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Records Storage and Retention Requirements
All raw data, protocols, reports, GLP documentation, quality
assurance records, GLP facility records, training records and personnel
qualifications, job descriptions, historical and current standard operating
procedures, equipment records, and study correspondence will be retained
according to the GLP regulations, system regulations, university rules, and
standard operating procedures. (Refer to Texas A&M GLP Archiving and Record
Retention SOP, Texas A&M University System Policy 61.99.01 – Retention and
Disposal of Public Records, Texas A&M Rule 15.99.03.M1.06 – Guidelines for
Gathering Storage, and Retention of Data and Results, Texas A&M University
System Policy 61.99.01.M0.01 – Records Management, and the System Records
Retention Schedule)
There will be archives for expedient retrieval and orderly
storage of GLP records. Conditions of storage will minimize deterioration of
documents, specimens, and other media for the duration of the retention period.
Each organizational unit involved in GLP studies will maintain a record and
specimen archive (as applicable). An individual and a backup person will be
responsible for the organizational unit’s archive. Access to record and
specimen storage areas will be limited to authorized individuals. If records are transferred to other
facilities, the location will be specified in the organizational unit’s
archive.