<p> Puerto Rico Clinical and Translational Research Consortium</p><p>I. Procedure Title: Phlebotomy in Control Subjects for Research Issuing Date: August 1, 2011</p><p>II. Overview/Procedure Description: A. Policy: The Puerto Rico Clinical and Translational Research Consortium (PRCTRC) ensure the safety and welfare of participants in research studies performed in its facilities. </p><p>B. Purpose: Ensuring the safety and well-being of participants during the collection of blood samples as established in the Federal and institutional regulations. </p><p>III. Area(s) of Responsibility: Clinical staff of the PRCTRC, Principal Investigator, Study Coordinator, Staff Members of the protocols</p><p>IV. Procedure Details: A. Before the phlebotomy, the Investigator and/or Study Coordinator must submit to the research nurses the signed informed consent. </p><p>B. The phlebotomy will be performed only in the peripherals veins of the upper limbs. </p><p>C. Research nurses will undertake a maximum of three attempts to obtain the blood sample. </p><p>D. It is standard general of the consortium that blood samples are taken according to the Protocol provided by the researcher. </p><p>E. Additional samples to those required by the protocol procedures are not allowed. </p><p>F. Phlebotomy must be stopped immediately if the participant experiences any adverse reaction such as dizziness, sweating or nausea. The PI and/or Study Coordinator will be notified as soon as possible. The protocol for management of reactions due to the phlebotomy will be followed.</p><p>G. If the participant shows any adverse events during and/or following the phlebotomy, the research staff will notify the situation to the PI and shall observe the participant for 15-30 minutes or until symptoms have disappeared. Vital signs will be taken to verify if they are stable and the instructions given by the PI will be followed.</p><p>H. If the participant fails to re-establish the normal vital signs parameters, the PI and/or Study Coordinator will be responsible for evaluating the participant and, if it is necessary, the subject will be referred to the emergency room for treatment. </p>