The NDA Director, working with NDA staff, will develop a data federation agreement between the prospective data resource and the NDA. NDA notifies requester and all recipients on the DAR with the outcome of the DAC decision. Access to shared NDA data is provisioned at the level of an NDA Permission Group. The user clicks to accept the Terms and Conditions for accessing NDA data. The user is responsible for resolving errors produced in the validation report by correcting the file or contacting NDA to resolve any issues in the Data Dictionary. NDA requires that all submitted data do not contain any information that even resembles PII. Office of the Vice President and Chief Information Officer 517 Capen Hall Buffalo, NY 14260 Phone: 716-645-7979 Email: vpcio@buffalo.edu Website: http://www.buffalo.edu/ubit.html, Information Security Office 201 Computing Center Buffalo, NY 14260 Phone: 716-645-6997 Email: sec-office@buffalo.edu Website: http://security.buffalo.edu, Request UB Learns Administrative Course Site, Request or Renew Secure Server Certificate, New Daily Health Check requirements for spring, UB Minimum Security Standards for Desktops, Laptops, Mobile, and Other Endpoint Devices, UB Minimum Server Security and Hardening Standards, Standards for Protecting Category 2-Private Data, Procedure for Accessing Accounts of Deceased or Incapacitated Individuals, Information Security Incident Response Plan, Avoiding Financial Social Engineering & Cyber-Fraud, Guidelines for Retention of Security Log Data, UBIT Policy: Portable Two-way FM Radio Use, Guidance Document: VPCIO Equipment Management Lifecycle and Disposition Procedure, UBIT Policy: Log Data Access and Retention Policy, Requesting Administrative Access for Your Customers, Guidance Document: Wi-Fi COVID-Proximity Dashboard, Social Security Number Data Access Request, Social Security Number (SSN) Usage Guidelines, Social Security Number Access Request Procedure, University Administrative Information Systems: Access to Information Compliance Form, New York State Information Security Policy. If this happens, the following procedure applies. It provides important information about the project, funding amounts, reported enrollment, data sharing schedule, and results. A request for an NDA user account is the first step in obtaining access privileges in the NDA system. This SO should be listed as having signing authority in the eRA Commons system. The submission web service used by the web browser-based tool is also available to contributors for use with their own applications. Lead recipients should add data recipients to a DAR before the institutional business official has signed the DUC and before the request has been reviewed by the NDA DAC. Vice President and Chief Information Officer (VPCIO). Designated as the president, provost, vice provosts, executive vice presidents, vice presidents, associate vice presidents, and deans who are eligible for access to enterprise-wide aggregate and summary university data. Access will be revoked one year from the DAC approval if a renewal request has not been approved. Once approved, NDA Staff will send an email to the lead investigator with the decision. Violations of this procedure will result in appropriate disciplinary measures in accordance with university policies, applicable collective bargaining agreements, and state and federal laws. The tool provides the user with a report of the validation results. A user with appropriate privilege uploads a document into an NDA Collection or NDA Study. May grant, renew, and revoke access to Data Managers and/or Data Users (as delegated by Data Trustees). Data can be submitted at any time. Access Coordination Data Stewards will designate individuals to coordinate Institute Data access for each functional data grouping. Maintain an library and a … As Data access layer completely decoupled from Application layer we just need to change the Application layer in case of any change in underlying database schema. The NDA system notifies NDA staff that the request is awaiting review. Each DAR requires an NDA Data Use Certification (DUC) signed by the lead recipient and an authorized Signing Official from the recipient’s research institution. The purpose of this SOP is to establish the steps for requesting new or continued access to a subset of shared, Open Access data available in the NIMH Data Archive (NDA). 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. Each NDA Collection contains data with the same subject consents and is associated with one NDA Permission Group. This procedure should only be completed once per grant, contract, project, or once for each NDA Collection. 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. Use data for the purposes in which access is granted. NDA Staff will then generate a report on the location and type(s) of PII found, and an automated notification including this report will be sent to the Contributor. EtQ is Standard Operating Procedures (SOPs) software used in simplifying … 3.0 Applicability This Procedure … NDA maintains a document describing these checks and the issues potentially identified. Full-face videos unless actor or actress. The user must log in to the tool after a successful validation session. Upon request, this document The investigator uploads the PDF file to his/her NDA account or emails the document to. A Standard Operating Procedure (SOP) is a document . This Quality check is a service provided by NDA and validates that data elements and data values within the dataset are consistent with the NDA Data Dictionary. These containers may be shared either to specific individuals through NDA's Ongoing Study capability or broadly with other researchers. These users may submit a new request to maintain access, which will be reviewed by NDA staff. This procedure establishes how NDA identifies potential issues within submitted datasets and notifies contributors. This is someone listed as a Signing Official in the institution's eRA Commons profile. The recipient’s research institution must have an active Federal-Wide Assurance (. This is a RESTful interface for creating a submission package for multiple data files that have successfully passed validation. Final approval of the request to submit to another repository instead of the NDA is contingent upon approval from both the Program Officer and the DAC. The NDA holds biannual submission periods between December 1 and January 15, and between June 1 and July 15 of each year. The actual text of the Act is available online at: Minnesota Office of the Revisor of Statutes website. Standard Operating Procedures Ensure Data Security. After completing SOP-01 and obtaining a valid user account, the user downloads and completes the. Requests from users who are supporting NDA data submission but do not have submission permission to their respective NDA Collection will be marked as pending. This procedure applies to all NDA technical staff, NDA operational staff, and extramural program staff who must have the ability to query and review data within NDA or access NDA-maintained tools to perform their job. NDA extends the approved user’s access to the given Open Access Permission Group. Responsible Office: Information Security Office, Responsible Executive: Vice President and Chief Information Officer (VPCIO). The Data Coordinator will maintain records of authorized Data Users, and serve as contact point for the Data Administrator(s). This procedure applies to NDA contributors or participants in workshops or other projects affiliated with NDA, requiring short-term access to NDA. Separate policies and procedures apply to HIPAA regulated data. DAR renewals should be submitted 60 days prior to access expiration to avoid any lapse in access. Ryan Duguid, Experts Corner, _Experts-Operations, _Experts-Programs. All recipients must agree to the DUC terms and conditions before gaining data access. EtQ. Have supervisory responsibilities for defined elements of institutional data. This resource may only be used in a legal, ethical and responsible manner. According to the Data Classification Risk Policy, Category 1- Restricted Data and Category 2- Private Data are considered non-public data. An email is sent to the user with instructions on using the account or taking further steps to obtain approval. computational pipelines, integrating data submission/extraction tools, developing phenotypic constructs, etc.). The ITSS Data Center is vitally important to the ongoing operations of the University of Minnesota Duluth. Access is granted only to those with a legitimate business need for the … In order to request access to SSNs in UB InfoSource, individuals are required to complete the. Data Access Guidelines are the communication media between the Data Steward and Security Administrators, Data Custodians, Application Sponsors and end users on controls and special security considerations for the individual or grouped data elements in their respective oversights. NDA staff will notify the lead recipient that the data recipients have been added to the existing active DUC. If the lead recipient has changed or if the lead recipient’s research institution affiliation has changed, a new DAR must be submitted. Other recipients cannot be added by editing the downloaded DUC PDF. This level of security is defined by NIST publication 800-18 Guide for Developing Security Plans for Federal Information Systems: "The unauthorized disclosure of information could be expected to have a serious adverse effect on organizational operations, organizational assets, or individuals.". The College provides employees with the information they need to do their jobs. Access is granted only to those with a legitimate business need for the data. The request is sent to the appropriate Data Access Committee (DAC). The user downloads the Data Use Certification (DUC) PDF, which is then signed by 2 parties: (1) The investigator who will be the lead recipient of the data, who is also the user who has initiated the Data Access Request and (2) The NIH-recognized Signing Official (SO) at the investigator's sponsoring institution. The authenticated user initiates a Data Access Request (DAR) for an NDA Open Access Permission Group by selecting to “request access” in the. The following policies and procedures are necessary to ensure the security and reliability of systems residing in the Data Center. Sharing a Collection or Study only makes general information available to others. Administrative access is defined as user account privileges needed to perform tasks associated with administering the system or carrying out oversight prescribed by a project’s funding organization, rather than for research purposes. SCOPE This SOP applies to data management for all clinical studies … NDA staff will forward the request to the DAC and appropriate NIH Program Officer. NDA hosts three types of Permission Groups: This procedure applies to all investigators who submit data, or may be expected to submit data, to NDA. DICOM images), they will add those files to the tool, which will match them to associated records in the data. NDA will revoke that recipient’s access to the permission group on the DUC. Access control is any mechanism to provide access to data. The user names the package. The NIMH Data Archive (NDA) is a protected resource for research data contributed by investigators, funded by the NIH and other organizations. A DAR renewal must be associated with the same lead recipient and research institution. Investigators submitting data to the NDA must certify that all data is de-identified as defined in the NDA Data Submission Agreement. The VPCIO provides leadership for development and delivery of information technology (IT) services to the university. Complete the form by filling in the information required. While NDA reviews all data submitted for PII (see SOP-5), the potential still exists for PII to be found. Information Security and Privacy Advisory Committee (ISPAC). A user, system, or process is considered to have access to data if it has one or more of the following privileges: the ability to read or view the data, update the existing data, create new data, delete data or the ability to make a copy of the data. This procedure applies to all individuals submitting data as described in the Terms and Conditions of the Data Submission Agreement. Prevent unauthorized access to Category 1 Restricted Data and Category 2 Private Data. The matrix can be created at a departmental level, a job description level, or even by individual name. Defined as items of information that are collected, maintained, and utilized by the university for the purpose of carrying out institutional business. The investigator emails the NDA with the reason for the time extension. Warnings: Aspects of the file which may require attention, or do not conform to best practices, but will not affect the submission of the data. The approved receives a confirmation email from NDA. SOP-04B describes the Data Access Request (DAR) procedure for Open Access Permission Groups in NDA. The purpose of this SOP is to outline the steps to request removal of participant data from the NDA. These procedures apply to the NDA generally and all research clusters operated within the NDA infrastructure. A description of data that will be released in the original timeframe. NDA staff will then work with the submitting lab to expunge the data. If the data are associated with NIH-funded research, the NDA Data Access Committee or its representatives will consult with the NIH Program Officer to decide whether to support the request. The user confirms that no Personally Identifiable Information is included in the package. The user creates an Adobe PDF file of the signed agreement. that provides step-by-step instructions on how to complete a specific task properly. The purpose of this SOP is to outline the steps for receiving administrative access to NDA systems. Contact the. The “Data Center” is a restricted area required a much greater level of control than normal non-public spaces. However, to ensure that data remains available to the research community, only repositories that are federated with the NDA, make the data generally available to the research community, and have a Memo of Understanding (MOU) in place with the NDA ensuring such data deposited remain available to the research community in perpetuity, will be considered. Data Access Procedures This page provides an overview of the key stages in the CKB Data Access Procedures and the CKB Data Access System that are used to register individual data requests. NDA staff review the account information provided. These are “Correcting CRFs and source document errors” and “Handling of case report forms (CRFs).”. Users should name their submission packages as specifically as possible. Data Trustees may work directly with Data Stewards, Data Managers, and/or Data Users. Individuals requesting development access to the NDA may send requests to the NDA Help Desk providing a reason for the request and the length of time development access is requested, not to exceed 30 days. Please consult the most recent version of this document for more information. 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. The NDA will then curate the definition and if no changes are needed, publish it in the NDA Data Dictionary. 3. Individual units or departments have stewardship responsibilities for portions of the data. 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. Senior management is authorized to delegate access of enterprise-wide aggregate and summary university data, as deemed appropriate. Over the course of research, circumstances may arise that necessitate a change in the terms. The purpose of this SOP is to define the steps necessary to request, review, and approve data submission privileges in the NDA. The notification includes details on which records and datasets are affected by the identified errors. Comply with the Data Risk Classification Policy and secure Category 1-Restricted Data and Category 2 Private Data. The investigator emails the concern to the. NDA staff will use automated procedures or file-type specific tools to validate that the data can be opened and that the files that which is specified by their extension or in the data structure. BMS Procedures. If a determination is made that the data contains PII and those data have been downloaded from the NDA, the data will immediately be moved to a private state to prevent any further downloads. A Data Access Workflow provides a visual guide to the relevant stages and associated timelines. Resubmission of the data without PII is expected in a timely manner. If the Program Officer believes that it is appropriate for the investigator to submit to another repository, the investigator should provide the following information to the NDA Help Desk: NDA Staff will provide the request to submit and share data through a federated repository and any related information to the NDA Data Access Committee (DAC) for a decision. In order to add new data recipients after a DAR has been approved: The lead recipient on a DUC must notify NDA if a recipient is no longer affiliated with the research institution on the DUC. This includes GUID Tool request initiation, review, approval, verification, and access expiration. This procedure applies to investigators who have submitted data to the NDA. Senior leaders of the university (vice-presidents, vice-provosts, and deans) who have responsibility for areas that have systems of record. The purpose of this SOP is to establish the steps for requesting new or continued access to a subset of shared data available in in the NIMH Data Archive (NDA). NDA will notify the requester that the appropriate permissions are required prior to approval. Standard Operating Procedures (SOP) are insufficient to resolve the situation. Define what people can do with the data when they access it. NDA contributors are responsible for ensuring their data submissions are free of errors. Newly added other recipients will be subject to the original expiration date for that DUC. 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). NDA contributors will correct any errors identified in this NDA QA/ QC process and update their data in a timely manner, as described in the following procedure. Only the investigator and NDA staff will have access to these documents unless indicated otherwise. The user is presented with the NDA Data Use Certification Terms and, which outline expectations for responsible data use. NDA Staff will review newly submitted data to detect any Personally Identifiable Information, focusing primarily on data types that are generally most at-risk for containing direct identifiers. This means that the specific user, or all users who have a given role, will no longer be able to see this SOP in their list of SOPs. This SOP applies to all users submitting and sharing data through NDA. SOP-05A establishes the quality control steps NDA contributors are expected to perform as part of the standard process for submitting and sharing data through NDA. The authenticated user initiates a Data Access Request (DAR) renewal for an NDA Open Access Permission Group to which they are already authorized to access by selecting to “renew access” in the. Data Trustees and their delegates grant and revoke access to Category 1- Restricted Data and Category 2- Private Data (non-public) university data. This will be a CSV file that can be opened and edited in Microsoft Excel. Users with NDA credentials must submit Data Access Requests (DAR) for one NDA Permission Group at a time. The NIMH Data Archive provides an additional Quality Assurance service as part of its ingestion and sharing processes (SOP-05B NDA Quality Assurance and Quality Control). 2.5 Enterprise Operations and Monitoring (EOM): A section of OIT Client Technologies, whose responsibilities include providing a secure, stable physical environment for servers and mainframes. Minnesota Statutes, sections 13.025 and 13.03 require this policy. The responsibility for the activities of data administration, including detailed data definition, is shared among the Data Stewards, Data Managers, and the VPCIO. The act of accessing may mean consuming, entering, or using information. The Standard Operating Procedure (SOP) document management software assists the procedure of implementing new SOPs as well as revisions to SOPs. SOP-15 applies to individuals with access to NDA protected data that may have discovered potential PII in the NDA or one of its federated repositories. Change Control. The decision to share a Collection or Study is based solely upon the discretion of the owner. The DAC reviews data access requests based upon research subject protection and adherence to the data use limitations consented to by the research subjects, and not on scientific merit or availability of data. As per NDA policy, data that have been distributed for approved research use will not be retrieved. The University at Buffalo is the data owner of all university data; individual units or departments have stewardship responsibilities for portions of the data. SOP for Data Integrity Standard operating procedure for data integrity and error free documentation with their tractability to the original data generated by the computer systems. The NIH-recognized business official at the investigator's affiliated institution. Names (Patient, Operator, Physician, Relative, Employer, etc. Decisions to approve access are typically made within 10 business days from receipt of a completed. The DAC and federated data resource approve the data federation agreement. The user enters a progress report that lists any publication, computational pipeline, or other public disclosure of results from the analysis of NDA data accessed during the previous access period. There is a need for robust system which keeps the data in organised manner for Access control. 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 objective of this policy is to ensure the Institution has adequate controls to restrict access to systems and data… NDA Staff send a single notification to the Principal Investigator or other Owner of each affected Collection, and responsible NIH Program and Grants Management staff. No additional review is necessary. Users may not submit Data Access Requests on behalf of other NDA users. Develop and maintain clear and consistent procedures for data access and use in keeping with university policies. NDA will review the updated DUC to ensure that no other changes have been made to the DUC, the two required signatures are present, and the new data recipient(s) are affiliated with the lead recipient’s research institution. An employee will be granted privileges c… This procedure applies to all investigators and data managers who will submit descriptive data, analyzed data, and supporting documentation associated with a research study to an NDA Collection, or a point of contact responsible for acting on behalf of the investigator and/or data manager. GUID Tool access for NDA data submitters expires when a user no longer has submission permissions on an active NDA Collection. NDA Staff validate those files according to the following procedure. The entire procedure typically requires 10 business days. NDA staff are notified that the request is awaiting review. If no PII are identified, NDA will certify that the data does not contain any Personally Identifiable Information. Responsible for planning and policy-level responsibilities for data in their functional areas. For data regulated by the Health Insurance Portability and Act (HIPAA), refer to the applicable HIPAA policies or Director of UB HIPAA Compliance. 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. For any other questions or feedback, please contact the NDA Help Desk. Collaborators at different research institutions may submit a DAR with the same research data use statement, sponsored by their affiliated institution. SOP-04A (Data Access Permission Request – Institutional Sponsorship) describes the Data Access Request (DAR) procedure for Broad Use and Controlled Access Permission Groups in NDA. ISPAC is responsible for evaluating, developing, and recommending information security and privacy policies, procedures, and operations vital to protecting and sustaining the university’s mission. December 31, 2015. Verified requests are approved and NDA staff will notify the user with instructions to access the GUID Tool with their NDA login credentials and to accept the GUID Tool terms of use. Data Centre Standard Operating Procedures Here's a list of the top 10 areas to include in data center's standard operating procedures manuals. The investigator develops a written request to extend the sharing of data associated with a specific NDA Collection or NDA Study which includes the following: The title of the NDA Collection or NDA Study for which the extension is requested. Investigators may create an NDA Collection or Study many months prior to submitting data to them. Prior to the creation of a new structure in the NDA Data Dictionary or the establishment of a federated data resource whereby NDA users can access data in an external database, NDA Staff will review each data field and certify that the fields defined do not appear to include any information that can be reasonably used to identify a research subject or another individual associated with the research. Extensions are not granted for the sole purpose of delaying QA/QC activities. Therefore, the NIH has implemented a multi-tiered quality control procedure for data contributed to NDA. SOP-05A Contributor Quality Assurance and Quality Control describes the procedure for contributors to resolve these issues. All recipients on a Data Access Request/Data Use Certification must be affiliated with the lead recipient’s research institution. The authenticated user initiates a Data Access Request (DAR) renewal for an NDA permission group to which they are already authorized to access by selecting to “renew access” in the. Data access is renewed on an annual basis, or more often as needed. Data federation provides investigators with a single point of access to multiple data sources in addition to the shared data stored in the NDA. Information security incidents must be reported to the ISO. The name will appear in their Collection as the title of the Submission and is also what secondary data users will see when accessing the Collection data. NDA staff review the DUC for completeness. Applies to university data in hard copy and electronic format. Classify university data in accordance with the Data Risk Classification Policy. The user provides a description of the package contents. Broad Use Permission Groups consist of one or multiple NDA Collections that contain data that all have been consented for broad research use. Extracts of data, data feeds, and data within shadow systems, extension systems, extender systems, or other applicable systems that store university data have the same classification level and utilize the same protective measures as the same data in the systems of record. A matrix of database management and administration functions should be developed that documents each support task and who within the organization provides the support. 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. As a Federal Information System, the NDA will follow NIH Security Certification and Accreditation. The successful operation of a DBMS requires the coordinated management efforts of many skilled technicians and business experts. Transmit research data only when you know the recipient's systems are secure. 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