Based on the information provided and results of the review, the NDA Data Access Committee has delegated to NDA staff the ability to approve user accounts for privileges required to work on projects submitting data (SOP-02), or initiate the process to request access to shared data (SOP-03). This SOP should be used when any form of data is collected, accessed, transferred or stored by a trial. The purpose of this SOP is to outline the steps for requesting a delay in the transition of submitted data from its initial private state to a shared state beyond the NDA prescriptive timelines. Information security incidents must be reported to the ISO. NDA Staff compile the results of this assessment into a single report for each Collection. The (MHRA) Medicine and Healthcare Products Regulation Agency state that the Data Protection Act 1998, Human Rights Act 1998 and the Freedom of Information Act are linked. NDA staff will then work with the submitting lab to expunge the data. Control university data by granting access, renewing access, and revoking access to Data Stewards, Data Managers, and/or Data Users. Account requests that involve access to shared data or data submission privileges will take longer. Data access is renewed on an annual basis, or more often as needed. Each recipient must log into the NDA Data Permissions Dashboard to submit a DAR for an Open Access Permission Group. Contributors are asked to respond as described in SOP-05A Contributor Quality Assurance and Quality Control. Although ensuring the quality of shared data is the responsibility of the contributors, NDA provides a set of Quality Assurance/Quality Control services as part of its ingestion and sharing processes. Change Control. These procedures apply to the NDA generally and all research clusters operated within the NDA infrastructure. NIH Extramural Program Staff automatically have access to research data and supporting information concerning their portfolio through the NDA infrastructure. The DAC and federated data resource approve the data federation agreement. Reassessing classification levels at least … That recipient will be removed from the DUC and access revoked. Senior management is authorized to delegate access of enterprise-wide aggregate and summary university data, as deemed appropriate. Within 1 business hour, NDA staff will review and make a determination if the data is PII. A Data Access Workflow provides a visual guide to the relevant stages and associated timelines. These containers may be shared either to specific individuals through NDA's Ongoing Study capability or broadly with other researchers. Other recipients cannot be added by editing the downloaded DUC PDF. This procedure requires that users complete SOP-02 Data Submission Privilege Request, and they harmonize their data with the NDA Data Dictionary as described in SOP-05A Contributor Quality Assurance and Quality Control. Data Trustees and their delegates grant and revoke access to Category 1- Restricted Data and Category 2- Private Data (non-public) university data. All recipients listed on a DAR must be affiliated with one research institution. Recipients on denied data access requests have the option to submit a new data access request that addresses the DAC reason for denial. Names (Patient, Operator, Physician, Relative, Employer, etc. Computer systems and devices used to support data must adhere to the specific, protective measures as set forth in the. Access control is any mechanism to provide access to data. Limit access to personally identifiable information through password protection and other means. computational pipelines, integrating data submission/extraction tools, developing phenotypic constructs, etc.). The following procedure should be followed for such cases. The Data Access Committee (DAC) or its representatives and the Program Officer will approve the request or consult with the investigator for clarification/modification. The purpose of this SOP is to outline the steps for individuals to request access to NDA for software development purposes. Supplements the Protection of University Data Policy and the Data Risk Classification Policy. The University at Buffalo is the data owner of all university data; individual units or departments have stewardship responsibilities for portions of the data. This procedure must be completed after SOP-01 NDA Account Request. The purpose of this SOP is to define the steps for using the NDA GUID Tool software to securely generate a de-identified research participant identifier. This procedure applies to all investigators and data managers who need to generate GUIDs and pseudoGUIDs for data submission, or researchers who have been approved to use the NDA GUID Tool to generate identifiers for their non-NDA supported projects. Includes centrally-stored data, as well as data generated and stored in university departments and decanal units All university data is required to have an identified Data Trustee. A request for an NDA user account is the first step in obtaining access privileges in the NDA system. This procedure is typically completed within 10 business days after receiving a completed Time Extension for Sharing Request. Data Access Procedures: Public Data. The NDA holds biannual submission periods between December 1 and January 15, and between June 1 and July 15 of each year. If a determination is made that the data includes PII and those data have not been shared or downloaded, the NDA will immediately expunge the data. Prevent unauthorized access to Category 1 Restricted Data and Category 2 Private Data. SOP-03 NDA Certification and Assurance to Operate, SOP-05 Quality Assurance and Quality Control, SOP-06 Establishment of a Federated Data Resource, SOP-08 GUID Generation Permission Request, SOP-10 Request Time Extension for Sharing, SOP-13 Request to Submit Data to an NDA Federated Repository, SOP-14 Removal of Subjects Data from the NDA, SOP-15 Discovery of Personally Identifiable Information (PII) within NDA Protected Data, https://www.hhs.gov/ohrp/federalwide-assurances-fwas.html, https://nda.nih.gov/get/manuscript-preparation.html, https://ndar.nih.gov/api/validation/docs/swagger-ui.html, https://ndar.nih.gov/api/submission-package/docs/swagger-ui.html. Ryan Duguid, Experts Corner, _Experts-Operations, _Experts-Programs. Data Users are explicitly prohibited from releasing, sharing, or transmitting data to others, other than for the legitimate business purposes for which the data access was granted. The contributor resolves the errors within their version of the dataset(s). For data regulated by the Health Insurance Portability and Act (HIPAA), refer to the applicable HIPAA policies or Director of UB HIPAA Compliance. Data can be submitted at any time. A sample ma… The University at Buffalo is the data owner of all university data. The investigator emails the NDA with the reason for the time extension. Note that these procedures may require an investigator to upload a document into their NDA user account profile and possibly associate these documents with an NDA Collection or NDA Study. Through password protection and other means integrating data submission/extraction Tools, developing phenotypic constructs,.. Purposes and within the terms of this SOP applies to all account requests involve. 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