRC.  

Grant Writing & Editing Services for BUSM and Non-BUSM Investigators
Non-B USMInvestigators: Grant writing, editing and formatting services for NIH and other federal applications are provided as part of a CTSI collaboration with Boston Medical Center's Development Department . To request services, please go  here to complete a short form

BUSM: The OPD (Office of Proposal Development) is pleased to offer grant writing and editing assistance. In addition to providing copyediting services for investigators , they will guide new and non-native English-speaking principal investigators in developing and writing grant submissions. In addition to technical assistancein all aspects of the writing process, from conceptualizing specific aims, to developing successful submission strategies, and guiding investigators in building compelling scientific narratives. To request one or all of these services, please go here to complete a short form

REDCap: Research Electronic Data Capture
REDCap is a secure web-based application for building and managing online surveys and databases for research. Using REDCap's streamlined process for rapidly developing projects, users can create and design projects applying:  the online method from your web browser via the Online Designer; and/or the offline method by constructing a "data dictionary" template file in Microsoft Excel, which can be later uploaded into REDCap. 

Research Recruitment and Retention Program (R3)  
Delays in recruiting participants are a major barrier to progress in clinical and translational research. BU CTSI's Research Recruitment and Retention Program (R3) exists to help researchers succeed in efficiently meeting participant recruitment goals for clinical and translational research studies, including randomized clinical trials. We assist both investigator-initiated and industry-sponsored research at BU, BMC, and our partner institutions. Services offered: Initial consultation, recruitment strategies, and monthly roundtable speakers. 

The BUMC StudyFinder is a medical campus website that lists research studies for public view, both for purposes of recruitment and/or general publicity/collaboration. Study listings for general publicity/non-recruitment purposes only include the title, study summary from INSPIR, and the investigator name and e-mail address. 

Trial Innovation Network  
(TIN) is a new collaborative initiative within the CTSA Program and is composed of three key organizational partners - the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC) that seek to address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies. 

Sound Bites Soundbites
Congress Rejects Trump Proposals to Cut Health Research Funds

WASHINGTON - Back in March, when President Trump released the first draft of his budget proposal for the coming fiscal year, he asked lawmakers for deep cuts to one of their favorite institutions, the National Institutes of Health - part of a broad reordering of priorities, away from science and social spending, toward defense and border security.
Six months later, Congress has not only rejected the president's N.I.H. proposal; lawmakers from both parties have joined forces to increase spending on biomedical research - and have bragged about it.  

Appropriations Committee has increased the budget by $17 towards  research in addition to mandating NCATS maintain the current number of CTSA's. 

Natural Language Processing Seminar 
1pm to 5pm
Room L112
Presentation from 8/16/17 Seminar  view here

7th Annual CTSI Symposium Coming Soon! 

Annual Symposium Coming Spring 2018. 

CTSI Announcements
We are delighted to announce the newest addition to our team,  Angela Oaks, MS. 
Angela who is the Program Evaluation Manager,  joins us from the University of Wisconsin-Stout. 

Congratulations to Hubert Wong on his recent promotion to Assistant Director, Finance and Operations for the CTSI. Since joining the CTSI as a Project Manager, Hubert has overseen the development of the various WebCAMP modules and has successfully deployed these modules across all CTSI programs. 
Upcoming Events events
Rm. L-206
Research Professional Network Workshop
Study Start-Up Timeline 
Time: 1:00 p.m. to 2:00 p.m. 
Presenter: Jenna Bhaloo, MPH
Rm. L-109
Networking Event for Research Professionals
Time 2:30- 4pm
All Research Professionals welcome to register. 
Rm. L212
Research Professional Network Workshop
Time: 3:30 p.m. to 4:30 p.m.
Classifying & Reporting Adverse Events, Deviations, and Unanticipated
Problems. Presenters:  Alana Ewen, MPH and Claire Oppenheim, MPH
Research Professional Network Workshop
Time: 1:00 p.m. to 2:00 p.m.
Monitoring, Auditing, and Self-Assessments
Presenter: Fiona Rice, MPH
Rm. L112
Natural Language Processing Symposium
1pm to 5pm 
Registration Required

Help us continue our support by citing our grant number
in relevant publications:   1UL1TR001430 

All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH Funding acknowledgment and must comply with NIH Public Access Policy.

Boston University  Clinical & Translational Science Institute
Accelerating Discoveries Towards Better Health 

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