Type 1 Diabetes TrialNet: Clinical Centers (U01): RFA-DK-08-011
Key RFA Dates:
Letter of Intent Receipt Date: February 10, 2009
Application Submission/Receipt Date: March 10, 2009
Frequently Asked Questions* (Initial Posting: January 7, 2009)
Question 1: Should applicants propose a study using the data and/or samples being collected as part of the TrialNet Natural Study and/or an ongoing or approved TrialNet intervention protocol AND an intervention study in individuals at-risk for T1D or newly-diagnosed with T1D?
Answer: Applicants should propose only one study. This study can use the data and/or samples being collected as part of the TrialNet Natural Study and/or an ongoing or approved TrialNet intervention protocol OR can involve an intervention in individuals at-risk for T1D or newly-diagnosed with T1D.
Question 2: Should study proposals include a study budget?
Answer: The study proposal should not include a study budget. Because TrialNet studies are conducted at numerous sites, estimation of a study budget by an individual center is not feasible. However, applicants should consider feasibility, including budgetary feasibility, in proposing a study. The budget in the application should be developed based on infrastructure support needed for expected participation in multiple TrialNet studies as described in the amended RFA.
Question 3: Can the proposed infrastructure for a site include more than one Co-Investigator?
Answer : The proposed infrastructure may include more than one Co-Investigator as long as the combined effort from the PI and Co-Investigators is commensurate with the levels of effort indicated in the RFA.
Question 4: Can applicants submit more than one application, provided that they are scientifically distinct?
Answer : Individual applicants should not submit more than one application, and institutions should not submit more than one application.
Question 5: The RFA states that, "Applications should include a Principal Investigator with demonstrable experience in the conduct of T1D clinical research as well as a Co-Investigator with significant expertise in the area of T1D immunology . If the Principal Investigator is a T1D immunologist rather than an endocrinologist, the Co-Investigator should be a pediatric or adult endocrinologist with expertise in the area of T1D clinical research. The experience of both of these individuals should be described in detail in the application." What is meant by "expertise in T1D immunology"?
Answer: The Principal Investigator (whether an endocrinologist or immunologist) must have significant experience in the operation of T1D clinical trials. If the Co-Investigator is an immunologist, he/she must have experience that is pertinent to the study of immunologic approaches to T1D prevention/intervention.
Question 6: Where in the application should the documentation addressing required federal citations (human subjects protection, data and safety monitoring plan, sharing of research data, inclusion of women/minorities/children, ethics training, etc.) be included?
Answer: This documentation should be included in the body of the application. There are designated areas on Form PHS 398 for these items. Therefore, these items are included on pages that are subject to the 45 page application limit.
Question 7: Can the individual site recruitment reports provided by the TrialNet Coordinating Center (to existing TrialNet Centers and Affiliates only) be included in the application Appendix, or does this report need to be included in the body of the application?
Answer: These recruitment reports may be included in the Appendix of the application and need not be counted toward the 25 page research proposal limit or the maximum 45 page limit. Appendices should be submitted on a Compact Disk (CD). These reports can be included in the body of the application but will then be counted toward page limitations.
Question 8: Can two institutions submit a joint TrialNet application to be a single TrialNet Center?
Answer: It is possible for two institutions to submit a joint TrialNet application as a single Center. However, there can only be one Principal Investigator. The lead Investigator from the second institution would need to be a Co-Investigator. Further, the application would need to include a T1D clinical research endocrinologist and an immunologist with research experience pertinent to T1D (as is outlined in the RFA).
Question 9: The screening/recruitment reports only show numbers and do not reflect the nature and intensity of the individual studies. How will reviewers know the nature and intensity of these studies?
Answer: The applicant may include descriptions of the nature and intensity of each of these studies in the Appendix of the application. In addition to the three Targeted/Planned Enrollment Tables, the application should include data addressing gender, minority, human subjects, inclusion of children, etc. issues as required by the PHS 398.
Centers that have not participated in TrialNet should include a recruitment plan specific to TrialNet’s ongoing and planned studies (http://www.diabetestrialnet.org/patientinfo/studies.htm). This plan should contain details of past accomplishments and available resources that will enable the site to become an effective and productive TrialNet Clinical Center. This section should also include a description of available facilities at the Center for the conduct of TrialNet studies. This should include details regarding the availability of extended and weekend hours to accommodate patients and available support services, such as research centers, to assist TrialNet in the conduct of study-related drug administration (including infusions) and testing (such as Oral and IV Glucose Tolerance Testing and Mixed Meal Tolerance Testing). A description of experience (if any) that the Center has had in managing one or more affiliate sites as well as a plan for recruiting and maintaining a productive network of TrialNet Affiliate Centers should also be included in this section.
The remaining 10 pages of the application should include any required items that have not been covered in other parts of the application as well as any information that the applicant feels is pertinent to the application.
Question 10: What information should be included in the Target/Planned Enrollment Table(s) of the PHS 398 form?
Answer: Current TrialNet Centers should include projected enrollment for all phases of the Natural History Study as well as projected enrollment for new-onset type 1 diabetes studies (in general). The projected/targeted enrollment for all studies should reflect what the Center feels it can enroll based on past performance. If the Center feels that it can enroll in excess of what has been enrolled in the past, the proposal must state why the Center feels this is the case as well as how it plans to accomplish this. For institutions that have not participated in TrialNet in the past, realistic estimates should be included in these tables with justification (based on institutional data) to support these estimates.
Question 11 (REVISED): How should the components of the TrialNet application be put together?
Answer : Applicants must use the currently approved version of the PHS 398. In Section IV, #2 of the RFA, the content and form of the application are outlined. In Section IV, #6 of the RFA, the following research plan page limitations are stated:
Research Plan Page Limitations: The complete application may exceed the 25 page limit to a maximum of 45 pages. The research proposal portion of the application should be no more than 25 pages in length and the recruitment/retention plan portion should be no more than 10 pages in length.
Appendix Materials: All paper PHS 398 applications must provide appendix material on CDs only, and include five identical CDs in the same package with the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html ). Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
The completed application should be no more than 45 pages in length. These 45 pages should include:
Three Targeted/Planned Enrollment Tables should be included in the recruitment/retention plan. These are being included to enable reviewers to evaluate the site’s projected ability to enroll subjects into TrialNet studies. The first table should detail projected screening for Phase 1 of the Natural History Study, the second should detail projected enrollment into Phases 2 and 3 of the Natural History, and the third should detail projected enrollment for new-onset type 1 diabetes studies (in general). For current TrialNet Centers, the projected/targeted enrollment tables should reflect what the Center feels it can enroll based on past performance. If the Center feels that it can enroll in excess of what has been enrolled in the past, the proposal must state why the Center feels this is the case as well as how it plans to accomplish this. For institutions that have not participated in TrialNet to date, realistic estimates should be included in these three tables with justification (based on institutional data) to support these estimates as well as a report detailing the Center’s experience in the conduct of T1D clinical research studies.
A research proposal that is no more than 25 pages in length as detailed in the RFA and FAQs. The research proposal should include a comprehensive background and rationale for the study, the study design, the number of subjects required, the projected time for study completion, a power analysis, and proposed mechanistic studies to be done in conjunction with the trial. The proposal should be sufficiently detailed to understand what the study entails for the Centers, the patients, and the Coordinating Center but need not include a detailed accounting of exactly what will be done at each individual study visit.
A recruitment/retention plan. Pertinent portions of this plan can go into the Human Subjects Section (Section E) of the PHS 398. The Human Subjects Section does not have a page limitation. Additional portions of the recruitment/retention plan should utilize no more than 10 pages. Overall, the recruitment/retention plan should include a detailed description of the Center’s prior experience in the performance of T1D clinical research studies as well as data supporting the Center’s past and present ability to recruit T1D patients for treatment studies. The Center must demonstrate access to a population of T1D patients and family members at high risk for developing T1D.
- The application should provide a detailed accounting of the Center’s recruitment and retention goals, and its plans to accomplish these, for each type of study that TrialNet conducts: new onset T1D, prevention, and natural history.
The following items can be included in either the body of the application or in the Appendix:
- A detailed recruitment report generated by the Coordinating Center for Centers that have participated in TrialNet.
- Letters of support.
Question 12: Can TrialNet Clinical Center applications include multiple Principal Investigators (PIs)?
Answer: In the past, some TrialNet Clinical Centers have had a Principal Investigator (PI) and a Co-Investigator (Co-I) who are equally involved in TrialNet leadership at their Clinical Center and on the TrialNet Steering Committee. In response to the presence of this arrangement at some Clinical Centers, sites anticipating comparable involvement of two investigators (as described here) may choose to submit an application listing both of these individuals as Principal Investigators (PIs). If the decision is made to submit an application including multiple PDs/PIs, one PI should be an endocrinologist with demonstrable experience in the conduct of T1D clinical research and the other should be an immunologist with substantial expertise pertinent to the study of immunologic approaches to T1D prevention/early intervention. Guidelines for the submission of applications including multiple PIs can be found in the Notice (NOT-DK-09-007) published on March 3, 2009 (http://grants.nih.gov/grants/guide/notice-files/NOT-DK-09-007.html).
Please note that this webpage will be updated as additional questions arise.