The Musc IRB for Human Research has established procedures for the identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records. Records are identified in the applicable procedure. Records, including all records required by government regulation, are maintained to demonstrate achievement of the required quality and effective operation of the Quality System. 1.0 Quality Records will be retained for 3 years as a minimum and will be retained longer if required by government regulation.
All records are in the form of filed documents.
Subjects can not be identified by name in any records retained by the IRB Office. Each individual is responsible for maintenance of all assigned records per Attachment 16-1 . Records shall be legible, identifiable and retrievable. Each assigned individual is responsible for controlling access to the records for which they are responsible. 1.2 Records will be protected from damage or inadvertent loss.