Puerto Rico Clinical and Translational Research Consortium s1

Puerto Rico Clinical and Translational Research Consortium

I. Procedure Title: Phlebotomy in Control Subjects for Research Issuing Date: August 1, 2011

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.

B. Purpose: Ensuring the safety and well-being of participants during the collection of blood samples as established in the Federal and institutional regulations.

III. Area(s) of Responsibility: Clinical staff of the PRCTRC, Principal Investigator, Study Coordinator, Staff Members of the protocols

IV. Procedure Details: A. Before the phlebotomy, the Investigator and/or Study Coordinator must submit to the research nurses the signed informed consent.

B. The phlebotomy will be performed only in the peripherals veins of the upper limbs.

C. Research nurses will undertake a maximum of three attempts to obtain the blood sample.

D. It is standard general of the consortium that blood samples are taken according to the Protocol provided by the researcher.

E. Additional samples to those required by the protocol procedures are not allowed.

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.

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.

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.