User Guide for Bulk Application Process Velos eResearch Bulk Application Manual
Transcription
User Guide for Bulk Application Process Velos eResearch Bulk Application Manual
Velos eResearch Bulk Application Manual User Guide for Bulk Application Process Manual Version: 1.0 Manual Version Date: May 12, 2014 UC San Diego Health Sciences-Clinical & Translational Research Institute Page 1 Velos eResearch Bulk Application Manual Table of Contents About the Manual ..............................................................................................................................3 Section 1: Getting Started ..................................................................................................................4 Requirements................................................................................................................................................ 4 Pop-Up Blocker ............................................................................................................................................. 4 Logging into eResearch ................................................................................................................................. 5 Error Messages at Login ................................................................................................................................ 6 Access Details ................................................................................................................................................ 6 Session Management .................................................................................................................................... 6 Section 2: Requesting Study Creation .................................................................................................7 Section 3: Accessing Forms and Overview ...........................................................................................8 Selection of a Study and Associated Forms .................................................................................................. 8 Bulk Account Form Overview........................................................................................................................ 9 Bulk Account Form Statuses ....................................................................................................................... 12 Section 4: Bulk Account Form Detailed Review ................................................................................. 14 1 – Bulk Account Information Form ............................................................................................................ 14 2 – Bulk Account Laboratory Form ............................................................................................................. 17 3 – Bulk Account Imaging Form .................................................................................................................. 22 4 – Bulk Account Billing Form ..................................................................................................................... 25 Checking Form Statuses .............................................................................................................................. 29 Completed Bulk Applications ...................................................................................................................... 30 Section 5: Appendix ......................................................................................................................... 31 Bulk Account Application Process Transition Timeframes ......................................................................... 31 Helpful Contact Information ....................................................................................................................... 31 Bulk Account Allowable Form Status Matrix .............................................................................................. 32 Bulk Account Application Process Visio ...................................................................................................... 33 UC San Diego Health Sciences-Clinical & Translational Research Institute Page 2 Velos eResearch Bulk Application Manual About the Manual Outline The Velos eResearch Bulk Application Manual is designed to help new and experienced users complete a bulk account application in Velos. This manual provides a general and detailed review of each form encompassed in the bulk application process. It also has many helpful tips to ensure you are only completing the bulk account application forms required for your particular study. Please note that you will not be allowed to access the bulk account application forms in Velos until hands on training has been completed. Structure The objective of this document is to explain the bulk account application process easy-to-understand terms. This manual is divided into the sections listed below: Section 1: Getting Started Section 2: Requesting a Study Record Section 3: Accessing Forms and Overview Section 4: Bulk Account Form Detailed Review Section 5: Appendix UC San Diego Health Sciences-Clinical & Translational Research Institute Page 3 Velos eResearch Bulk Application Manual Section 1: Getting Started This section describes how users access their Velos eResearch account along with the step-bystep instructions to begin using the application. Requirements To access Velos eResearch you will need: • A computer • An Internet connection • An Internet browser Velos eResearch supports the following platforms/Internet browsers: • Internet Explorer v8, 9, 10 or 11. If you are using IE v10 or 11 you must put your browser in compatibility mode. • Firefox version 19 and lower Monitor Resolution recommended: • 1280 x 1024 • 1024 x768 (minimum resolution) Compatibility Mode for IE v10 or 11 • • Internet Explorer version 10 (with compatibility mode enabled) - To enable compatibility view follow these steps: o Open a new browser window o Hit “Alt-T” on your keyboard – A menu will appear below the address bar in the browser o Make sure the Compatibility View box is checked , otherwise check the box to enable it Internet Explorer version 11 (with compatibility mode enabled) - To enable compatibility view follow these steps: o Open a new browser window o Hit “Alt-T” on your keyboard – A menu will appear below the address bar in the browser o Select Compatibility View Settings o In the “Add this website:” field, enter “ucsd.edu” and click Add. o Close the Compatibility View Settings window. Pop-Up Blocker The eResearch application opens in a new window to comply with HIPAA regulations. If the user’s internet browser or third-party toolbar has the Pop-up Blocker option enabled, the user will not be able to login as the application will not appear. A page will display with instructions on how to manage the Pop-up Blocker to allow the application URL to have pop-ups. The internet browser or third-party toolbar can be setup to have the Pop-up Blocker option enabled UC San Diego Health Sciences-Clinical & Translational Research Institute Page 4 Velos eResearch Bulk Application Manual and allow the application URL to have pop-ups. Refer to the browser or third-party toolbar “Help” feature to have the Pop-up Blocker option enabled and allow specific URLs to have popups. Logging into eResearch Before you are able to login to eResearch you must first receive a User Name, Password, and eSignature. You will need to apply for these by completing a form provided to you by the Velos Team and they will create a user account. You will receive an e-mail with the required information. To access eResearch open your internet browser and type the following URL into the address bar: https://velos.ucsd.edu. The Velos eResearch Login page will display. 1. Enter the user name provided to you by the Velos Team. 2. Enter the password provided. 3. Click on the eResearch homepage. button. A successful login will direct you to the Velos UC San Diego Health Sciences-Clinical & Translational Research Institute Page 5 Velos eResearch Bulk Application Manual Error Messages at Login If your Login attempt is unsuccessful, the following error message will display: Access Details • Check that you are accessing the correct URL. • Make sure Caps Lock is not on. • If you copied and pasted the User Name or Password, try typing the information, as sometimes an extra space may have been inadvertently included. • If none of the above actions fix the situation, check with the Site Administrator to verify that the User Account is active. • If the User Account is deactivated, check with the Site Administrator to determine if you are authorized to have access to Velos eResearch. Session Management Always make sure to click the Logout icon at the top right side of the screen when logging out of the Velos system. If you don’t click the logout button and merely close the browser, your Velos session will remain active and you will be unable to log in again. If this happens, you will need to contact the Velos Team at ctri-velos@ucsd.edu to have your session reset. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 6 Velos eResearch Bulk Application Manual Section 2: Requesting Study Creation Requesting Study Creation In order to initiate a Bulk Application in Velos, a study must be created. Please email ctrisupport@ucsd.edu with the following information: 1. IRB or IACUC (animal study) number 2. Proposed study name 3. Study protocol must be attached 4. In the subject line please follow this format – “Velos – IRB Number – PI Last Name, PI First Name” a. For example, your email in the subject line with say “Velos – IRB # 12345 – Dr. Smith, Brian” A copy of the study protocol is required to create a study record. You will receive an email acknowledgement that the request was received. Please allow 24 -48 hours for your request to be processed. Once the study record is created, you will receive an email notification and your ticket will be closed. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 7 Velos eResearch Bulk Application Manual Section 3: Accessing Forms and Overview This section describes how users access forms associated with their study and provides an overview of each bulk account application form. This section also highlights the similarities between each bulk account application form. Selection of a Study and Associated Forms Once you have logged in, type in the study (IRB or IACUC) number in the field. Then click the button. When you see your study number under the side of the study number under the column, click on the (clipboard) on the left column. This will take you to the summary page of your study. Click on the the bulk application documents. tab on the far right to access UC San Diego Health Sciences-Clinical & Translational Research Institute Page 8 Velos eResearch Bulk Application Manual The first form (1 - Bulk Account Information Form) will automatically present for completion once you are in the Forms section. Bulk Account Form Overview Once you are within the Forms section, you will be able to select which bulk account forms you want to populate. The complete bulk application consists of four forms. • • For a new bulk account application, all four forms must have all mandatory fields populated and be saved as either: o “Completed” for forms that DO NOT require approval (Bulk Information/Billing Form) or o “Approved”/“Not Required” for the forms that DO require approval (Bulk Laboratory/Imaging Form) For changes to an approved bulk application, only the form with the information that must be changed has to be completed. 1. Bulk Account Information Form – this is primarily used to populate basic contact/demographic information about the study team. There are also some general questions about the study. A new bulk application won’t be finalized until this form is saved with a Form Status of “Completed”. As noted above, this form will automatically present for completion once you are in the Forms section. a. If you are filling out a brand new bulk account application, please start AND complete this form before moving on to subsequent forms. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 9 Velos eResearch Bulk Application Manual 2. Bulk Account Laboratory Form – this form is used to request research related Laboratory/Anatomical Pathology services. The UCSD Clinical Laboratory Department is notified of a pending request for services only when all mandatory fields are populated and the form is saved as “Submitted”. A new bulk application won’t be finalized until this form is ultimately saved with a Form Status of either “Approved” or “Not Required”. Hit the present for completion. button to have this form 3. Bulk Account Imaging Form – this form is used to request research related imaging services. The UCSD Imaging Department is notified of a pending request for services only when all mandatory fields are populated and the form is saved as “Submitted”. A new bulk application won’t be finalized until this form is ultimately saved with a Form Status of either “Approved” or “Not Required”. Hit the button to have this form present for completion. 4. Bulk Account Billing Form – this form is used to capture all billing related questions pertaining to a study, which includes operating ledger information and whether or not your study requires a case rate. Once a “99” bulk number has been created for your study, it will be populated on this form by the Information Services Department. A new bulk application won’t be finalized until this form is saved with a Form Status of “Completed”. Hit the completion. button to have this form present for UC San Diego Health Sciences-Clinical & Translational Research Institute Page 10 Velos eResearch Bulk Application Manual As described above, each form of the bulk application serves a very specific purpose. It is very important to read all pertinent information on each form. However, the items below are consistent across all forms: • The “Date Application Submitted” and “New or Revised Application” questions will have to be answered for each form. These are the 1st two questions on all forms. All forms can either be a “New” or “Revised” form type. o If you are completing a bulk application that has never been finalized, please ensure the form type on all four forms is set to “New” o If you are updating information for a bulk application that has already been finalized, please ensure the form type on the applicable form is saved as “Revised” o Selecting the correct form type (“New” or “Revised”) is very important because it helps ensure the appropriate parties are notified when necessary • All mandatory fields will have a * next to the question. If you are unable to answer all mandatory questions when you are populating the form, you will be able to save the form as “Incomplete” and return at a later time to finish. It is your responsibility to go back and change the Form Status from “Incomplete” to “Completed”/”Submitted” once you have updated the form with missing information. • You may see a next to some questions. This is “help text” to provide additional context/information relating to the question being asked. Hovering your mouse over the question mark will allow the additional information to be seen. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 11 Velos eResearch Bulk Application Manual Please note that an e-Signature is required to submit any of the Bulk Application forms Bulk Application Form Statuses • Each form will have “Form Status Instructions” right above the section where you set the form status. Please read the instructions carefully as they are different for each form. Only the form statuses of “Completed”, “Incomplete”, “Submitted”, and “Not Required” are allowable for the applicant to use for the Bulk Account Application forms. Below is the definition for each form status: o “Incomplete” – Use this form status when you are unable to populate all mandatory fields and need to return at a later date to populate those items. The system will prohibit you from selecting any other form status when mandatory information is missing with this error message: o o o “Completed” – Use this form status when you are able to populate all mandatory fields AND it is either the Bulk Account Information Form or the Bulk Account Billing Form “Submitted” – Use this form status when you are able to populate all mandatory fields AND the form needs to be reviewed by either Laboratory or Imaging. Laboratory and/or Imaging will not be notified of a pending form requiring their review until these conditions are met For the forms requiring approval from the Laboratory or Imaging, the applicable Department will change the form status to “Approved”. Applicants will not be able to use this Form Status “Not Required” – Use this form status ONLY on the Bulk Application Laboratory/Imaging Form when you do not require Laboratory and/or Imaging services UC San Diego Health Sciences-Clinical & Translational Research Institute Page 12 • Velos eResearch Bulk Application Manual All forms must have a Form Status set and be submitted. All form statuses are in the Form Status drop down. The only form statuses allowable for the bulk account forms are “Incomplete”, “Completed”, “Submitted”, and “Not Required”. Please note that you may see additional form statuses within the Form Status drop down menu than the ones that are allowed for this process. Please disregard them as they are not applicable to the bulk application process. Below is a matrix reflecting the final form statuses required for your application to be considered finalized: UC San Diego Health Sciences-Clinical & Translational Research Institute Page 13 Velos eResearch Bulk Application Manual Section 4: Bulk Acccount Form and Detailed Review This section provides a detailed review of each bulk account application form. It highlights the nuances between the forms and provides tips on how to complete each form in the most efficient manner. 1 - Bulk Account Information Form • • • This form must be completed in its entirety for each bulk account application, regardless if Laboratory and/or Imaging services are not required. Please complete this form in its entirety first before completing subsequent forms. UCSD Health System Bulk Account Application section o Please ensure all mandatory information is populated for this section. If you don’t have the mandatory information, leave the field blank and save the Form Status as “Incomplete” until you have the necessary information. o Selecting the correct form type (“New” or “Revised”) for the “New or Revised Application” question is very important because it helps ensure that the appropriate parties are notified when necessary Study Coordinator/Principal Investigator/Fiscal Contact Information sections o Please ensure all mandatory information is populated for these sections. If you don’t have the mandatory information, leave the field blank and save the Form Status as “Incomplete” until you have the necessary information o Please note that you will be required to have an Epic User ID before your bulk application can be finalized. Please contact EMR Access at emraccess@ucsd.edu for assistance in obtaining an Epic User ID. Please also see the Research Compliance INTRAnet for additional information UC San Diego Health Sciences-Clinical & Translational Research Institute Page 14 Velos eResearch Bulk Application Manual UC San Diego Health Sciences-Clinical & Translational Research Institute Page 15 Velos eResearch Bulk Application Manual • Account Information section o It is very important that you know whether or not your study requires a Coverage Analysis. If you are not sure, please contact OCAA at ocaa@ucsd.edu and include the IRB number in the subject line within the email. o For your study type, please ensure that you select ALL descriptions that apply. For example, if your study is PI Initiated and OCAA has advised that a Coverage Analysis is not required, please check both the “PI Initiated” and “Coverage Analysis not required in Velos” checkboxes (see example below) o Please ensure all mandatory information is populated for these sections. If you don’t have the mandatory information, leave the field and/or checkboxes blank and save the Form Status as “Incomplete” until you have the necessary information • UCSD Clinical Laboratory and Imaging Services section o Please ensure an option is selected for each question. If you are unable to select an option for each question, leave the field as “Select an Option” and save the Form Status as “Incomplete” UC San Diego Health Sciences-Clinical & Translational Research Institute Page 16 • Velos eResearch Bulk Application Manual Form Status Instructions section o Please ensure that you thoroughly read the instructions in this section before selecting a Form Status o The Bulk Account Information Form can be saved as “Incomplete” or “Completed”. Ultimately, this form must be saved as “Completed” in order for your application to be finalized. Please complete this form FIRST before moving on to other forms. 2 - Bulk Account Laboratory Form • UCSD Health System Bulk Account Application section o Please ensure all mandatory information is populated for section. If you don’t have the mandatory information, leave the field blank and save the Form Status as “Incomplete” until you have the necessary information. o Selecting the correct form type (“New” or “Revised”) for the “New or Revised Application” question is very important because it helps ensure the appropriate parties are notified when necessary. • Section A: Laboratory Procedures o If “No” is selected for this item, you are not required to populate any other items on this form other than setting the Form Status. Save the form with a Form Status of “Not Required” when this response is selected. An answer of “No” means you do not have any laboratory or anatomical pathology Medical Center services for your study UC San Diego Health Sciences-Clinical & Translational Research Institute Page 17 o Velos eResearch Bulk Application Manual If “Yes” is selected, please ensure all mandatory fields are populated. If you don’t have the mandatory information, leave the field(s) blank and save the Form Status as “Incomplete” until you have the necessary information. • Section A – Laboratory Services and Tests o Please populate laboratory service details in this section. If you have questions or a comment for the Laboratory, place those comments in the “Coordinator Comments” column. After the Laboratory reviews your application, they may place comments in the “Laboratory Comments” column. • Section B: Anatomical Pathology-Services and Tests o Please populate Anatomical Pathology service details in this section. The Laboratory requires specific information for Anatomical Pathology requests. Please put in as much detail as possible under the “Protocol Technical Specifications (Applicant to provide specifications)” column. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 18 Velos eResearch Bulk Application Manual • Section B: Anatomical Pathology Processing Info o Please note there is important information here about the release of tissue blocks. Contact information is listed here if you have questions about tissue blocks. Please list any other special Anatomical Pathology requirements here that were not listed above. • Clinical Contact section o Please provide a name of the person with in-depth knowledge of the procedure details. • General Comments section o This field can be used by both the applicant and the Laboratory. Please place any comments here that you have not mentioned above. Please include your name and date in the “comments” box. • For Laboratory use ONLY section o Please leave this field blank. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 19 • Velos eResearch Bulk Application Manual Form Status Instructions section o Please ensure that you thoroughly read the instructions in this section before selecting a Form Status. o The only Form Status allowed for an applicant to use is “Submitted”, “Incomplete” or “Not Required”. A “Submitted” Form Status ensures the Laboratory is notified of your pending application. An “Incomplete” Form Status means you are unable to populate all mandatory fields and need to return at a later date to populate those items. A “Not Required” Form Status means you do not have any laboratory and/or anatomical pathology services. This coincides with answering “No” to the 1st question in Section A: Laboratory Procedures. o After the Laboratory reviews your request, they will also select a Form Status to communicate the status of your request. A Form Status of “Approved” means the Laboratory does not have any questions about your pending application and it is approved. The Study Coordinator listed on the Bulk Application Information Form will be emailed when this occurs. A Form Status of “Clarification Required” means the Laboratory DOES have questions about your pending application and it has not yet been approved. The Study Coordinator listed on the Bulk Application Information Form will be emailed when this occurs. • The Laboratory will place their questions either in the “General Comments” section or in the “Laboratory Comments” column in Section. A – Laboratory Tests and Services • Answer the question in either the “General Comments” section (with the comment parameters described above) or in the “Coordinator Comments” column in Section A – Laboratory Tests and Services. Save the Form Status as “Submitted” after you answer the question. The Laboratory will be notified each time you submit a form with a Form Status of “Submitted” • Ultimately, a Form Status of “Approved” or “Not Required” must be submitted for a new bulk application to be finalized. It is your responsibility to sufficiently answer all of the Laboratory Department’s questions so that one of these Form Statuses can be achieved. You will receive an email when the Laboratory has saved your Bulk Application Laboratory Form as either “Approved” or “Clarification Required”. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 20 Velos eResearch Bulk Application Manual Example of Bulk Account Laboratory Form approval email: Example of Bulk Account Laboratory Form clarification required email: UC San Diego Health Sciences-Clinical & Translational Research Institute Page 21 Velos eResearch Bulk Application Manual 3 - Bulk Account Imaging Form • UCSD Health System Bulk Account Application section o Please ensure all mandatory information is populated for this section. If you don’t have the mandatory information, leave the field blank and save the Form Status as “Incomplete” until you have the necessary information. o Selecting the correct form type (“New” or “Revised”) for the “New or Revised Application” question is very important because it helps ensure the appropriate parties are notified when necessary • UCSD Imaging Services section o If “No” is selected for this item, you are not required to populate any other items on this form other than setting the Form Status. Save the form with a Form Status of “Not Required” when this response is selected. Please note that ONLY the following services are provided by the Imaging Department for the Medical Center: CT, MR, Nuclear Medicine, Ultrasound, PET/CT and Plain Films. • If one of these services will be provided for your study AND all services will be performed at a School of Medicine location, please see additional instructions below. The Imaging Department for the Medical Center DOES NOT perform the following services (please save form as “Not Required” if these are the only types of services your study requires): • ECG/EKG (Echocardiogram)– Cardiology • EEG (electroencephalogram) – Neurology o Please contact the Research Compliance Program if you have questions on how to handle non Imaging services required for your study o If you have questions regarding what department provides which services, please check your CPT book or you can contact Kim VanLeeuwen at kvanleeuwen@ucsd.edu o If “Yes: School of Medicine Service location - Sorrento Valley, Bydder Lab, URLJ, RIL, or KECK (fMRI)” is selected, please note that you must contact the representative for the School of Medicine location to arrange research related imaging services. If all of your services will be performed at a School of Medicine location, you are not required to populate any other items on this form other than setting the Form Status. Save the form with a Form Status of “Not Required” when this response is selected. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 22 Velos eResearch Bulk Application Manual o • If “Yes: Medical Center Service location - Hillcrest, Thornton, MCC, or Lewis St.” is selected, you are required to populate all other mandatory questions on this form. Please note the special instructions if your study requires electronic transmission of images. If you will have services performed at BOTH the Medical Center and School of Medicine, then select “Yes: Medical Center Service location - Hillcrest, Thornton, MCC, or Lewis St.” so that Medical Center personnel are notified accordingly. Imaging Tests (CPT Code/Rates Imaging Use Only) section o Please populate Imaging service details in this section. If you have questions or a comment for the Imaging Department, place those comments in the “Coordinator Comments” column. After Imaging reviews your application, they may place comments in the “Imaging Comments” column. o Please note that the “CPT Code”, “Tech Fee”, and “Pro Fee” columns are for Imaging Department use only. Please do not populate information in these columns. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 23 Velos eResearch Bulk Application Manual • For Imaging Use ONLY section o Please do not populate any information here • General Comments section o This field can be used by both the applicant and Imaging. Please place any comments here that you have not mentioned above. Please include your name and date in the “comments” box. • Form Status Instructions section o Please ensure that you thoroughly read the instructions in this section before selecting a Form Status. o The only Form Statuses allowed for an applicant to use is “Submitted”, “Incomplete” or “Not Required”. A “Submitted” Form Status ensures Imaging is notified of your pending application. An “Incomplete” Form Status means you are unable to populate all mandatory fields and need to return at a later date to populate those items. A “Not Required” Form Status means you do not have any Imaging services for your study or all of the services are being performed at a School of Medicine location. o After Imaging reviews your request, they will also select a Form Status to communicate the status of your request. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 24 Velos eResearch Bulk Application Manual A Form Status of “Approved” means Imaging does not have any questions about your pending application and it is approved. The Study Coordinator listed on the Bulk Application Information Form will be emailed when this occurs. A Form Status of “Clarification Required” means Imaging DOES have questions about your pending application and it has not yet been approved. The Study Coordinator listed on the Bulk Application Information Form will be emailed when this occurs. • Imaging will place their questions either in the “General Comments” section or in the “Imaging Comments” column in the Imaging Tests (CPT Code/Rates Imaging Use Only section. • Answer the question in either the “General Comments” section (with the comment parameters described above) or in the “Coordinator Comments” column in the Imaging Tests (CPT Code/Rates Imaging Use Only section. Save the Form Status as “Submitted” after you answer the question. Imaging will be notified each time you submit a form with a Form Status of “Submitted”. • Ultimately, a Form Status of “Approved” or “Not Required” must be submitted for a new bulk application to be finalized. It is your responsibility to sufficiently answer all of the Imaging Department’s questions so that one of these Form Statuses can be achieved. You will receive an email when Imaging has saved your Bulk Application Imaging Form as either “Approved” or “Clarification Required”. 4 - Bulk Account Billing Form • UCSD Health System Bulk Account Application section o Please ensure all mandatory information is populated for this section. If you don’t have the mandatory information, leave the field blank and save the Form Status as “Incomplete” until you have the necessary information. o Selecting the correct form type (“New” or “Revised”) for the “New or Revised Application” question is very important because it helps ensure the appropriate parties are notified when necessary. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 25 Velos eResearch Bulk Application Manual • Account Information Section o Please ensure all mandatory fields are populated. o If your study is affiliated with the Moores Cancer Center, please answer “Yes” to the “Is this study managed by MCC” question. o If your study has Inpatient and/or Outpatient procedure/surgery requirements, please ensure to obtain a case rate from the Budgeting Office. The Budgeting Office will be notified via email when you answer “Yes” to this question so that they are also aware of an upcoming case rate request. o If you need additional information about the ClinicalTrail.Gov number, please visit this link: http://medcenter.ucsd.edu/researchcompliance/training/Documents/CTGov%20Registr ation%20and%20results%20reporting%20of%20Clinical%20Studies%20140130.pdf • UCSDHS Account Billing Information o Please ensure all mandatory fields are populated. o If you are not sure of what Index, Org, or Fund Number to use, please contact your Fiscal Contact or Principal Investigator for assistance. Patient Financial Services or the Velos team will not have this information to provide. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 26 Velos eResearch Bulk Application Manual • For Patient Financial Svcs Use ONLY o After your bulk application has been finalized, a member of the Information Services team will generate a “99” bulk number and put that information in this field. Please leave this field blank when you are completing this form. You will be notified when the bulk account number has been generated. o If your study has a Coverage Analysis, you do not have to wait for a bulk number to provide research related services to your enrolled patients (contingent upon all other UCSDHS research policy requirements have been met). o If your study DOES NOT have a Coverage Analysis, you will have to wait until a bulk number is generated before research related services are provided. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 27 Velos eResearch Bulk Application Manual Example of Bulk Account Billing Form notification when a bulk number is populated: • Form Status Instructions section o Please ensure that you thoroughly read the instructions in this section before selecting a Form Status. o The Bulk Account Billing Form can be saved as “Incomplete” or “Completed”. Ultimately, this form must be saved as “Completed” in order for your application to be finalized. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 28 Velos eResearch Bulk Application Manual Checking Form Statuses • If you want to check the statuses of your forms, there are two ways: o For the forms that do not require approval (Bulk Information/Billing Form), the last Form Status saved will be the Form Status that you see. o For the forms that do require approval (Bulk Laboratory/Imaging Form), you will be able to see any Form Status you are allowed to set. Please see the Bulk Account Allowable Form Status Matrix on page 32 in the appendix for a listing of the Form Statuses an applicant can use. o For the forms that do require approval (Bulk Laboratory/Imaging Form), you will have to go into the Audit trail to see Form Statuses that are only allowed to be set by Laboratory/Imaging. Select Audit Trail. o (located under the form drop down menu) to see the Here you will be able to see if the Laboratory or Imaging Department has changed the Form Status. You will also receive a corresponding email when this occurs. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 29 Velos eResearch Bulk Application Manual Completed Bulk Account Applications • • Once all bulk account forms reflect a Form Status of “Approved”, “Not Required”, or “Completed”, your bulk application will be considered finalized. You will be notified via email when this occurs: o If a Coverage Analysis was created for your study it will not be activated until you bulk account application is finalized. o The Office of Coverage Analysis Administration (OCAA) will receive the same bulk account application finalized email notification mentioned above. This is when OCAA will begin the Coverage Analysis activation process with the Velos team. Please allow 48 hours for your Coverage Analysis to be activated in Velos o A “99” bulk account number will be generated after your bulk account application is finalized. Please see the matrix on page 13 for a breakdown of the required Form Statuses for each form in order for your bulk application to be considered finalized. UC San Diego Health Sciences-Clinical & Translational Research Institute Page 30 Velos eResearch Bulk Application Manual Section 5 - Appendix Bulk Account Application Process Transition Timeframes: Please see details below for timeframes related to applications pending completion or completed applications requiring revisions: • Incomplete Bulk Applications (have not been finalized): o Effective 5/19/2014: Bulk application requests submitted to Patient Financial Services (PFS) before 5/19/2014 and have the following statuses will require the applicant start a new bulk application in Velos: Bulk applications that are older than 6 months with no activity Bulk applications submitted without an IRB All other bulk applications in the pipeline with no activity within the last 3 months (“No Activity” means information has been pending from the applicant/coordinator for 3 months or more) All other bulk application requests submitted to PFS that do not fall within the aforementioned categories will be finalized by the PFS Bulk team • Revision of Bulk Applications (Effective 5/19/2014): o Revisions to a completed bulk application made on or after May 19, 2014 will require the applicant to submit the request within Velos o If the applicant submits the request to PFS prior to May 19, 2014, PFS staff will complete and process the applicant’s request • Completed Bulk Applications (Effective 5/19/14): o PFS Staff will start transitioning all “completed” bulk applications to the Velos System. In the interim, if an applicant needs a copy of their “completed” bulk application that was processed through the PFS office, please send an email request to bulkapplication@ucsd.edu and a copy will be provided • Corporate Bulk Applications (applications not related to research studies): o PFS will continue to process all Corporate Bulk applications. The current Corporate Bulk Application form and process is being re-engineered. Information will be provided at a later date. Helpful Contact Information: Charge correction requests: bulkchargecorrection@ucsd.edu General bulk application questions: bulkapplication@ucsd.edu, ctri-velos@ucsd.edu Velos team – ctri-velos@ucsd.edu, (858) 657-1892 Budget Office for case rates: Michael Roulan, mroulan@ucsd.edu, 619.543.3470 Research Compliance INTRAnet: http://medcenter.ucsd.edu/researchcompliance/Pages/Home.aspx o Look under the “Finance” tab for bulk account information Patient Financial Services (Technical/Hospital Fees): bulkapplication@ucsd.edu Medical Group (Professional Fees): Petite Hadley, phadley@ucsd.edu, (619) 543-7807 Laboratory Administration: Dea Butterfield djbutterfield@ucsd.edu, (619) 543-7075 Imaging Services: Kim Vanleeuwen, kvanleeuwen@ucsd.edu, (619) 543-6760 UC San Diego Health Sciences-Clinical & Translational Research Institute Page 31 Velos eResearch Bulk Application Manual Bulk Account Allowable Form Status Matrix UC San Diego Health Sciences-Clinical & Translational Research Institute Page 32 Velos eResearch Bulk Application Manual Bulk Account Application Process Visio UC San Diego Health Sciences-Clinical & Translational Research Institute Page 33