NICHD CONTRACEPTION CLINICAL TRIALS NETWORK CCTN MALE

NICHD的避孕临床试验网络对各种新的女性和男性避孕方法进行第一、第二和第三阶段的临床试验。该合同的目的是让CCTN承包商进行男性避孕临床试验，并根据不确定交付/不确定数量(IDIQ)合同按任务顺序制定研究方案。 临床试验地点的合同网络将在第一、第二和第三阶段的临床试验中系统地评估新型男性避孕药和装置的安全性和有效性，以及条件下的药物治疗。研究设计将在每个请求任务订单建议书中具体说明。这些临床试验的结果将成为通过开发推进候选药物和设备的基础，最终目标是提交给FDA，以支持新药申请(NDA)、上市前通知510K、上市前批准(PMA)或研究设备豁免(IDE)。根据现场能力，首席调查员(以及其他适当的现场人员)应与统计和临床协调中心人员以及NICHD项目人员合作，参与制定方案。根据本合同进行临床评估的候选方案、药物或装置应由NICHD与CCTN的科学咨询委员会协商后选择。

The NICHD's Contraceptive Clinical Trials network conducts Phase I, II and III clinical trials of a wide variety of new female and male contraceptive methods. The objective of this contract is for CCTN contractors to conduct male contraceptive clinical trials and to develop research protocols on a task Order basis under an Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The contract network of clinical trial sites will evaluate systematically the safety and efficacy of new male contraceptive drugs and devices as well as drug treatment of conditions, in Phase I, II, and III clinical trials. The study design will be specified in each Request for Task Order Proposals. The results of these clinical trials would be the basis for advancing candidate drugs and devices through development, with the ultimate goal of submission to the FDA in support of a New Drug Application (NDA), Premarket notification 510k, Premarket Approval (PMA) or Investigational Device Exemptions (IDE). Based upon site capabilities, the Principal Investigator (and other site personnel as appropriate) shall participate in the development of protocols in cooperation with personnel from the Statistical and Clinical Coordinating Center and with NICHD program personnel. The candidate protocols, drugs or devices to be evaluated clinically under this contract shall be selected by the NICHD with consultation from the Scientific Advisory Committee of the CCTN.