The Center for Clinical Investigation (CCI), offers educational services designed to promote high quality clinical research at BWH for both investigators and study coordinators. A range of workshops is offered to help train new research coordinators in how to conduct clinical studies. In addition, CCI offers ongoing continuing education sessions for experienced study coordinators who want to increase their knowledge regarding good clinical practices and current methods for performing high-quality clinical trials. Below is a detailed list of courses offered by the Center for Clinical Investigation. The CCI educational initiative is designed to:
Increase knowledge of current concepts in conducting high quality clinical research.
Help researchers obtain clinical research skills, e.g. navigating the IRB, "Good Clinical Practice" and basic statistical approaches.
Provide continuing education credits.
Direct researchers to CCI services and other resources at BWH and HMS for clinical investigation and training.
Current Courses Enrolling
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DESCRIPTION OF UPCOMING CCI COURSES & EVENTS
New Research Assistant Orientation
This 2 hour class is designed for new research assistants who will be primarily working on data collection, data entry, recruitment, etc, with no subject consenting or IRB responsibilities. New research staff with subject consenting and IRB responsibilities should plan to attend the full-day New Study Coordinator Orientation.
Next Course Date: 6/11/08
Compliance in Clinical Research: What You Must Know
Who Tells the IRB What to Do? The Effect of Case Law
This presentation will include: A brief description of research oversight, how case law has informed the current oversight system A bioethical chronology: a history of broken rules providing a historical perspective of challenges to existing guidelines and regulations More current case law situations including events at the University of Pennsylvania and Johns Hopkins Current challenges to regulations and effect of case law regarding research oversight
FDA Warning Letters - Lessons Learned from Others
This session will discuss citations from FDA warning letters and provide corrective actions, as well as preventive measures for clinical investigators and study staff, who are conducting FDA-regulated, as well as non-FDA-regulated studies. The QI staff will also be available to answer study site-specific questions before and after the presentation.
Lecture Date: 6/18/08
The Secrets of a Sucessful Researcher
Start the new academic year primed for success. Dr. Joanne Ingwall, Professor of Medicine, will speak about the secrets of the successful researcher. She will talk about the pitfalls she has seen and the steps you can take to improve your chances for success by avoiding the common mistakes she has observed.
Lecture Date: 7/1/08
Study Coordinator Orientation - Repeated every 2 months:
In this class, you will receive valuable information about navigating the research system here, as well as reference materials that address institutional policies and contacts, regulations that govern clinical research, and the principle duties of research coordinators. Repeated every 2 months
Next course date: 7/10/08
IRB Lecture: Issues for Bench & Desk Scientists
The purpose of this seminar is to discuss ethical, regulatory, and institutional issues relevant to analysis limited to human biological samples and medical records, and databases. Some of the questions and topics that will be covered include: What needs IRB Review?; What is exempt?; What is "Minimal Risk?"; What is expedited review, and what research qualifies for expedited review?; What is a "secondary use" of data samples?; How to effectively provide all information the IRB needs to review your project promptly!; Outside collaborations - sharing your data and specimens properly. Pitfalls and problems to avoid.
Lecture Date: 7/17/08
IRB Lecture: What does the IRB Really Want?
This lecture will provide important practical advice for investigators submitting protocols to the Partner's Human Research Committees (IRBs). Find out exactly what the IRB needs to review your study, and how to best and most efficiently present your scientific, ethical, and logistical information to the IRB.
Lecture date: 7/22/08
Selecting, Retaining and Motivating Staff
After attending this presentation, you should be able to: -- Use selection interviews more effectively -- Prepare for an interview and maximize the time you spend with a candidate -- Sharpen your interviewing skills to enable you to elicit the most valuable job-related information -- Explain the laws surrounding the interview and other terms and conditions of employment -- Distinguish between appropriate and inappropriate questions -- Write objectives for your staff (and yourself) designed to increase productivity and job satisfaction -- Appreciate the importance of giving performance feedback to your staff -- Describe the process of a feedback review and the skills required for it.
Lecture Date: 7/24/08
New for 2007-2008
Monthly Luncheon Lecture Series for Research Nurses/Coordinators
Upcoming Lectures:
Tuesday, June 17: Clinical Research Advertising and Recruitment - Ian Shempp, Sr. Clinical Research Manager
Recruitment issues are very common problems that delay or derail many ongoing clinical research studies. Delays in recruitment can cause both financial and timeline overruns, and at times can lead to early study closure. Advertising and recruitment vary in all studies, but there are methods that can be of assistance to your research team. This lecture will provide an overview and case study approach to the basics of recruitment and advertising using methods both within and outside the hospital to help find subjects for your PHRC approved trial. Discussion will include different types of recruitment and advertising methods that are in use at Brigham and Women's Hospital. We will also discuss allocation of resources for clinical research recruitment and different methods that may be applicable for your various types of trials.
Sampling of Other CCI Courses
Building a Diverse, Inclusive Work Team
Today's workplace is more culturally-diverse, more racially-diverse, more gender-diverse and more values-diverse than at any other time in our history. As members of our workforce come together across differences in values, backgrounds, and workplace expectations healthcare employees and managers at all levels are asking: How can we leverage our enormous diversity to build productive high performing work teams for the future? How can we develop our individual skills in valuing and managing differences as we work together to serve our diverse patient population? This seminar will outline the latest thinking in diversity education, and use group dialogue to explore how these developments are shaping the way we work together to reinvent our workplaces and leverage diversity for the future.
Seminar Date: TBD
K-Panel Discussion
A panel discussion from BWH K-award recipients, who will share their perspectives, experiences, and wisdom, about this important career development program from the NIH. This is the second of the series of events from the Clinical Research Career Development Program.
Seminar in Statistics for Medical Researchers
The BWH Center for Clinical Investigation is sponsoring a Seminar in Statistics for Medical Researchers. This weekly seminar will be given by Dr. Robert Goldman, Professor of Statistics, Graduate School for Health Studies, Simmons College and past president of the Boston Chapter of the American Statistical Association. Dr. Goldman’s interests and publications are in the area of statistical education. He has written several statistical textbooks and was an organizer of a series of conferences on statistics education. Some familiarity with basic statistics is required as this course offers insights and clarifications to statistics. Topics to be presented include: Exploring Data, Statistical Inference, Linear Models, Study Design, and Sample Size Determination.
Next course date: Fall 2007
Conflicts of Interest in Clinical Research
Nikki Zapol, an attorney in the Partners Office of General Counsel, will discuss conflicts of interest concerns and policies relating to investigators engaged in clinical research.
IRB Adverse Event Reporting Update
Deb Barnard will address the upcoming changes that have been made to the Partners Human Research Committee's adverse event reporting policy. She will identify the federal regulations regarding reporting requirements for IRBs, sponsors, and PIs. She will review the revised reporting requirements for Partners investigators regarding adverse events and unanticipated problems.
Lecture date: TBD
Introductory Course on Genetics in Clinical Research
This course, sponsored by Brigham and Women's Center for Clinical Investigation (CCI), is directed to individuals interested in an introduction to human genetics research. It will consist of a six session series of lectures presented by Drs. Juan Celedón, Benjamin Raby, and Edwin Silverman. Lectures will cover basic principles in genetics, population genetics, and genomics; design of genetic studies of linkage and association; and genotyping and sequencing.
Next course date: Early Spring of 2008
Advanced Biostatistics: Data Mining, a 3 part series:
Dr. Marsha Wilcox will be presenting and advanced, three part series on data mining. Part 1 - 11/7/07: A Survey of Methods Part 2 - 11/14/07: Tree-based Data Mining Part 3 - 12/5/07: Application of Data Mining & Genetics with a Focus on Phenotype Identification
Course dates: TBD
Evidence Based Guide to writing grant proposals for clinical research
Dr. Inouye will present recommendations for the essential grant-writing process for clinical researchers, based on observations from a NIH study section. Sections of grants that are frequently scrutinized and critiqued will be highlighted so that areas commonly cited as deficient will be improved. Application of Dr. Inouye's systematic approach will make the critically important task of grant writing more manageable for the clinical researcher.
Lecture date: TBD
Nuts and Bolts of Clinical Trials: An Investigator's Review
Randomized clinical trials are often considered the gold standard of epidemiologic study designs. If well-designed and conducted, they can achieve a degree of assurance in the detection of small to moderate, yet clinically meaningful, effect sizes of a drug or an intervention that cannot be achieved with any other study design. Yet, they also have added complexity in terms of ethics, costs and feasibility, as well as in ensuring that bias and confounding are minimized through techniques such as randomization, blinding, placebo-controlled, and intention-to-treat analyses. This seminar will review the principles of the design, conduct and analysis of a randomized clinical trial, using studies such as the Women’s Health Study and Physicians’ Health Study as examples.
Lecture Date: TBD
Refresher Course:
Have you been a research nurse or study coordinator for more than a year? Are you always sure you are up to date on the best ways to manage your studies? Join us for a refresher session to discuss some do's and don'ts of consenting, amendments, violations, and record keeping.
Next Course Date: TBD
RPDR - Using the Web-Based Partners Research Patient Data Registry to Recruit Patients From Your Own Practice
This lecture will provide an overview of RPDR functionality and will demonstrate how researchers can use the RPDR to recruit patients from their own practice. The RPDR is a large data warehouse that serves as a central clinical data registry for BWH, MGH, and Partners community hospitals. The RPDR brings clinical information to researchers through the online Query Tool, which is used to query RPDR data for aggregate totals, such as total patients with userdefined diagnoses, procedures or medications, etc. during a particular time frame. With proper IRB approval, researchers can request more detailed medical record data on the user-defined group such as demographics, contact data, diagnoses, labratory results, LMR data, operative notes, pathology, procedures, microbiology, pulmonary reports, radiology reports and graphics, and discharge summaries.
Next Course Date: TBD
Research Coordinator Networking Breakfast:
This informal breakfast is an opportunity to meet and network with other coordinators, the CCI education staff, and representatives from some research related departments, such as Corporate Sponsored Research, Investigational Drug Services, GCRC, Quality Improvement Program, CTC, RCNet, and more. Please join us for a respite hour of breakfast, casual conversation with your peers, and a chance to gather information, ask questions, and share your thoughts and suggestions for future educational offerings.
2008 Breakfast Date: TBD
Budget Creation for Clinical Research: Possibilities and Pitfalls
Douglas Reichgott, clinical research manager of Partners Research Ventures & Licensing/Corporate Sponsored Clinical Research will focus on the important aspects to remember when drafting a corporate budget.
Essentials of Good Clinical Practice:
The objective of this full day course is to provide a comprehensive overview of the principles of International Conference on Harmonisation Good Clinical Practice, according to applicable Federal Drug Administration regulations. You will receive a better understanding of roles and responsibilities consistent with both hospital policy and quality principles. Topics will include: Introductions and Goals of Training Regulations that Cover Research International Conference on Harmonisation/Code of Federal Regulations; Role of sponsor’s and Contract Research Organization’s; Role of IRB’s; Role of Investigator’s; The Development Team; Data and Safety Monitoring; Protocol Compliance and Good Clinical Practice; Managing Challenging Good Clinical Practice Situations; Investigational Drug Accountability; Adverse Experience and Serious Adverse Experience; Reporting Required Documentation ; Ensure the Successful FDA Audit. This course will incorporate a combination of lectures, discussions, case studies, and activity.
How to Give a Talk - Dr. Andrew Nierenberg
Worried about your next talk? Have you realized that you have never had any training about how to give a great talk? This presentation will cover basic principles of communicating research in oral presentations. Structuring and organizing text and graphics, as well as basic presentation skills (including the uses and dangers of humor), will be covered.
Lecture Date - TBD
Problem-based Biostatistics for Medical Researchers
The Center for Clinical Investigation is sponsoring a four session Problem-Based Biostatistics Seminar for Physiologic Investigators. The seminar will be run by John Orav, Ph.D., Associate Professor of Medicine (Biostatistics), Harvard Medical School. Each of the four sessions will focus on a different theme and an actual research project and database will be used to provide concrete and realistic examples. The goal of the seminars is to demonstrate alternative statistical approaches to questions explored by physiologic investigators.
The four topics to be covered are:
1.) Analysis with missing data
2.) Longitudinal analysis
3.) Non parametric methods
4.) Logistic regression
Course dates: Winter 2009
Research Leadership Seminar Series: Developing a Business Plan for Clinical Researchers
Business plans are a strategic management tool for clinical investigators. Why develop a business plan? What goes into a successful plan? How can a businessplan contribute to your long-term success?
Next lecture date: TBD
Additional past topics have included: Genetics and Genomics for Clinical Investigators, Statistical Epidemiology,IRB Seminars, Monthly Lecture Series for Study Coordinators, Genetics for Study Coordinators, Research Patient Data Registry, Insight, and RSVP - Research Study Volunteer Program
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Dangerous Goods/Specimen Shipping
Human Research Quality Improvement Program (QI)
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