A Standard Operating Procedure (SOP) is a document . Access control is any mechanism to provide access to data. Prevent unauthorized access to Category 1 Restricted Data and Category 2 Private Data. 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 ârenew accessâ in the. The approved receives a confirmation email from NDA. Have supervisory responsibilities for defined elements of institutional data. Duplication of data structures and data elements is to be avoided as much as possible. Complete the form by filling in the information required. After completing SOP-01 and obtaining a valid user account, the user downloads and completes the. This includes GUID Tool request initiation, review, approval, verification, and access expiration. Operational procedures have been established to ensure that the data contained in the NDA are efficiently made available to qualified researchers according to the protections defined for the NDA and other federal policies. The NDA Director is responsible for granting individual access to those administering the NDA. A Data Access Workflow provides a visual guide to the relevant stages and associated timelines. May grant, renew, and revoke access to Data Managers and/or Data Users (as delegated by Data Trustees). 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. To use an existing definition as a starting point for submitting changes or a new structure, download the definition file you wish to change, or one to use as an example, from the structure's definition page. These users may submit a new request to maintain access, which will be reviewed by NDA staff. Investigators may create an NDA Collection or Study many months prior to submitting data to them. Each NDA Collection contains data with the same subject consents and is associated with one NDA Permission Group. Defined as items of information that are collected, maintained, and utilized by the university for the purpose of carrying out institutional business. The purpose of this SOP is to outline the steps for individuals to request access to NDA for software development purposes. The contributor determines which, if any, of the NDA-identified records constitute true data errors. 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 Director may choose to delegate the responsibility of granting access to other NDA staff. The DAC authorizes the data resource (or specific views into that resource) to be available through the NDA as defined by the agreement. The NDA will then curate the definition and if no changes are needed, publish it in the NDA Data Dictionary. 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. 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 purpose of this SOP is to define the steps necessary to request, review, and approve data submission privileges in the NDA. … BMS Procedures. 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. The lead recipient submits via email to the NDA Helpdesk an updated version of the original, active DUC that includes the name and contact information for the new data recipient(s). This SO should be listed as having signing authority in the eRA Commons system. EtQ. An email is sent to the user with instructions on using the account or taking further steps to obtain approval. The purpose of this SOP is to outline the steps necessary to change the data-sharing terms associated with NIH-funded research. Data Access Procedures: Public Data. 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. These containers may be shared either to specific individuals through NDA's Ongoing Study capability or broadly with other researchers. The user identifies a Signing Official (SO) at their research institution who will review and sign the Data Use Certification (DUC) and then agrees to follow the NDA data use terms and conditions. NDA will notify the requester that the appropriate permissions are required prior to approval. Computer systems and devices used to support data must adhere to the specific, protective measures as set forth in the. ), Background and reason for submitting into another repository, Submission and data sharing schedule, if different from the terms of award. 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. If PII are identified, NDA staff will immediately mark the data as containing PII, making it unavailable to all users. Users may not submit Data Access Requests on behalf of other NDA users. Classify university data in accordance with the Data Risk Classification Policy. Decisions to approve access are typically made within 10 business days from receipt of a completed. NIH grant information (title, PI, grant number, etc. The owner of the Collection or Study requests that the document be shared. ISPAC is responsible for evaluating, developing, and recommending information security and privacy policies, procedures, and operations vital to protecting and sustaining the universityâs mission. Ensure that training and awareness of the terms of this procedure are provided. The description will be seen by NDA staff and not by secondary data users. 4.3 Data Processing Data processing mainly involves a sequence of events that begin at the participating research site that is enrolling the patient with the collection of Individual units or departments have stewardship responsibilities for portions of the data. All recipients listed on a DAR must be affiliated with the lead recipientâs research institution. A description of the data requiring the extension. 2. This is someone listed as a Signing Official in the institution's eRA Commons profile. 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. This procedure must be completed after SOP-01 NDA Account Request. Account requests that involve access to shared data or data submission privileges will take longer. Other recipients cannot be added by editing the downloaded DUC PDF. NDA notifies requester and all recipients on the DAR with the outcome of the DAC decision. DICOM images), they will add those files to the tool, which will match them to associated records in the data. The user enters a Research Data Use Statement, the lead recipientâs contact information, and names and contact information for all other recipients who would access and work with the data. 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. Shadow system, extension system, extender system. 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 agreement must be signed by two parties: The Principal Investigator or person responsible for collecting the data. Open Access Permission Groups consist of one or multiple NDA Collections that contain data that have all been consented for broad research use and for which the submitting investigator and their research institution have agreed in their NDA Data Submission Agreement (DSA) that access to qualified individuals is available without the need for Institutional Sponsorship. An email is sent notifying the investigator of these changes. 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. The “Data Center” is a restricted area required a much greater level of control than normal non-public spaces. The user visits the web location of the NDAâs Validation and Upload Tool. 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. The key functions of the SOP Version Management Database are: Management of the SOP document development and revision review procedure. Data Users who misuse data and/or illegally access data are subject to sanctions or penalties in accordance with employee relations policies. Within four months of each biannual submission period, NDA Staff use an automated process to assess each dataset. The Data Coordinator will maintain records of authorized Data Users, and serve as contact point for the Data Administrator(s). The Standard Operating Procedure (SOP) document management software assists the procedure of implementing new SOPs as well as revisions to SOPs. NDA staff are notified that the account is awaiting review. NDA staff will notify the submitting lab that the users downloading the data have been contacted. The NDA is rated at a Security Objective of Confidentiality and a Potential Impact Level of Moderate. 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. All recipients must agree to the DUC terms and conditions before gaining data access. The following procedure should be followed for such cases. Over the course of research, circumstances may arise that necessitate a change in the terms. All other recipients must be added in the NDA DAR software. NDA staff will notify the lead recipient that the data recipients have been added to the existing active DUC. Control university data by granting access, renewing access, and revoking access to Data Stewards, Data Managers, and/or Data Users. Prior to submission of data, contributing users will make use of a tool provided by NDA to validate that the data are consistent with the associated structures in the NDA Data Dictionary. 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. NDA staff will notify the lead recipient and other recipient that the data recipient has been removed from the existing active DUC and access is revoked. An investigator who wishes to use another repository for data sharing should first consult with his/her Program Officer. To change the default access for an SOP, you can select a role or employee and change the dropdown from "Visible" to "Hidden". NDA provisions data to authorized users for secondary analysis and thus masked PII may appear to secondary users as true PII. No additional review is necessary. 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. The agreement will define the specific views of data to be made available and the persons or groups the federated resource has determined to have authority to grant access to those views. The investigator emails the NDA with the reason for the time extension. The contributor resolves the errors within the NDA version of the dataset(s) by re-submitting it or them through the Validation and Upload Tool. The NDA portal performs a virus scan of the document and accepts it. that provides step-by-step instructions on how to complete a specific task properly. NDA Staff compile the results of this assessment into a single report for each Collection. If the user is uploading data with associated files (e.g. 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. NIH Extramural Program Staff automatically have access to research data and supporting information concerning their portfolio through the NDA infrastructure. This includes NDA staff, program staff, an individual at the submitting lab, or a user with permission to access data in the NDA. Controlled Access Permission Groups consist of one or multiple NDA Collections that contain data with the same subject consent-based data use limitations. Administrative access is defined as user account privileges needed to perform tasks associated with administering the system or carrying out oversight prescribed by a projectâs funding organization, rather than for research purposes. 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. Sanctions or penalties are based on the standards outlined in university policy, state or federal regulations, and the appropriate collective bargaining agreements. Access Coordination Data Stewards will designate individuals to coordinate Institute Data access for each functional data grouping. This procedure requires 1-3 business days for accounts. Datatsets that contain information with any of these 19 characteristics will be handled on a case by case basis by NDA staff, investigators, and the appropriate institutional points of contact. An NDA Collection is a virtual container for data and other information related to a project/grant. This procedure applies to all investigators who submit data, or may be expected to submit data, to NDA. The NDA system notifies NDA staff that the request is awaiting review. Access to NDA shared data is valid for one year and will be revoked one year from the DAC approval if a renewal request has not been approved. Where applicable cumulative datasets are compared to previous uploads of the same dataset and datasets are checked for internal consistency. NDA data access privileges are updated accordingly. NDA maintains a document describing these checks and the issues potentially identified. 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. The purpose of this SOP is to outline the steps required to establish a federated resource. Getting all staff access to … A DAR renewal must be associated with the same lead recipient and research institution. Ryan Duguid, Experts Corner, _Experts-Operations, _Experts-Programs. The full Validation and Submission of Data procedure is described in SOP-18 Validation and Submission of Data. As applicable, Data Trustees and/or Data Stewards issue detailed guidelines for their respective data. NDA contributors must correct all errors identified by the Validation Tool prior to submitting a data package. Upon request, this document If this happens, the following procedure applies. Security. NDA staff are notified that the request is awaiting review. Note: When editing an SOP's access "By … In order to remove data recipients after a DAR has been approved: 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). In the event that a research participant withdraws his/her consent, please email the NDA Help Desk with the request referencing this procedure and the GUID(s) associated with the subject(s) requiring removal. The Standard Operating Procedures (SOPs) described below are to be followed by the NIH, their designees, and NDA users. The entire procedure typically requires 10 business days. See SOP-05A Contributor Quality Assurance and Quality Control for a list of identifiers. The scientific rationale for the extension. An SOP may have several distinct parts to help organize and outline all parts of the process. Users should name their submission packages as specifically as possible. Grant read/list access to the user, the Delivery … Only the investigator and NDA staff will have access to these documents unless indicated otherwise. Therefore, the NIH has implemented a multi-tiered quality control procedure for data contributed to NDA. The NDA Validation Web Service used by the browser-based tool is also available to contributors for use with applications of their own. They have a right to see any data held and amend/delete/apply for compensation if any details are not correct, this is called “subject access”. There is a need for robust system which keeps the data in organised manner for Access control. 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. The purpose of this standard operating procedure (SOP) is to provide internet access to the employee to achieve their business goals and objectives and at the same time control the same to avoid the misuse so that it shall not create unnecessary business risk. NDA will revoke that recipientâs access to the permission group on the DUC. The Data Access Committee (DAC) or its representatives and the Program Officer will approve the request or consult with the investigator for clarification/modification. If the Lead Recipient on a DUC changes institutions, they may identify another Recipient on the DUC as a replacement. The Data Coordinator will inform the appropriate Data … A description of data that will be released in the original timeframe. Maintain an library and a … SOP-14 applies to all investigators who have submitted data to the NDA and who have received a request from a previously consented participant to have their data removed from the NDA. The account holder certifies that the information contained in the document contains no identifying information. Enterprise information security strategy, governance, and when control notification from NDA describes! The requester that the appropriate data access Committee ( DAC ) must assert that data! 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