Standard Operating Procedure
1 Standard Operating Procedure (SOP) Title: Electronic Records Management SOP Number: OSP-001 Office of Accountability: Office of Sponsored Programs I. PURPOSE This standard operating procedure establishes the electronic management of sponsored programs records created or received within the Office of Sponsored Programs to ensure compliance with all requirements of 2 CFR part 200 “Uniform Administrative Requirements, Costs Principles, and Audit Requirements of Federal Awards”, and in accordance with University policies, sponsor regulations, and terms and conditions of an award. II. DEFINITIONS 1. "Electronic" relates to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities. 2. An "electronic record" is a record created, generated, sent, communicated, received, or stored by electronic means. 3. “HIPAA” is the Health Insurance Portability and Accountability Act. 4. “IACUC” is the Institutional Animal Care and Use Committee which reviews and approves protocols for research using animal subjects. …
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1 Standard Operating Procedure (SOP) Title: Electronic Records Management SOP Number: OSP-001 Office of Accountability: Office of Sponsored Programs I. PURPOSE This standard operating procedure establishes the electronic management of sponsored programs records created or received within the Office of Sponsored Programs to ensure compliance with all requirements of 2 CFR part 200 “Uniform Administrative Requirements, Costs Principles, and Audit Requirements of Federal Awards”, and in accordance with University policies, sponsor regulations, and terms and conditions of an award. II. DEFINITIONS 1. "Electronic" relates to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities. 2. An "electronic record" is a record created, generated, sent, communicated, received, or stored by electronic means. 3. “HIPAA” is the Health Insurance Portability and Accountability Act. 4. “IACUC” is the Institutional Animal Care and Use Committee which reviews and approves protocols for research using animal subjects. “IRB” is the Institutional Review Board which reviews and approves protocols for research using human subjects. 5. A "record" is information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form related to grant and contract proposals, awards, agreements and supporting documentation, animal welfare, institution review board human subjects, conflict of interest, and export controls. 6. “Record Retention Period” is the period in which a record is required to be maintained in order to comply with federal requirements and university policy as listed in Table 1. 2 III. PROCEDURES 1. Receipt of Records: Records may be received in electronic or hard copy format. Hard copy files will be scanned into electronic format within five business (5) days upon receipt. 2. Naming Conventions: Each document file name should at minimum include the below when naming the file: i. PI Name ii. Agency Name iii. Document Type iv. Date (Submission, Effective or Closeout if Closed) 3. Documents included in the electronic file: i. Proposal/Award/Agreement ii. IRB and IACUC protocols iii. Conflict of interest disclosures iv. Internal Forms v. Approval Documents vi. Technical Reports 4. Electronic Storage of Records: i. Sharepoint: Working documents and Non‐Financial Agreements will be stored in the UVI Sharepoint “Sponsored Programs” folder. Files stored in Sharepoint are backed‐up regularly into a UVI cloud environment. ii. Cayuse: Final submitted proposals, Awards/Agreements, Certifications, technical reports and/or Approval documents will be uploaded and stored in Cayuse software under the documents tab. Documents stored in Cayuse are back‐up by a Cayuse cloud environment. iii. IRBNet: All IRB and IACUC applications, proposals, protocols, and associated documents will be stored in the IRBNet software system. Documents stored in IRBNet are backed up by an IRBNet cloud environment. 5. Access to Records: i. The Office of Sponsored Programs staff has administrative rights to view and edit all electronic records in Sharepoint, Cayuse and IRB Net. ii. Should Principal Investigators, UVI Senior Management, or other internal units need access to the electronic files, a formal request will be made to the Director of Sponsored Programs, who will review the request. If the request is approved, the Director of Sponsored Programs will authorize the University’s IT Helpdesk toprovide the requestor with access to Sharepoint . 6. Retention and Destruction: When the prescribed record retention period for sponsored program records has passed, the electronic record will be disposed of unless it is determined by the Director of Sponsored Programs to be of historical value. All destruction of records will comply with UVI Document Retention, Archival and Disposal Policy. 3 Record retention periods of Sponsored Program records may be increased by governmental regulation or the terms and conditions of an award. Such modifications supersede the requirements listed in this SOP. Type of Record Record Retention Un‐funded Pre‐Award Files 5 years after notification of decline or withdrawal Grant and contract award proposals, awards, agreements, associated internal forms and supporting documentation 7 years after financial status report is issued or as mandated by sponsor IACUC Records 3 years after the study closure or termination If any claim or litigation arises out of the study, records shall be kept until all such claims or litigation have been resolved and final action taken. Disclosures of external financial interests and commitments 7 years post‐disclosure or 7 years after the grant period has ended (whichever is greater) Export Control Records 5 years after the grant period has ended, from when export is complete, and/or after export license has expired, if applicable (whichever is greater) IRB Records 3 years after study closure or termination If any claim or litigation arises out of the study, records shall be kept until all such claims or litigation have been resolved and final action taken. HIPAA Records 6 years after study closure or termination If any claim or litigation arises out of the study, records shall be kept until all such claims or litigation have been resolved and final action taken. Scientific Misconduct Investigation Documents 7 years after completion of the proceeding or, where relevant, completion of any proceeding. 4 IV. REFERNCES 1. Policy on Public Access To Documents and Information 2. Retention, Archival and Disposal Resolution V. HISTORY 1. Revision 0: Reviewed by Stacey Chados, Controller, on October 4, 2019 and Sharlene Harris, Vice President of Institutional Assessment and Information Services, on November 26, 2019, Institutional Review Board (IRB) record retention reviewed by the UVI IRB on February 19, 2020, Institutional Care and Use Committee (IACUC) record retention reviewed by the University IACUC on February 28, 2020. SOP APPROVAL Signature: Date: Mindy Solivan, Director of Sponsored Programs February 28, 2020