OnCore Clinical Research Management System Standard Operating Procedures

Transcription

1 Purpose: This standard operating procedure (SOP) provide definitions for terms used in the OnCore clinical research management system at Georgia Regents University (GRU). 2.0 Scope: Applies to all site personnel using OnCore for clinical-trial related activities. 3.0 Definitions: Billing Grid: is a line item list of the study activities and visit schedule which displays the billing designation(s) for each event and/or item. Once entered in the procedures page, the billing designation codes are seen on the Billing Grid page next to the appropriate procedure and visit. Consortium Institutions: In OnCore the consortium institutions by default roll up to the Research Center (GRU), and has the option of using GRU s IRB or their local. Accrual from Consortium Member institutions is considered GRU accrual in OnCore reports and displays, including Research Center accrual on the Data Table 4 report. Staff of a Consortium Member will only have access to protocols and subjects within that Consortium Member institution. More than one institution can be designated as a Consortium Member institution. Coverage Analysis (also known as a Medicare Coverage Analysis or MCA ): Is used to record information about the charges and their billing designations made for a particular protocol. It is a detailed review of clinical research items, services, procedures, and Medicare billing rules to determine the appropriate payer/funding source for each item or service. The use of Medicare billing rules for all payers mitigates the primary compliance risk and provides the most defined standards for clinical research billing. There also is an area to record decisions made about the protocol. Data Safety Monitoring Board: Also known as the Data Safety Monitoring Committee (DSMC): The data and safety monitoring board (DSMB) is an independent group of experts that advise the principal investigator and study team. Members of the board serve in an individual capacity and provide their expertise and recommendations. The DSMB is responsible for patient safety and privacy protection, compliance with required reporting, and study integrity for all trials conducted at GRU. ecrfs: Also known as Forms, ecrf stands for electronic Case Report Form. The ecrf function in OnCore is used primarily in Investigator-initiated trials where there are no sponsor-provided CRFs. Forms can be accessed via the ecrfs/calendars horizontal tab. eprms: OnCore electronic protocol review and monitoring system (eprms) is a paperless committee management system. It is designed to assist the workflow of a Protocol Review and Page 1 of 6

2 Monitoring Committee (PRMC). OnCore protocols are required to have an approved PRMC review prior to opening to accrual. Institution Administration: Institutions are the logical business units of clinical trials, generally the hospitals and clinics that participate in a protocol. An institution may also represent the administrative arm of OnCore (the group of people who work with and manage the OnCore software). An institution is necessary to define study sites, which are the locations where subjects are seen. Study sites may be institutions, clinics, doctor s offices, etc. An institution is necessary to define staff records, which are created to track clinical and non-clinical personnel that are working on trials. Additional institution data includes labs that the institution uses along with lab regulatory information. Institutions are assigned to a type, such as Office of Clinical Trials, Research Center, Study Site, Consortium Member, Affiliates, Network Affiliations, or VA. IT System Administrator: An IT System Administrator is generally an Information Technology employee that assesses and/or coordinates the effort to develop the plan for hardware or operating system changes at the server level. The IT System Administrator ensures that the System Administrator is notified when critical changes to the computer configuration (i.e., hardware, operating system, development and supporting software) occur that may affect the integrity of the application. The IT System Administrator typically has full access rights to the application on the server. Lab Console: Labs are those used by the institution, and lists regulatory details such as CAP and CLIA information. Sponsor central laboratories are not included in this console. Labs and Panels Administration: Each lab and panel has been configured for GRU with associated items (i.e. tests or exams). In the case of labs, lab normal values can be defined for each item. Labs and panels are based on the Hospital s Charge Master. Multi-center Studies: A study involving more than one performance site (non-gru study site) engaged in research with GRU. OnCore Coordinator: The OnCore Administrator functions as the "product manager" for OnCore. The OnCore Administrator is the link between OnCore users, technical support personnel, and policy makers. Frequently the OnCore Coordinator and the OnCore Trainer is the same person. OnCore Financial Coordinator: Person responsible for financial management, which may include feasibility, pre- and post-award activities such as billing, invoicing, and account reconciliation. OnCore Learning Portal: Training videos and documents for the OnCore database. OnCore Protocol Coordinator: Person responsible for entering initial protocol data that includes the protocol definition, management and treatment staff, sponsor, participating institutions, regulatory information, investigational drug and device information, and the protocol s calendar. Page 2 of 6

3 OnCore Specialist: The OnCore Specialist functions as the primary point of contact with investigators and clinical trial coordinators for preparation of study components including study protocol, calendar of events, and Case Report Forms (CRFs) based upon protocol specifications for Investigator-initiated trials. The Specialist analyzes clinical data from the ecrfs and generates tables for use in presentations publications and posters, and prepares customized reports about GRU clinical trials and their accrual for the Principal Investigators. The Specialist also assists with Training. OnCore Trainer: The OnCore trainer assists with super user and end user training during the implementation and supports ongoing training needs. The ongoing training needs range from follow up training with existing staff to regular new employee training. The OnCore trainer participates in the training for both the initial functional area that goes live and for each subsequent area that your organization brings live. Frequently the OnCore Coordinator and the OnCore Trainer is the same person. OnCore User: Anyone who is granted access to the OnCore web-based database system with a User ID and password (includes affiliate sites and personnel). Operating System Server Administrators: The Operating System Server Administrator is a member of the information technology department and is usually charged with installing, supporting, and maintaining servers or other computer systems, and planning for and responding to service outages and other problems. Other duties may include scripting or light programming, project management for systems-related projects. Parameters: Initial step to creating a budget. If the parameters are not filled out, the rest of the budgeting process cannot be done. The parameters involve decisions that help to drive the workflow later in the process. PRMS Chair: The PRMC Chair is typically responsible for reviewing those submissions that do not require Full Review. The Chair requires access to meeting attendee lists, reviewer assignments, reviews, and decisions (except for those protocols where the Chair is listed as protocol staff). PRMS Coordinator: The PRMC Coordinator manages the PRMC meeting agendas, tracks submissions, tracks committee decisions, and manages communications between the investigators and the PRMC. The Coordinator requires access to all PRMC submissions, reviews, and decisions. The Coordinator is responsible for assigning Reviewers to submissions. PRMS Members: The PRMC Members are individuals who have been appointed to the PRMC and whose period of appointment is current. Members require access to view all the submissions on the agenda for a PRMC meeting. Members cannot be assigned to review their own protocols nor can they view the reviewer assignments or notes. Page 3 of 6

4 PRMS Non-Member Reviewers: Reviewers (as opposed to Members) are individuals who may be assigned to review a protocol for the PRMC but who are not currently committee members. Reviewers may access all the submissions on the agenda for a PRMC meeting. Reviewers cannot be assigned to review their own protocols. PRMS Submitter: An Investigator (or staff person acting on their behalf) creates a submission and sends it to the PRMC for review. Protocol Calendar: Defined by a Protocol Specification, the Protocol Calendar is protocol-specific and is populated with milestones (e.g. Consent Date, On Study Date, On Follow-up Date, etc.) which are based upon offsets and used to trigger study visit dates. The Protocol Calendar is accessed via the ecrfs/calendars horizontal tab. Protocol Coordinator: Person responsible for entering data into OnCore. Reference Codes Administration: Reference codes are codes and definitions that are used throughout OnCore, often to define lists of choices when entering data. Some Reference Codes are industry standard, some are defined by Forte, and others are defined by GRU. Reference Codes may be added or modified. Due to the consequences to the system that may be associated with changes to reference codes, adding or modifying reference codes will only take place after consultation with Forte. Sponsor Administration: Sponsors means a person/entity that takes responsibility for and initiates a clinical investigation. The sponsor type in OnCore are Industry, Institutional, Externally Peer Reviewed, National Group, or Other. The sponsor type list can be updated but since it is used for Cancer Center reporting, Forte does not recommend changing it as NCI reports will be impacted. Staff Administration: Staff information includes a staff ID, first and last name, phone number, and address. Credentials (along with expiration dates) will not be maintained by OnCore as the source of record; IRBNet is responsible for this function. Staff records (user accounts) are created for clinical and non-clinical personnel working on studies. Each staff record is associated with the staff member s institution (default). Staff access to protocols are based on organizational unit, department, management group, and/or institution affiliation. OnCore allows a protocol to be reassigned from one staff member to another staff member. Subject Calendar: Follows the guidelines defined in the Protocol Calendar to create a personalized visit schedule with actual dates automatically populated based upon milestones. The Subject Calendar is accessible via the Subject Console. Superuser: Superusers are typically responsible for the actual management of day to day operations. They may be mid-level management staff and other team members who will complete post go-live new employee and other ongoing training. As OnCore implementation team Page 4 of 6

5 members, Super Users may be key contributors to creating the detailed process and other end user documentation. System Administrator(s): A System Administrator is generally one of the primary users of an application. They should be conversant with the application and should play an integral role in the coordination of application changes (e.g. version upgrades, software patch etc.) and conducting change control assessments. The System Administrator typically has full access rights. The OnCore Coordinator, Specialist, and/or Trainer may function as the System Administrator. Organizational Units: The OnCore system contains different levels of system access. Organizational Unit (OU) is the broadest category used to group protocols and staff within OnCore. An OU can be attributed to each protocol, and staff can be assigned to multiple OUs. OU assignment will be based on the Access Request Form, user s department and System Administrator s judgment. Management Groups: Within each OU, management groups are defined. Staff can be assigned to multiple management groups. Management groups are used to limit user access and the scope of reports. Each OU can have several management groups. The user s supervisor will be responsible for assigning the user to a particular management group via the User Access Request Form. Department: A department is a reporting group that engages in research activities that are monitored by the institution. Departments (also known as Funded Departments) are typically used to identify financial reporting areas. Departments are independent of OUs. A department can contain protocols from different OUs and different management groups. Staff can belong to multiple departments. Departments can be used to manage user privileges. In OnCore, the department will be the same as the user s NetID department. Library Assignment: Each workgroup in a research institution can define a library that customizes its clinical research and data management environment. A library is a set of forms, reference codes, protocol annotations, notifications, and sign offs. Libraries support a group s workflow while sharing common data elements across the institution. When a protocol is created in OnCore, a library is assigned to the protocol. Libraries drives which Forms, Protocol Annotations, Notifications and Signoff information that can be used and/or revised. 3.0 References: None. Page 5 of 6

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