DRAFT Services (formerly known as Pre-Review Service) stands for "Document Revision And Feedback Team". The mission of the DRAFT Service is to improve submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices. It is highly recommended that the DRAFT Service is used by investigators prior to submitting new studies or substantial modifications to existing studies in eIRB.
Investigators may also opt to use this service for assistance with responding to IRB Memo requests post IRB review. In some instances, the IRB may require that the study team consult with the DRAFT Team prior to re-submitting to the IRB.
DRAFT Services Team
The DRAFT Services team is comprised of highly knowledgeable IRB and HRPP staff, as well as key Committee Members on the IRB. The team provides subject matter expertise and feedback for all study documents prior to the researcher’s formal submission or resubmission for review by the IRB in eIRB. When a DRAFT request is made, the team will review all shared documents and provide comments, suggestions, and guidance. It is recommended, but not required, that the study team update their submission based on DRAFT team 's feedback.
The DRAFT process begins when the IRB receives a request for DRAFT Services. The process ends when the investigator has been notified by the DRAFT team that the process is complete. The investigator will find instructions and feedback within the submitted documents. Instructions are provided below to initiate the DRAFT process.
To begin the process, please upload relevant documents as Microsoft Word files in Rutgers OneDrive or Rutgers Box.
Documents that should be included:
- Protocol and/or local context supplement
- All surveys, questionnaires, and data collection tools
- All recruitment text/materials used (flyers, scripts, emails, etc.)
- Any other document relevant to the research
After sharing via Rutgers OneDrive or Box, please send an email to all of the DRAFT Team Members (listed below) to alert them of your service request.
Please share the folder with all of the following DRAFT team members:
- Jason Lin, Sr. Research Project Manager
- Angela Cartmell-McGlyn, Sr. Research Project Manager
- Rebecca Chen, ClinicalTrials.Gov
- Claribel Vega, Sr. Reliance Manager
Submitting Applications in eIRB
If using the DRAFT service, please do not submit your application in eIRB until after the service is completed. Though it is not required that you implement the feedback provided by the DRAFT team, it is highly recommended that you do. The study documents that you upload into your eIRB application (protocol, study instruments, recruitment materials, consent forms, etc.) should be the latest versions and ideally reflecting the revisions suggested by the DRAFT service.
DRAFT Service Completion
We will notify you via email once the process is completed. Please keep in mind that this courtesy service is intended to help expedite the approval process and the comments are recommendations. Once you submit your study to the IRB via eIRB for review, IRB members (faculty familiar with a variety of research) may have additional feedback during the review process.
Virtual Office Hours
The mission of DRAFT (Document Revision And Feedback Team) Services is to improve submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices. Virtual office hours are hosted on select Tuesday's and Thursday's.
Please join us if you have a question on process, design, best practices, regulations/policies, or need help in the development of a document! Each individual consultation is limited to less than 10 minutes. If there are multiple attendees, we may limit the consultation time accordingly. When you join the Office Hours Zoom, you will remain in the waiting room until the prior attendee’s session has ended. All those who join the Office Hours Waiting Room during the designated times will have their questions addressed. More information on what to expect during DRAFT virtual office hours.