Announcements of educational opportunities from the MassGeneral Hospital for Children Research Council.
UPCOMING EDUCATIONAL OPPORTUNITIES
Click on the link above for dates and times
The CRP is offering Phlebotomy Training for Clinical Research Coordinators. These trainings will provide a review of the fundamentals of phlebotomy as well as a guided practice session where attendees will practice drawing blood on a mannequin arm.
IRB & QI Roundtable Series: Consent Form Writing
Thursday, December 5, 12:00 – 1:00pm, Garrod/Mendel Conference Room
Learn how to write the simplest, clearest consent forms, so that every one of your subjects can be fully informed. This workshop will teach you specific skills for writing easy-to-understand documents. The learning objectives of this session are for participants to understand the elements of consent, acquire plain language tips for editing research consent forms, and identify which Partners consent form template is appropriate for your protocol.
Hands-on MORA Training: Managing Monitor Online Record Access
Friday, December 6th, 2013 10:00am – 11:00am
Computer Lab 230, 165 Cambridge Street, Floor 2
Greg Estey, Senior Project Manager, MGH Lab of Computer Science
Do you want an alternative to sitting with study monitors when they need to review electronic medical records or printing out piles of paper before the monitors arrive? At this session, you will learn how to grant secure, appropriately tracked electronic access to your study subjects' medical records to clinical trial monitors who are authorized to use the Monitor Online Record Access (MORA) system. The session will consist of a brief slide presentation providing an overview of the system, followed by a hands-on session in which you will learn how to connect monitor accounts to your protocols, link patient records to your protocols and teach monitors how to use MORA.
Prerequisites: To sign up you must have Manager permission on an active protocol listed in Insight.
This course is limited to 11 participants.
Registration is required. Please contact Jillian Tonelli with any questions about registration.
Workshop on Study Design: Using MGH Clinical Care Data for Clinical Effectiveness Research,
December 10* & 17, Simches 3.130, 3:30 - 5:00 pm
Sponsored by the MGH Clinical Research Program
James Meigs, MD, MPH, Director, MGH Clinical Research Program's Clinical Effectiveness Research Unit
Clemens Hong, MD, Instructor in Medicine, HMS, Co-Director, MGH Clinical Research Program's Clinical Effectiveness Research Unit
The Clinical Research Program is offering a five-session seminar series on Clinical Effectiveness Research in the fall of 2013. Throughout these sessions, distinguished faculty will take participants step-by-step through the process of designing an outcomes study using MGH clinical care data.
In parallel to didactic teaching, participants will be expected to develop their own projects, obtain Medical Records IRB approval, submit an RPDR query, and present their work for critical feedback by the end of the course.
Essential curriculum content will include: framing a testable hypothesis, developing a testable hypothesis, using MGH clinical care data, using the Research Patient Data Registry and transforming clinical care data into analytic datasets.
Office hours on Medical Records IRB submission and the RPDR will be offered to assist those who need additional guidance.
Please note that there is a moderate amount of work required outside of the classroom for this course. If you register for this course, please make sure you will be able to devote some time outside of class to complete the assignments.
Enrollment is limited to 20 participants to facilitate interaction and individual attention. Application and approval is required. To ensure placement in the course, early registration is recommended.
*The session on Wednesday, December 10th will be a hands-on computer lab. Each participant must bring a laptop to this session (connected to the Partners network) for an RPDR workshop.
Please contact Molly Morrow
Study Electronic Data Capture: REDCap and StudyTRAX
Monday, December 16, 3:30pm – 4:30pm, Simches 3.130
This goal of this presentation is two-fold. First, provide an overview of two electronic data capture (EDC) applications offered through Partners Research Computing, REDCap and StudyTRAX. Second, provide common reasons, factor and issues related to choosing between these two EDC applications. Attendees will also learn about common factors, issues and investigator interests related to selecting the best fit.
IRB and QI Roundtable Series: Session IV: Part II: Informed Consent Process
Thursday, December 19, 12:00 – 1:00pm, Garrod/Mendel Conference Room
If your study involves vulnerable populations, such as children, are you knowledgeable of the special protections afforded to them, and the Partner’s policies governing their consent? In this session, Charlene Malarick, RN, BSN, CCRC of the Partners Quality Improvement Program will discuss these issues and how to fulfill the Partner’s policies for documenting the informed consent process. She will describe the informed consent process, review vulnerable populations, the special protections afforded to them, and how these apply to the informed consent process, and discuss how to effectively comply with the Partners policies for documenting informed consent.
2014 Scientific Advisory Committee (SAC) Poster Session
Where: Wyndham Hotel, 15th Floor Time: 11:00 AM - 1:45 PM Date: April 2, 2014
ECOR is now accepting submission of abstracts for the 2014 SAC Poster Session!
Deadline for Submission: Tuesday, December 10, 2013 - 9:00 PM
The SAC Poster Session gives researchers the opportunity to create a compelling visual display of their work, and present it to some of the best scientific minds in the nation. It is an essential part of the two-day meeting, which highlights excellence in research at MGH. Presenters must be a MGH employee.
Twelve $1,000 Awards of Excellence
for Scientific Meeting Travel
-6 for Clinical Research
-6 for Basic Research
For Submission Form and Instructions Go To:https://ecor.mgh.harvard.edu/SAC/SubmitPoster.aspx
Please contact email@example.com with any questions.
Partners Innovators Forum
The Partners HealthCare community is invited to attend the newly launched Partners Innovators Forum, a monthly 5-part education series focused on key issues in academic innovation.
The Forum is free for the PHS community and is also open to the public. Future sessions will rotate between MGH and BWH
To register go to: https://partnersinnovatorsforum.eventbrite.com/
Walk-in registrations will be available on the day of the event.
Upcoming Sessions: Please mark your calendars and save the date.
Innovators Forum: Corporate Venture Funding for Academic Ventures
Monday, December 9, 2013, BWH Bornstein Family Amphitheatre
5-7PM with a reception to follow, BWH Bornstein Family Amphitheater
The Partners HealthCare community is invited to attend the newly launched Partners Innovators Forum, a monthly 5-part education series focused on contemporary issues in academic innovation. The Forum is free for the PHS community and is also open to the public. Future sessions will rotate between MGH and BWH.
RVL Innovators Forum: Corporate Venture Funding for Academic Ventures
This session will feature the leaders of some of the largest corporate venture funds in the world. Executives will share perspectives on investing in academically based ventures. The Forum is free for the PHS community and is also open to the public.
REGISTRATION - To register go to: https://partnersinnovatorsforum.eventbrite.com/ Walk-in registrations will be available on the day of the event.
The Bornstein Family Amphitheater is located on the 2nd Floor "Pike" in Brigham and Women's Hospital. From main lobby on the 1st floor at 75 Francis Street, walk down the "lower pike" corridor to the Connors Center for Women's Health elevators. Take the elevator up one level. Turn left into the main corridor. Find the entrance to this room on your left, between exits 5 and 6.
To learn more about the entire 2013-2014 Innovators Forum series and dates, please click here: http://rvl.partners.org/resource_center/innovatorsforum
Innovators Forum: My Commercial Journey - Four Partner's innovators share their story
Thursday, January 23, 2014, MGH Simches Research Center Auditorium
Innovators Forum: Corporate Collaboration: Getting It Right From the Start
Tuesday, February 4, 2014, BWH, Bornstein Family Amphitheatre
Innovators Forum: Accelerating Innovation in the Electronic Era of HealthCare
Thursday, March 6, 2014, MGH Simches Research Center Auditorium
Each session 5-7 pm with reception to follow
ONLINE EDUCATIONAL OPPORTUNITIES
Introduction to Clinical Research at MGH
The Clinical Research Program’s Education Unit is pleased to announce the debut of a new online training for investigators and study staff. Introduction to Clinical Research at MGH is designed to provide basic training in clinical research and a list of resources for the research community at the Massachusetts General Hospital (MGH).
This online training is composed of different modules which will:
- Review the history of clinical research
- Define the different types of research and research-related terminology
- Provide an overview of the general principals of clinical research including the basics of study design, procedures and management
- Review Federal Regulations and Guidelines, essential documents and the basics of Good Clinical Practices (GCP)Discuss the differences between NIH, industry and investigator-initiated studies
- Provide an overview of the electronic applications available at MGH to manage a clinical research study
- Summarize the different departments at MGH that are involved in clinical research (Research Management, Partners Human Research Committee, Quality Improvement etc.).
To receive credit for this training, you must take the quiz, which is posted below the content on the course page. To access this training, please click here (https://hub.partners.org/register/?return_url=%2fclinical-research-101%2f).
Basics of Manuscript Writing for Clinical Researchers This training will review the pre-writing phase, the writing phase, and the submission, acceptance and review phase of writing a manuscript. The objectives of this course are: to encourage participants to write and submit manuscripts to peer-reviewed journals, to facilitate the writing process, and to outline the submission, peer-review and acceptance process. To receive credit for this training, you must go through all of the modules and submit a course evaluation.
Introduction to Clinical Research at MGH This training is designed to provide basic training in clinical research and a list of resources for the research community at Massachusetts General Hospital (MGH). To receive credit for this training, you must take the quiz and submit a course evaluation, both of which are posted below the content on the page.
Guide to the Research Patient Data Registry (RPDR) These tutorials will review features of the RPDR Enhanced Query Tool and data wizards. Multiple walk-through sections will illustrate how to use the tool and create queries in greater detail.
Submitting your Medical Records/Health Information Research Protocol to the IRB This training will review submitting your medical record or health information research protocol to the IRB. In this course, you will learn what are considered “medical records” and what the various issues are that should be considered when developing a medical record IRB submission; how to address identifiers in your application; how the IRB determines your study’s regulatory classification; regulatory requirements regarding consent/authorization and waiver of consent/authorization; and how to submit a medical record study in Insight.
Good Clinical Practice and Study Management Basics This series is geared towards anyone who is looking to learn or review the essentials of Good Clinical Practice and clinical research study management. The program will review Good Clinical Practice guidelines, Essential Regulatory Documents, and Research Record Keeping, with a focus on the subject’s file. The modules of this course may be viewed separately and/or used as a resource for future reference.
Infection Control Principles and Practice in Clinical Research This program serves as an annual mandatory training in Infection Control for clinical research staff. According to OSHA and The Joint Commission (TJC) standards, infection control training is required for all clinical research nurses, coordinators, and any study staff who handle human specimens. Mandatory re-training must occur annually. This lecture meets standards for initial training or annual re-training. The training will review standard precautions, as well as infection control practices when handling specimens or performing phlebotomy.
IATA Shipping Training for Transportation of Biological Materials and Dry Ice This shipping training is intended for the certification of clinical research personnel who package or ship biological specimens. Regulations state that no person shall handle, offer for transport, or transport dangerous goods unless they are trained. Retraining must occur every 2 years (IATA requirement). This training will provide people who ship specimens via ground or air with the ability to appropriately classify their specimen or agent. They will also learn how to properly package and correctly document specimens, in order to be in full compliance with all regulations.
MGH Center for Comparative Medicine (CCM) Animal Orientation & Training Lecture As part of the process to obtain access to an MGH CCM animal facility, MGH research personnel must attend the CCM Animal Orientation & Training. This lecture is intended to acquaint the research staff with the practices and procedures associated with the use of live animals within MGH animal facilities. This is a weekly orientation that is held every Wednesday from 9:00am-10:00am in CNY 114, Room D1. Beginning February 6, 2013, we are now offering the MGH research community the ability to attend this lecture online via webinar.
For more information, please visit our web site at http://intranet.massgeneral.org/ccm/.
Series on Subject Recruitment and Retention is an online course designed to help study staff develop an adaptable recruitment and retention plan. The majority of studies fail to meet recruitment goals. This course will present the reasons why studies are delayed, the factors that motivate subjects to participate in a clinical study and review the barriers to recruitment and retention. This series will also describe the different methods for advertising to potential subjects as well as the allowable content of advertisements according to FDA, NIH Regulations and Partners Human Research Committee Policies.
To receive credit for this training, you must review all of the modules, complete the quiz and submit a course evaluation.
To access this training, please click here. Contact Lauren Michaels with any questions.
ATGU consulting service
From: Daly, Mark J. (please see attachment)
Center for Faculty Development, Office for Research Career Development, MGH Women’s Careers, ECOR
Need Career Advice? Schedule a meeting with our OWC Director, Nancy Rigotti, MD -
Nancy Rigotti, MD, Director of the Office for Women's Careers is available for individual meetings for women faculty seeking career advice.
She is available to meet with you to discuss:
- Career advancement
- Gender specific issues
- Work/Life balance issues
If you would like individual meeting with Dr. Rigotti, please email firstname.lastname@example.org.
WOULD YOU LIKE TO LEARN MORE ABOUT MANAGING DIFFICULT CONVERSATIONS?
Below are some recommended readings on difficult conversations from Gillien Todd, JD, the facilitator of the Managing Difficult Conversations seminars.
"Difficult Conversations: How to Discuss What Matters Most"
by Douglas Stone, Bruce Patton, and Sheila Heen
"First, Break All the Rules"
by Marcus Buckingham and Curt Coffman
"Divide or Conquer: How Great Teams Turn Conflict into Strength"
by Diana McLain Smith
"How to Talk So Kids Will Listen & Listen So Kids Will Talk"
by Adele Faber and Elaine Mazlish
Data Management Consultations Available to the MGH Clinical Research Community
Data Management Consultations are now available to the MGH clinical research community through the MGH Clinical Research Program (CRP). Susan Regan, Ph.D., will provide the following consultation services:
- Review protocol and data collection forms
- Review existing or planned data entry system
- Training in skills for day-to-day management of ongoing projects in Access databases
- Report and query design
- Integrating external sources of data (e.g. from laboratories, other sites)
- Data export for analysis
For more information and to schedule a consultation, please fill out the request via http://www2.massgeneral.org/crp/mghstaff.html
MGH Researchers: Consulting for your IT needs
MGH Research Computing/Enterprise Research IS (ERIS) offers IT/IS assistance or IT architectural consulting for your research project:
- Review protocol and data collection forms
- Informatics and High Performance Computing
- Web Hosting
- Electronic Data Capture/Surveys
Contact us with a description of your needs: email@example.com.
Corrective Action Implementation for Clinical Research Projects.
This service is geared towards those who may have learned clinical research best practices but are seeking hands-on help in their application and/or those who are required to respond to an audit and are seeking support in cleaning up their systems prior to re-review.
This service will provide one-on-one consultation with an experienced Clinical Research Project Manager who will:
- implement corrective action plans outlined by auditors
- consult on the creation/revision of research team infrastructure and operational systems
- support the development of study subject binders, data collection sheets, study checklists and/or financial spreadsheets
- guide the preparation of Standard Operating Procedures (SOPs)
- serve as a communication conduit between exiting and incoming investigators and study staff during periods of study team transition
- provide ongoing monitoring of implemented corrective action plans
The first six hours of service provision are free of charge. Fees are then negotiated based on a rate of $50/hour.
To make a Corrective Action Implementation service request please visit the CRP website. To find out more about this service, please contact the CRP at 617-724-5200.
Clinical Research Program and MGH Research
Clinical Research Education Unit Program for Clinical Research Staff: For course descriptions and registration please see: http://hub.partners.org/catalog/
Clinical Research Program The MGH Clinical Research Program (CRP) can help with:
Preparing grant applications, including:
- Biostatistical consultation on study design
- NIH budgets and referral to Corporate Sponsored Clinical Research for industry budgets
- Investigator-initiated IND’s and Data Safety Monitoring Plans (DSMP),
- Coordination of the application process for large program project grants
IRB Submissions: work with PI from submission through IRB approval. $2500 flat fee and $2700 for pediatric studies
- Providing experienced study coordinators ($41/hour)
- Developing study databases
- Identifying potential funding sources
- Subject recruitment strategies