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Tennessee Secretary of State Tre Hargett
Records Management Division
RDA
RDA Management System
RDA Details
RDA
RDA: 11150
Database ID: 2079
Record Series Title: Institutional Review Boards Research Records
Record Series Abstract: The IRB (Institutional Review Board) forms/checklists are used to collect and document the required information & consent while conducting approved subject research studies, as well as to ensure all proper documentation has been completed and proper procedures are followed. IRB Forms contain information related to the research project such as: title of study, study/investigator(s) (name(s), degree(s), contact information, etc.) funding sources, summary of study description, consent statement, protocol, data use agreement(s) (if required), data steward authorization (if required), identifiable information (if requested), specimens (if applicable), confidentiality pledges, type of data requested (if applicable), etc. The information gathered on these forms pertains to Research involving human subjects that are conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research (Research projects involving secondary data analysis of existing datasets that include protected health information and/or request a waiver of consen). Disclosure will comply with the requirements of this agreement and applicable law & as well as TDH (TN Dept. of Health) data release policies.
Record Series Active: Yes
Cut Off at End of: Other
If Other, Explain: Cutoff is at the end of the completion of the study
Total Retention: 5 Years 0 Months
Retention End Action: Destroy
Disposition Notes: TDH IRB checklists/forms are initially developed/stored on the TDH IRB Administrator’s workstation in the Policy Planning and Assessment (PPA) Division, 2nd floor, Andrew Johnson Building. These IRBNet checklists/forms, once approved for use, are uploaded to IRBNet by the TDH IRB Administrator. Researchers/committee members who register with IRBNet and then “affiliate” with the TDH IRB on IRBNet can then download the checklists/forms from IRBNet, fill in the checklists/forms, and reload the checklists/forms to their assigned on-line IRBNet package. The files are going to be cut off at the completion of each study and maintained in agency for 5 years.
View Signed Form: Form Not Received
Worksheet
Worksheet ID: 2083
Record Location: IRBNet server, 2775 Northwoods Parkway NW Norcross, GA 30071
File Arrangement: Chronologically
Media Format Generated: Electronic
Media Format Stored: Electronic: Text
Date Range: 2012 - current
Annual Accumulation: ~.4 gigabytes data/images
Current Volume: ~1.3 gigabytes data/images
Record Value: Administrative
Audit Requirements: Both
Reference Frequency:
Current Year per Month: 25
Past Year: 300
2 - 5 Years: 800
Over 5 Years: 0
Data Update Frequency: Daily
Information Shared Outside of State: Yes
If Shared, List Agencies: Centers for Disease Control(CDC) (GA), National Institutes of Health (MD), Emory University (GA), University of Florida (FL), MDRC (NY), RAND (VA), VPI (VA), NIOSH (OH), Northwestern University (IL), Mount Sinai (ON), Indiana University (IN), Walton University (MN), Brigham and Women’s Hospital (MA), International Epidemiology Institute (MD), John Hancock (MA), Boston University (MA), Riverside University (CA), Westat (MD)
Essential Record: Yes - Original
Essential Record Stored: Original records kept on researchers workstations and copies are kept on IRBNet server(s).
Essential Record Media Type: Electronic
Confidential: Yes
Confidential Legal Citation: 45 CFR 46.116(a) (5)/ 21 CFR 50.25 (a) (5)
Media Recommendation: Other
Media Recommendation Other: Electronic
Agency Retention: 5 yrs after completion of research project
Agency Retention - Years Active: N/A
Agency Retention - Years Inactive: N/A
Records Center Retention Period: N/A
Final Disposition after Retention Expires: Destroy
Legal Citation: 45 CFR 46.116(a) (5)/ 21 CFR 50.25 (a) (5)
Record Sample: No Sample
Legal Documentation: No Legal Documentation
Electronic Records Plan Inventory
System Name: IRBNet. IRBNet servers are owned and operated by IRBNet. These servers are located at the PEAK10 datacenter in Atlanta, GA. These servers are the \\\\\\\\\\\\\\\\
IT-ABC Number:
Hardware Description: IRBNet: This is an intel-based virtualized cloud environment
Software Description: IRBNet is an n-tier java web application running on Apache/Tomcat/Linux
System Location: IRBNet: Atlanta, GA. IRBNet servers operate out of the PEAK10 datacenter in Atlanta, GA, at the following location: 2775 Northwoods Parkway NW Norcross, GA 30071
Backup Procedures: IRBNet data is mirrored in real time between geographically diverse datacenters in Atlanta, Georgia and Research Triangle Park, North Carolina to facilitate rapid failover and disaster recovery. Snapshot backups are also generated on a rolling basis nightly, weekly and quarterly and are retained on disk in the ATL and RTP datacenters for up to one year.
Disaster Recovery: IRBNet maintains a disaster recovery facility in RTP, NC. All data is mirrored in real time, and disaster recovery failover can occur in less than 1 hour.
Data Migration Description: IRBNet commits via our Enrollment Document to provide you one copy of your data, on 30 days notice, upon exit.
Metadata Description: IRBNet is a document workflow system. Metadata includes document description (text, variable length) and filename (text, variable length).
Contact Information
Contact Name: Shannon Douglas Potts
Job Title: Records Officer
Address 1: 710 James Robertson Parkway
Address 2: Andrew Johnson Tower, 5th Floor
City: Nashville
Zip: 37243
Phone: 615-741-4411
Email: shannon.potts@tn.gov
Agency: Dept. of Health
Agency Head: Dr. John J. Dreyzehner
Director: Darla Powell
Allotment Code: 34301
Status
Action Requested: New RDA
Comments
  Date Comments
Records Management Division (RMD): 01-21-2016 No recommended changes.
Tennessee State Libary and Archives: 02-01-2016 No recommended changes.
Comptroller Audit Review: 2016-01-21 We have reviewed RDA 11150 from an audit standpoint. We concur with the recommended retention and disposition specifications.
Agency: 02-03-2016 I agree with RMD Comments.
RMD Director Recomendations: 02-11-2016 RDA 11150 is a request for a new RDA. The retention period will be five years and the format will be electronic. Recommend approval of request to create RDA 11150.
Signed Form Received: 2016-02-11
PRC Meeting Date: 02-25-2016
PRC Comments: PRC approves RDA 11150.
PRC Action: Approved
RDA History
ID RDA PRC Reviewed PRC Action
2079 11150 2016-02-25 Approved