The Network is very interested in fostering collaborative interactions with the broader
surgical community and will consider clinical research ideas from colleagues in the surgical
community, allied health specialties, and academic areas. To bring ideas forward for consideration by the CTSN,
an investigator outside the Network should perform the following:
- Identify a collaborating CTSN Clinical Site Principal Investigator, Data Coordinating Center,
the NHLBI Program Director, Dr. Marissa Miller at firstname.lastname@example.org ,
or respond to the 'Contact Us' page of this website.
- In collaboration with the Network Principal Investigator, develop a brief study proposal concept that contains the following:
- Abstract: Brief summary of the proposed research that includes the primary hypothesis and research question.
- Background and Significance: Brief summary of supporting research and preliminary studies.
- Primary endpoints with justification.
- Study Design: Preliminary description of how the study will be implemented, including the study population,
inclusion/exclusion criteria, treatment arms, if applicable, and methods. A sample size calculation is not required
at this time but may be included.
- Budget: Include a preliminary budget estimate.
- In collaboration with the Network Principal Investigator, present the protocol concept to the full Steering Committee,
which will review the proposal for feasibility and scientific importance.
- If the proposal is accepted by the Steering Committee, develop the full protocol in accordance in accordance with established
procedures described in the Manual of Operations.
Outside collaborators who collaborate with the Network during protocol development and for the duration of the study can participate
as co-authors in the development of publications from the study. The outside collaborator's site will have first consideration for
inclusion as a Network Ancillary site for the specific protocol in the event the trial under development requires additional sites
to enable timely and complete enrollment.