Puerto Rico Clinical and Translational Research Consortium

Puerto Rico Clinical and Translational Research Consortium

I.  Procedure Title: File of Inactive Research Studies Documents

Issuing Date: August 1, 2011

II.  Overview/Procedure Description:

1.  Policy: The Puerto Rico Clinical and Translational Research Consortium (PRCTRC) will provide a specific area to the researchers to keep their study documents after the close-out visit.

2.  Purpose: To provide guidance to researchers on the terms of study documents storage once the close-out visit is performed.

III.  Area(s) of Responsibility:

Administrative staff, Research Nurses, researchers and collaborators

IV.  Procedure Details:

1.  The PRCTRC will provide files in the record room area to those researchers who request it, to save the documents of the study such as participant’s files, administrative binders and any other documents of the study. When the study finishes, and the file is needed for another study, the investigator will be instructed about the alternative of storing the documents in a specialized facility outside the PRCTRC. The Principal Investigator will assume the costs associated with the storage service.

2.  The file in the record room of the PRCTRC can be used by the researcher while the study is ongoing.

3.  After the close-out visit of the study, the PI and /or collaborators should notify it to the Nursing Supervisor or its staff.

4.  The PI and/or collaborator will be responsible for packing the study documents in the boxes provided by the storage company.

5.  The PI will have no more than 30 days after the close-out visit of the study to coordinate the packing and storage of the documents and/or any other study materials.

6.  This process must be coordinated with the Nursing Supervisor or the Research Subject Advocate.

7.  If the PI needs an extension to the established term, it should be requested to the Nursing Supervisor or the Research Subject Advocate.

8.  All inactive studies documents will be transferred to an external facility approved by the Administration of the PRCTRC, the Internal Advisory Committee and the Chancellor of the RCM. This storage facility complies with all federal and institutional requirements for the handling and storage of private health information.

9.  The PI and/or collaborators are responsible for discarding all those documents and materials that does not need to keep after the closure of the protocol.

10. If after the final removal of documents, the investigator left any document in the file

of record room, the Nursing Supervisor will send a notification emphasizing the

need to remove or discard all study documents. If the PI does not respond to such notice within a period not exceeding 30 days, the Nursing Supervisor shall discard all documents following the confidentiality guidelines.