IMPAC II GM Lead User’s Group
Minutes from April 11, 2001 Meeting

Attendees
Representatives from 21 ICs, OPeRA & LTS were in attendance.

A GMAC policy announcement issued in 1999 suggested standard wording for terms in 11 topic areas . As part of the announcement it was suggested that IMPAC II could be modified to automatically generate 6 of the 11. A show of hands indicated that some of the ICs had modified terms to comply. This item was placed on hold pending a little more research. Debbie Hendry, NIAAA, has volunteered to survey the ICs to see if indeed there are any of these standardized terms that are currently used by all ICs.

As a subgroup of the GM Vision Committee, the Lead Users Group will be represented at a retreat at the end of April. In response to Marcia's request for input, the lead users came up with the following list of their strengths and accomplishments:

• foster communications among OER staff, developers and IC staff;
• offer suggestions to improve IMPAC II modules;
• provide expertise to developers;
• identify problems and find solutions;
• serve as resource for cross-training;
• constitute forum for consensus and prioritization;
• act as first-tier trouble shooters (filter problems for Help Desk);
• assist users and make them feel more comfortable.

3.  Terms and Conditions on Revised Awards

Marcia surveyed the group to determine if ICs repeat the terms and conditions or use a catchall phrase. Most ICs seemed to be repeating the terms. Marcia pointed out that IMPAC II makes it easier to repeat the terms since they are stored. Any new condition can be inserted at the top of the list. To reduce the length problem for clinical trials and cooperative agreements, an IC can point to the URL of the RFA.

4.  Additions to IMPAC II GM Module Enhancement Priority List

1. Add column with assigned Program Official's name (medium priority).
2. Date sent to program official (removed from priority list)
3. Incorporate of Routeslip report (not recommended at this time)
4. As a companion suggestion-add to ICO the T-5 Receipt date field. (This will be forwarded to the appropriate ICO contacts)

Customizable Checklist (Deferred for additional study)

Tim, Cathy, Dave, Mike and Usha will meet to discuss requirements and report back. Cathy Walker is coordinating and will include Sherry Zucker.

GM Worksheet (high priority).

1. Add data element for increase/decrease in award
2. Add Phase III Clinical Trial Code
3. Add Institutional Assurance Filed indicator.
4. Add the IRB Certification Filed Indicator

Add editable Phase 3 clinical trial data code indicator (medium priority).

As a companion discussion to the issue adding the Phase III Clinical Trials Indicator, it became evident that many ICs are maintaining local databases to track and monitor a variety of additional information for grants involving human subjects. Such data items include clinical research designators, other phases of clinical trials, additional terms & conditions, Data Safety Monitoring Board info. Interest around the table was expressed in analyzing the possibility of incorporating this information into the IMPAC II system. Lead users from AI & AM will make a recommendation to the group at a later date. Any other lead users interested in this initiative should contact Cathy Walker or Mike Loewe.

5.  IMPAC II GM Module Fixes

1. A fix was implemented to allow a training grant to be issued without an IRB date. The system used to bar this action but now issues a warning.



2. There is a bug in the human subjects code field. If you blank out the field, you will not be able to edit it. A fix is required. Users are reminded that when changing a Human Subjects Code, don't totally blank out the field-you must have some code there or a bar automatically prohibits an award. In addition, the field becomes un-editable in GM so only folks in OEP can make the correction for you.

In 1998 NIH issued a revised conference grant (R13) announcement that indicated the acceptance of applications for multi-year conference grants on a biennial cycle. The IMPAC system has never been modified to handle this type of skip-year funding . Marcia asked the group about workarounds to handle the off years until skip-year support is built into the system. Some issue a $1 award; others extend the 01 year. If any IC has other creative solution, they should e-mail Marcia.

7.  Grant Folder Concept

Marcia introduced the grant folder concept that involves logically grouping documents associated with an application. In the May release of IMPAC II software, the following will be included in the grant folder: the grant application image in PDF with bookmarks to sections; PI grant history (brief live report), PI grant history (detailed live report), current summary statement, prior summary statements, abstract and notice(s) of grant award. Although the requirement originated in Review, the enhancement will be launched in all business areas. This is a concept with great potential for the Grants Management community so Marcia asked the group to considered how the grant folder could be customized to serve its own needs. For example, the GM worksheet and FSRs might be included. This could be considered the initial step down the path of e-document management. In the GM application, access to the Grant Folder will be part of the "Grant" dropdown menu.

8.  Awards Ceremony

Members were reminded to attend the GMAC Vision Awards Ceremony, Thursday, April 12^th beginning @ 1 PM. Lead Users that represented their ICs by attending the majority of meeting during calendar year 2000 would be recognized with Letters of Appreciation.

9.  Update on Potential System Change to Incorporate the 2-week Hold-NIH is now generating a weekly report for the Department which itemizes those competing awards >$500K that ICs plan to pay in the next 2 weeks. Once an award appears on the list, ICs cannot issue the award before the 2-week period unless otherwise instructed. Tim Twomey attend the EPMC meeting just before the Lead Users meeting and reported back that there would be no changes to the system to implement an automatic 2-week hold. For the first list submitted, all but 3 grants were given the OK to issue awards immediately. It will be the responsibility of the IC to make sure awards are either held and not processed for 2 weeks or that the issue date is 2-weeks out.

Action Items

1. Study requirement for customizable checklist (Tim, Cathy, Dave, Mike, Usha).
2. Study requirements for capturing other Human Subject data elements (Cathy, Mike)
3. Determine the volume of skip-year conference grants and report on IC workarounds (all).
4. Think about how the grant folder can be adapted for GM (all).

The next regularly scheduled meeting is Wednesday, May 9, 9:00-11:30 am in NIMH Conference Room 8120. NIMH will be our parking sticker host.