Puerto Rico Clinical and Translational Research Consortium, Research Subject Advocate

Summary:

The Research Subject Advocate's main responsibility is to assure that all steps are taken throughout any clinical research activity to protect the participating subjects and to ensure that their safety is given the highest priority. Also it is her responsibility to assure that all investigators/collaborators and CRC personnel are managing patient health information according to the Health Information Portability and Accountability Act.

People:

• PI: Rodríguez, Rafael
  

Member: Rivera Cruz, Adelma, BSN, RN, CCRC
Role: Research Subject Advocate

Resources:

Protocols

• Access to clinical records protocol ( Protocol )
  

  Source document in Spanish.

• Advocate intervention with participant protocol ( Protocol )
  

  Source document in Spanish.

• Advocate intervention with participant with Clinical Research Center staff protocol ( Protocol )
  

  Source document in Spanish

• Advocate intervention with participant with investigators and collaborators protocol ( Protocol )
  

  Source document in Spanish.

• Blood sampling guidelines protocol ( Protocol )
  

  Source document in Spanish

• Clinical records removal protocol ( Protocol )
  

  Source document in Spanish.

• Computer management, Clinical Research Center offices protocol ( Protocol )
  

• Computer management, informatic unit protocol ( Protocol )
  

  Source document in Spanish.

• Computer management, nursing unit protocol ( Protocol )
  

  Source document in Spanish.

• Delivery of laboratory results protocol ( Protocol )
  

  Source document in Spanish.

• Disposition of preliminary results and other documents containing private health information protocol ( Protocol )
  

  Source document in Spanish.

• Expired approval protocol ( Protocol )
  

  Source document in Spanish.

• Filing of clinical research documents protocol ( Protocol )
  

  Source document in Spanish

• Laboratory reports with critical values protocol ( Protocol )
  

  Source document in Spanish.

• Management of clinical laboratory results protocol ( Protocol )
  

  Source document in Spanish.

• Medicine storage for research studies protocol ( Protocol )
  

  Source document in Spanish.

• Participant consent protocol ( Protocol )
  

  Source document in Spanish.

• Pediatric phlebotomy protocol ( Protocol )
  

  Blood collection from pediatric patients.
  Source document in Spanish

• Phone usage protocol ( Protocol )
  

  Source document in Spanish.

• Private health information management protocol ( Protocol )
  

  Source document in Spanish.

• Receiving and delivering documents via fax protocol ( Protocol )
  

  Source document in Spanish.

• Reception computer management protocol ( Protocol )
  

  Source document in Spanish.

• Reports of illnesses and health conditions reportable to health department protocol ( Protocol )
  

  Source document in Spanish.

• Research studies audit protocol ( Protocol )
  

  Source document in Spanish.

• Sample delivery to reference laboratories protocol ( Protocol )
  

  Source document in Spanish.

Services

• Incident investigation service ( Support service )
  

• Patient consent process audit service ( Support service )
  

• QA reviews research protocol service ( Support service )
  

• Unbiased observer to potential patients service ( Support service )
  

Web Links:

• http://prctrc.rcm.upr.edu/researchers