| Abbreviation | Definition |
|---|---|
| Community Member | A member of the community that includes all stakeholders connected to clinical and translational research. Communities may include but are not limited to non-profit or industry entitiesengaged in translational research, and might include disease advocacy groups, local health providers, community-based organizations, and other national or local communities. |
| CC | CTSA Program Coordinating Center |
| CO | Coordinator |
| CTSA | Clinical and Translational Science Awards |
| DCI | Division of Clinical Innovation |
| DTF | Domain Task Force |
| EC | Enterprise Committee |
| IOM | Institute of Medicine |
| NCATS | National Center for Advancing Translational Sciences |
| PM | Project Manager |
| SC | Steering Committee |
| WG | Working Group |
Definition of Enterprise Committees (ECs) / What is the purpose of the ECs?
The ECs advance CTSA Program objectives in high priority areas in clinical and translational science.
Are all of the current DTFs going to transition to an EC?
DTFs will propose in their transition plan (due July 31, 2019) to continue as is or propose revised objectives. DTFs also have the option of proposing to sunset.
Can a hub have more than 1 voting member?
No; 1 voting member per EC.
How many WGs may an EC have?
ECs may propose any number of WGs. It is the responsibility of the SC to review and approve a maximum of 12 WGs at any time. It is expected that the SC would support and approve WGs in all areas of clinical and translational science with a target of ≤2 WGs from a specific EC.
How will information filter up to the SC when there is no SC representation in the EC?
The ECs will report annually to the SC via an SC teleconference meeting. ECs will report annually to the Consortium via a CTSA Program Webinar. ECs will hold an annual face-to-face meeting.
Not all hubs need to have an EC representative. So, who is considered a “voting” EC member to elect lead members?
See CTSA Program Groups Guidance document
Please define the relationship between the ECs and WGs?
WGs are one way that ECs can carry out projects that fill identified gaps and/or further the program objectives.
Under the new CTSA Program Group Structure, the ECs no longer contain a Steering Committee Co-chair . How can the Steering Committee Co-chair be retained on the lead team for the EC?
As SC Co-chairs were appointed by NCATS as the DTF SC Co-Chair member of the lead team they must be nominated (by themselves or others) to be on the Lead Team of the EC and go through the election process. If elected, the EC Lead Team can choose to make them the chair or co-chair of the EC. In this capacity they are not serving as a SC member. For any Working Groups originating from their EC they will have to recuse themselves from WG considerations by the SC due to conflict of interest.
What happens to the content for the DTF once it becomes an EC? Does it need to be archived? Does it need to be accessible? If so, who needs to still have access?
All content will remain available on the CC website on the new EC pages as historical content.
What is the difference between a DTF and an EC?
The function of DTFs and ECs is very similar (see Q/A 1 above). The changes are largely to rename the groups to reflect their function and provide the DTFs the opportunity to review and possibly refocus their objectives.
What is the process for electing the Lead Team for the ECs?
See CTSA Program Groups Guidance document
Which lead team decides who will be chair and co-chair, if the team decides there needs to be a co-chair?
The incoming lead team will decide who will be the chair/co-chair for the coming year.
Who can join an EC?
Each CTSA Program hub is required to have membership on ≥1 EC.
Will the current members of DTFs automatically be part of the corresponding EC or will membership need to be reestablished?
Current DTF members should decide whether to continue participating based upon the final focus of the transitioned EC.
Will the ECs be new groups or just the DTF with a new name?
DTFs will propose in their transition plan to continue as is or to revise the objectives, and have the option of proposing to sunset. The focus of some may shift.
Definition of Working Groups (WG)
WGs consider and develop solutions around a specific clinical and translational science issue. A maximum of 12 active WGs will be supported across the consortium. WGs propose and deliver well-defined projects or deliverables that fill identified translational gaps and/or further the CTSA Program objectives in high priority areas in clinical and translational science.
Can a WG begin as a DF?
Yes, but must formally submit a WG proposal for consideration.
Do WG have to be 24 months?
No, they can be as long as needed to complete the deliverables up to 24 months
How many people can be on a WG?
The size of a WG will depend on the project and must be approved by the Steering Committee. As large groups may be unwieldy in terms of meeting timelines and project goals, WGs may propose to allow broad membership but task a smaller core group to do the majority of the work and report back to the larger group for input.
If a current DTF WG still needs to continue its work past December 2019, what is the process for continuing that work?
The current DTF will submit a completion plan to the SC for review. The SC may approve a brief extension (e.g., 2 months), request that a proposal for a new WG be submitted, or request that the WG transition to a DF to complete its work.
If a current DTF WG that still needs to continue its work past December 2019 and has been approved to transition to a DF, how does the DF continue to report?
WGs that have transitioned to a DF will be required to update the Working Group Report twice a year until the completion of the work.
If a WG transitions to a DF, would they sunset first?
Yes
If anyone can submit an application for a WG, how do you decide which WG will fall under an EC and which WG will be separate?
If an EC wishes to “support/sponsor” the initiation of a specific WG, that WG would fall under that EC.
Is there a minimum number of members for a WG?
The number of WG members is not prescribed.
Is there a specific time frame that someone can submit an application or can an application be submitted anytime and whatever applications have been submitted before the review process deadline be considered?
See CTSA Program Groups Guidance document.
Is there a sunset process for WGs?
See CTSA Program Groups Guidance document.
What happens to all content once a WG sunsets? Does the privacy change?
All content will be archived and requests may be made to access the information.
What happens to the content from the current (2019) WGs when the transition happens? Is it still available? Privacy?
All content will remain available on the CC website on the new EC pages as historical WG content.
What is the maximum timeframe a WG has to meet its deliverables?
2 years. Requests for additional time require SC review, and may result in transition to a DF.
What is the process for requesting a WG?
See CTSA Program Groups Guidance document.
Who can join a WG?
Anyone in the CTSA Program and a limited number of community members (See CTSA Program Groups Guidance document.)
Who can submit an application for a WG?
Most members of the CTSA Program who want to propose and deliver well-defined projects or deliverables that fill identified translational gaps and/or further the CTSA Program objectives in high priority areas in clinical and translational science. For example, WG proposals may be submitted by DF members, hub or pod members, or consortium committees. CLIC, CD2H, and TIN are not allowed to propose WGs through this process, as they have other available resources.
Will there be a WG slot reserved for a rapid response WG?
No. An emergent need would be addressed via a SC Task Force.
Definition of Discussion Forums (DF)
The DF advance CTSA Program objectives in high priority areas in clinical and translational science by focusing on specific topics and may develop plans for projects that fill identified gaps and/or further the program objectives through a Working Group proposal.
Are DF requests vetted by the SC or NCATS?
No, but creators and members must register via the CC
If a current DTF WG that still needs to continue its work past December 2019 and has been approved to transition to a DF, how does the DF continue to report?
WGs that have transitioned to a DF will be required to update the Working Group Report twice a year until the completion of the work.
Is content for a DF public; private to website users; and/or private to group members?
Is there a minimum number of membership for a DF?
Is there an approval process or governance for DFs?
No, but DF members are required to register per CTSA Program Groups Guidance document and will be provided a digital workspace by the CC. There is no formal governance for DFs, but they may choose to create one. DFs make decisions on how to operate as a group and whether they have a leadership structure within it.
What decides if a DF is inactive?
Unless the CC is notified in advance, DFs will be considered inactive if the workspace is not used for 6 months
What happens to the digital workspace for a DF if the DF becomes inactive?
All content will be archived and requests may be made to access the information.
Who can create a DF?
Anyone within the CTSA Program
Who can join a DF?
Membership is determined by the initial creator(s), who will serve as the DF POC(s). For example, the creators may wish to have a small group or completely open membership.