Overview

The COVID-19 Clinical Trial Rapid Start-Up Program, provided by Tufts CTSI’s Biostatistics, Epidemiology, and Research Design (BERD) Center, supports new COVID-19 research by offering quick project start-up for projects that have received institutional and IRB approval to proceed, but have not yet secured funding. The goal of this program is to allow projects to get up and running quickly by building the study database (i.e., the data collection tool) for the research team.

The COVID-19 Clinical Trial Rapid Start-Up Program will accept database development requests on a rolling basis between May 1 and July 31, 2020. 

Summary of Key Dates

  • Program begins: May 1, 2020
  • Requests accepted: on a rolling basis, subject to BERD Center approval and resource availability
  • Program ends: July 31, 2020

Who is eligible?

Principal investigators (PIs) with a position or faculty appointment at one of Tufts CTSI’s partners and collaborators may request COVID-19 Clinical Trial Rapid Start-Up assistance. The PI must:

  • Have institutional and IRB approval to proceed with the project.
  • Be ready for immediate study implementation and data collection.
  • Expect to receive funding from a specific entity within three months.

How Should I Request COVID-19 Clinical Trial Rapid Start-Up Assistance?

PIs meeting the above-referenced criteria should follow these instructions:

  1. Click on this link to open the online service request form: https://informatics.tuftsctsi.org/pims/request.htm#/
  2. Fill out your contact information.
  3. Click the box next to Study Design.
  4. In the description, please type “request for COVID-19 Clinical Trial Rapid Start-Up Assistance“; briefly describe your project and data collection needs; and include your anticipated funding source and timeline for funding receipt.
  5. Fill out the rest of the form. At the end, click the box next to “I have read and accepted the terms and conditions related to this request.”
  6. Click the blue “submit” button.

Please follow the above instructions carefully, or your request will not be triaged properly.

The BERD Center will offer up to 40 hours of database development services per project.

Requests will be accepted on a rolling basis, with priority given to projects involving new diagnostics or therapeutics for the treatment of COVID-19. Registries and behavioral intervention studies related to COVID-19 will also be considered.

What Happens After I Submit a Request?

A representative from the BERD Center will contact you to schedule an appointment for a project review/interview.

If your project is approved for COVID-19 Clinical Trial Rapid Start-Up Assistance, the BERD Center will provide an estimate for all development costs and downstream data management costs.

What Happens After I Receive COVID-19 Clinical Trial Rapid Start-Up Assistance?

Funded projects that receive COVID-19 Clinical Trial Rapid Start-Up Assistance will be expected to pay for services received and any additional future services (BERD Center services are billed monthly).

Projects that remain unfunded after three months will be returned to the PI for completion.

Citation Requirements

All publications, projects, posters, patents, trademarks, or other tangible outcomes resulting from Tufts CTSI funding and services must cite Tufts CTSI and comply with the NIH Public Access Policy. Guidelines for citations are available here.

Confidentiality and Non-Disclosure

All projects will be deemed proprietary and confidential and will be protected against any unauthorized use and any unauthorized or uncontrolled disclosure beyond Tufts CTSI and the BERD Center.

About the BERD Center

The BERD Center is a joint program between Tufts CTSI and the Institute for Clinical Research and Health Policy Studies (ICRHPS). BERD statisticians and epidemiologists hold faculty and scientific staff appointments at Tufts Medical Center and Tufts University School of Medicine. They provide pre- and post-award services, including guidance in framing research questions, developing study designs, selecting and conducting statistical analyses appropriate for research aims, calculating and justifying sample size, evaluating threats to study validity, and addressing human subject concerns.

Questions?

Please send any questions to Theodora Cohen, PhD, Director, BERD Center.