The 60-Day Challenge
On October 1, 2017, the CTSI implemented an initiative called the 60-Day Challenge. The goal of the challenge, which is ongoing indefinitely, is to complete all central office internal reviews and approvals for industry-sponsored multi-center clinical trials in 60 calendar days or less.
A Summary of the Challenge
- This initiative will require a partnership between Study Teams, the Office of Sponsored Programs (OSP), the Office of Clinical Research (OCR), and the Institutional Review Board (IRB) to expedite the start-up process for these studies.
- At the chair level, departments may voluntarily opt in to the challenge, and will receive training on expectations and goals from and for all groups.
- A few minor changes have been made in InfoEd to the Route Form to capture information related to the 60-Day Challenge as well as to the eIRB system requiring the GTS # to be included as part of the initial IRB questions. Linking the systems in this way will assist in making the 60-Day challenge a success.
Details of the Challenge
Study team obligations and expectations
Study Routing: InfoEd Submission must be received within 5 Days of receipt of sponsor start-up documents; WISER Submission must be received within 10 Days of receipt of sponsor start-up documents; eIRB Submission must be received within 14 Days of receipt of sponsor start-up documents.
- OSP needs a clean InfoEd Submission = no placeholders, a PDF of startup email, appropriate keywords, all effort, etc.
- OCR needs study teams to complete the PC Console and provide applicable study documents at the time of WISER submission: Ancillary Services Contract (as applicable) and Draft Sponsor Budget.
- IRB needs study teams to submit IRB application no later than 14 days from receipt of study startup documents from sponsor or CRO.
Communication: Prompt and careful communication will be required for participation in the Challenge.
- Study team needs to respond to OSP questions in 2 business days.
- Study team needs to move ICF forward in 2 business days from receipt of injury language from OSP.
- Study team will be responsible for checking InfoEd Activity Log for contract updates before calling and/or emailing OSP Contracts Officer.
- Study team needs to respond to OCR inquiries/emails within 2 business days.
- Study team needs to respond to comments/questions logged in the task list of WISER within 2 business days.
- Study team needs to respond to IRB concerns in 5 business days.
PI Sign-offs and Signatures: Study teams need to actively engage PIs for any required PI sign-offs.
- Study team will be responsible for the follow-up with PI to ensure completion of all required system sign-offs.
- Study team will be responsible for communicating with CTSI any long term PI unavailability.
- PI Signature on Contracts needs to be obtained in 2 business days.
OSP, OCR, and IRB Commitments
OSP, OCR and IRB will endeavor to make every effort to complete all internal reviews for these studies within 60 days.
The CTSI is confident that we can accomplish this initiative, and we are excited to invite any department that desires faster study startup to reach out to us for further information
Assistant Director, Contracts