Reported” and “# of is the number of specimens actually used for some sort of Specimens Analyzed?” testing, assay, diagnostic, or characterization. Table 11: Are the SOPs All that is required is a list with only the name of the SOPs for requested for the LAO only or the LAO and AOs. If the LAO and AO share the same SOP, it for AOs as well? We do not want copies of only needs to be listed once. the SOPs. Tables 2-10: is the The primary purpose of the resources tables is to document expectation to include data the PI’s and site(s)’s ability to effectively conduct early phase for all applicable clinical trials clinical trials. It should clearly convey the investigators ability conducted at our institution to accomplish the goals and objectives of the study. The or only clinical trials in which applicant should use his/her best judgment as to which studies the ET-CTN investigators are included. participated? Can non-CTEP trials (e.g. Yes, pharmaceutical trials can be included. Pharmaceutical pharmaceutical trials) be trials should be clearly labeled. included in any of the tables that fit in the phase ½ category? If a study opened in 2006 and Accrual information is placed in the table in the year the study accrued until it was closed in was closed or completed. 2009, how would the information be reported on the tables? Would the accrual and samples only be reported from 2008-2009? RFA/FOA Is this RFA considering new This RFA will fund new awards. awards or is it only going to re-fund existing awards?
Reported” and “# of Specimens Analyzed?” is the number of specimens actually used for some sort of testing, assay, diagnostic, or characterization. Table 11: Are the SOPs requested for the LAO only or for AOs as well? All that is required is a list with only the name of the SOPs for the LAO and AOs. If the LAO and AO share the same SOP, it only needs to be listed once. We do not want copies of the SOPs. Tables 2-10: is the expectation to include data for all applicable clinical trials conducted at our institution or only clinical trials in which the ET-CTN investigators participated? The primary purpose of the resources tables is to document the PI’s and site(s)’s ability to effectively conduct early phase clinical trials. It should clearly convey the investigators ability to accomplish the goals and objectives of the study. The applicant should use his/her best judgment as to which studies are included. Can non-CTEP trials (e.g. pharmaceutical trials) be included in any of the tables that fit in the phase ½ category? Yes, pharmaceutical trials can be included. Pharmaceutical trials should be clearly labeled. If a study opened in 2006 and accrued until it was closed in 2009, how would the information be reported on the tables? Would the accrual and samples only be reported from 2008-2009? Accrual information is placed in the table in the year the study was closed or completed. RFA/FOA Is this RFA considering new awards or is it only going to re-fund existing awards? This RFA will fund new awards.
etctn_faqs.docx