Prior Approval

Policy Overview

According to the NCATS policy, all projects funded through Spectrum that involve human subjects and/or vertebrate animals are required to secure prior approval from NCATS before funds can be released and work on the project can begin. This process enables NCATS to ensure that human subjects and/or vertebrate animals are protected and appropriate data and safety monitoring is used.

Timeline Expectations

Detailed information about what documentation is required is below. Please note that this process is estimated to take a minimum of 30 days. The official award notification cannot be released until prior approval is secured. Here at Spectrum, we recognize that this is going to lengthen the time between submission and award, and we will do everything we can to expedite the process. If you are notified that your proposal will be funded, Spectrum staff will work with you to compile the documents and submit them to NCATS.

Prior Approval Submission Instructions

Please refer to the following links for Prior Approval submission instructions for research involving:

• Human Subjects
• Vertebrate Animals
   

For answers to common questions, please see the NCATS’ FAQ page.

Submission Guidelines

When ready to submit:

1. Name and save the required documents (listed on NCATS’ FAQ page) according to the File Naming Conventions:
   1. Human Subjects: Pilot_HS_Stanford_Study PI Last Name_Date
   2. Vertebrate Animals: Stanford_InvestigatorLastNameFirstInitial_ProtocolShortTitle_YYYYMMDD
2. Send the required documents to KL2 Program Manager Ellen Orasa. Documents will then be submitted to Stanford’s Authorized Organization Representative who in turn submits to the appropriate NCATS Grants Management Specialist.