August 2011 Archives

Unique NIH funding available

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The National Institutes of Health Common Fund recently posted two funding opportunities. The NIH Director's Pioneer Award which supports innovative approaches to major challenges in biomedical or behavioral research. Deadline is Oct. 7. Applications do not require preliminary data or detailed budgets and provide up to $2.5 million over 5 years. Read RFA-RM-11-004 for detailed instructions on how to apply.

The NIH Director's New Innovator Award supports highly innovative research for new investigators with awards up to $1.5 million over 5 years. Deadline is Oct. 14 and details are available here. The NIH expects to make at least seven Pioneer Awards and at least 33 New Innovator awards in summer 2012.

Travel and reimbursement process refined

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As CTSI staff make trips related to national consortium meetings or site visits of other institutions, please keep these travel reimbursement tips in mind:

1. Traveler or traveler's primary administrative support staff person is responsible for making travel arrangements, subject to UMN travel policies: http://policy.umn.edu/Policies/Finance/Travel/TRAVEL.html

2. Registration and airfare can be prepaid on UMN P-cards; hotel and miscellaneous expenses during the travel must be paid by the individual and reimbursed after the trip.

3. Traveler must retain receipts for hotel and other miscellaneous expenses of $25 or more, except for individual meals. Meals will be reimbursed at federally approved per diem rates; therefore, receipts for individual meals are not required.

4. Refer to the Travel Per Diem Rates website to identify the reimbursable rates.

5. If travel includes a group meal for a bona fide business purpose, then an itemized receipt for all meal expenses is required. In addition, traveler must document names of individuals participating in the meal and include a brief summary of the business-related purpose. CTSI will not reimburse alcohol.

6. Upon return, traveler must complete and sign the Employee Expense Worksheet

7. When completing the justification section, attach all required receipts and be sure to include:


  • WHO traveled?

  • WHAT was purpose for travel?

  • WHERE and WHEN did the travel take place?

  • HOW travel benefitted CTSI?

  • Include information regarding any prepaid expenses on the worksheet. Leave the chart-string information blank; this section will be completed by CTSI Finance.

8. Ensure traveler's supervisor has signed as "Authorized Signature," indicating approval; travel for CTSI associate directors must be approved by CTSI director or his delegate.

9. Submit original, completed Employee Expense Worksheet and receipts to Lisa Johnson (717 Delaware, room 222).

10. Employee Expense Worksheet will be reviewed for policy compliance by CTSI Finance. Any questions and concerns will be directed to traveler.

11. CTSI Administrative staff will process the reimbursement in the EFS financial system.

Questions? Contact Lisa Johnson, CTSI Senior Financial Officer, 612/624-9159.

Corrected Effort Certification form now available

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As a follow up to the Aug. 19 post concerning CTSA effort certification, please note the updated Effort Certification form is now available. Contact Lisa Johnson with questions.EFFORT CERT INSTR_8.26.11-laj.docx

P&A staff can view appointment details

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Information about your current (and past) Professional and Administrative appointments can be found at UMN's Employee Self-Service by selecting Notice of Appointment in the left column of the Self-Service Actions. CTSI will not provide appointment letters to P&A employees. Please refer to the Notice of Appointment link for questions about your current salary or appointment period, as this is the official UMN notice.

Staff additions and departures

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Michelle Lamere joins CTSI as the new Education, Training, and Research Career Development (EdTRCD) Coordinator working with Dr. Jas Ahluwalia. Michelle holds a Master of Public Administration with distinction from the Humphrey School and a graduate minor in Integrative Therapies and Healing Practices. Michelle has experience with training programs as she handled daily operations for Dr. Mark Herzberg's MinnCResT T-32 training program.

Also, Front Door Coordinator Patti Hatchett accepted a new position as a Clinical Research Associate at a local medical device company. The Front Door will continue to be staffed by our administrative support team and no operational interruptions are expected.

Delaney shares vision for CTR portal

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Please join Connie Delaney, PhD, RN, FAAN, FACMI, CTSI Associate Director, Biomedical Informatics (BMI) and Director, UMN Biomedical Health Informatics (BMHI) for an overview of a development plan for the Clinical Translational (CTR) portal.
When: Wednesday, Sept. 7 from 2:30 to 3:30 pm
Where: 717 Delaware, room 303
Contact Lisa Johnson with questions.

Bantle named CRIS leader

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Effective Aug. 29, John Bantle, MD, will assume the responsibilities of Clinical Research Implementation Services (CRIS) Leader. Dr. Bantle has considerable experience with clinical research operations from a long tenure in key posts with the General Clinical Research Center. He will work closely with the CRIS team including Jeanne Eull, CRIS Manager; Laure Campbell, Research Subject Advocate; Dr. Tom Nevins, Medical Safety Officer; and with Karen Johnson, CTRS Operations Manager.

We are grateful for the fine service of Dr. Julia Steinberger, who helped us launch CRIS in the new age of the CTSA. Dr. Steinberger will continue as an active CTSI investigator and part of a working group to help chart future initiatives.

How and when to acknowledge CTSA grant funding

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By receiving the Clinical and Translational Science Award, the University of Minnesota is now required by NCRR and NIH to ensure an acknowledgment of the CTSA in any publications that result from UMN CTSI assistance with a project.

When to acknowledge CTSA support
Please note that assistance is not limited to monetary support (e.g., pilot grant funds), but also includes use of CTSI space, consultation with CTSI faculty or staff, and use of any CTSI Internal Service Organization services (Project Management, Clinical Research Coordinators, Nursing and Nutritional Services, Biostatistical support, and Regulatory assistance such as IND/IDE support, clinical trial monitoring, or ClinicalTrials.gov support).

How to acknowledge CTSA support

All publications resulting from the use of CTSI resources are required to credit CTSA by using the text below.

"This publication [or project] was supported by Grant Number 1UL1RR033183 from the National Center for Research Resources (NCRR) of the National Institutes of Health (NIH) to the University of Minnesota Clinical and Translational Science Institute (CTSI). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the CTSI or the NIH. The University of Minnesota CTSI is part of a national Clinical and Translational Science Award (CTSA) consortium created to accelerate laboratory discoveries into treatments for patients."

Save the date

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Learn about new treatments for genetic neurologic disorders. Dr. Chester Whitley PhD MD is the next featured speaker for the CTSI Science Café on Sept. 22 at 7:30 AM in Coffman Memorial Union's Mississippi Room. Dr. Whitley will discuss his clinical research that spans a spectrum of metabolic and enzyme deficiencies resulting in conditions such as Hurler syndrome, Hunter syndrome, Gaucher disease, Sanfilippo syndrome and Tay-Sachs disease. Contact Christi Powers for more information.Science Cafe

VA seeks to pilot cloud-based applications

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PrivacyCompliancePublicSector.pdfFierceHealth IT
Privacy and communications issues surround planned pilot testing of cloud-based tools by the Department of Veterans Affairs that could impact as many as 134,000 VA medical workers. Specifically, the VA wants to move its Microsoft Exchange-based collaboration system to a cloud-based system, according to InformationWeek.

The issues date back to last December, FierceGovernmentIT reported last month, when doctors and residents at several VA hospitals used GoogleDocs and Yahoo Calendar to manage their workflow. By storing patient information in each application, however, patient information was put at risk, according to Roger Baker, the VA's chief information officer.

Baker admitted, though, that such tools were "easier to use and more broadly available."

Currently, the VA is in search of an established cloud-based vendor, according to a Federal Business Opportunities notice posted Aug. 11. Ultimately, the VA said its tools need to meet Federal Information Security Management Act (FISMA) standards.

Once established, the tools will be tested on 5,000 VA doctors and residents, according to the notice. The pilot would expand to 17,000 VA physicians, 36,000 residents and 81,000 other medical personnel if deemed a success.

To learn more read InformationWeek article

Ahluwalia awarded grant

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Dr. Jasjit S. Ahluwalia was recently awarded $200,000 from Pfizer Global Research Awards for Nicotine Dependence (GRAND) for his research proposal Factors Influencing Nondaily Cigarette Smoking and Cessation. Dr. Ahluwalia and his postdoctoral colleague, Dr. Taneisha Buchanan, will study nondaily smoking behavior and associated psychosocial influences in African Americans, Latinos, and non-Hispanic Whites.

Dr. Ahluwalia is the associate director for CTSI's Education, Training and Career Development (EdTRCD) unit and oversees the UMN Center for Health Equity. Contact John Jodzio for details.

Ethics seminar offered

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The UMN Consortium on Law and Values in Health, Environment and the Life Sciences is offering a one-day ethics seminar on Sept. 26 from 8:30 am to 4:45 pm at the Hubert H. Humphrey Center. Supported by the National Institutes of Health and the Genome Research Institute, the Nanodiagnostics and Nanotherapeutics: Building Research Ethics & Oversight conference offers an overview of the challenges facing nanomedicine research and human subject protection. Cost is $50. View the list of speakers and register here.

Effort certification for CTSA begins

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During the next several weeks, changes will be made to CTSI employee records, allowing CTSA funds to pay for at least a portion of salaries beginning June 1, 2011. Due to the timing of the changes, all individuals paid by CTSA funds will be required to "certify" their effort for the period of June 1-June 19, 2011. It is likely that staff members will begin receiving messages about certifying this effort soon after the changes are made to their employee record.

Those paid by CTSA funds will need to certify effort three times each calendar year. Please review these detailed instructions for effort certification and contact Laura Ayala or Lisa Johnson with questions.

CTR Portal: Additional FAQs for CTSI staff members

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1. My phone number is not correct on the Project Personnel page; how can I change that?

The information appearing on the Project Personnel page is pulled from the Human Resources database, therefore changes can be made through the "Employee Self-Service" system. If, once you are in the "Employee Self-Service" form you find that your office address information is not correct, please contact Lisa Johnson (lisaj@umn.edu) and she will work with AHC-HR to update your record.

If you notice that the information for a non-CTSI staff or faculty member is not correct, the affected individual will need either access "Employee Self Service" on their own or work with their HR personnel.


2. On the Request for Services, why are all CTSI staff grouped into the "CTSI Staff" role rather than having each of the staff roles identified separately?

The individual CTSI staff roles were consolidated into the "CTSI Staff" role in an attempt to minimize the knowledge a requestor needs to have about the CTSI operations when completing the Request form. There is not a CTSI Operational need to have the individual staff roles identified at the time of request submission, as staff assignments and access to given projects are made as a part of the request review and acceptance process.


3. For the Request for Services, why not ask for all of the Project Details (Gather Project Details tab) before having the requestor select the general service categories?

The requestors are asked to specify which general areas of assistance are desired prior to being asked questions about the project because a future enhancement is to tailor the questions asked on the Gather Project Details page to the specific assistance required. Because this request form will be used for other CTSI functions (i.e., Bioinformatics, Discovery and Translation, and possibly Education), the current questions may not be appropriate for the other functions. The system's functionality will allow for easier adaption of the request form for the other functions.

4. How can I provide feedback about the Portal?

Beth Mohr (mohr@umn.edu) is collecting all information regarding bugs, glitches, issues, concerns, and enhancement requests. Please send all information to Beth.

1. The IRB and the Portal databases do not currently share data directly. How are projects linked (for communication and to avoid duplication of effort) in the IRB and the Portal databases?

CTSI is working with the IRB to identify all projects currently in the IRB database that CTSI also touches. We are currently working with the IRB to automatically add the nomenclature "UMNCTSI" in the "Full Title" field for all current CTSI projects in the IRB database. Going forward, there will be an opportunity to indicate CTSI involvement on an IRB application, automating the addition of the "UMNCTSI" nomenclature.

UPDATE (8/10/11)
There is a concern that adding "UMN CTSI" to the full title on the IRB application will result in issues with Sponsors, as it will be modifying the title of the study. This concern has been expressed to the IRB and is currently under review by the IRB.


2. RPMs are not able to edit project information after the first time a record is created in the CTR Portal. Why not? What is the process for a CTSI staff member to update project information?

System permissions and roles are still in development, and permissions within the My Projects module are set to "Read Only" for both CTSI staff and study team members. It is helpful to remember that the Portal has a broad potential user base with widely variable needs and levels of access to information. Overall security of the system will be taken into consideration when determining roles and related permissions.

CTSI staff members should complete a Project Update Request Form to update information on a single project. In order to simultaneously and efficiently update many projects, a spreadsheet can be completed and submitted to Beth Mohr (mohr@umn.edu).


3. The "Quick Search" box does not display results when the query includes both a first and last name of an investigator, but rather, it only displays results when either the first or last name is used.

This issue has been passed along to the programmer for correction.


4. RPMs often need to access protocol documents, as well as create and submit cost estimates related to those protocols. How can an RPM access protocols and submit cost estimates?

Personnel assigned to create cost estimates should have access to view protocols within the new Request for Services System. Please contact Carolee Wieneke (minck001@umn.edu) or a back up checker (Patti Hatchett [phatchet@umn.edu] or Rachel Pappas [papp0051@umn.edu]) if you believe you do not have appropriate access.

RPMs cannot currently upload documents after a Request is "In Review" status. Please send all documents, including cost estimates, to Carolee Wieneke or a back up checker (Patti Hatchett or Rachel Pappas); the checker will upload documents on your behalf. Enhanced access to documents will be addressed as part of the Asset Management System development.

UPDATE (8/10/11): A new role of "Cost Estimator" will be added to the system, to allow for RPM access, once they have been assigned as the person responsible for the Cost Estimate. This access will allow for reviewing of all materials once the request is submitted and will allow for direct upload of the Cost Estimate by the person assigned to this role. This functionality will be completed prior to development work beginning for the scheduling system.


5. Documents and application forms submitted to the GCRC or through the old Application for Services system are not yet available in the Portal. Where can I access documents, such as protocols, submitted prior to the launch of the Portal?

• For CTSI IDs greater than 20602: Portal→ My Projects→ Documents tab
• For CTSI IDs between 20000-20602: old Application for Services
• For CTSI IDs beginning with 15xxx: refer to share drives
• For CTSI IDs less than 15000: eDocs 


6. How will protocol amendments be handled in the new system?

Protocol amendments will continue to be handled manually, via IRB or investigator notification to the CTSI Front Door. Carolee Wieneke will continue to work with appropriate CTSI administrators and staff members to process amendments and resulting changes to projects, services, and cost estimates. The Portal development team has, however, communicated with the SIRC team about the critical need for improved and automated communication around protocol amendments. This discussion will continue as CTSI engages more fully with the SIRC team.


7. RPMs often submit Request for Services forms for investigators, and it was helpful in the past to view reviewer and/or editor comments. Why can't an RPM see reviewer and editor comments and deadlines/due dates for decisions?

Programmers are currently working on this functionality. The "back end" or "review side" of the Request for Services system was developed to meet basic operational needs, and will be enhanced over time. The current goal is to show decisions once they are made and provide a relevant summary at that point. In the past, pre-decision notations were problematic, particularly when CTSI staff members took some action prior to decision. Finally, it was determined that scientific reviewers should not see other reviewers' comments before their own decision has been made.


8. Some projects use only regulatory and clinical trial monitoring services, and it appears that not all of these projects are included in the database. How are regulatory projects added?

The CTSI regulatory team provided a list of projects, which was uploaded into the database. New regulatory projects must be registered in the Request for Services system, indicating that clinical trial monitoring services are requested.

UPDATE (8/10/11): Functionality to display the date submitted, expected date review due, and request completed dates will be added prior to the start of the scheduling system development.


9. The search functionality in the My Projects module does not currently include some useful terms from other systems. Will this be included in the future?

These would be future enhancements. Requirements have been gathered to include these data elements. However, importantly, staff can still use TASCS to access these data. TASCS will remain viable until a Clinical Trial Management System (CTMS) is in place and full integration with Portal.


10. Can a CTSI staff member update information about the study team (i.e., a new coordinator)?

Not directly. The Principal Investigator (PI) must approve changes to study personnel by completing the Access Request Form. In conversations with AHC's privacy officer, it became clear that the approach for modifying access to project information must be more fully investigated. For example, if IRB approval is required, it may be necessary to maintain tighter control over who has access to make these changes in system.


11. Some short or full titles are not consistent across systems (i.e., the Portal, TASCS, BDAC). Is there a plan for cleaning up data to ensure consistency?

All data in the Portal were pulled from other systems/databases, such as the GCRC or BDAC databases or spreadsheets. Corrections can be made; see question #2 above. The development team recognizes that an easier process is needed and a plan for data clean up will be developed and shared for your input. However, with any system implementation, dirty data in is dirty data out. On a positive note, by the end of August, we will have all IRB approved information without necessarily requiring manual update.


12. How should investigators respond to stipulations from the Administrative and/or Scientific Review Committees?

Investigators receive a letter detailing the committee's concerns and specific stipulations. That letter also instructs investigators to forward their response and any associated documents to ctsi@umn.edu. The checker uploads the response and documents into the Request for Services system and facilitates a review of the response. Communication with the investigator continues via formal letter attached to an email.


13. What is the Front Door Initial Contact Database and how is it being used?

The Initial Contact Form (https://ctsi.ahc.umn.edu/public/contact/) and the associated "back end" contact database were developed to track and report on all inquiries received by the CTSI Front Door. We would also like to use this database as a way to facilitate and document communication among CTSI teams related to specific projects. At this time, the Front Door Coordinator is using the database in a limited manner, by logging all inquiries. The Front Door Coordinator may email a specific CTSI staff member, attaching a PDF file with details about an inquiry, in order to facilitate better communication. CTSI staff members are not asked to enter any data about inquiries at this time, but discussion and decisions are needed about how this database might help facilitate communication and improve quality of service provided to investigators.


14. How should CTSI staff complete the personnel tab for his/her role when completing the Request for Services?

Statisticians and Coordinators should select "CTSI Staff." RPMs should also select "CTSI Staff," but may select "Protocol Contact" if he or she is the individual (designated by the PI) as holding responsibility for protocol amendments.

About this Archive

This page is an archive of entries from August 2011 listed from newest to oldest.

September 2011 is the next archive.

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