Greenphire ClinCard Subject Remuneration Process. Thomas Jefferson University 4/22/2016 Ver. 1.0

Transcription

1 Greenphire ClinCard Subject Remuneration Process Thomas Jefferson University 4/22/2016 Ver. 1.0

2 Greenphire ClinCard Subject Remuneration ClinCard is Jefferson s new patient remuneration format, mandatory for all new clinical research trials, and optional for current trials that choose to switch to ClinCard. If the Sponsor of a clinical trial has their own remuneration method that does not involve any financial transactions by TJU, those trials will not be required to use ClinCard. The Master Study is set up by the System Administrator (SA) o Master Study: used to track patients who have received a ClinCard and prevent duplicate entries All coordinators (SC) will search for/enroll their patients in the Master Study This study has no payment schedule All new studies conducted at Jefferson will be entered into the GreenPhire system by the Clinical Research Administrator or Grants Administrator (titled Financial Administrators FA) after they have been approved by the IRB o Universal consent language has been created and is available on the OHR website. o During budget and contract negotiations, the FA will incorporate the $1 load fee per card and initial $3.50 card cost per patient based on the n for the protocol. FAs will contact the SA when new studies need to be added to the system. Send an to JCRI@jefferson.edu with the subject New GreenPhire Study The body of the should include the: o Department o Principal Investigator o Sponsor o 3 digit entity# o 5 digit Dept. # o 6 digit Grant # o JT# o the study s short title o Remuneration budget o Any travel reimbursement specified in the protocol Page 1 of 20

3 The SAs will Set up study using the following universal naming convention: Trials managed by the JCRI Business Operations team will begin with JC Trials managed by RACE Grants Administrators will begin with RC JC/RC_3 digit entity#_5 digit Dept #_ 6 digit Grant #_JT#_study short title Example: JC_080-XXXXX-XXXXXX-JT9999_Sample GreenPhire Study ID and Description are optional fields that can be used for further details about the study. Always: Select Required in the SNN drop down field Check the box for Subject ID Set the Study Status to Active Identify the Sponsor o If the sponsor isn t listed, please contact JCRI staff by at JCRI@jefferson.edu Select Always in the Manual Payments drop down field Enter the amount designated for remuneration in the Study Budget field o Note: If a total budget amount is not directly provided, the remuneration will be calculated based on the payments per visit, projected number of patients, and travel provisions listed in the protocol. Enter the Principal Investigator for the study. o Co-PIs do not have to be listed. If desired, their names can be entered in the optional Description box. Click Submit The Mileage Section will be used only if specified in the study protocol/budget. The tax amount reflects the current IRS rates. Activate the study and enter SCs based on the staff listed in JeffTrial o If JT staff list isn t updated, the SA will contact the department directly o Staff list must designate a Study Site Contact and Coordinators. Listing staff as Other Staff isn t sufficient. Page 2 of 20

4 The FA will be contacted when the study is created. At this point the FA will review the entered information for accuracy. To do so: o Click on Admin o Click on Edit Study o Select your study from the drop down menu The FA will enter the payment schedule o If the study payments are variable each visit, a payment schedule is not required. The SC will enter manual payments for the visit with a description of the visit events totaling the payment entered. FAs will receive an alert twice daily regarding pending approvals. Sample: Subject: "New Pending Payment for study CUP14366 at Columbus Clinical Services" Page 3 of 20

5 Body: "You have a new payment pending for Subject belonging to the CUP14366 study for the amount of $ You can review this pending payment at Review the Pending Approvals to ensure manual payments are accurate and properly justified by the SC in the comments section. o To view the comment, click Show Details If correct, check the box for the study and click Approve If incorrect, contact SC Payments should be approved within 48 hours of the visit o To enter the study payment schedule: Click on "Admin" Click on "Maintain Study Payments" button Select the study from the drop-down list and click "Edit Study Payment Options" Click "Add Option" and a pop-up window will appear, populate "Name" and "Amount" text fields before clicking "Submit" Note: Repeat step for each additional payment Page 4 of 20

6 Once all payments are added, review the order in which they display as this is the same order in which they will appear in the drop-down box Note: You can click on "Up" and "Down" in the third column to adjust the order of a particular payment Once all payments are added and appear in the correct order, click "Save Changes" The Site Coordinator (SC) will register and pay the patient in the GP system o During the consent or first visit, the SC will review the ClinCard information with the patient. SCs should debrief the patient on the functions of the card and encourage them to keep it for future use in other studies. Replacements cards can be provided if the card is lost, stolen or damaged A fee of $3.50 will be deducted from the visit that the patient receives the replacement card Page 5 of 20

7 The replacement card will contain the prior balance along with any future payments. The original card will be deactivated. o The patient must complete and sign a new W9 for each calendar year (for payments using the ClinCard or check). This will be kept within the department as a source document in case the Accounting department conducts an audit. o The SC will have the patient sign the ClinCard Receipt to confirm the patient received card *This is a sample form, available in the Resource section on the JCRI website. Each department has the option to use this form or something similar that includes ALL listed fields.* Signed receipts will remain in the patient s binder Each form should be completed in its entirety. If a patient meets the exception requirements or strongly refuses the ClinCard, please provide a detailed explanation. Page 6 of 20

8 Exceptions will be at the discretion of the Coordinator with the understanding that the ClinCard is the preferred method of payment. If a card is not given, the only alternate payment option is a check. o For all check payments use current TJU process which includes completing the W9 and a request for payment form (RFP). Consult with your research administrator for specifics. In the event that a replacement card is given to the patient, the SC will print a separate receipt and check the Replacement Card box. Both receipts should be kept in the subject binder Prior to Registration o Search for the patient within the Master Study Select the Master Study and click Search or enter patient information in the open fields. If found click on the patient s name and add the current study to the patient s profile Add a study to a patient: Page 7 of 20

9 o Click Add Study Enter the patient s Study ID number and select the correct study in the drop down menu. Page 8 of 20

10 o If not found, Register the patient and add them to the Master Study first, then add the current study to the patient s profile Register the patient: o Click on Register Subject o Enter the required information into the brief form o Note: Once you select a study, the rest of form will appear as seen below. Page 9 of 20

11 o Click on the Register button o Note: If you would like the Subject to receive payment confirmations or appointment reminders, be sure the (Enable) and/or Text Messaging (Enable) checkboxes are selected You will be brought to the Subject Information screen where you can assign a card number, make a payment, schedule an appointment reminder, replace a ClinCard or edit a Subject s information If you have difficulty making a payment for the first time please call JCRI at Outside of normal business hours, please call the ClinCard site support team at Once registered, the SC uses the predetermined payment schedule to pay the patient for the visit(s) For studies without a set payment schedule or where an unspecified amount is required for payment, a manual payment will be entered. Manual payments require approval from the FA responsible for that study. Page 10 of 20

12 o FAs will receive an alert twice daily regarding pending approvals. Assign ClinCard to patient o Click on Assign ClinCard and a pop-up screen will appear o In the New Card field, enter the 16 digit number visible through the window of one of the ClinCard card packages you received Note: There is no need to open the envelope prior to providing to the Subject o Click on the Assign button o Once the card has successfully been assigned, you will receive a confirmation message at the top of the Subject Information screen Page 11 of 20

13 o Now an option to Replace ClinCard appears. In the event that a Subject loses their card, you can replace it by clicking on Replace ClinCard, and follow the steps above, using a card number from a new ClinCard card package Note: This will deactivate the lost card and automatically transfer any available/pending balance to the newly assigned ClinCard Once registered, the SC uses the predetermined payment schedule to pay the patient for the visit(s) Make a visit payment o Click on Make Site Visit Payment and a pop-up screen will appear Page 12 of 20

14 o Select from the dropdown box which milestone the patient is being paid, e.g., Visit 1, Visit 2, etc. o Click on the Pay button o Once the payment has successfully been requested the Pending Payment area of the Subject Information screen will reflect the payment. It will also be reflected in your Recent Activity on the left-hand side of the screen. o Once a payment request has been approved and processed, the amount will be removed from the Pending Payment area and reflected in the Available Balance area o If the Subject has opted to receive and/or text messages, the Subject will receive a payment confirmation communication when the payment is made For studies without a set payment schedule or where an unspecified amount is required for payment, a manual payment will be entered. Page 13 of 20

15 Manual payment o Click on Manual Subject Payment and a pop-up screen will appear o Enter the payment value that you want to pay to the Subject in the Amount field o Add an appropriate comment in the Note field, e.g., Unscheduled Visit, Week 32, etc. o Click on the Pay button Manual payments require approval from the FA responsible for that study. Page 14 of 20

16 o FAs will receive an alert twice daily regarding pending approvals. o Once a payment request has been processed, the amount will be removed from the Pending Payment area and reflected in the Available Balance area o If the Subject has opted to receive and/or text messages, the Subject will receive a payment confirmation communication when the payment is made Travel payments also require approval from the FA Travel reimbursement must be listed separately in the protocol as it is in addition to (or in place of) a visit payment. The mileage rates or flat rate must be entered when the study is created. If you are unable to make a travel payment and believe it is an option for your study, please contact your FA directly or the JCRI SA at or by at JCRI@jefferson.edu To make a travel payment o Within the patient s profile, Click Make Travel Payment Page 15 of 20

17 o Select the correct study in the drop down menu and click Choose Study o Click Add Drive and enter the start and finish addresses o Check the box for Round Trip if necessary for the protocol and enter any pertinent notes. o Click Continue when finished Page 16 of 20

18 o Review the request prior to submitting Note if there is a flat rate set up for the study, the preset dollar amount will be the same for all patients. All other amounts will be calculated using the distance traveled and the rate per mile as described in the protocol If you notice an error, cancel the request and reenter the data. Page 17 of 20

19 o There is also the option to Add Other within the travel reimbursement section. If the travel amount is a maximum flat rate, use Add Other and manually enter the amount. Proof of travel is required and should be detailed in the description box. Fill in the required fields and click Continue This will also be considered a manual payment and will require FA approval Page 18 of 20

20 Appendix Short Name FA JCRI POC SA SC Meaning Financial Administrator Jefferson Clinical Research Institute Point of Contact System Administrator Study Coordinator Page 19 of 20