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Institutional Review Boards Research Records

RDA Number
11150
Effective Date
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 Years
5
Total Retention Months
0
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.
Allotment Code
34301
Record Location
IRBNet server, 2775 Northwoods Parkway NW Norcross, GA 30071
File Arrangement
Chronologically
Date Range
2012 - current
Annual Accumulation
~.4 gigabytes data/images
Current Volume
~1.3 gigabytes data/images
Record Value
Administrative
Audit Requirements
Both
Information Shared Outside the State
Yes
Shared 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
No
Confidential Legal Citation
45 CFR 46.116(a) (5)/ 21 CFR 50.25 (a) (5)
Does this Record Series Contain Sensitive Information?
No
Agency Retention
5 yrs after completion of research project
Records Center Retention Period
N/A
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.
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.
Legacy Revision UUID
2079