c. Provided by: NCI Manufacturer Other, d. For this study, is the agent/drug/biologic being used under an IND? Yes No If yes, please provide: IND#: Holder of IND: e. Is there an Investigator’s Brochure? Yes No If yes, please provide a copy of the Investigator’s Brochure. f. Is the agent/drug/biologic being used off-label? Yes No 4.0 Radiation 4.1 Does this study involve radiation? Yes No (If no, skip to Section 5.0.) If yes, specify the type of radiation that the participant will receive: Diagnostic Therapeutic Both 4.2 Is any radiation modality or dose experimental? Yes No If yes, describe. You may cite the consent form or protocol section and page number as long as the information is provided in lay language; otherwise provide a lay language description here. 5.0 Surgery 5.1 Does the study question involve experimental surgery? Yes No (If no, skip to Section 6.0.) If yes, describe. You may cite the consent form or protocol section and page number as long as the information is provided in lay language; otherwise provide a lay language description here. 6.0 Genetic Research Genetic research is carried out on a continuum comprising of four stages: (1) to discover the pattern of inheritance of a disease and to catalog the range of symptoms involved (pedigree studies); (2) to localize and identify specific genes (positional cloning studies); (3) to develop techniques for determining the presence of specific DNA mutations (DNA diagnostic studies); and (4) to develop treatments for genetic disease at the DNA level (gene therapy research). 6.1 Will the research identify genetic characteristics? Yes No If yes, complete this section. If no, go to Section 7.0. 6.1.1 Will the identified genetic characteristics be disclosed to the study physician? Yes No
c. Provided by: NCI Manufacturer Other, d. For this study, is the agent/drug/biologic being used under an IND? Yes No If yes, please provide: IND#: Holder of IND: e. Is there an Investigator’s Brochure? Yes No If yes, please provide a copy of the Investigator’s Brochure. f. Is the agent/drug/biologic being used off-label? Yes No 4.0 Radiation 4.1 Does this study involve radiation? Yes No (If no, skip to Section 5.0.) If yes, specify the type of radiation that the participant will receive: Diagnostic Therapeutic Both 4.2 Is any radiation modality or dose experimental? Yes No If yes, describe. You may cite the consent form or protocol section and page number as long as the information is provided in lay language; otherwise provide a lay language description here. 5.0 Surgery 5.1 Does the study question involve experimental surgery? Yes No (If no, skip to Section 6.0.) If yes, describe. You may cite the consent form or protocol section and page number as long as the information is provided in lay language; otherwise provide a lay language description here. 6.0 Genetic Research Genetic research is carried out on a continuum comprising of four stages: (1) to discover the pattern of inheritance of a disease and to catalog the range of symptoms involved (pedigree studies); (2) to localize and identify specific genes (positional cloning studies); (3) to develop techniques for determining the presence of specific DNA mutations (DNA diagnostic studies); and (4) to develop treatments for genetic disease at the DNA level (gene therapy research). 6.1 Will the research identify genetic characteristics? Yes No If yes, complete this section. If no, go to Section 7.0. 6.1.1 Will the identified genetic characteristics be disclosed to the study physician? Yes No
CIRB_IR%20Application_v042414_Updated_7-7-17.docx