Featured
CTSA Committee
The CTSA Regulatory Knowledge Workgroup promotes the protection of human subjects and facilitates communicating shared regulatory compliance issues and improvements. Members of the group strive to provide investigators with integrated training, services, or tools for protocol and informed consent authorization and tracking, adverse event reporting, safety, and regulatory management and compliance. By sharing best practices that reduce institutional barriers and enhance inter-institutional collaboration, the group ensures that collaborative clinical and translational research activities are facilitated, are in compliance with the Institutional Review Board (IRB), and KEEP RESEARCH PARTICIPANTS SAFE.
The CTSA Regulatory Knowledge Workgroup has created taskforces to address key issues and specific objectives defined by the workgroup. Each is devoted to addressing one of the following topics: Alternative IRB Model Pilots, Clinical Research Management, Research Subject Advocacy, Research Coordination, Investigational New Drugs and Investigational Device Exemptions Support, and Centers for Medicare & Medicaid Services Regulations impact.
Current activities of the workgroup and its taskforces are listed below:
- At the CTSA Consortium Oversight Committee Web meeting in November 2007, the CTSA Regulatory Knowledge Workgroup provided an update on its progress, defined focus areas, identified challenges and CTSA opportunities, and set short-term and long-term goals. The workgroup plans to focus on these priority areas and collect metrics of study implementation timelines as immediate goals.
- The Clinical Research Management Taskforce is serving as a planning committee for a workshop taking place in June 2008. The taskforce is developing subcommittees to address key workshop issues such as metrics, challenges, team building, workflow management, and communications to improve the efficiency of the clinical research process from start to finish.
- The Clinical Trial/Study Registration Tracking Taskforce is forming to examine various CTSA institutional approaches to address the new requirement to register clinical studies on ClinicalTrials.gov. The taskforce will look across all the CTSA Consortium institutional approaches to ensure that the principal investigators register their clinical studies on http://clinicaltrials.gov and make their findings available for viewing. Various institutions may have unique approaches in clinical study registration tracking that may also improve and benefit study recruitment.
Upcoming CTSA Consortium Oversight Committee Activities
Representatives from the CTSA Consortium Oversight Committee (CCOC) will participate in two upcoming meetings this month to discuss the consortium’s priorities, challenges, and opportunities.
At the January 15–16, 2008, CCOC meeting in Bethesda, Maryland, NIH Director Elias Zerhouni, M.D., will join members of the committee to discuss the vision of the CTSA program and its priorities, examining milestones, achievements, and deliverables across the consortium. Other draft agenda items include CTSA committee news; organization, and management; the CCOC co-chair election process; principal investigator feedback about successful methods; and possible funding for consortium promotion.
On January 30, 2008, six members of the CCOC will present the opportunities and challenges faced by the consortium at the National Advisory Research Resources Council (NARRC) meeting on the NIH campus in Bethesda, Maryland. The NARRC meets three times a year to conduct second-level reviews of applications and to advise NCRR on funding activities, policies, and program considerations.
The council meeting will be Webcast. The link to the meeting will be live on January 30, 2008, and will be accessible under “Today’s Events” at http://videocast.nih.gov. For additional information about the council or the meeting, including a draft agenda, visit http://www.ncrr.nih.gov/about_us/advisory_council.
Announcements
NCRR CTSA Web Systems Update
As part of the transfer of responsibility for the CTSA Web systems to the CTSA support contractor and to enhance capabilities, the CTSA Web systems were recently migrated and upgraded.
The CTSA Wiki has a new URL: http://www.ctsawiki.org/wiki.
Please update any links or bookmarks you have to the CTSA Wiki.
Should you have any questions or experience any issues with the systems, please contact CTSA User Support at CTSA_Help_Desk@bah.com.
CTSA Wiki—NIH EXT Passwords Expire Every 90 Days
Please note that NIH EXT passwords, managed by the Center for Information Technology (CIT) at NIH, expire every 90 days. NCRR is working with CIT to develop an alert system for the NIH EXT members, and we will notify you when this system is in place. In the meantime, please visit http://password.nih.gov and click “Change Password” to change your password if you are no longer able to access the CTSA Wiki.
If you continue to experience problems accessing the wiki, please contact CTSA User Support at CTSA_Help_Desk@bah.com.
New NIH CTSA RFA Released
NCRR released a new RFA for the CTSA program on December 27, 2007. The new RFA can be found at http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-002.html.
Upcoming Committee Meeting Dates
Key: CTSA Consortium Meeting CTSA Consortium Workshop NIH Staff Meeting
| January 2008 |
| Mon |
Tue |
Wed |
Thu |
Fri |
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1
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2
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3 |
4
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7
Pediatrics
3:30 p.m.–5:00 p.m.
Rockledge II, Room 10091 |
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9 |
10
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14
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15
CTSA Consortium Oversight
12:00 p.m.–7:00 p.m.
View Link
Call: 1-800-256-1922
Access Code: 447142
NIH coordinator
Anthony Hayward
|
|
16
CTSA Consortium Oversight
9:00 a.m.–3:00 p.m.
5635 Fishers Lane, Atrium Level, Rockville, MD
NIH coordinator
Anthony Hayward
|
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17 |
18 |
| 21 |
22 |
23 |
24 |
25
Regulatory Knowledge Clinical Research Management
2:00 p.m.–3:00 p.m.
View Link
Call: 1-877-713-2255 Access Code: 243769
NIH coordinator
Jody Sachs
|
|
| 28 |
29 |
30
|
|
|
| February 2008 |
| Mon |
Tue |
Wed |
Thu |
Fri |
4
Pediatrics
3:30 p.m.–5:00 p.m.
Rockledge II, Room 10091
|
|
|
6
|
7
|
|
| 11 |
12 |
13 |
14
|
15
|
18
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19
CTSA Consortium Oversight
1:00 p.m.–2:00 p.m.
View Link
Call: 1-800-256-1922
Access Code: 447142
NIH coordinator
Anthony Hayward
|
|
20 |
21 |
22
Regulatory Knowledge
Clinical Research Management
2:00 p.m.–3:00 p.m.
NIH coordinator
Jody Sachs
|
|
| 25 |
26 |
27
Clinical Research Ethics
3:00 p.m.–4:00 p.m.
Democracy 1, 9th Floor, Conference Room 987
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28 |
29
|
* Please note that the meetings and events listed in this
newsletter are provided for your information. If you wish to
participate, please contact the NIH coordinator.
Updated Information
on CTSAweb.org
CTSAweb.org was developed to ensure access to CTSA resources, enhance communication, and encourage sharing. The site continues to evolve with the CTSA in promoting this new direction of clinical and translational science.
Additional features and updates:
- Get to the CTSA Wiki from CTSAweb.org! Click on the “Consortium Login” link from the top banner on the CTSA home page to go directly to the CTSA Wiki.
- Download CTSA Fact Sheets highlighting the 2006 grantees and 2007 grantees from the Communication Toolkit page.
- View committee and workgroup activities from the left menu bar on the home page.
- View upcoming meetings and access previous meeting information, including meeting summaries, through the Calendar.
- View CTSA Committee Representatives from each grantee institution.
- View publicly available resources that promote clinical and translational research on the Resources for Researchers page.
- The “Articles” page has been renamed “CTSAs in the News.”
Access archived CTSA e-Newsletters on the CTSAweb.org CTSAs in the News page.
We
hope you find this newsletter helpful and informative. If you
have any questions or comments, please direct them to Kameha
Kidd, Office of Science Policy and Public Liaison, NCRR.
