Summary:
Research records must be prepared and maintained, and kept, stored, and accessed as allowed by federal regulation and approved by institutional policy. A procedure will be developed to address each of the areas pertaining to research records. Currently, we have developed a procedure for Clinical Research Records Documentation that identifies specific requirements that must be followed in setting up and maintaining research records when they have the potential to impact current or future care of the patient. Three charts have been attached that outline which research records belong in the Medical Record, Investigational File for Clinical Research, and in the Investigator’s Research files (administrative). Subsequent procedures will also be developed in the future to address retention, storage, and access.
Both documents are now available online at: http://www.llu.edu/pages/handbook/lluahsc_policies/index.php?dir=H-Research%2520Affairs/
Please review the documents. Plans for training are in process, and a subsequent announcement will be sent out with details on when training will occur.
If you have any questions about this policy, please contact Lorraine Sarmiento at ext. 49478 or lsarmiento@llu.edu. For more information, visit Integrity, Storage, and Retention of Research Data.