DDRS Consults–What to Expect

  • To initiate contact with the DDRS, investigators or team members must complete and submit a Connection Request.

  • Submitting a Connection Request can be done by logging into the ICTR Connection Request website and selecting the DDRS service from the available options.

  • All Connection Requests received will be reviewed by the Research Navigators in the order received in order to determine the basic nature of the request.

  • Initial responses to Connection Requests can be expected within 5 to 7 working days, so please plan accordingly.

  • Requests for general information requests will be answered directly by the Research Navigators wtihin 5 to 7 working days. Individuals submitting requests may also be referred to the DDRS website for additional information and resources applicable to their inquiry.

     

  • An Intake Questionnaire form will be provided to investigators or study teams members who have Project-Specific Consultation requests.

  • This form allows the Research Navigators to collect more detailed information in order to fully assess the project prior to meeting with investigator/project team.

  • After the Intake Questionnaire is completed and returned, Research Navigators will review the information provided and identify potential regulatory issues, support needs, and develop a preliminary plan.

     

  • Next, the Research Navigators will send a Project Analysis and/or meet with investigator/project team. If a meeting, this may be in person or via teleconference.

  • It is at this point that the eight-hour free consultation clock will start and an effort tracking tool will be used by the Navigators to record time spent with each project received.

  • Prior to discussing their initial review of the project, the Research Navigators will provide the investigator with an overview of the Navigator role; explain the initial consultation period and present information about the regulatory support available on a fee-for-service basis once the complimentary consult period is concluded.

  • Throughout the course of the eight-hour consultation period, the Research Navigators will discuss any identified regulatory concerns, provide necessary guidances, templates and resources to the investigator as appropriate via telephone, email and in person meetings as per investigator request and Research Navigator availability.

     

  • As Research Navigator effort approaches the eight-hour cut-off point, the Navigators will contact the investigator to discuss need for additional support.

  • It would be at this point that the investigator will either 1) conclude consultation without additional support from the Project Specific Consultation Service or 2) engage the services of the Research Navigators with their own funds or 3) submit an application for scholarship funding.

  • The scholarship program is available to subsidize Project Specific Consultation Service fees of those investigators without sufficient financial resources to engage the service on their own and whose project merits support.

  • Each scholarship application will be reviewed by members of an oversight committee.

  • As there are limited funds for the scholarship program, the committee may suggest cost sharing with the department/division as appropriate.

  • If the investigator has decided to pursue additional project support via the DDRS service, the funding status of the investigator has been finalized (e.g., the investigators receives ICTR sponsored scholarship funding or has adequate independent funds) and the level of the fee-for-service support has been agreed upon, a mutually determined start date of the 12-month service period will be set and a service agreement letter outlining the terms and conditions of the services and the scope of Research Navigator work to be done will be sent to the investigator for signature.

     

General inquiries and requests for support

Please submit an ICTR Connection Request.