Where applicable cumulative datasets are compared to previous uploads of the same dataset and datasets are checked for internal consistency. As applicable, Data Trustees and/or Data Stewards issue detailed guidelines for their respective data. Define what people can do with the data when they access it. Note: When editing an SOP's access "By … Broad Use Permission Groups consist of one or multiple NDA Collections that contain data that all have been consented for broad research use. This procedure applies to NDA staff and the NDA Data Access Committee (DAC). 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). 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. Access to shared NDA data is provisioned at the level of an NDA Permission Group. Users should name their submission packages as specifically as possible. 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. A user with appropriate privilege uploads a document into an NDA Collection or NDA Study. Vice President and Chief Information Officer (VPCIO). 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. The investigator emails the concern to the. The matrix can be created at a departmental level, a job description level, or even by individual name. 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. Change Control. All recipients listed on a DAR must be affiliated with one research institution. 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. The description will be seen by NDA staff and not by secondary data users. The DAC authorizes the data resource (or specific views into that resource) to be available through the NDA as defined by the agreement. NDA users with active accounts initiate a GUID Tool Access request by emailing the NDA Help Desk from the email account associated with their NDA user account. 2.2.5 Set security for the directory. 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. Federation with a repository is used when the data source wishes to retain greater control over the access of data and not directly submit the data to the NDA.While most data are expected to be submitted directly into the NDA, there may be valid scientific and/or operational reasons for submitting data, either descriptive and/or experimental, into another repository and not the NDA. EtQ is Standard Operating Procedures (SOPs) software used in simplifying … The purpose of this SOP is to establish the technical steps necessary for users contributing data to NDA to validate that their data are compatible with the NIMH Data Archive (NDA) Data Dictionary and to submit validated data to the NDA database. Use data for the purposes in which access is granted. The Director may choose to delegate the responsibility of granting access to other NDA staff. NIH Extramural Program Staff automatically have access to research data and supporting information concerning their portfolio through the NDA infrastructure. 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.". Access, retrieve, update, process, analyze, store, distribute, or in other manners use university data for the legitimate and documented conduct of university business. 2.2. For computer access, a User must first log in to a system, using an appropriate authentication method. This procedure applies to all investigators and data managers submitting data who wish to create a data structure. 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. These containers may be shared either to specific individuals through NDA's Ongoing Study capability or broadly with other researchers. 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. Access controls manage the admittance of users to system and network resources by granting users access only to the specific resources they require to complete their job related duties. The NDA Director is responsible for granting individual access to those administering the NDA. All other recipients must be added in the NDA DAR software. 2.2.4 Create a directory for user’s data under the correct EPA directory. This article explains about executing a single stored procedure or batch of stored procedures from the application layer. The NIMH Data Archive (NDA) is a protected resource for research data contributed by investigators, funded by the NIH and other organizations. Prevent unauthorized access to Category 1 Restricted Data and Category 2 Private Data. Recipients who change institutional affiliation will be removed from an existing active DUC and they must submit a new DUC from their new institution in order to retain access. The investigator uploads the PDF file to his/her NDA account or emails the document to. If this happens, the following procedure applies. Prior to submitting data, contributing users and their institutional business officials will sign an NDA Data Submission Agreement in which they certify that the data do not contain any Personally Identifiable Information. All university data must be classified and protected in accordance with the Risk Classification Policy: The Data Access Procedure does not apply to research data, scholarly work of faculty and students, and intellectual property. As per NDA policy, data that have been distributed for approved research use will not be retrieved. NDA Permission Groups consist of one or multiple NDA Collections that contain data with the same subject consents. If the user is uploading data with associated files (e.g. Access to Social Security Numbers (SSN) in UB InfoSource is highly restricted and granted only to employees with a specific legal or business need that cannot be met in another way. NDA contributors regularly upload supporting documentation for NDA Collections and NDA Studies. 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 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. 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. Have supervisory responsibilities for defined elements of institutional 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. Senior leaders of the university (vice-presidents, vice-provosts, and deans) who have responsibility for areas that have systems of record. Data Centre Standard Operating Procedures Here's a list of the top 10 areas to include in data center's standard operating procedures manuals. 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. The authenticated user uploads the signed DUC to the appropriate “active request” on their NDA Permissions Dashboard, completing the access request process. 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. NDA staff are notified that the request is awaiting review. While NDA reviews all data submitted for PII (see SOP-5), the potential still exists for PII to be found. The purpose of this SOP is to outline the steps necessary to change the data-sharing terms associated with NIH-funded research. The user names the package. The user selects a destination for their submission package from a list of their available Collections or other endpoints. Data Stewards may delegate data administration activities to Data Managers. Minnesota Statutes, sections 13.025 and 13.03 require this policy. 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. A Standard Operating Procedure (SOP) is a document . Administrative access is granted to NDA staff by system administrators on an as-needed basis when authorized by the NDA Director. GUID Tool access expires after one year for users who are not submitting data to NDA. computational pipelines, integrating data submission/extraction tools, developing phenotypic constructs, etc.). Standard Operating Procedures Ensure Data Security. 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 includes NDA staff, program staff, an individual at the submitting lab, or a user with permission to access data in the NDA. NDA adds the user as an approved user to the given Open Access Permission Group. Investigators may create an NDA Collection or Study many months prior to submitting data to them. The authenticated user initiates a Data Access Request (DAR) for an NDA Permission Group by selecting to “request access” in the. Navigate to an account request page on an appropriate website operated by the NDA. This procedure requires 1-3 business days for accounts. The validation results report both errors and warnings for each affected data element and record number within the data files: Errors: Discrepancies between the Data Dictionary structure and the data file that must be resolved before data can be submitted. 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. NDA maintains a document describing these checks and the issues potentially identified. SCOPE This SOP applies to data management for all clinical studies … NDA staff provide the agreement and a summary of the request to the NDA Data Access Committee (DAC) for decision. Upon request, this document The College provides employees with the information they need to do their jobs. NDA staff are notified that the account is awaiting review. 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. 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. The NDA Data Permissions Dashboard lists each of the Permission Groups for all shared data in NDA. The investigator defines the scientific need to deviate from the established terms and conditions. NDA Staff may contact investigators and/or the Program Officer for additional information, if required. If PII are identified, NDA staff will immediately mark the data as containing PII, making it unavailable to all users. 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. This procedure applies to all investigators who submit data, or may be expected to submit data, to NDA. The full Validation and Submission of Data procedure is described in SOP-18 Validation and Submission of Data. Access- Flow of information between a store of data and a user, system, or process. 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. NDA staff will notify the submitting lab that the users downloading the data have been contacted. NDA hosts three types of Permission Groups: Complete the form by filling in the information required. Limit access to personally identifiable information through password protection and other means. It provides important information about the project, funding amounts, reported enrollment, data sharing schedule, and results. 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. Small-scale databases and/or spreadsheets developed for and used by end users, outside the direct control of an organization's official information access, management, and/or security protocols. DICOM images), they will add those files to the tool, which will match them to associated records in the data. This procedure typically requires 5-7 business days. All recipients on a Data Access Request/Data Use Certification must be affiliated with the lead recipient’s research institution. This is defined as access to the NDA to properly implement informatics approaches (e.g. Separate policies and procedures apply to HIPAA regulated data. This procedure should only be completed once per grant, contract, project, or once for each NDA Collection. The decision to share a Collection or Study is based solely upon the discretion of the owner. The NDA Director determines whether or not to grant development access for the time period requested. The user clicks to accept the Terms and Conditions for accessing NDA data. The user is expected to create an NDA Study for these outcomes and to include the NDA Study ID in the progress report (. 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. The NDA will then curate the definition and if no changes are needed, publish it in the NDA Data Dictionary. Data users who access, retrieve, update, process, analyze, store, distribute or in other manners use university data for the legitimate and documented conduct of university business must agree to the guidelines below. 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. Policy Objective 3.1. Each DAR is for one NDA Permission Group. The Standard Operating Procedures (SOPs) described below are to be followed by the NIH, their designees, and NDA users. Data Access Requests (DAR) for Controlled Access Permission Groups should include a Research Data Use Statement that appropriately addresses consent-based data use limitations for that Permission Group. Once the necessary signals and user data has been authenticated in the cloud, a corresponding signal is sent to remotely unlock the door for … The following Standard Operating Procedures (SOPs) were developed collaboratively with the involvement of the directors from all BMS Centers and apply to both internal and external use of data from the BMS Database. Responsible Office: Information Security Office, Responsible Executive: Vice President and Chief Information Officer (VPCIO). 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. Once a set of files has passed validation, the browser-based tool will allow the user to proceed with the creation of a submission package for those validated files. Control university data by granting access, renewing access, and revoking access to Data Stewards, Data Managers, and/or Data Users. 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. After making your desired changes, email the updated spreadsheet and documentation of the changes made to the NDA Help Desk. For data regulated by the Health Insurance Portability and Act (HIPAA), refer to the applicable HIPAA policies or Director of UB HIPAA Compliance. NDA requires that all submitted data do not contain any information that even resembles PII. It is very difficult to keep the manual data of resources and access rights assigned to the employees as per IT SOP for Access control. 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. Develop and maintain clear and consistent procedures for data access and use in keeping with university policies. The purpose of this SOP is to outline the steps for individuals to request access to NDA for software development purposes. The user provides a description of the package contents. Information Security and Privacy Advisory Committee (ISPAC). GUID Tool access for NDA data submitters expires when a user no longer has submission permissions on an active NDA Collection. These procedures apply to the NDA generally and all research clusters operated within the NDA infrastructure. Defines the roles, responsibilities, data management environment, and procedure for granting access to UB’ non-public data. 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. BMS Procedures. The VPCIO oversees an enterprise IT services organization, Computing and Information Technology (CIT), and works in partnership with UB’s schools, colleges and administrative IT units to enable a unified and productive IT experience for students, faculty and staff. 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. Extensions are not granted for the sole purpose of delaying QA/QC activities. Once approved, NDA Staff will send an email to the lead investigator with the decision. The purpose of this SOP is to outline the steps for receiving administrative access to NDA systems. 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. To change the default access for an SOP, you can select a role or employee and change the dropdown from "Visible" to "Hidden". Senior management is authorized to delegate access of enterprise-wide aggregate and summary university data, as deemed appropriate. The NDA contains detailed research data derived from consenting human subjects. Once approved, the investigator makes the appropriate changes to the Data Expected schedule, and NDA staff will update their records on when the specified data will be submitted. Documentation is available here: https://ndar.nih.gov/api/validation/docs/swagger-ui.html. May grant, renew, and revoke access to Data Managers and/or Data Users (as delegated by Data Trustees). This procedure establishes how NDA identifies potential issues within submitted datasets and notifies contributors. All recipients listed on a DAR must be affiliated with the lead recipient’s research institution. This includes GUID Tool request initiation, review, approval, verification, and access expiration. This resource may only be used in a legal, ethical and responsible manner. This procedure must be completed after SOP-01 NDA Account Request. 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. An email is sent to the user with instructions on using the account or taking further steps to obtain approval. These parts may include a title, purpose (what), scope (who), responsibility (why), … 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. NDA contributors must correct all errors identified by the Validation Tool prior to submitting a data package. A description of the data requiring the extension. Reassessing classification levels at least … Data federation provides investigators with a single point of access to multiple data sources in addition to the shared data stored in the NDA. The NDA holds biannual submission periods between December 1 and January 15, and between June 1 and July 15 of each year. Data Trustees may delegate this responsibility to Data Stewards or Data Managers. Other recipients cannot be added by editing the downloaded DUC PDF. The user selects the data files intended for submission. 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. The NDA Director, working with NDA staff, will develop a data federation agreement between the prospective data resource and the NDA. 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. The key functions of the SOP Version Management Database are: Management of the SOP document development and revision review procedure. This procedure applies to all account requests and the users who request them. The NDA system notifies NDA staff that the request is awaiting review. The purpose of this SOP is to outline the steps to request removal of participant data from the 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. No additional review is necessary. This procedure applies to all individuals and their institutions submitting a Data Access Request (DAR) to access shared research data in one of NDA’s Open Access Permission Groups. NDA will revoke that recipient’s access to the permission group on the DUC. 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. Name of the federated repository proposed for data submission where the data will be made available. NDA staff will forward the request to the DAC and appropriate NIH Program Officer. The entire procedure typically requires 10 business days. SOP manual for data access and publication requests This SOP manual for data access and publication requests addresses harmonized procedures for the data access requests and publication of data collected under the protocol entitled: “Collaborative European NeuroTrauma effectiveness Research in TI”, Acronym “ … The user initiates the upload through the tool. The SOP for developing the double data entry system is detailed in SOP-IT-0014 and its testing procedure is described in SOP-DCC-0009. The lead recipient submits via email to the NDA Helpdesk a request to remove a recipient from an active DUC. 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. Therefore, the NIH has implemented a multi-tiered quality control procedure for data contributed to NDA. These requests may be made if there are reasons for which the release of data would be considered premature. A sample ma… NDA staff request DAC approval to pursue data federation with a specific data resource. It unavailable to all users submitting and sharing data through NDA 's ongoing Study capability broadly... Renewal must be signed by the identified errors will not be added by editing the DUC. Information they need to deviate from the NDA DAR software by selecting to “request access” in the NDA for... 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