Identify Funding Opportunities Proposal Development Award Management Compliance Review and Oversight Education and Training Technology Transfer
Office of Research and Technology Management
Identify Funding Proposals Proposal Development Award Management Compliance Review and Oversight Education and Training Technology Transfer

CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Spring 2019

1/18/2019
11:00
- 12:00 PM
SpartaIRB - Getting Started (CWRU)
This 1-hour session will introduce CWRU IRB investigators to the SpartaIRB system. Investigators, administrators and students who will submit IRB applications are encouraged to attend.

This training will focus primarily on submissions to the CWRU IRB.
3 Sears Library Building, Room 670 Register
1/22/2019
12:00
- 1:00 PM
New Common Rule
Regulations that govern research (known as the “Common Rule”) are being updated for the first time since 1981. These changes will take effect on January 21, 2019. Any new study approved on or after that day will have to comply with the New Common Rule.

This is an education session going over the new regulations.

In person in UH Lakeside 1400 or via WebEx:

WebEx Link:

https://meetings.uhhospitals.org/orion/joinmeeting.do?MTID=1515b77baafce32e56367f59b65a2015

WebEx Access Code: 994 232 276
0 UH Lakeside, Room 1400 Register
1/22/2019
10:30
- 12:00 AM
The Basics, MODULE 1: FDA Regulations and Good Clinical Practice (GCP)
By the end of this module, you will have an understanding of the Federal Regulations and ICH Good Clinical Practice guideline requirements as they relate to clinical research.

Alison Campbell Presenting
4 UH Lakeside, Room 1400 Register
1/24/2019
1:00
- 2:00 PM
SpartaIRB - Submitting Modifications and Continuing Reviews
This session will cover how to submit modifications continuing reviews, as well as closures and personnel changes in SpartaIRB.

This training will focus primarily on submissions to the CWRU IRB.
3 Sears Library Building, Room 670 Register
1/25/2019
12:00
- 1:00 PM
New Common Rule
Regulations that govern research (known as the “Common Rule”) are being updated for the first time since 1981. These changes will take effect on January 21, 2019. Any new study approved on or after that day will have to comply with the New Common Rule.

This is an education session going over the new regulations.

In person in UH Lakeside 1400 or via WebEx:

WebEx Link:

https://meetings.uhhospitals.org/orion/joinmeeting.do?MTID=cd5b1f7e92746d864c8dd32b2d0b232e

WebEx Access Code: 993 374 473
0 UH Lakeside, Room 1400 Register
1/29/2019
10:00
- 11:00 AM
New Common Rule
Regulations that govern research (known as the “Common Rule”) are being updated for the first time since 1981. These changes will take effect on January 21, 2019. Any new study approved on or after that day will have to comply with the New Common Rule.

This is an education session going over the new regulations.

In person in UH Lakeside 1400 or via WebEx:

WebEx Link:

https://meetings.uhhospitals.org/orion/joinmeeting.do?MTID=5efdebd84fff7531280cdceb8044569b

WebEx Access Code: 993 591 297
0 UH Lakeside, Room 1400 Register
1/29/2019
11:30
- 1:00 PM
The Basics, MODULE 2: Required Regulatory Documentation & Essential Documents
During this session, we will define essential regulatory documents and discuss what your regulatory binder should contain.

Bring your “reg binder” to the session and we can help you identify missing information or help you get started in putting one together.

Carrie O'Neill Presenting
0 UH Lakeside, Room 1400 Register
1/31/2019
9:30
- 12:00 PM
Study Visit Workshop 2: Study Visit
During this interactive workshop, participants will walk through a mock visit for a practical look at what happens before, during, and after a clinical research study visit.

Participants will also learn how to use a protocol, how to develop source documents, how to fill out a case report form (CRF), steps for developing an informed consent form (ICF), and how to identify and report adverse events.

Various Presenters
2 UH Lakeside, Room 1400 Register
2/5/2019
11:30
- 1:00 PM
The Basics, MODULE 3: Study Feasibility through Study Activation
This module will describe the study feasibility process at UH as well as qualification visit, site initiation, and study activation.

Carrie O'Neill Presenting
0 UH Lakeside, Room 1400 Register
2/7/2019
11:30
- 1:00 PM
REDCap 101: An Introduction
Come learn how to build a questionnaire and/or survey in REDCap (Research Electronic Data Capture), a secure web application for building and managing online surveys, questionnaires, and databases.

Sheree Hemphill Presenting
3 UH Lakeside, Room 1400 Register
2/11/2019
1:00
- 2:30 PM
The Basics, MODULE 4: Coverage Analysis, Research Billing Compliance & Subject Calendar
Attendees will receive an overview of the entire billing process from patient registration through claim resolution to ensure appropriate patient billing.

Developing an adequate budget, necessary consent language, populating a coverage analysis (which is required for all studies involving clinical care), and completion of RBNFs will also be discussed.

Lhotse Voege Presenting
0 UH Lakeside, Room 1400 Register
2/21/2019
9:30
- 12:00 PM
Study Visit Workshop 3: Maintenance, Monitoring, and Closeout
During this interactive workshop, you will learn how to manage protocol changes, research staff training, data management and query resolution. We will also take a look at preparing a study for closure.

Various Presenters
2 UH Lakeside, Room 1400 Register
2/26/2019
1:30
- 3:00 PM
The Basics, MODULE 5: Prescreening, Eligibility & Enrollment Process
This module will define the process of pre-screening, eligibility review, and verification as well as enrollment and appropriate documentation for subjects enrolled at University Hospitals.

3 UH Lakeside, Room 1400 Register
3/1/2019
10:00
- 11:30 AM
Investigator and Study Team Responsibilities
Do you understand the responsibilities of an investigator when conducting clinical research?

It is essential that all members of the clinical research team, including the Principal Investigator, understand these responsibilities and also the appropriate delegation of these responsibilities to study staff.

Carrie O'Neill Presenting
3 UH Lakeside, Room 1400 Register
3/5/2019
11:30
- 1:00 PM
The Basics, MODULE 6: Informed Consent & Re-consent
This presentation will define the requirements of the informed consent process, forms used, required documentation & re-consent.

Carrie O'Neill Presenting
4 UH Lakeside, Room 1400 Register
3/11/2019
1:00
- 2:30 PM
The Basics, MODULE 7: Good Documentation Practices & Clinical Data Management
Adequate documentation of the research process is essential for good quality research. It is from this documentation that protocol specific data is abstracted, submitted and analyzed. Learn best practices by attending this session.

3 UH Lakeside, Room 1400 Register
3/14/2019
11:30
- 1:00 PM
Everything You Need to Know About HIPAA & Research
Accessing PHI? It is your responsibility to prevent a data breach. Find out what a breach is, how to prevent it, who to contact and what to do.

Think you know everything about PHI as it relates to Research? Did you know that all UH PHI must only be stored on a UH computer or encrypted device? There are NO exceptions. Case scenarios will be discussed as well as the IRB’s involvement in these matters.

Carrie O'Neill Presenting
3 UH Lakeside, Room 1400 Register
4/11/2019
11:30
- 1:00 PM
The Basics, MODULE 8: Adverse Events & Protocol Deviations
Understand how to define, identify, document, and report adverse events and protocol deviations.

4 UH Lakeside, Room 1400 Register
4/16/2019
11:30
- 1:00 PM
Getting Started with your Research
This session is ideal for new investigators, residents, fellows, students, and their advisors. Tips for obtaining IRB approval will be reviewed at this session.

Dr. Lydia Furman Presenting
3 UH Lakeside, Room 1400 Register
4/18/2019
11:30
- 1:00 PM
The Basics, MODULE 9: Avoiding Non-Compliance Findings
We will review the most common non-compliance findings and provide tips and tools to help research teams prevent them.

Alycia Slaton Presenting
3 UH Lakeside, Room 1400 Register
5/3/2019
11:30
- 1:00 PM
Submitting an Investigational New Drug (IND) to the FDA
This session will review the process from beginning to end of submitting an IND Application to the FDA and maintaining the application.

Jenna Arlow Presenting
3 UH Lakeside, Room 1400 Register
5/16/2019
11:30
- 1:00 PM
FDA & IRB Regulatory Pathway for Devices
This session will review the process for submitting an IDE Application to the FDA and the pathway in the IRB.

Learn what the FDA will look for when reviewing your device, what items are transferable from the FDA application to the IRB, and long term maintenance steps to ensure compliance with the FDA and IRB

Jenna Arlow Presenting
4 UH Lakeside, Room 1400 Register
5/21/2019
11:30
- 1:00 PM
Ethics of Clinical Research
During this session, we will explore issues related to ethics and professionalism in the conduct of clinical research, and gain knowledge about how to address and resolve ethical issues related to research.

Dr. Lydia Furman Presenting
3 UH Lakeside, Room 1400 Register

Summer 2019

6/7/2019
10:00
- 11:30 AM
Informed Consent and the Decisionally Impaired or Vulnerable Participant
The intricacies associated with consenting decisionally impaired human subject research participants will be the focus of this presentation. Different types of impairment will be highlighted as well as the legal implications of research with this population.

O.Mary Dwyer Presenting
3 UH Lakeside, Room 1400 Register
6/13/2019
11:30
- 1:00 PM
Special Interest IND
This session will discuss other circumstances that may fall into IND’s:
-Emergency Use
-Expanded Access
-Dietary Supplements & Vitamins.

Jenna Arlow Presenting
3 UH Lakeside, Room 1400 Register