Announcements of educational opportunities from the MassGeneral Hospital for Children Research Council.
UPCOMING EDUCATIONAL OPPORTUNITIES
Study Electronic Data Capture: REDCap and StudyTRAX
Thursday, May 23, 10:00am – 11:00am, Simches 3.130
The goal of this presentation is to provide an overview of two electronic data capture (EDC) applications offered through Partners Research Computing, REDCap and StudyTRAX. Additionally, provide common reasons, factor and issues related to choosing between these two EDC applications. This presentation is intended for researchers considering the use of REDCap or StudyTRAX. Attendees will also learn about and compare functionality in both applications and examine differences in application development, product roadmap, and support model.
Bioinformatics: Introductory Mini-Course
This mini-course is intended mainly for experimentalists who would like to get oriented in basic Bioinformatics concepts and tools. It is intended as a primer that would allow you to better understand general ideas and approaches and to start asking the right questions about your data. If you want to drill very deeply into a specific question or to get hands-on experience, this probably isn't a course for you. However, we are open to organizing more in-depth courses and workshops in the future. This course will consist of five seminars with basic introduction to specific topics.
If you have any questions, please feel free to contact Ruslan Sadreyev: email@example.com
• Tuesday, May 21, 1:00 – 2:30pm, Simches Room 3.130
Basic statistics and introduction toR: Overview of basic statistical concepts and methods, brief introduction to R (www.r-project.org)
• Tuesday, June 4, 2:00 – 1:30 pm, Simches Room 3.120
Protein/gene sequence analysis and protein structure prediction: Overview of methods for protein/gene sequence alignment, sequence-based homology detection, and protein 30 structure analysis
• Friday, June 14, 12:00 – 1:30 pm, Simches Room 3.120
Microarray expression analysis and gene set enrichment analysis: Overview of basic concepts, methods, and tools
• Wednesday, June 19, 1:30am – 1:00pm, Simches Room 3.130
Next generation sequencing (NGS) analysis -- part 1: Sequence acquisition and processing; genome mapping and alignment manipulation
• Friday, June 28, 12:00 – 1:30 pm, Simches Room 3.120
Next generation sequencing (NGS) analysis -- part 2: Specific NGS applications: ChiP-seq, RNA-seq, metagenomics analyses; public NGS datasets
This Mini-Course is sponsored by the Department of Molecular Biology, MGH and by The Nutrition Obesity Research Center at Harvard.
Ref Works: A Web-based citation manager
Learn how to save the results of your Ovid and PubMed searches, organize your references and access your files from home. See how to create CVs and bibliographies in minutes.
Wednesday, June 12, 10 - 11 am
Register for a class online OR call 617-726-8601
On Site, On Your Desktop: Learn How to Use Treadwell Library
Save time. Work smart. See how to access electronic journals. Learn how to find out if Treadwell owns a book or journal. Learn how to request a book or journal article not at Treadwell Library.
Tuesday June 11, 11:30 am - 12:30 pm
Register for a class online OR call 617-726-8601
QUOSA: An Information Manager
Learn how to retrieve multiple PDFs with one click from a PubMed or Ovid MEDLINE search.
See how QUOSA helps organize your PDFs and other documents into a searchable personal library.
Wednesday, June 19, 10 - 11 am
Register for a class online OR call 617-726-8601
Classes are held at Treadwell Library, Bartlett Hall Extension. If the scheduled times are inconvenient, please call 617-726-8601to arrange an individual or group session.
Learn to use the easy Ovid interface to search the biomedical and nursing literature. Learn how to link to Treadwell's electronic journals from your Medline search. For an individual or group consultation, please call 617-726-8601
CINAHL is the Cumulative Index to Nursing and Allied Health.
Learn how to search the literature of nursing, social work, PT, OT and other allied health disciplines.
Contact hours for nurses. For an individual or group consultation, please call 617-726-8601
Learn How to Search PsycINFO
Find articles on psychology, social work, human services, sociology and behavioral sciences.
For an individual or group consultation, please call 617-726-8601
Treadwell Library Class on the NIH Public Access Policy
Tuesday, May 21, 3 - 4 pm & Wednesday, May 29, 10 - 11 am
The NIH Public Access Policy: a Class for Grant Administrators, R.A.'s and Other PI Delegates
Learn how to:
-Submit manuscripts to PubMed Central to comply with the NIH policy and learn about the different submission methods available
-Use the myNCBI tool in PubMed to link bibliographies to NIH grants for progress reports and to manage policy compliance
The Spirit Catches You and You Fall Down: A Hmong Child, Her American Doctors, and the Collision of Two Cultures
Tuesday, May 28 12:00pm — 1:00pm, Garrod/Mendel Conference Room
The mission of the Research Nurse Roundtable is to provide a forum for nurses who work in clinicalresearch to discuss issues common to their practice. The roundtable meets once a month and is led by experienced research nurses in collaboration with the MGH Clinical Research Program Education Unit. This forum provides a great opportunity for knowledgesharing, problem solving, peer support and community building.
Registration is recommended. Feel free to bring your lunch.
For questions about registration please contact Suzanne Powell.
For questions about the Research Nurse Book Club please contact Amy Sbrolla, RN.
Orientation Program: Clinical Research Resources at MGH
Thursday May 30, 11:00am – 4:00pm, Simches 3.120
This Orientation Program will provide valuable information about the clinical research system at MGH. New investigators and research coordinators/assistants are invited to meet with representatives from Research Management, Partners Clinical Research Office, Partners Human Research Committee, Partners Quality Improvement Program, Clinical Research Program, Clinical Research Center, Research Compliance, Investigational Drug Service and Clinical Research Laboratory Core. Please click here for a more detailed schedule. Lunch will be provided.
Continuing Review and Amendments
Thursday, June 6, 12:00pm – 1:00pm, Garrod/Mendel Conference Room
Learn how your Continuing Review and Amendments are handled by the IRB staff at intake and what is required at full board for review. Also, how and what the Administrative Chairs (voting members of the IRB) review and consider at Continuing Review. The Administrative Chairs will use the PHRC Guide to Review of Non-Exempt Human Subjects Research to identify and discuss ethical and scientific issues, including how recruitment, consenting and safety monitoring is handled and how some of these issues can be addressed in your submission.
The Principles and Practice of Clinical Research Data Management
Thursday, June 13 2:30pm – 3:30pmSimches 3.110
Lynn Simpson, MPH, Research Data & Analytics Services Manager, Enterprise Research Infrastructure & Services (ERIS)
This seminar will present an insight into the key considerations in managing your clinical research data in accordance with Good Clinical Practice (GCP) Guidelines. This course will review data management terminology and the regulations governing GCP. It will provide the conceptual framework for thinking about overall data management processes from study start (case report form and database design) to study maintenance (data cleaning, monitoring, and report generation), so that researchers will be able to obtain the ultimate goal of clean and analyzable data sets. The course will also compare different data capture systems and outline data management priorities for studies with limited resources.
This course is geared towards investigators, research nurses, study coordinators and all other study staff.
Getting Started With REDCap
Monday, June 10, 10:00am – 11:30am, Garrod/Mendel Conference Room
This session is to help REDCap users design databases and surveys. Learn about study start up, project life cycles, data management, and how to program data fields and branching logic. The first hour is an overview demonstration and then time is devoted to user’s Q&A and design questions.
The Principles and Practice of Clinical Research Data Management
Thursday June 13, 2:30pm – 3:30pm, Simches 3.110
This seminar will present an insight into the key considerations in managing your clinical research data in accordance with Good Clinical Practice (GCP) Guidelines. This course will review data management terminology and the regulations governing GCP. It will provide the conceptual framework for thinking about overall data management processes from study start (case report form and database design) to study maintenance (data cleaning, monitoring, and report generation), so that researchers will be able to obtain the ultimate goal of clean and analyzable data sets. The course will also compare different data capture systems and outline data management priorities for studies with limited resources. This course is approved for CEU credit.
Thursday, June 20, 12:00pm – 1:00pm, Garrod/Mendel Conference Room
Per Federal Regulations, Good Clinical Practice, and Partners HRC policies, investigators and research staff are required to keep case histories on enrolled subjects. Charlene Malarick, RN, BSN, CCRC, of the Partners Quality Improvement Program will review requirements for source documentation and record keeping of subject files. The presentation will include a hypothetical protocol with enrolled subjects and its appropriate source documentation. Proper record keeping and study management will assist study staff with the annual Continuing Review process.
Good Clinical Practice in Research at an Academic Research Institution
Mondays, June 17, 24, July 8, and 15, 8:00am – 12:30pm, Simches 3.120
The MGH Clinical Research Program, Partners Human Research Committee and Partners Quality Improvement Program are sponsoring this program.
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting human subjects’ research. GCP guidelines define the roles and responsibilities of the IRB, investigator, and sponsor throughout the clinical trial and also describe the essential documents needed for the conduct of a clinical trial. This is a highly interactive, four session course on the principles of GCP. In order to receive a certificate of completion a participant must attend all 4 sessions and successfully pass a post-course exam online. This course is approved for CME, RCR and CEU credit. Registration is required. Please contact Suzanne Powell with any questions.
Maintaining Research Subject Privacy and Information Security: What Clinical Researchers Must Know
Tuesday, July 9, 3:00pm – 4:30pm, Simches 3.110
With federal and state agencies holding all covered entities to new standards for securing personal and protected information, Paula Moran will discuss the importance of applying these regulations within the clinical research setting. This presentation will include real life examples, and ways to prevent potentially damaging privacy and security breaches from occurring, and it will also focus on the security standards and how staff should implement required technical and physical solutions. Elizabeth Hohmann, MD will describe the IRB’s actions and mandatory reporting requirements for research privacy breaches.
Part 1: Amendments and Reporting to the IRB – Thursday, July 11
Part 2: Protocol Adherence and Reporting Requirements – Thursday, July 18
Part 1: Consent Form Writing - Thursday, August 1
Part 2: Informed Consent Process – Thursday, August 15
Attendees may choose to attend all sessions or can attend whichever sessions are pertinent to their learning needs.
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