ORA
Newsletter - Week ending 12/07/01
Please note that if a link breaks across lines, you will
need to copy both lines of the link and paste it into your browser window to
access the page.
Section 2 - New Funding Opportunities
Section 3 - Reminders
Section 4 - Closing Information and
Unsubscribe Instructions
«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»
1) From the IRB Investigator: Match
Grant Titles with Project Titles. Protocol titles and grant titles
need to be the same in order for the Division of Sponsored Research (DSR) to
determine that grant activities have IRB approval. DSR staff access the IRB
database to verify IRB approval and use the grant title as a point of
reference. Keep this in mind when choosing a title for your grant or protocol.
When titles are different, one or the other will have to be revised to
accommodate the disparity. Plan ahead to avoid potential funding problems and
administrative delays. (Posted 12/07/01)
2) From the IRB Investigator: When Investigators Leave UF. Any
IRB project associated with a Principal Investigator (PI) who has left the
University of Florida cannot continue without modification. These projects must
be closed or a new PI must be signed to take full responsibility for the project
and the subjects enrolled in the project. If the study cannot be closed because
of safety issues related to participant involvement, it is mandatory that a
local, affiliated investigator be named as PI. The IRB considers a change in PI
to be a major revision, usually requiring a full Board review before the change
can be officially implemented. A change in sub-investigators must also be
reported to the IRB. It is the responsibility of the PI to notify the IRB when
a sub-investigator is dropped from
a study and when a new sub-investigator joins an IRB-approved project.
Sub-investigator changes are considered minor revisions, but must also be
approved before the change can be implemented. (Posted 12/07/01)
3) From the NIH Guide : APPLICATIONS DIRECTED TO NATIONAL CANCER INSTITUTE. (NOT-CA-02-002) All United States Postal Service (USPS) mail and courier deliveries (i.e. FEDEX, UPS, DHL, etc.) for the receipt of additional copies of grant applications (in response to RFAs and PAs) addressed to the National Cancer Institute must be SENT to the following address:
Referral Officer: Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8329
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED.
Please note that this delivery policy does not change any application receipt date requirements for RFAs and PARs. The application receipt dates for RFAs and
PARs are published in their respective announcements.
This change in practice is effective immediately. The cooperation of applicant
and grantee organizations is greatly appreciated. (Posted
12/07/01)
4) From the NIH Guide :
NIDCD RESEARCH CORE CENTER GRANT (P30): UPDATED APPLICATION GUIDELINES. (NOT-DC-01-007)
The purpose of this Notice is to announce
that the Application Guidelines for NIDCD Research Core Center Grants (P30)
have been updated to assist potential applicants. Applications for NIDCD
Research Core Centers (P30) continue to be sought through Program Announcement
PA-01-011 for three receipt dates per year (http://grants.nih.gov/grants/guide/pa-files/PA-01-011.html).
The NIDCD P30 application procedures are outlined in the NIDCD Application
Guidelines for Research Core Centers (P30) which can be obtained in updated
form on the NIDCD
Home Page. Potential applicants are urged to obtain these guidelines.
For further information, contact: Amy
M. Donahue, Ph.D. (Posted 12/07/01)
«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»
1) The Drug Information Association (DIA) is hosting its 8th Annual Workshop, "Case Report Form Design". The workshop will focus on topics related to case report form planning, design, and production. This program is of particular interest for those involved with case report form design, electronic data capture, and data collection and management.
The workshop will be held at the Denver City Marriott, Denver, CO on April 22-23, 2002. Full program details will be available by mid-February 2002. For more information or registration, visit DIA Case Report Design. (Posted 12/07/01)
2) The Drug Information Association (DIA) announces its 6th Annual conference, “Good Clinical Practices (GCP), Audits and Surviving a FDA Inspection”. The workshop will discuss current trends in GCP, audits and reduce inspections of clinical investigators, sponsors, contractors and IRBs. The workshop will be of benefit to: GCP Auditors, Clinical Research Associates, Clinical Research Coordinators, Clinical Investigators, Regulatory Specialists, Clinical Data Managers, and Medical Research Staff.
The workshop will be held on May 6-7, 2002 at the Hyatt Regency Irvine, Irvine, CA. Full program details will be available by mid-February 2002. For more information or registration, visit GCP. (Posted 12/07/01)
3) The Drug Information Association (DIA) announces the second offering the “Risk Management Comes of Age” workshop. Workshop topics will include: Risk Management from FDA’s prospective, Including Risk Management Initiatives in the Drug Development Process, Developing Risk Management Programs, and Legal and Communications Issues of Risk Management. The workshop will be of benefit to: Regulatory professionals, and Risk assessment/management professionals.
The workshop will be held on May 16-17 at the Hyatt Regency Bethesda, Bethesda, MD. Full program details will be available by mid-February 2002. For more information or registration, visit Risk Management. (Posted 12/07/01)
4) The Drug Information Association (DIA) and the Agency for Healthcare Research and Quality announces its 4th Annual workshop, “Pharmaceutical Outcomes Research”. This workshop provides an opportunity to present and discuss new and interesting findings in the varied fields of pharmaceutical outcomes research, through a mixture of didactic session, abstracts presentations, special facilitated poster discussion, and a pre- meeting tutorial. The finale of the meeting is a roundtable discussion with experts in the field and active audience participation to discuss issues of current interest in outcomes of research.
The workshop will be held on October 17-18, 2002 at the Hyatt Regency Newport, Newport, RI. Full program details will be available by mid July 2002. For more information or registration, visit Pharmaceutical Outcomes. (Posted 12/07/01)
«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»
REMINDERS! (For Internal
Competition Only)
«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»
If you do not want to receive any more issues, please reply to Cindy
Weinbrecht with "REMOVE FROM ORA NEWSLETTER" in the
subject line or body of the email.