Policy H-42 Research Records, Documentation, Retention, Storage, and Access For Human Subject Research and H-42.A Procedures for Clinical Research Records Documentation has been approved on August 30, 2011. Full compliance with this policy/procedure must occur by November 30, 2011.
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 firstname.lastname@example.org. For more information, visit Integrity, Storage, and Retention of Research Data.
On Friday, October 7 and Saturday, October 8, eRA Commons will undergo a ‘technical refresh.’ What does this mean for you? Wherever possible, NIH has made a concerted effort to minimize the changes to the eRA Commons. Many of the technology updates are occurring behind the scenes; however, there are a few things you’ll notice that have changed, and some additional features and functionality that you may be pleased to see.
Different sections of eRA Commons will be enhanced during the technical refresh including a move toward more secure electronic systems such as updating the log-in for each of its systems. No changes are required for Commons users who are not federal employees. You will continue to log in to the system using your existing username and password.