The table presents a list of submission components, outlining a full application cycle from Letter of Intent to project launch. Applicants will work towards developing a nearly complete package required for prior approval by funding agency NCATS, with each application step serving as a building block.
The Letter of Intent step involves submission of the following components:
- Project summary
- Background and significance
- Project rationale
- Potential benefits of the proposed research
- Importance of the knowledge gained
- Description of translational path
- Specific aims
- Primary and secondary aims
- Project feasibility statement
- Key personnel
- Names and affiliation
The Proposal step involves submission of the following components:
- Project summary
- Background and significance
- Project rationale
- Potential benefits of the proposed research
- Importance of the knowledge gained
- Description of translational path
- Specific aims
- Primary and secondary aims
- Project feasibility statement
- Key personnel
- Names and affiliation
- Biosketch(es)
- Project abstract
- Research procedures
- Stakeholder engagement plan
- Applicant authorization and approval form
- Project budget
The post-award NCATS step involves submission of the following components (for human and animal subject research):
- Project summary
- Background and significance
- Project rationale
- Potential benefits of the proposed research
- Importance of the knowledge gained
- Description of translational path
- Specific aims
- Primary and secondary aims
- Project feasibility statement
- Key personnel
- Names and affiliation
- Biosketch(es)
- Research procedures
- Project budget
- Certification of IRB/IACUC approval (as applicable)
- For clinical trials and greater than minimal risk human subject studies:
- Human subjects training certificate(s)
- Study protocol
- Protection and monitoring plan
- Protocol synopsis (for clinical trials only)