Should the Data Coordinating Center proposal also include a concept protocol?
Yes. QUESTION 2A: What percentage of the 25 page limit is the concept protocol expected to require? How much detail (or how many pages) do you expect in the concept protocol? ANSWER: For Clinical Site applications, the concept protocol should be provided in the Research Plan section of the PHS-398. We recommend that you follow the general instructions provided for the PHS-398 application form. In general, the concept protocol should follow the format of the Research Plan, including Specific Aims (1 page), Background and Significance (2-3 pages), Preliminary Studies (6-8 pages), and Research Design and Methods. As stated in the RFA, under Special Requirements (page 5), “Applicants should outline the rationale and background of the proposed study, study design and protocol, eligibility criteria, and initial sample size and power analyses.” Applicants should provide as much detail as page limits permit. In addition to the concept protocol, applications for the Data Coordinating Center sho
