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Information for Research Participants
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Institutional Review Boards
UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

28.3 Record/Document Storage and Deletion



approval date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

September 15, 2008



policy

Plans for the maintenance and storage of study records and documents must be submitted by the principal investigator to the IRB for approval. These plans should define record storage procedures and conditions and identify those with access to the records.  Electronic data should be saved on a device that has appropriate security safeguards to protect against data loss or theft and to avoid any potential breach in subjects’ privacy and confidentiality. IRB approval shall be based on documented assurance that all hard copy and electronic data is securely stored to prevent unauthorized access, disclosure, or loss.  Principal Investigators should also submit for IRB approval provisions for destruction of study records after the required data retention period has elapsed if the destruction of study records is necessary for confidentiality or other matters that protect participants. 


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