Justify the feasibility of recruiting the required number of suitable subjects within the agreed recruitment period. For example, how many potential subjects do you have access to? What percentage of potential subjects do you need to recruit? Describe the time that you will devote to conducting and completing the research. Describe your facilities. Describe the availability of medical or psychological resources that subjects need as a result of an anticipated consequences of the human research. Describe your process to ensure that all persons assisting with the research are adequately informed the protocol, the research procedures, and their duties and functions. Approvals Describe any approvals that will be obtained prior to commencing the research. (E.g., school, external site. funding agency, laboratory, radiation safety, or biosafety approval.) Local Recruitment Methods This section is for recruitment methods the control of the local site and not central recruitment managed by the sponsor. Describe when, where, and how potential subjects will be recruited. Describe the source of subjects. Describe the methods that will be used to identify potential subjects. Describe materials that will be used to recruit subjects. (Attach copies of these documents with the application. For advertisements, attach the final copy of printed advertisements. When advertisements are taped for broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape.) Describe the amount and timing of any payments to subjects. Local Number of Subjects Indicate the total number of subjects to be accrued locally. If applicable, distinguish between the number of subjects who are expected to be enrolled and screened, and the number of subjects needed to complete the research procedures (i.e., numbers of subjects excluding screen failures.) Confidentiality
Justify the feasibility of recruiting the required number of suitable subjects within the agreed recruitment period. For example, how many potential subjects do you have access to? What percentage of potential subjects do you need to recruit? Describe the time that you will devote to conducting and completing the research. Describe your facilities. Describe the availability of medical or psychological resources that subjects need as a result of an anticipated consequences of the human research. Describe your process to ensure that all persons assisting with the research are adequately informed the protocol, the research procedures, and their duties and functions. Approvals Describe any approvals that will be obtained prior to commencing the research. (E.g., school, external site. funding agency, laboratory, radiation safety, or biosafety approval.) Local Recruitment Methods This section is for recruitment methods the control of the local site and not central recruitment managed by the sponsor. Describe when, where, and how potential subjects will be recruited. Describe the source of subjects. Describe the methods that will be used to identify potential subjects. Describe materials that will be used to recruit subjects. (Attach copies of these documents with the application. For advertisements, attach the final copy of printed advertisements. When advertisements are taped for broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape.) Describe the amount and timing of any payments to subjects. Local Number of Subjects Indicate the total number of subjects to be accrued locally. If applicable, distinguish between the number of subjects who are expected to be enrolled and screened, and the number of subjects needed to complete the research procedures (i.e., numbers of subjects excluding screen failures.) Confidentiality
hrp-508-template-site-supplement-sponsor-protocol_0.docx