| Seminar Title and Content |
Date, Time & Location |
Responsible Conduct of Research
- This session will cover data management practices including data collection, data ownership and data protection. We will also discuss the sharing of data and the “rules of the road” regarding authorship.
|
Friday 10/5/12
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout |
What Requires IRB Review?
- Definitions; Categories
(full/expedited/exempt); how to choose the appropriate IRB
application; how to differentiate between QA, Research, Clinical Care,
Quality Assessment; tutorial on IRB website.
|
Monday 10/22/12
9:30-11 am*
Tishman 5 (Montefiore)
Download Handout |
Use of Specimens in Research
- Use of existing data/specimens; ongoing collection of
data/specimens; research involving data/specimen analysis as
part of a collaboration
|
Wednesday 10/24/12
9:30-11 am*
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout |
Conduct of Genetic Research
- Definition of Genetic Research; consent requirements (GWAS/dbGaP);
Storage of Specimens - repositories; use of specimens collected
for other purposes;
|
Thursday, 11/8/12
9:30-11 am*
Binswanger Auditorium (Montefiore)
Download Handout |
How to Prepare a Budget for NIH and
Private Industry Sponsored Trials
- Definitions of Direct Costs Overhead, Personnel Budgets,
Fringe Benefits, Administrative Costs - Institutional
Requirements.
|
Thursday 11/15/12
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout
|
Research Billing Compliance
- Audience is coordinators and support staff: overview of
elearning module on Billing Compliance, Consequences of
non-compliance; Q&A.
|
Tuesday 12/11/12
9:30-11 am*
Dean's Conference Room
Belfer 303 (Einstein)
Canceled (will be rescheduled in the spring) |
IRB, ICTR and OCT Open House: Get
Your Questions Answered
- Come and meet the staff
- Have your questions answered
- Find out what institutional resources are available to
assist you
|
Wednesday 12/19/12
3 - 4:30 pm*
Neuro Conf Room
023 NW1 Blue Zone (Montefiore) |
Recruitment of Research Subjects
- Advertisements; Recruitment tools; Use of the internet;
transmission of data
|
Tuesday 1/15/2013
9-10:30 am*
Tishman 5 (Montefiore)
Download Handout |
Common Findings of the IRB, OHRP and
FDA
- How to navigate the IRB website, Common findings related to
Informed Consent, Recordkeeping, Protocol Deviations, What is
OHRP?, Overview of 45 CFR 46, FDA Regulations, Determination
letters, warning letters, published statistics.
|
Friday 2/1/13
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout
|
IRB, ICTR and OCT Open House: Get
Your Questions Answered
- Come and meet the staff
- Have your questions answered
- Find out
what institutional resources are available to assist you
|
Thursday 2/7/13
9 am - 10:30 am*
Dean's Conference Room
Belfer 303 (Einstein) |
Informed Consent
- Required elements; review of consent templates; translations
services and short forms; consents for minors and other
vulnerable subjects (cognitively impaired, unable to
consent, limited English proficiency; HIPAA Authorizations
(including waivers, alterations and exemptions), Informed
consent process; informed consent waiver guidelines; alternate
consent mechanisms.
|
Monday 2/11/13
12-1:30 pm**
Tishman 4 (Montefiore)
Download Handout |
Post IRB Approval Requirements:
Progress Reports, Amendments, Adverse Event Reporting
- Progress Reports; amendments; adverse event reporting -
internal and external AE policies; what to report; protocol
deviation policy; how to close a study
|
Wednesday 2/27/13
12-1:30 pm**
Board of Overseers Room Forchheimer G28
Download Handout |
What Requires IRB Review?
- Definitions; Categories (full/expedited/exempt); how to
choose the appropriate IRB application; how to differentiate
between QA, Research, Clinical Care, Quality Assessment;
tutorial on IRB website.
|
Thursday 3/14/13
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Download Handout |
Research Misconduct
- Definition of research misconduct; institutional policies; how
to handle subject complaints.
|
Monday 3/18/13
12-1:30 pm**
Tishman 4 (Montefiore)
|
Data Safety Monitoring
- How to develop an appropriate plan for your study; factors
to consider: single v. multisite studies; blind v. open label,
randomized v. non-randomized; risks to subjects; investigator
monitoring; external board monitoring; who could/should be on a
DSMC/B; how to document monitoring activities.
|
Thursday 4/4/13
9:30-11 am*
Tishman 4 (Montefiore) |
| IND/IDE Requirements
|
Tuesday 4/16/13
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein) |
Statistical Integrity of Research
Proposals
- What is a Pilot Project; What are the criteria; What are the
requirements.
|
Wednesday 4/24/13
12-1:30 pm**
Tishman 4 (Montefiore)
Register |
Handling/Administration/Documentation of Study Drugs
- A session for nurses and research coordinators on
administering care to patients who are enrolled as study
subjects - record keeping, storage and dispensing for on site
study drugs; how to acquire research medications stored in the
pharmacy; device studies
|
Friday 5/3/13
12-1:30 pm**
Tishman 5 (Montefiore)
Register |
Humanitarian Devices and Emergency
Use Procedures
- Clinical Care v. Research; Institutional Policies; consent
issues; Emergency Use
|
Monday 5/6/13
9:30-11 am*
Tishman 4 (Montefiore)
Register |
How to Maintain Research Data
- Subject Research Files; How to maintain a regulatory binder;
how to prepare for a sponsor or FDA audit; clinical notes vs.
research documentation; secure maintenance and transfer of data.
|
Tuesday 5/21/13
12-1:30 pm**
Dean's Conference Room
Belfer 303 (Einstein)
Register (waiting list only - this session is fully booked)
|
New Research Coordinators: What Do I
Need to Know About Data?
- EPF and CareCast - Electronic Medical Records, Using
software to track research, Clinical Looking Glass (CLG), data
for the clinical trial record
|
Monday 6/3/13
12-1:30 pm**
Tishman 5 (Montefiore)
Register |
Investigator Initiated Protocols:
Key Elements to Consider
- Ensuring elements are well documented in the protocol:
randomization; implementation; how confidentiality/blinding is
maintained; drug dispensing; data safety plan; sample size, etc.
|
Wednesday 6/19/13
9:30-11 am*
Dean's Conference Room
Belfer 303 (Einstein)
Register |