• Session 1 - Basics of study development & clinical research language and culture.This session will explore and define the life cycle of a clinical research study and the study coordinator role within each stage. We will also define and compare the roles of research study team members, explaining how the roles vary and how they interface. We will recognize barriers to communication and identify specific strategies to enhance communication between study team members. 

• Session 2 - Good clinical practice & essential documents for clinical research. Topics in this session will help explain how GCP impacts the clinical research process and will examine root causes on non-compliance. We will explore actions to prevent research non-compliance, define source documents, list techniques for maintaining accurate source documents, and learn to recognize common errors.

• Session 3 - Recruitment and Retention. Effective recruitment strategies will be explored, as well as methods to keep your subjects engaged through the life of the project.
  

• Session 4 - Conducting & obtaining valid informed consent. This session will give you the opportunity to demonstrate necessary language and communication skills when interacting with potential study participants and their families.

• Orthognathic/Obstructive Sleep Apnea
• Pain/Anesthesia
• Dentoalveolar/Implant
• Pathology/Reconstruction
• TMJ

• Overview of Design Options for Clinical Trials: Types of clinical research (prospective, retrospective, observational, random clinical trials, administrative databases, meta-analysis); issues unique to surgical trials.
• Statistical Concepts in Clinical Trials I: The null hypothesis, rationale for randomization, sample size generation, power, statistical testing, and intent to treat analyses.
• Statistical Concepts in Clinical Trials II: Tests of significance, multiple end points, stratification, repeated measurements, subgroup analyses, crossover problems
• Errors in Clinical Trials
• Research Ethics and Integrity
• Patient Selection: Recruiting issues and strategies, retaining subjects, inclusion and exclusion criteria and its impact on validity, stratification, randomization techniques and IRB approval.

This 3-Part series: June 14, June 26, and July 12, 2012
Palmer Commons Great Lakes South and Board Rooms 1-5
5:30-7:30 p.m.

Registrants MUST attend all 3 sessions.
Your mentor is expected to attend session 3.

Attendance is strictly limited to 30 participants who are currently preparing a K grant

July 10, 2012
Palmer Commons Great Lakes Rooms
Breakfast at 7:30 AM, 8:00 AM - 12:30 PM

• Session 1 - Basics of study development & clinical research language and culture.This session will explore and define the life cycle of a clinical research study and the study coordinator role within each stage. We will also define and compare the roles of research study team members, explaining how the roles vary and how they interface. We will recognize barriers to communication and identify specific strategies to enhance communication between study team members. 

• Session 2 - Good clinical practice & essential documents for clinical research. Topics in this session will help explain how GCP impacts the clinical research process and will examine root causes on non-compliance. We will explore actions to prevent research non-compliance, define source documents, list techniques for maintaining accurate source documents, and learn to recognize common errors.

• Session 3 - Recruitment and Retention. Effective recruitment strategies will be explored, as well as methods to keep your subjects engaged through the life of the project.
  

• Session 4 - Conducting & obtaining valid informed consent. This session will give you the opportunity to demonstrate necessary language and communication skills when interacting with potential study participants and their families.

A 4-Part series over 12 weeks. This course was piloted in early 2012.  Will be offered in Fall 2012.

Get responsible conduct of research off your desk!
MICHR is offering a new approach to Responsible Conduct of Research (RCR) training that aligns with your priorities for conducting pilot research, taking courses, and working with your mentor.

Registration is required.

When you described RCR training in your K proposal did you patch together a schedule of workshops and online learning to meet the NIH requirements? Now you can meet that requirement with one high quality seminar. This winter MICHR will offer a 4-session (8 hour) seminar for K awardees and other Career Development Training (CDA) recipients. This seminar meets the requirements for the NIH K 23 application, or any federal or non-federal career development grant and responds to your needs.

Through this seminar you will learn key concepts in the responsible conduct of research by identifying and addressing RCR issues in your own research. It's relevant, hands-on, and includes mentoring from experienced faculty.

What will you get?

• 8 hours of face-to-face faculty-led RCR training
• Expert consultation and resolution of an ethics or integrity issue in your research
• Practice using a rational approach to recognize and address RCR issues
• Experience presenting to other how you addressed and RCR issue

• Session 1 - Basics of study development & clinical research language and culture.This session will explore and define the life cycle of a clinical research study and the study coordinator role within each stage. We will also define and compare the roles of research study team members, explaining how the roles vary and how they interface. We will recognize barriers to communication and identify specific strategies to enhance communication between study team members. 

• Session 2 - Good clinical practice & essential documents for clinical research. Topics in this session will help explain how GCP impacts the clinical research process and will examine root causes on non-compliance. We will explore actions to prevent research non-compliance, define source documents, list techniques for maintaining accurate source documents, and learn to recognize common errors.

• Session 3 - Recruitment and Retention. Effective recruitment strategies will be explored, as well as methods to keep your subjects engaged through the life of the project.
  

• Session 4 - Conducting & obtaining valid informed consent. This session will give you the opportunity to demonstrate necessary language and communication skills when interacting with potential study participants and their families.

Piloted in December 2011. Watch for future offerings.
Sponsored by U-M Medical School Office of Faculty Affairs

This workshop if for FACULTY ONLY. REGISTRATION IS REQUIRED

Please join us for an interactive workshop focused on key elements of scientific writing presented by Tom Annesley, Ph.D., Department of Pathology and Jasna Markovac, Ph.D., Senior Advisor for Publishing and Related Business Development at UMMS.

In this workshop, the presenters will:

5-part series:
Offered in January - February 2012.  Watch for future offerings.

Session 1 (January 18): Basics of Study Design [discuss design issues in a hypothetical research proposal]

Session 2 : January 25 Getting Started With Your Study [critique methods sections of grants and a study protocol, discuss alternative recruitment methods]

Session 3 : February 1 Pitfalls in Study Design and Interpretation [review ethical challenges in study design]

Session 4 : February 8 Research Funding and Budgets [develop goals for seeking funding and review sources of help to find grants; develop a study budget]

Session 5 : February 15 Next Steps in Your Research Career [practice networking and communicating your research to potential mentors and collaborators]

This event is guaranteed to improve your score!

The MICHR Mock Study Section is a unique and highly motivating experience. If you register you will review a grant as if you were participating in a real NIH Study Section. The Mock Study Section experience will help you to think like a reviewer and improve your grant writing skills.

Participants choose to be assigned to a health services research study section or a clinical and health research study section, each chaired by an experienced NIH reviewer.

Requirements: As with the real NIH Study Sections in Washington, all participant experts (you) are required to attend and participate fully.

• Attend Kickoff session (1.5 hours)

• Read emails (.5)

• Review instructions and criteria (1)

• Review grant and return critiques to MICHR (3-4)

• Meet for Mock Study Section (2)

This widely acclaimed seminar addresses practical and conceptual aspects of the proposal writing process (with emphasis on NIH applications). Participants will learn to prepare a competitive grant proposal by:

• incorporating knowledge of the peer review process in a persuasive research description
• formulating a focused research plan that incorporates well-formulated hypotheses, rationales, specific objectives, and long-range research goals
• developing and justifying a budget for the proposed research activities
• using existing resources at the University of Michigan in research proposal development
• avoiding many common grant writing mistakes.

This workshop is open to all UM faculty, fellows, graduate students and staff.

All registrants will receive The Grant Application Writer’s Workbook – National Institutes of Health Version (a $75.00 value) as well as other course materials.

Visit the C3RG web page for current offerings and additional information.

Co-sponsored by the Cardiovascular Center and the MICHR Education Program

To learn more about C3RG, visit their website.

Visit the CSCAR web page for current offerings and additional information.

The Center for Statistical Consultation and Research (CSCAR) provides free statistical consulting to all UM faculty, staff, and graduate students with the design, planning, analysis, and presentation of research studies.

CSCAR also presents workshops on statistical methods, statistical software, qualitative data analysis and geographic information sytems. Fall, Winter and Spring workshop offerings include SAS,SPSS, Stata, SEM and Analysis with R.