User Guide For UCSF Clinical Research Coordinators (CRCs) Version 3.0 March 2015 The contents of this document are subject to change. Efforts were made to ensure that the information in this User Guide was complete and accurate at the time of publication. Please check Knowledge Bank to confirm that you have the most current version.
Version 3.0 Authors: Carissa Davis, APeX Research Team Lead Christine Nguyen, Sr. CRC Supervisor, CCRP, Pulmonary Chris Pua, Research Systems Specialist, Translational Informatics Sarahmay Sanchez, LVN, Sr. CRC, CCRP, Division of Cardiology David Scull, APeX Research Application Analyst Emily Verdin, Sr. CRC, CCRP, Radiology and Biomedical Imaging Contributors: Joan Campagna, CRC, CCRP, Electrophysiology Timothy Cyr, APeX Research Billing Analyst Nancy Kang, CRC, Early Phase Hematopoietic Malignancies Laura Lazure, RN, MSN, Hospital Billing Analyst Joan McElroy, RN, MSN, Transplant Coordinator/Research Coordinator Tamara Ryan, RN, Pediatric and Fetal Surgery APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 2 of 53
Table of Contents Glossary of Terms 1. Introduction 1.1 Process for Obtaining Access to APeX 1.2 Remote Access to APeX through the Citrix Application 2. APeX Basic Functions 2.1 Logging into EPIC Hyperspace 2.2 Research Dashboard 2.3 Navigation and Toolbar Personalization 2.4 Changing Login Context 3. Creating a Research Study Account in APeX 3.1 Process for Submitting a New Clinical Trial Study Request 3.2 Modifications to Existing Research Studies 3.3 Study Closeout 3.4 Submitting a ServiceNow Ticket 3.5 Identification of Your Clinical Trial Study Code and Study Name 4. Associating Patients to Research Studies 5. Scanning and Uploading Study Consents, including the HIPAA Authorization 6. Linking Research Encounters and Setting the Research Billing Flag 6.1 Linking Outpatient Encounters 6.2 Linking Inpatient Encounters/Admissions 6.3 Verifying an Encounter that has been Linked to a Study APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 3 of 53
7. Creating Orders and Pending Orders 7.1 Creating and Pending Orders under Existing Outpatient Encounters Research Association Diagnosis Association 7.2 Creating and Pending Orders under Existing Inpatient Encounters Research Association 7.3 Orders Only Encounters for Outpatient Future Orders 7.4 Routing Pended Orders Instructing Providers on How to Sign Pended Orders 7.5 Removing Orders Discontinuing Signed Orders 7.6 Creating your Research Personal Preference List Outpatient Preference List Inpatient Preference List 8. Patient Workqueues (WQs) 9. Reviewing the Charges in the Research Billing Review Report 10. Custom Reports CRC association to research study report REP0044921 All Research Studies for CRCs REP0059458 UCSF ES Appt Search for Research Coordinators 11. Clinical Trial Monitor/Auditor Access to APeX 12. Troubleshooting APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 4 of 53
Glossary of Terms Accession Activity Activity Period Ambulatory Care Ancillary Services APeX ARF CA Cadence CCRC Charge Router Workqueue Chart Review CHR COA Complete/Off Study CPT The process by which a specimen or specimens are logged and associated with a unique identifier. Biological samples submitted to UCSF Clinical Labs are accessioned using the SUNQuest system, which is used for both tracking and billing of lab samples and procedures. Activity describes the main place where users enter and view data in Hyperspace. For example, the Order History activity is used to view information for an order and the Medications activity is used to manage a patient's prescriptions. An activity can consist of a form, a report, or a series of forms. The 2-characters code for sponsored projects indicating what period the money was spent (See COA). Medical care provided on an outpatient basis. Those support services other than room, board, and medical and nursing services that are provided to patients in the course of care. They include such services as laboratory, radiology, pharmacy, and physical therapy services. Advancing Patient-Centered Excellence (APeX) UCSF s electronic medical record, inclusive of all systems that contribute to the permanent medical record. Account Request Form (ARF) a form used to request Medical Center network and application access, such as to APeX. This form must be completed by all CRCs requesting access to APeX and approved by a supervisor before access will be granted. Coverage Analysis (CA) a document representing a systematic review of all items, services, and procedures taking place as part of a clinical trial protocol. The coverage analysis defines how each item listed should be billed (ie. to insurance/patient or to a research study). This step needs to have a final sign-off BEFORE submitting a study build for qualifying clinical trials. The name for APeX s scheduling software, used to schedule and track patient appointments. CTSI Clinical Research Center (CCRC) (See CRS). The method of charge review and resolution (prior to 1/12/15) that displays charges requiring clarification on whether they are research-related or standardof-care. Replaced by Research Billing Review Report REP0045159. Activity where you can review reports about a patient s encounters, labs, imaging orders, procedures, medications and more. Committee on Human Research (CHR) UCSF s Institutional Review Board (IRB). Chart of Accounts (COA) is UCSF s coding structure that defines operations in financial terms. The COA are composed of blocks, called chartfields, create a chartstring to facilitate accounting, reporting and budgeting. On the Study Build they are listed in the following order: Dept ID Fund Function Project Period With respect to APeX means that the patient has completed all clinical activity related to the study AND all outstanding charges have been reviewed. Current Procedural Terminology (CPT) a medical code set used to describe medical, surgical, and diagnostic services. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 5 of 53
CRS CTA CTBSC Dept ID Detailed Review DOS Encounter Epic Exempt Function Fund Fund/DPA GCRC Guarantor HAR HB HC HIMS ICF The CTSI Clinical Research Services (CRS) integrates eight clinical sites across San Francisco and Oakland that provide an array of adult and pediatric services for clinical research. Clinical Trial Agreement (CTA) an agreement between the sponsor and the university to define the scope of work required by the protocol. The CTA includes the study budget. Clinical Trials Business Support Center (CTBSC) was established to strengthen and standardize compliance documentation in the areas of budgeting and medical service billing for clinical trials. The CTBSC helps Principal Investigators establish trials in OnCore, open/modify Medical Center APeX billing accounts, and properly document medical billing plans. clinicaltrials@ucsf.edu The 6-character cost center or unit responsible for the transaction (See COA). All ambulatory/ outpatient ancillary charges are held for review via Charge Review Report. This removes the requirement to review charges within 7 days, however all charges, including non-research related charges, must be reviewed for all patients as soon as possible. During the billing review activity refer to proxy documents such as the CA, ICF or CTA as applicable. Date of Service (DOS) The date the patient was seen by a health care practitioner or given medical treatment. A clinical contact with a patient. For example, an office visit, an admission, or a telephone call. In billing applications, charges or other transactions can be associated with encounters. The software company that supplies the electronic medical record system to UCSF. A study does not have charges billable to the research study. Sign-off is required from Compliance in order for a study to have except status. The 2-character code that indicates the function of the transaction (See COA). The 4-character code indicating the source of the money (See COA). UCSF s former coding structure that defined operations in financial terms. Now referred to as the chartstring (see COA). General Clinical Research Center (GCRC) (see CRS). Guarantor, with respect the research study build, refers to the department contact responsible for review of all study-related charges incurred by a patient. Also known as the Billing Contact on the research study build. Hospital Account Record, used to group charges for billing purposes. Each HAR is associated with one or more patient visits in APeX. A HAR is also created for each month of an active research study. Hospital Billing (HB) charges for procedures or supplies. Hospital Charge (HC) technical fee associated with a medical procedure or service. Health Information Management Services (HIMS) UCSF s health information and medical record department. The Informed Consent Form (ICF) is a document that contains all the important information about the study that must be communicated to potential and enrolled participants. The ICF is reviewed and approved by the CHR before it can be given to a participant. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 6 of 53
In Basket Inpatient iris KB LMS MyChart OnCore Outpatient Patient Header Patient WQ PB PCRC PFS PI PR Preference List Project Qualifying Trial Research Electronic messaging system used within APeX. A patient that stays in the hospital while receiving treatment and/or other medical services. iris is the online submission and review system for research studies utilized by the Committee on Human Research (CHR). The Knowledge Bank (KB) contains APeX resources such as Tip Sheets, recorded meetings and more. KB can be accessed from the Research Dashboard or http://myapex.ucsf.edu/index.htm over a VPN connection. Learning Management System (LMS) a software application for administration, documentation, tracking, reporting and delivery of e-learning education courses or training programs. UCSF s LMS is hosted by the UC Learning Center. APeX application that allows patients to view portions of their medical records and interact with their physicians over the Internet. At this time, CRCs are not able to communicate to patients through MyChart. The Online Collaborative Research Environment (OnCore) is a comprehensive clinical trial management system (CTMS) in use at UCSF. It is the system of record for formal coverage analysis of clinical trials. Administered by the Translational Informatics team. oncore@ucsf.edu A patient that receives medical services without being admitted to the hospital. Top of the patient chart that allows you to quickly see some basic patient information, such as age, date of birth, known allergies, etc. When a patient is enrolled in a research study, Research: Active should appear highlighted in pink in the patient header. Each department has three research Patient Workqueues (WQs) where CRCs can identify patient encounters that may need to be linked to a research study or have the research billing flag set. See Section 8 for more information. The UCSF ES Appt Search For Research Coordinators is an alternative to the Patient WQ. See Section 10 for more information. Professional Billing (PB) professional fees associated with a medical service or procedure. Pediatric Clinical Research Center (PCRC) (See CRS). Patient Financial Services (PFS) provides assistance with hospital charges and billing inquiries. For research billing inquiries contact: 415-353-3716 or 415-353-3750. Principal Investigator (PI) The person who is responsible for the oversight of a clinical research study and ensuring that study conduct is in compliance with applicable regulations, such as, but not limited to: the Code of Federal Regulations, State and local regulations, Good Clinical Practices. Professional Charge (PR) associated with a CPT code. A personalized set of frequently used orders that can be specified at the facility, department, or user level. The 7-character code that indicates which activity the transaction is tracking (See COA). A qualifying clinical trial requires that a coverage analysis is complete and has final sign-off before any participants are enrolled. This includes any clinical research studies that have billable medical procedures or services. The APeX homepage for a CRC. The Dashboard includes 4 sections (Favorite APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 7 of 53
Dashboard Research Flag Research SVC RSH Service Ticket Smart Phrase Snapshot SOC Some/Some Standard Review Study Build Study Code Study Name SUNQuest TI Toolbar VPN WQ Reports, In Basket Glance, Quick Launch to Research Activities, Research Links) as well as access to the Toolbar. A setting within APeX that assists in the appropriate routing of research-related charges, either to the research study or the guarantor. The guarantor is the patient, or patient s insurance, responsible for providing payment for services. CRCs are responsible for setting the research flag, where appropriate. Research Service Context, the APeX log in context/department assigned to study a coordinator that provides all the functionality necessary to carry out research related tasks in APeX. An abbreviation for Research used in APeX headers. A submission through the UCSF Service Now portal through which users can submit IT-related problems and track their resolution. A SmartTool that allows you to store commonly used text for comments. Displays a quick view of various patient data, such as the Problem List, medications, allergies and comments. Standard-of-care (SOC) procedures that are performed as routine clinical care and defined by clinical standards. Many clinical trial protocols will include SOC procedures. CRCs should take care to note whether SOC procedures (as defined in the coverage analysis document) are to be billed to research or to the patient/insurance. A billing designation meaning some charges for an encounter will be billed to a study, and some charges will be billed to the patient or their insurance. Seven day charge router hold for unlinked encounters that are research-related. After seven days the charge will automatically be billed to insurance or the patient if the encounter remains unmarked. Charge review done after the seven days window will not impact anything that has already been charged within the window. Encounters marked Some/Some will require review, referencing proxy documents such as the CA, ICF or CTA as applicable during the billing review activity. The actions performed by the APeX Research team to configure a research study in APeX. This build includes such things as creating a ZZ study account containing pertinent study information. The CHR number (two-digit year followed by 5 digits). The study code is one way to identify research studies in APeX. The name of the research study in APeX starting with ZZ (Example, ZZABC, STUDY) determined by the study team when completing a new Clinical Trials Request Form. The study name is another way in addition to the study code, to identify research studies in APeX. The accessioning and billing system used by UCSF Clinical Labs. Translational Informatics (TI) OnCore CTMS administrators. The row of buttons at the top of the APeX home screen including the Epic button. Virtual Private Network (VPN) provides remote users access to the organization s secure network through a public interface, such as the Internet. Workqueue (WQ) a generic term for a work list in APeX. Common WQs relevant to the CRCs primary tasks include patient WQs. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 8 of 53
1. Introduction APeX (Advanced Patient-Centered Excellence) is UCSF s Electronic Medical Record (EMR) supported by EPIC software. The goal of this User Guide for Clinical Research Coordinators (CRCs) is to outline the functionalities that a CRC will utilize for managing clinical research activities in APeX. Sections can be referenced independent of each other as CRC workflow varies. Clinical Research Coordinator activities and workflow within APeX can be summarized into seven key responsibilities: 1) Creating a Research Study Account in APeX (Section 3) 2) Associating Patients to Research Studies (Section 4) 3) Scanning and Uploading Study Consents Documents (Section 5) 4) Linking an Encounter to a Research Study (Section 6) 5) Setting the Research Billing Flag (Section 6) & Flag Status Verification via either: Patient Workqueques (Section 8) UCSF ES Appt Search for Research Coordinators (Section 10) 6) Creating Orders for Patients in a Research Study (Section 7) 7) Resolving Charges in the Research Billing Review Report (Section 9) 1.1 Process for Obtaining Access to APeX There are two main steps required for obtaining access to APeX as a CRC: 1) Complete the UC Learning Center (Learning Management Services) courses outlined within the Clinical Research Coordinator APeX Training Plan. These essential courses can be found on the UC Learning Center at: https://learningcenter.ucsfmedicalcenter.org/ Login with your UCSF ID Select from the Featured Courses section All other staff Function: Non Clinical Staff Clinical Research Coordinator CRC APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 9 of 53
For Learning Center support please refer to Learning Center Help. Alternatively, you can access the Learning Center through the Carelinks Portal. Additional instructions here: Learning Management System CRC Courses. NOTE: Failure to complete these courses will preclude access privileges to APeX. 2) Once you have completed your training, request access to the application using the Account Request Form (ARF). A link to the ARF and instructions for completing the ARF can be found on the APeX Knowledge Bank: CRC CRC Resources Tip Sheets/User Guides Creating an ARF for new Research Coordinators After submitting the ARF, you will be contacted by Identity and Access Management Team with your User ID and temporary password. NOTE: Accessing APeX for the first time must be done on a Medical Center Computer. You will be prompted to change the temporary password. 1.2 Remote Access to APeX through the Citrix Application It is important to access confidential patient information on a secure connection. When using computers and internet connections outside of the UCSF Medical Center Intranet domain, you can connect to VPN and log into APeX through the Citrix Access Gateway. Campus employees may access APeX through Citrix but do not have to establish a VPN connection when operating on a secure UCSF network. For information on how to VPN refer to IT Services. Alternatively, you can also utilize the Citrix Receiver which is client software that provides access to your XenDesktop and XenApp installations The first time you connect remotely to APeX, you will be required to install the Citrix XenApp plugin. Once installed, you will be asked to log in using your Active Directory account. If necessary, contact the IT Service Desk for software support. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 10 of 53
You can now launch EPIC Hyperspace by clicking the APeX icon. 2. APeX Basic Functions 2.1 Logging into EPIC Hyperspace In order to log into APeX you will need a User ID, password, and department. Your User ID is the Medical Center Active Directory User ID Your Password will be one that you establish after logging in the first time. For those who work in multiple departments choose your login context by clicking on the magnifying glass. For many CRCs, selecting the RESEARCH SVC department will provide the functionality necessary to carry out all research related activities. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 11 of 53
2.2 Research Dashboard The Research Dashboard is the home screen for the CRC in APeX that displays links to many commonly used resources and functions performed in APeX. 1) Favorite Reports Links to the Report Library. Custom reports saved as a favorite (Section 10) will be displayed in this area. 2) Quick Launch: Patient Research Studies Research study enrollment information Study Administration Records Quick views of research study build information 3) In Basket Glance Messages received via MyChart, or CC d by another user, plus quick view of open encounters and unsigned orders. 4) Research Links to the APeX Knowledge Bank, Research HUB, MyAccess, ClinicalTrials.gov, etc. 2.3 Navigation and Toolbar Personalization To access Activities click on and select the desired menu. For example, to access the patient chart: EPIC Patient Care Chart These pathways will be in blue throughout this document. Shortcuts to commonly used activities can be added under the EPIC button by clicking on the star under the recent activities. In Addition, commonly used activities that are not already on the Toolbar can be added by clicking on the wrench to personalize your Toolbar. Or EPIC Personalize Menu Personalization If you click on the wrench with the Research Dashboard open, this will show the Personalization Activity screen for Toolbar options. If you receive an error message, please open a ServiceNow ticket. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 12 of 53
Personalization Activity Select the desired activity from the menu options on the left side and drag the bar to the right side. This will place the button on your Toolbar. The green check mark indicates that the activity is on the Toolbar. To reorganize your Toolbar, drag and drop the items under My Toolbar to the desired location. You may remove activities by clicking on the black Navigating the Patient Chart: Activity tabs within the patient chart are directly associated to more specific information about the research participant and are located along the left side of the patient record. For example: Snapshot can provide quick information about the patient s allergies, medications, and history. Chart Review activity tab will provide you a view into the different ancillary services for the study participant. Care Everywhere contains medical records from external facilities Demographics activity tab will provide you with the patient s address information If you click on the wrench with a chart open, this will show the Personalization Activity screen for workspace. 2.4 Changing Login Context Users that work in two or more departments at UCSF may need to switch their APeX login department. This can be done when you first sign on to APeX (Section 2.1) or when you are already logged into APeX by selecting: EPIC Change Context APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 13 of 53
Changing Login Context The Provider field can be left blank. Select the magnifying glass to search for the alternative department. You may also enter the first few letters of the department into the field to narrow your results. NOTE: Complete your work in the department you are in before changing login context. This will ensure the information you ve entered is saved in the system correct department context. 3. Creating a Research Study Account in APeX Before any study-related activity can occur in APeX, a research study build, also known as a ZZ account, must first be created and configured by the APeX Team. For qualifying trials, the OnCore Coverage Analysis must have final sign-off. This indicates that the informed consent, contract and protocol have been reviewed and harmonized. For more information on opening a trial with the Clinical Trials Business Support Center (CTBSC) please refer to current instructions on the ITA Webpage or email clinicaltrials@ucsf.edu. NOTE: Exceptions to this process are Cardiology and Cancer studies. These exception study build requests may be submitted directly to APeX Research by the designee. The study build is a record of the following information: 1) General Information: The Study Name, Study Code (CHR number), Chart of Accounts (COA), National Clinical Trial Information, and Study Description NOTE: The IRB approval field contains the chartstring, or COA, in the following order: Dept ID Fund Function Project Activity Period 2) Guarantor Contact: The billing contact within the department designated to review monthly research statements 3) Users and Providers: This section identifies the staff permitted to enter research orders for the respective study. Staff members that are listed in the CHR application, and OnCore should be harmonized. Once the study is configured, you can view your study build in APeX by selecting the Study Administration Records link on the dashboard, or select from the Toolbar. To identify your study use the ZZ name or CHR number (3.5). APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 14 of 53
The following screen will open: 3.1 Process for Submitting a New Clinical Trial Study Request The APeX Knowledge Bank contains the current Clinical Trial Study Request Form, or Study Build, as well as additional helpful aids in ensuring the content of the form is correctly gathered and documented. Prior to submitting the Study Build request the following must be complete: CA sign-off, CTA/Budget finalized, and CHR approval must be obtained. For the most current form and general instructions: To complete an APeX Clinical Trials Study Request Form go to Knowledge Bank CRC CRC Resources Forms: New Clinical Trials Study Request Form COA NOTE: You must save the most current.pdf form to your hard drive and complete the fields using Adobe Acrobat or the information will not save on the form. Depending on the complexity of your study and department resources, the study build process may take some time. Plan your study requests accordingly. 3.2 Modifications to Existing Research Studies The Clinical Trial Study Request Form must be used to submit modifications to existing studies in APeX. Answer only the questions on the.pdf Clinical Trials Study Request Form that pertain to the modification being requested. Maintenance requests that do not require changes to the procedures section can be submitted directly to the APeX team via Service Now: 1) Change of Chart of Accounts (COA) 2) Change of Study Description 3) Change of personnel on the study (CRC, Providers, Nurses, Research Contact, APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 15 of 53
Billing Contact) NOTE: Study changes that affect coverage analysis must be processed through your coverage analyst prior to submitting an APeX study build maintenance request. Utilize the same resources listed in Section 3. 3.3 Study Closeout When a research study has been closed out in iris and all research-related charges have been cleared, you must submit a ticket indicating that the study is now complete. This will alert Patient Financial Services that charges to the study are no longer accepted, preventing any erroneous charges to the study. 3.4 Submitting a ServiceNow Ticket After completing the Clinical Trials Study Request Form, submit a ServiceNow Ticket: 1) Go to ServiceNow 2) Select APeX Support 3) Select Incident 4) For Type of Help select APEX/Clinical Application 5) Description of Request: New Study Build Request or Research Study Maintenance Request or Study Closeout Request 6) Attach the complete.pdf to the ticket (for new or maintenance requests). 7) Submit the form and you will receive and email confirmation with the ticket number. 3.5 Identification of Your Clinical Trial Study Code and Study Name The Study Code, or CHR Study Number, is always used as the key identifier for your research study in APeX. It is in the format of a two-digit year and a five-digit numeric ID (ie. 12-12345). The APeX application also stores the name of the study, which at UCSF begins with the letters ZZ (ie. ZZABN, STUDY). You can search for a research study by either the Study Code or Study Name. NOTE: Since some study names are longer in nature, you can search by using the first few letters of your ZZ study name and select from a filtered list that will appear.however, always confirm you are choosing the correct study by verifying the study code is the correct CHR# for your study. 4. Associating Patients to Research Studies A study participant must be associated with the research study once they have signed consent. This process must be completed before any other research activity takes place in APeX (ie. placing research orders). When patients are linked to a research study, they are identified in the financial system that allows for a detailed review of APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 16 of 53
claims. On the Research Dashboard Select Quick Launch: Patient Research Studies, alternatively, select from from the Toolbar. In Patient Lookup window under the Select Patient tab, enter the name or MRN of the patient that you want to enroll in the study and Find Patient. This will then open another window and list any research studies the participant is, or has enrolled in. Type in the name of your research study (either by ZZ study name or CHR study code) and click Add A dialog box will open, displaying the study name you just entered: 1) Select the coordinator(s) who are working on the study, or the primary/ lead coordinator if there are multiple CRCs. 2) Enter active start and stop dates: this will allow charges outside the dates of enrollment to be excluded from the review process, decreasing CRC workload. a. Active start date: The date the participant signs the informed consent b. Active end date: The participant has completed all study procedures/interventions and any study follow-up period. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 17 of 53
3) Enter the correct value in the Status field, and update the status as needed. Click on the magnifying glass to open the categories that are valid for this field. There are the only four options that will link the patient to the study for billing purposes: a. Enrolled/On Study b. Consented/Screening c. In Follow Up Data Only/Non-Billable d. In Follow Up Billable NOTE: Never set status to Complete/Off Study until all research related charges have been resolved (Section 9). 4) Enter the point of contact (name and number) for study related questions in the Comments field. This will allow the patient care team to easily identify the first point of contact for study related questions. This field can also be used to communicate additional details about the study that other APeX users may need to know when caring for the study participant. 5) Click Accept. To confirm that the patient was enrolled properly, refresh the chart and a pink Research: Active button should appear in the top banner. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 18 of 53
5. Scanning and Uploading Study Consents Documents Signed study consent forms and HIPAA Research Authorization forms should be scanned or imported into APeX. These two documents are the only research-specific documents that should be added to the Scan Clin Doc tab of a patient s electronic chart. Outside documents affiliated with research, and used for the patient s clinical care, may be scanned into the Scanned Outside Documents tab. This applies to results that impact how the patient will be treated in a clinical setting. These are usually validated procedures (ie., non-investigational laboratory, cardiology or radiology procedures), completed at an outside hospital or institution (ie., Kaiser), or centralized procedure services provided by the Sponsor). How to Scan Documents (directly connected to a scanner): 1) Epic Patient Care Media Manager and select your patient. Alternatively, can be selected from the Toolbar, if this has been added to your Toolbar using Menu Personalization (Section 2.3). Media Manager will open and display any documents that have previously been scanned to the patient s chart. 2) Research Consents should be scanned into APeX at the Encounter level. Click the down arrow next to Patient and select Choose an Encounter. An Encounter Selection window appears where you may choose the pertinent encounter. 3) Click on to initiate the scan process. 4) Complete the information in the Document Data section. The Description should clearly indicate that it is a research study document and the Doc type should be Consent Research. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 19 of 53
5) Select the Show additional data fields button. Complete the data fields in the Additional Data section, if applicable, as they pertain to your study. 6) Select How to Import Documents (from a network drive): 1) As with scanning a document, in select the encounter 2) Select and select the document 3) Complete the Document Information and click Accept NOTE: You must be using the UCSF intranet or establish a VPN connection in order to import files. By default you will be able to import files from your Medical Center network drive. For additional information please see the KB Tip Sheet. 6. Linking Research Encounters and Setting the Research Billing Flag An encounter in APeX is any clinical contact with a patient. For example: an office visit, admission, or a telephone call. All charges or transactions in APeX should be associated with an encounter. To prevent billing errors, a study participant s researchrelated encounter must be linked to the correct research study. The research billing flag within an encounter indicates how billing will occur. The billing flag will identify whether any associated charges are to be routed only to a research study, only to a patient s insurance, or to a mix of both a research account and the patient s insurance (Some-Some). APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 20 of 53
NOTE: If your study is in STANDARD REVIEW the research billing flag must be set for all research encounters within seven days from the DOS otherwise charges will be billed to the patient account automatically. If your study is in DETAILED REVIEW, it is best practice to complete the research billing flag within seven days from DOS, but all charges will be held for review regardless of billing flag. Setting the research billing flag is a crucial step to ensure all charges are routed appropriately and only the mixed encounters become available for the billing review process. See Section 9 for instructions on the billing review report. 6.1 Linking Outpatient Encounters In addition to decreasing billing errors, when an encounter is linked to research the medical records department will have a visual indicator that research documentation may exist in the chart. This indicates that documentation may not be permissible for release when handling request for patient information. To link a participant s outpatient encounter to a research study open the Appointment Desk: 1) EPIC Scheduling Appts Select Patient can also be selected from the Toolbar. The Appointment Desk displays future and past outpatient encounters, as well as inpatient admissions and surgeries/procedures. 2) Select a scheduled appointment in the Future tab. In some cases the encounter that must be linked to the study will appear in the Past tab. Future: Right click on the selected encounter and select Reg Appointment Contact from the list. This will open the Registration window for the patient s visit. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 21 of 53
In the Registration window, click on Encounter Info, which will open the form showing the patient s active research studies and the research billing flag. Past: For past encounters you will be able to follow the same steps as future encounters. In some cases after you right-click on the encounter you will have to either select Registration or Appointment Options Reg Appointment Contact. 3) Select the desired research study by checking the box next to the correct ZZ Study Name. 4) Select the Research Billing Flag; refer to the CA, or other proxy documents such as the ICF or CTA, which will help to route charges to the correct account. There are four options for the Research Flag: NOTE: Do NOT put any values in the Transplant status nor Corporate Flag If you DO NOT select a research study when a patient is actively enrolled, you will receive the following warning message. Confirm that the encounter was linked correctly. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 22 of 53
6.2 Linking Inpatient Encounters/Admissions To link a participant s inpatient encounter to a research study open the Appointment Desk: 1) EPIC Scheduling Appts Select Patient can also be selected from the Toolbar. The Appointment Desk displays future and past outpatient encounters, as well as surgeries/procedures. 2) Select the Admissions tab. 3) Right-click on the highlighted encounter and select Registration from the list. This will open the Registration window for the patient s visit. 4) Select the research study and billing flag using the same process in Section 6.1 NOTE: If you receive an error for Missing Referral Provider enter a value in the Referral source in the Provider Info screen. If the referring provider is unknown you can enter Provider, None 6.3 Verifying an Encounter has been Linked to a Study For both inpatient and outpatient encounters, once you select and link the Research Study to this appointment, a beaker icon will appear on the Appointment Desk. When a study participant s status is changed to Complete/Off Study, the icon will disappear from any future appointments linked to the research study. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 23 of 53
7. Creating Orders and Pending Orders Before entering research orders in APeX, the following are necessary: The patient must be associated to the research study An encounter must exist, which will allow research orders to be associated to the study and an appropriate research flag set according to the coverage analysis for qualifying trials. If the CRC is unable to find an appropriate encounter for a study participant such as a scheduled visit or future appointment within which to place research related orders, the CRC can create an Orders Only encounter (7.3). NOTE: Workflows for Creating Orders will differ from an inpatient and outpatient setting. Orders for outpatient encounters through the CRS are the same as the workflow for inpatient orders. Once an encounter has been linked to a study, the CRC may use that encounter to place orders in APeX. The CRC should make every effort to use an existing encounter to pend research related orders. 7.1 Creating and Pending Orders under Existing Outpatient Encounters For outpatient research orders, open the existing encounter. 1) EPIC Patient Care Encounter Select Patient will open. Select the desired encounter and click Accept. can also be selected from the Toolbar. The Encounter Selection window 2) The Visit Navigator will open. Select Order Entry. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 24 of 53
3) The Order Entry activity will be displayed. In the New order box search your order name or procedure code. In some cases you may have to do a Database Lookup. NOTE: Always refer to your coverage analysis to choose the correct code for your research order. 4) Select the desired order. If additional orders are required click Select & Stay otherwise click Accept. There are checkboxes that can be used to filter your search results. In particular, it is important to distinguish between a During visit order and an After visit order. Each type of order has distinct order details that only make sense if the order is completed during the visit or after the visit. Select the correct type of order by ensuring the icon (bed or house) to the left of the order reflects the type needed. NOTE: For outpatient orders, only select After visit orders with the house icon. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 25 of 53
An After visit order will create a future order, which is the correct type to order when placing outpatient orders or using an Orders Only encounter to create orders. From the Order Entry window click on the order name to view additional order details Here you can: Enter the expected date (the date the encounter is scheduled); selecting Approx will provide a buffer in the event the patient visit must be rescheduled. Select Routine or STAT Enter contact information for any questions the lab may have Add a note in the Comments (F6) field to add clarification or extra information the scheduler, lab, technologist, etc. may need to know. For example: Please contact XXX at ###-#### for any questions related to this order. For urgent values, please page XXX at ###-####. For imaging orders: Merck Migraine Imaging Protocol# ABC-123. Please contact XXX at ###-#### for any questions or urgent matters related to this order. Click Accept to save changes and exit this window. 5) From the Order Entry activity click on Research Association. All research orders billed to a ZZ study account MUST be associated with the correct research study. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 26 of 53
A research association grid will open, allowing you to associate the order with the research study. Check the box under the correct study and select Accept. The beaker icon will appear next to the order confirming that the order has been associated to a research study. 6) Associate a diagnosis to the order by entering either the ICD code, or diagnosis name in the Add Diagnosis box. In general the diagnosis code v70.7 Examination of participant in clinical trial can be used. A diagnosis association grid will open, allowing you to associate the order to the v70.7 diagnosis. Check the box under the correct diagnosis and select Accept. If you have multiple orders, you may select the Associate All button. The two linked circles will appear next to the order confirming that the order has been associated to a diagnosis. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 27 of 53
7) Once all orders have been selected, associated to the research study, and linked to a diagnosis you can Pend Orders. NOTE: You will not receive a confirmation in the Order Entry activity. You can confirm the orders are pended by returning to the Visit Navigator. You are now ready to route the Pending Orders for an authorized provider to review and apply a signature (7.4). 7.2 Creating and Pending Orders under Existing Inpatient Encounters For inpatient research orders, open the existing encounter. 1) EPIC Patient Care Patient Station Select Patient can also be selected from the Toolbar, if this has been added to your Toolbar using Menu Personalization (Section 2.3). 2) Highlight the Admission encounter and select Open Chart APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 28 of 53
3) Open the Research Navigator and select Manage Orders. 4) The Manage Orders activity will be displayed. In the Place new order box search your order name or procedure code. 5) Select the desired order. If additional orders are required click Select & Stay otherwise click Accept. If applicable, click on the order to edit inpatient specific details. This will open the following display for labs: APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 29 of 53
You can specify whether the priority of the order is Routine, STAT (expedite lab results), or Timed (time point specific). Once indicates a general one time occurrence lab order In AM (Lab) indicates that the labs should be drawn in the morning Add-on to existing sample OR Redraw if QNS (Quantity Not Sufficient) indicates that the priority will be to run lab as add-on lab, but in the case sample quantity/quality is insufficient, the lab ordered will be drawn again separately. Add-on ONLY to sample in Lab indicates labs ordered will only be processed from existing same day sample. If sample quantity/quality is insufficient, lab will not be processed. NOTE: For orders entered greater than 48 hours before the encounter, confirm that the order has not been cancelled prior to the visit. 6) From the Manage Orders activity, click on the Options button and select Research Association. All research orders billed to a ZZ study account MUST be associated with the correct research study. A research association grid will open, allowing you to associate the order with the research study. Check the box under the correct study and select Accept. The beaker icon will appear next to the order confirming that the order has been associated to a research study. Once all orders have been selected, click on the Save Work button and confirm that the orders are ready for others to view by selecting Save Work again in the pop-up window. Saving your work is equivalent to the Pend Orders step for outpatient orders. This will allow a provider to view the order for signoff. If you are not quite ready for a provider to sign and there might be more information APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 30 of 53
you need to include in this order, choose Not Ready. This allows you to save the order just for your viewing. You are now ready to route the pending order(s) for an authorized provider to review and apply a signature (7.4). Once they are signed the order will be routed to the appropriate service to be scheduled/ performed. NOTE: Diagnosis association is automatically indicated on the labs in accordance with the hospital admission encounter. However, if any of the orders are going to be billed to insurance and the encounter does not include a diagnosis that would justify the order, then a diagnosis should be entered. 7) To remove orders click on the from the Orders Management window. 7.3 Orders Only Encounters for Outpatient Future Orders The use of Orders Only encounters should be minimized to prevent potential duplication of effort. It should only be used by a CRC for creating future outpatient orders without an appropriate encounter already available. Orders Only encounters have certain unique characteristics: They do not generate a visit charge. They are independent of the provider s APeX schedule. They are the only type of encounter that a CRC should create in APeX unless they have received specific additional training. NOTE: Do NOT create Orders Only encounter for patients that will be admitted. The existing pre-admission encounter should be used. If the admission encounter has not yet been created in APeX, wait for admitting personnel to create it. 1) EPIC Patient Care Encounter Select Patient can also be selected from the Toolbar. The Encounter Selection window will open. 2) Select New only if there is not an existing appropriate encounter available. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 31 of 53
3) Click on the magnifying glass next to the Type field. 4) Select Orders Only and click Accept. 5) Enter the name of your PI or authorizing Provider and your Department and click Accept. NOTE: The provider may not be able to view the pended orders in his/her CC d charts if this field does not correspond with his/her department. Try entering the order under the same login context (Section 2.4), or department, to which the provider will log in when signing the pended order. 6) From the Visit Navigator link the encounter to the study by clicking on. Follow the same steps as (7.1) to do order entry, research association, diagnosis association, and pending orders. NOTE: For Orders Only encounters, only select the After visit order type designated by a house icon. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 32 of 53
7.4 Routing Pended Orders Once an order is pended and ready for an authorized provider s signature, you must route the order. 1) Select Follow-up/Route from the Visit Navigator. 2) Complete the Recipient name and comments. The fields under Disposition, Check-out and Follow-up should be left blank. 3) Click Close. NOTE: You can now review the Routing History from the Visit Navigator. Instructing Providers on How to Sign Pended Orders: The provider can sign into APeX and open CC d Charts in the In Basket Select the desired In Basket message and click to open the provider Visit Navigator Open the Meds & Orders section and Sign the pended orders The encounter should be closed after the provider signs the order. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 33 of 53
7.5 Removing Orders Orders created in APeX and pended, but not yet signed, can be easily removed by selecting the Remove button to the right of the order while in the Order Entry activity. Discontinuing Signed Orders If a signed order was created in error and it has not yet been released, it is simple for a provider to discontinue the order. The ability to cancel orders in APeX is controlled by security based on your user role. You will not be able to cancel orders if you do not have the proper security. Ensure the correct patient and encounter for which you want to discontinue orders have been selected. 1) Open the Order Entry screen and select This patient has open orders 2) The Order Review screen opens. Find the order that was created in error and highlight the order. 3) Select the Discontinue button in the Order Review screen. 4) The Cancel Orders dialog box appears. Select a reason from the list of 20 reasons for cancelling the order. NOTE: You may add a comment if necessary to further clarify why the order is being discontinued. 5) Click Accept 7.6 Creating a Preference List The Preference List can be used to create order sets that can be used for expedited order entry. You can create your research preference list while creating orders for a study patient. The preference list you create is independent of that patient, context, or encounter. NOTE: Outpatient research orders and inpatient research orders are different and have different order details. It is a best practice to have a distinct preference list for outpatient orders and inpatient orders if necessary for your study. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 34 of 53
How to Add an Outpatient Order to a New Preference List 1) Follow the instructions in 7.1 on placing Outpatient orders. From the Order Entry window click on the star next to the Remove button. 2) This will display the Add to Preference List window. Check the order details for accuracy and completion. You may add a note in the Comments (F6) field to add clarification or extra information the scheduler, lab, technologist, etc. may need to know. For example: Please contact XXX at ###-#### for any questions related to this order. For urgent values, please page XXX at ###-####. For imaging orders: Test Migraine Imaging Protocol. Please contact XXX at ###-#### for any questions or urgent matters related to this order. 3) Click New Section. Or to add orders to an existing list, click on the magnifying glass next to the section field. 4) Name your preference list in the Display name field. If you would like the orders in this preference list to be sorted alphabetically in order entry, enter Yes into the second field. Click Accept. 5) Click Accept. 6) A Replace Order window will open. If you would like to keep the order in progress you created for this patient (ie. if you have patient specific information), select Keep Order. The generic order you just added to your preference list, will be saved for the future. Otherwise, select Replace Order. NOTE: If you click Replace Order and the order has been added to the preference list, the star icon changes color to yellow. You can remove any order from the preference list by clicking the yellow star and selecting Remove preference list entry. How to Place an Outpatient Order From an Existing Preference List: APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 35 of 53
1) From the Order Entry activity select Pref List (instead of New order) and this will open the Preference List Browser. Check the Only Favorites box. If you have multiple lists you can select the desired list under the Orders section. 2) Select the desired order(s) and click Accept. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 36 of 53
How to Add an Inpatient Order to a New Preference List: 1) Follow the instructions in 7.2 on placing Inpatient orders. 2) In the manage orders screen, click on the star. 3) Click New Section. Or to add orders to an existing list, click on the magnifying glass next to the section field. 4) Name your preference list in the Display name field. If you would like the orders in this preference list to be sorted alphabetically in order entry, enter Yes into the second field. Click Accept. 5) Click Accept. 6) A Replace Order window will open. If you would like to keep the order in progress you created for this patient (ie. if you have patient specific information), select Keep Order. The generic order you just added to your preference list will be saved for the future. Otherwise, always select Replace Order. NOTE: If you click Replace Order and the order has been added to the preference list, the star icon changes color to yellow. You can remove any order from the preference list by selecting the yellow star and selecting Remove preference list entry. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 37 of 53
How to Place an Inpatient Order From an Existing Preference List: 1) From the Manage Orders activity select New to open the Preference List Browser. 2) Check the Only Favorites box If you have multiple lists you can select the desired list under the Orders section 3) Select the desired order(s) and click Accept. NOTE: Placing an order from a preference list still requires that you associate the order with the research study if the procedure will be billed to the study account as outlined in 7.1 for outpatient and 7.2 for inpatient. See Section 7.4 for routing orders for provider signature. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 38 of 53
8. Patient Workqueues (WQ) There may be times when an encounter is automatically generated after a scheduled encounter has been linked to research and a billing flag has been set. The Patient Workqueue (WQ) is a useful APeX utility for identifying patient encounters that may require association with a research study, both proactively and retrospectively. The timely linking of an encounter to the appropriate research study prevents the patient from being incorrectly charged for research procedures. An alternative way to check the status of research-related encounters with the option to set custom parameters is to use the UCSF ES Appt Search For Research Coordinators report. 1) Select from the toolbar. The research study accounts in APeX are divided into 20 departments. Each department has been assigned three unique Patient WQs, confirm with your supervisor which WQs are used for your department. 2) Select the desired WQ and click Add to Favorites 3) Click on List Favorites to display a filtered list RESEARCH ALL SCHEDULED APPOINTMENTS Any encounter for an enrolled research patient associated with the department appears here. If it is a research related encounter, link the encounter to the study and set the Research Flag. The entry will drop out of the WQ. RESEARCH FLAG FOLLOW UP Any encounter in which the encounter has been linked to a study but the Research Flag has not been set. Similarly, an encounter will be listed here if the Research Flag has been set but a study has not been checked. Set the Research Flag or select the research study to remove the entry. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 39 of 53
RESEARCH POST VISIT FOLLOW UP The patient is linked to a research study, and undesignated charges have been generated in an encounter. If these charges should be billed to the research account, link the encounter to the study and set the research flag. In some cases, it may be necessary to contact PFS to move the charges from the patient to the research account. NOTE: It is not necessary to set the research flag as Visit Not Research for all nonresearch encounters listed in the Patient WQs. 4) Double-clicking on any encounter listed in the Patient WQ will open the Registration window for the encounter, where you can set the appropriate research billing flag. See 6.1 for more information. 9. Reviewing Charges in the Research Billing Review Report The research study team will review and validate that charges for patients enrolled on a study are being billed appropriately to either the research study or the patient s insurance, in compliance with the coverage analysis, ICF or CTA as applicable. The PI is ultimately responsible for ensuring that charge review and validation for patients on their studies are taking place in a timely manner. However, in many cases PIs will designate a CRC or other member of the research team to perform this review. This section explains the process for reviewing and correcting charges. Adding the Patients Needing Research Billing Review REP0045159 report to your Research Dashboard: 1) From the Research Dashboard select 2) Select the Library tab and search REP0045159 3) Click Edit. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 40 of 53
4) Click on the magnifying glass and a list of studies to which you are associated will be displayed in a Record Select window. Select the ZZSTUDY account(s) you would like on the report. Multiple reports can be created if you prefer to segregate the charge review for each study separately. 5) Click checkbox for Coordinator Review Current 6) Select Save As and enter a name for your new report. Click on Accept and then Close. 7) Click on the star to add the report to your favorites. 8) Run the report to view the results. Charge Review using the Billing Review Report REP0045159 APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 41 of 53
1) You can now run the report directly from your Research Dashboard. 2) From the Billing Review Report double-click on the patient to display charges by DOS. 3) To Click the Restrictions button if you want to set parameters to see more or fewer of the patient's encounters. 4) Review the charges and confirm that they are either Non-Study or Study Charges, referencing the CA, ICF or CTA. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 42 of 53
5) If the charges are correct select Mark Account/Service Date as Reviewed to route the charges. You may add a comment and click Accept. For repeated phrases you can use the SmartPhrase functionality. A green check mark will appear next to the charges that have been reviewed. The encounter will drop off from the report the next time you run the report. If charges are incorrectly directed, you can modify the association in the Research Correction window. 1) Select the check box next to one or more transactions and click Research Correction. This will open the Research Charge Correction display. 2) Select Not research-related or Researchrelated. For Research-related charges select the correct study. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 43 of 53
NOTE: Only the studies that the patient is enrolled on will be available. There are four status options that will link the patient to the study for billing purposes. Please refer to Section 4 for additional information. 3) In the Modifier type field, select either Investigational/Device or Routine a. Investigational/Device is used for the actual investigational device or drug. This choice will rarely be used. b. Routine is used for all charges that are related to research but billable to the patient or his/her insurance. Research-related means that the research study required this test/procedure/service be completed per the schedule of events, but is not paid for by the research study as it may have also been done as standard of care. NOTE: If you have any questions regarding which modifier type to use, if any, please refer back to your coverage analysis. 4) The system automatically selects the corresponding option in the Bill to field, although you may override this selection. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 44 of 53
5) Click Accept and you will receive a confirmation. To view Account Notes click on the Account hyperlink. This will take you to the account. Select the Acct Note tab. The left hand menu that appears will be different depending on outpatient or inpatient status. Guar Acct (Outpatient) Hosp Acct (Inpatient) APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 45 of 53
10. Research Reports Reports can be helpful tools for study management. There are several reports available to CRCs to personalize and use as needed. This section will provide a general overview of creating custom reports. 1) From the Research Dashboard Select My Favorite Reports. 2) Select the Library tab, on the left-hand side, and search for the desired report. Report names are listed in the table below, with links to the instructions on configuring your custom report. Once complete, add the report to your favorites. Name of Report CRC association to research study report REP0044921 All Research Studies for CRCs REP0059458 UCSF ES Appt Search for Research Coordinators Research Enrollment CRC Compare to Research Study REP0048914 Functionality Displays research studies for which the CRC is listed on the Study Record (study build). Generates a list of participants associated to a research study. Shows all scheduled appointments for participants associated to a research study within the custom defined parameters. View Only: Search for the report in the Library and click on view. Compares the Study Record (study build) to the RSH Record at the patient level and displays records where a CRC is listed at the patient level but no longer listed on the Study Record. 3) After configuring your report and adding it as a favorite in Library you can organize your reports in My Reports. Create new folders then drag and drop reports to the desired folder. 4) To delete an unwanted report, rightclick on the report and select Remove From Favorites. To delete an unwanted folder, hover over the folder and click on the in the top right corner. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 46 of 53
CRC association to research study report REP0044921 This report displays research studies for which the CRC is listed on the Study Record (study build). 1) Select, if you are unable to see this button make sure that the Show Templates box is checked 2) For studies you re currently listed on, as of today s date, enter T for the From and To date range fields. Otherwise, enter a custom date range. 3) Select the CRC by clicking in the Study Coordinator field, which will display the magnifying glass (see picture). Click on the magnifying glass. The Record Select window defaults to recent results, click on search to lookup a different user and click Accept. 4) Select the General Tab and name your report. 5) Click Save, then Close. 6) From the Library click on the Star to save the report as a favorite. 7) To view the report from the Library hover over the report name and select Run. Alternatively, from the Research Dashboard Click Refresh or Select Run in the Status column. All Research Studies for CRCs REP0059458 This APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 47 of 53
report generates a list of participants associated to a research study. 1) Select, if you are unable to see this button make sure that the Show Templates box is checked 2) Check Lookup 3) Select the study, or studies, by clicking on the Study Code: field, which will display the magnifying glass. Look up the study by ZZ name or study code and click Accept. Repeat this step for additional studies. 4) Select the General Tab and name your report. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 48 of 53
5) Click Save, then Close. 6) From the Library click on the Star to save the report as a favorite 7) Run the report from the Library by hovering over the report name and select View then Request. You will be able to see the status in two locations: My Reports Research Dashboard click Refresh or in the status column on the Requested 8) Once the status is Ready to view you can view the report from the library by clicking on the report name, or from the Research Dashboard APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 49 of 53
UCSF ES Appt Search for Research Coordinators This report shows all scheduled appointments for participants associated to a research study within the custom defined parameters. 1) After searching for the report, hover over the report name to display the button (to the right of the report name), if you are unable to see this button make sure that the Show Templates box is checked. 2) Enter a date range 3) Select the Research Study by clicking in the Research Study ID field, which will display the magnifying glass (see picture to the right). Click on the magnifying glass. In addition, you can filter by Enrollment Status. 4) Select the General Tab and name your report 5) Click Save, then Close. 6) From the Library click on the Star to save the report as a favorite 7) To view the report from the Library hover over the report name and select Run To view the report from My Reports (left hand menu), hover over report name and Click to view results. To view the report on the Research Dashboard click Refresh or and select Run in the Status column. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 50 of 53
The UCSF ES Appt Search For Research Coordinators displays the following: Patient s name and MRN Date and time of encounter A beaker icon to easily identify a research-related encounter Study code Billing Flag designation ZZSTUDY name Enrollment dates To link an encounter to research click on the desired encounter and click the button. Check the desired study and click Accept. Conversely, for an encounter that has been incorrectly linked to research you may click on the button, un-check the study, and then click Accept. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 51 of 53
NOTE: Prior to making corrections to billing flag designations, confirm that the participant is not enrolled in multiple trials and that the flag is not intended for the alternative study. 11. Clinical Trial Monitor/Auditor Access to APeX Clinical trial monitors and external auditors may access patient records in APeX through the system s release of information (ROI) inspector functionality. This functionality grants an individual access only to specified pre-approved records. The monitor/auditor will be provided instructions with an APeX log-in, password, and access key to sign into the system that expire will after a certain number of uses or after a certain date. Contact the HIMS Release of Information Office at (415) 353-2885 for any forms and necessary documentation (ie. CHR approved ICF) for inspector access and release of medical records. Please plan enough time to process these requests. Summary of Steps: The request is sent to HIMS on behalf of the Monitor along with required approvals (ie. CHR approved ICF) Specify patient names, MRNs, and records to include in the request HIMS staff processes, and creates extracts for each electronic record HIMS generates an ROI inspector key, and provides instructions on access and what the Monitor can see The Monitor must have their identification verified by HIMS personnel After ID is verified, and ROI inspector key is provided, auditor has access via any APeX workstation or through the Citrix Application (Section 1.2) If the Monitor is accessing APeX through the Citrix Application verify whether the vendors IT department must install the Citrix Application prior to the visit. For additional information you can refer to Knowledge Bank Non-Clinical HIM HIM Resources Release of Information External Auditor Requests 12. Troubleshooting When reviewing a problem you have encountered with your research-related activities in APeX, please review the following steps first: 1) Has a research study build been completed for your study? a. Look to see if the CHR number/study Code already exists in APeX. Select Study Administration Records on the dashboard and enter your CHR number, which is also the Study Code in APeX. If the Study Code does not exist, see Section 3 for information on completing and submitting a New Clinical Trial Study Request form. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 52 of 53
2) Is your research study build up-to-date? The study build must include: ALL active study personnel ALL procedures that are billable to the study The current Chart of Accounts (COA) and study year a. Review the study build by selecting Study Administration Records on your dashboard. Enter your ZZRESEARCH, STUDY Name or Study Code (CHR number). Browse through the different forms to view the different components of your study. See Section 3.2 for information on submitting a study maintenance request if you need to make changes to your research study account. 3) Is your patient linked to the research study? a. See Section 4 for information on associating a patient to a research study. 4) Is the research billing flag set for your patient s encounter? a. See Section 6 for information on setting the research billing flag. Opening a Service Now Ticket Most issues can be resolved by reviewing the basic troubleshooting steps in the previous section. However, if you are still encountering a problem, contact the Service Now team via web-based ticket submission for non-urgent issues, or by phone 415-514-4100, for urgent issues. Open a ticket for issues related to: Access, LMS, Training, Registration, Scheduling, Clinical Documentation, Orders, Billing, New Study Build, Maintenance of Study, Clarity/Chronicles, Reporting To open a ticket: 1) Go to ServiceNow 2) Select APeX Support 3) Select Incident 4) For Type of Help select APEX/Clinical Application 5) Provide a detailed explanation of your problem 6) Attach illustrative screenshots, if applicable 7) Submit the form and you will receive and email confirmation with the ticket number. Your service ticket may be routed to a specific service team based on the nature of your request. For more information, refer to the document Process for CRC in contacting the Service Now Team for Incident Management available on the APeX Knowledge Bank. For all other matters please email CRC.Connect@ucsf.edu. APeX User Guide for UCSF Clinical Research Coordinators v3.0 Page 53 of 53