The initial notification of selection for possible implementation is to inform you that NCATS would like to explore the possibility of collaborating. Depending on the completeness of the information provided in your proposal, NCATS may request additional information before making a decision about the development of the provisional milestone-driven collaboration plan.

Collaboration Plan 

• If the proposal is selected for possible implementation, the program manager will arrange an in-depth meeting with the collaborators. If the meeting is to be face-to-face, funding will be provided for the lead collaborator to travel to NCATS as needed. 
• The NCATS Division of Preclinical Innovation (DPI) collaborating lab will discuss with the selected collaborators what the needs are, discuss what the collaborator will contribute to the collaboration, and determine whether to proceed with developing a detailed collaboration plan and further refine the milestones that define the go/no-go decision points.
• NCATS will notify the potential collaborator of the decision to proceed to collaboration plan development or stop. 
• The NCATS Office of Strategic Alliances will engage with the collaborator and the DPI lab to execute the appropriate agreements, such as Cooperative Research and Development Agreements (CRADAs) and Research Collaboration Agreements (RCAs). 

Test of Concept/Model System Validation 

• The first implementation go/no-go decision ― NCATS will determine the reproducibility of the concept and/or the model system. 
  • Successful reproducibility will result in full study implementation.
  • Unsuccessful reproducibility will serve as the first no-go decision point. The program manager will set up a meeting with relevant personnel to discuss troubleshooting options. If no options are viable, the project will be closed.

Project Progression 

• Lead collaborators and NCATS project leads will provide progress reports when milestone dates occur AND when prompted by NCATS leadership. 
  • Go/no-go decision points will prompt project review. The National Institutes of Health (NIH) Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, lab leads will determine whether the milestones have been met and whether the project should proceed. 
    • Missed milestones will trigger project review. The program manager will arrange a meeting with the team lead, project lead and lead collaborator to determine why the milestone was missed and possible remedial approaches or project termination. 
    • If the recommendation is to terminate the project, the NCATS Director and Scientific Director will be consulted prior to termination.

Publication of Results 

If a proposal is accepted for collaboration, the collaborator will agree that data (positive and negative results) and resources generated under the collaboration will be shared with the public through appropriate mechanisms that respect intellectual property, including pre-print servers, peer-reviewed publications and data-sharing sites, such as PubChem, for high-throughput screening data.