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["How to fill out the Epic Research Protocol Request Form"]
["1.       Introduction"]
["         a. This form does not replace any required forms from other departments/services like Radiology, Lab, IDS, etc.."]
["         b. The General Information sheet needs to be completed for all study requests and must be submitted with your CAS Work Request along with the Study Personnel Form or Delegation Log."]
["         c. The Arm tabs need to be completed to provide all the information necessary for an Epic Research Treatment Plan/SmartSet to be built and moved to Production."]
["                                       i.            Both Investigational and non-investigational drug records (ERX) are required"]
["                                     ii.            Study labs are required"]
["2.     Look for the latest Excel sheet on the Child Health Research Enterprise department website or the CAS Work Request Form to ensure you are using the most up to date version"]
["3.       General Information sheet"]
["a.      New Study/Amendment:  Is this form for a new study build, or an amendment to existing Epic study build."]
["b.      Last IRB Approval Date:  This is usually the date the IRB has approved the study"]
["c.     Funding Source:  Choose between Industry, Federal, or Unfunded"]
["d.      Study Type:  Choose between Observational, Interventional, or Expanded Access"]
["e.     Study Title:  This may or may not be in the sponsor's protocol.  Generally, it is just a quick and easy way to identify the study."]
["f.     Brief Study Format:   A brief description of the study. "]
["g.      Approved # of Participants:   How many participants was this study approved for."]
["h.     Study Team:  Add the Department/Group conducting the study, Primary Investigator, Clinical Research Coordinator(s) and the Co-I(s)/Sub-I(s),and their contact numbers.  Multiple names can be entered. Ensure the appropriate research training has been completed by the training team."]
["i.    Epic Study Title:   This is what the study is to be titled in Epic. We will also include the primary contact information for the PI and Primary Coordinator"]
["j.      Network of Care Locations:  Will the study be conducting research related activities at any CHCO NOC locations like North, Uptown, South, Memorial, etc."]
["k.      MyChart Study Title:  How the study will appear to enrolled participants in their MyChart"]
["l.    MyChart Study Description:  Description of the study visible to enrolled participants in their MyChart."]
["m.      Patient Consents:  Will you be consenting in outpatient setting, inpatient setting, or both?"]
["n.  Patient Consents Scanning:  Will the PI or any of the CO-I's be scanning in consents?"]
["o.    Investigational Drug or Device?:  List any investigational drugs or devices involved in the study if applicable"]
["p.    Radiology Orders?:  Will the study involve any radiology orders?"]
["q.    Ancillary Services Used?:  Will any ancillary services be used for the study?"]
["r.     Adverse Events?:  What Adverse Event (CTCAE) term set does the study specify?"]
["s.     Study Results Notification?:  Would the study team like to receive results for study related orders in your Inbasket?"]
["t.     Appt. Change Notification:  Would the study team like to receive notifications in your Inbasket about any research related appointments that have been cancelled, changed, or missed."]
["u.   Contraindicated Medications:  Does the study specify any contraindicated medications? If yes, the Contraindicated Meds section must be completed."]
["          v.    Treatment Period (days):  Generally, this is just 1 number.  Occasionally, it is more complicated.  E.G. \"Phase A = 21days;  Phase B = 28day\" or \"Arm A: cycles 1-2 are 21 days and cycle 3+ are 42 days.\""]
["w.  Number of Arms:  How many Arms does the study have"]
["x.    Names of Arms:  List the name of each Arm if more than one."]
["y.    CHCO Financial Representative:  A CHCO Financial Representative must review the form to validate expected procedures and charges. Please enter the analyst that's been assigned to your study for budget review."]
["z.    PI Sign Off:  PI must sign off on this document after reviewing it."]
["4.        Arm Sheets"]
["a.    Overview:  "]
["                                    The orders in an Epic Smartset/Protocol are divided into Categories.  These help organize the orders for easy viewing. "]
["                                    Within the study calendar, designate if the procedure is considered Standard of Care (S) or  Research (R)"]
["1.       Patient Care:   These are for direct patient care and do not include interdepartmental orders such as laboratory, radiology, or pharmacy. E.G. Vital Signs, Respiratory Rate, etc."]
["2.    Consults/Referrals: This section contains any orders that refer the patient to another department for consults, procedures, or exams."]
["3.       Study medications:"]
["a.       Generally provided by the sponsor unless the study indicates something different."]
["b.      When entering drugs, please enter the following information:\nName, dose, route, duration (if necessary), refills (if necessary)."]
["4.      PRN/Additional Medications:"]
["a.       Again: Name, dose, route, duration (if necessary), refills (if necessary)."]
["5.       Labs:   This contains labs done at CHCO or sent to a Central Lab.   Back Office, Point of Care, or Research labs that are sent to an outside lab are not resulted in Epic, but must still be recorded through Enter/Edit Results. All studies will have a Safety Lab order set available in Production."]
["6.    Radiology: This section contains radiology exams that will be built by our Radiant team to be scheduled and performed in Radiology"]
["a.       In a Treatment Plan, these are built as Schedulable Orders"]
["7.    Cardiology: This section contains cardiology exams that will be scheduled and performed in Cardiology or on study specific equipment"]
["a.       If an ECG is done on the Sponsor's machine (not on a hospital machine), then this needs to be noted."]
["8.    Respiratory Therapy: This section contains exams like Pulmonary Function Tests (PFT's). "]
["a.       If using a Sponsor's equipment, this needs to be noted."]
["9.       Other Research Orders and Information:  "]
["a.      Research Orders:  Think \"someone needs to do something.\"   E.G. \"  Complete Quality of Life Surveys\""]
["b.       Research Information:  Think \"someone needs to know this.\"  E.G. All IMP supplies collected.\" This is not an order that can be built in Epic, but we can have the system contain this information."]
["b.   Columns"]
["           1.      Orders:  This is the first column on the left (column A).  What is the Order?  E.G. CBC +Diff, CMP, Study Medication, etc."]
["           2.      Order Code: This is the second column (column B). Input the Epic order code (NOT CPT code). Codes can be found in an order search window. Lab ID's can be found in the Epic Procedure Catalog. "]
[]
["           3.      Charge Code: This is the third column (column C). Input the Epic charge code (NOT CPT code). Work with the CHCO Financial Analyst for this data."]
["           4.      Details/Comments:  These are the 3rd, 4th, and 5th columns (column D-F) and should include exact text or more details about the order entered in Column A.  E.G. for a CBC, column B-D should include who is collecting, performing, and processing the lab sample. "]
["            5.      Cycles/Phases & Days:  Cycles/Phases that the orders are done on"]
["i. In Row 2 (directly under the word \"Cycle/Phase\"), type in the #/name of the cycle(s)/phase(s) where these orders will be done.  You could have something like \"1-4\" or \"screening; treatment\" cycles/phases depending on the study."]
["ii. Starting at row 4, column E, you can type in the days that something needs to be done (treatment days)."]
["iii. Then, at row 6, column E, you can enter the research tolerance window for the treatment days"]
["iv. Finally, under each day, just enter an \"X\" to indicate that that order is to be included."]
["5.        Contraindicated Medications Section"]
["a.  This functionality will only catch orders within CHCO.  The study team will still need to teach patients or guardians on what to do with medication orders outside of the CHCO system."]
["b.    This functionality is meant to act as an additional safety strategy to supplement current processes., not be a replacement."]
["c.   The list of medications supplied by the study team will not be updated/maintained by anyone else.  The PI is responsible for submitting an amendment request to add any medications to said list.  Addition can be based on multiple factors including but not limited to new FDA approved medications, or changes to the contraindicated medications list in a study protocol. "]
["d.   These alerts are not hard stops.  CHCO providers may choose to override the alert and order the medication without calling the study team.  The ordering provider will be required to provide a reason or comment for all overrides."]
["e.  Alerts may not be effective in emergency situations where medications are given before an order is submitted in Epic and thus before an alert is presented to the provider."]
["f.  In the unlikely situation a contraindicated medication is administered due to a missing alert, the study team should call it in to the helpdesk to report it as an incident so that the CAS willow team can investigate the cause. This is different from an amendment request and should only be used for studies that have already added contraindicated medications to their study with the help of CAS analysts."]
["g.  Study teams may opt out of using this functionality, but it is not recommended by the EHR Medication Management Governance committee."]
["g.  Please state which of the following messages you would like to include each group"]
["                       Very High: Potential Study Disqualification\n                                          1. This medication will affect this patient’s participation in a research study. EXCLUDING EMERGENCY SITUATIONS, please consider ordering an alternative medication or contacting the study PI at  \n                                                (720-555-5555) or (720-555-5555).\n                                          2. This medication may cause harm to the patient and affect this patient’s participation in a research study.  EXCLUDING EMERGENCY SITUATIONS, please consider ordering an alternative \n                                                 medication or contacting the study PI at (720-555-5555) or (720-555-5555).\n\n                       High: Investigational Medication Interaction\n                                           3. This medication may interact with the patient’s research study medication. EXCLUDING EMERGENCY SITUATIONS, please consider ordering an alternative medication or contacting the study PI \n                                                 at (720-555-5555) or (720-555-5555)\n                                            4  This medication may cause harm to the patient and interact with the patient’s research study medication. EXCLUDING EMERGENCY SITUATIONS, please consider ordering an alternative \n                                                   medication or contacting the study PI at (720-555-5555) or (720-555-555)."]
["6.        Amendment"]
["a.   Complete the amendment sheet if you need to change existing Epic study build. "]
["          b.  If extensive changes are needed to a treatment plan, detail those changes in the study calendar"]
["c.    CHCO Financial Representative:  A CHCO Financial Representative must review the form to validate expected procedures and charges. Please enter the analyst that's been assigned to your study for budget review."]
["d.    PI Sign Off:  PI must sign off on this document after reviewing it."]
["7.        Submission"]
["a.   Submit the completed sheet through a CAS Work Request along with a study Personnel Log or DOA. CAS Work Requests missing these documents will not be approved. "]
["          b.  Once approved the CAS Research team will contact you to schedule an EUP or Validation "]
[]
[]
["Version 11.2021"]

{"sheet":"General Information","index":1,"n_rows":80,"n_cols":2,"rows_kept":80,"cut":false,"hidden":false,"merged":[]}
["Study Information"]
[]
["New Study/Amendment","New Study"]
[]
["Study IRB#","xx-xxxx"]
["22-2222"]
["Last IRB Approval Date","x.x.xxxx"]
[234]
["Funding Source","Federal"]
[]
["Study Type","Interventional"]
[]
["Study Title","ABC"]
[]
["Brief Study Format "]
[]
["Approved # of Participants",50]
[]
["Study Team"]
["  Dept/Group"]
[]
["PI"]
[]
["PI Contact #"]
[]
["Primary Coordinator"]
[]
["Primary Coordinator Contact #"]
[]
["Other Study Coordinator(s)"]
[]
["Co-Is/Sub-Is"]
[]
["Study Details"]
["Epic Study Title"]
[]
["NOC Sites"]
[]
["MyChart Study Title"]
[]
["MyChart Study Description"]
[]
["Patient Consents"]
[]
["PI Consent Scanning"]
[]
["Study Build Questions"]
["Electronic Signatures"]
[]
["Investigational Drug or Device"]
[]
["Radiology Orders"]
[]
["Ancillary Services Used"]
[]
["Adverse Events"]
[]
["Study Results Notification"]
[]
["Appt. Change Notification"]
[]
["ADT Notification"]
[]
["Contraindicated Medications"]
[]
["Treatment Plans"]
["Treatment Period (days) "]
[]
["Number of Arms "]
[]
["Names of Arms "]
[]
[]
[]
[]
["Default Dosing Option (Select One)","Use Documented Weight and BSA"]
[]
["CHCO Financial Representative"]
[]
["PI has reviewed and approves of all information and orders listed in this document"]

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[null,null,null,null,null,null,null,"Cycle/Phase # or Name",null,null,null,"Cycle/Phase # or Name",null,null,null,null,null,"Cycle/Phase # or Name",null,null,null,null,null,"Cycle/Phase # or Name",null,null,null,null,null,"Cycle/Phase  # or Name",null,null,null,null,null,"Cycle/Phase  # or Name"]
["EXAMPLE- Venipuncture",null,null,null,null,null,null,"Visit 1",null,null,null,"Visit 2",null,null,null,null,null,"Visit 3",null,null,null,null,null,"Visit 4",null,null,null,null,null,"Visit 5"]
["Refer to 'Read Me' Tab for basic information on each section of this form.",null,null,null,null,null,null,"Days",null,null,null,"Days",null,null,null,null,null,"Days",null,null,null,null,null,"Days",null,null,null,null,null,"Days",null,null,null,null,null,"Days"]
[]
[null,null,null,null,null,null,"Need to add a line?  Use \"Insert\".","Research Tolerance",null,null,null,"Research Tolerance",null,null,null,null,null,"Research Tolerance",null,null,null,null,null,"Research Tolerance",null,null,null,null,null,"Research Tolerance",null,null,null,null,null,"Research Tolerance"]
[null,"Order",null,null,"Details/Comments"]
["Patient Care Orders, Tasks, Information    ","Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         Patient Care Orders, Tasks, Information                                         "]
[null,null,"Epic Order Code","Epic Charge Code","Performed By",null,"Details/Comments"]
[null,"Example: Vitals, Assessments, Communications",null,null,"Study Team"]
["\n"]
[null,"Vitals",null,999010501,"CTRC",null,null,"R",null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R"]
[null,"Anthros",null,999010081,"CTRC",null,null,"R",null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R"]
["Labs","Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 Labs                                                 "]
[null,null,"Epic Order Code","Epic Charge Code","Who is Collecting?","Who is Processing?","Who is Performing?"]
[null,"Example:  CBC","lab1234",null,"Outpatient Lab","Outpatient Lab","CHCO Main Lab",0,null,null,null,0,null,null,null,null,null,0,null,null,null,null,null,0,null,null,null,null,null,0]
[null,"Interleukin-6 ",null,null,"CTRC Nurses","CTRC Nurses","CTRC Peds Lab","R",null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R"]
[null,"CBC",null,null,"CTRC Nurses","CTRC Nurses","Central lab","R",null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R"]
[null,"Urinalysis",null,null,"Study Team","CTRC Nurses","Central lab","R",null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R",null,null,null,null,null,"R"]
[null,"PRN/Additional Medications  (Drug, Dose, route, frequency, # of doses)                PRN/Additional Medications  (Drug, Dose, route, frequency, # of doses)                PRN/Additional Medications  (Drug, Dose, route, frequency, # of doses)                PRN/Additional Medications  (Drug, Dose, route, frequency, # of doses)                PRN/Additional Medications  (Drug, Dose, route, frequency, # of doses)                "]
[null,null,"Epic Order Code","Epic Charge Code","In-Clinic Administration/Take Home Med","Study Supplied? (Y/N)","Details/Comments"]
[null,"Example:           EMLA, Emergency Meds",123456,null,"In Clinic","N","0.5mg, Topical, PRN"]
[null,"EMLA",null,null,"In Clinic","N","0.5mg, Topical, PRN","R"]
[]
[]
["EPIC Charge Codes"]
["For any questions on EPIC charge codes, contact your CHCO Finance Analyst."]
[null,"Contraindicated Medications : Potential Study Disqualification"]
[null,"Medication Name ","Epic Order Code","Epic Charge Code","Message 1 or 2 (see read me section g)\nand Phone number",null,"Details/Comments"]
[null,"Example: Melatonin",123456,null,1,"720-777-7777"]
[]
[]
[]
[null,"Contraindicated Medications : Investigational Medication interaction"]
[null,"Medication Name ","Epic Order Code","Epic Charge Code","Message 3 or 4 (see read me section g)\nand Phone number",null,"Details/Comments"]
[null,"Example: Midazolam",123456,null,4,"720-777-777"]
["Any questions? EUP Request Form queries for CTRC studies can be addressed to CTRC@childrenscolorado.org"]
[]
[]
[]
[]
[]
["Outpatient Lab"]
["CTRC Nurses"]
["Study team"]
[]
[]
["CHCO Main Lab"]
["Central Lab"]
["Back Office"]
["CTRC Peds Lab"]
["CTRC Adult lab"]

{"sheet":"CTRC services Links","index":3,"n_rows":3,"n_cols":2,"rows_kept":3,"cut":false,"hidden":false,"merged":[]}
["Topic","Link"]
["CTRC Nursing services, pricing and EPIC charge codes","https://cctsi.cuanschutz.edu/resources/ctrc/services/chcoservices"]
["CTRC Lab assays and pricing","https://cctsi.cuanschutz.edu/resources/ctrc/services#ft-core-lab-services-1"]

{"sheet":"List Options","index":4,"n_rows":16,"n_cols":22,"rows_kept":16,"cut":false,"hidden":true,"merged":[]}
["Collecting","Processing","Performing","Yes/No","Administration","Radiology Performing","Cardiology Performing","Respiratory Performing","Default Dosing Option","Build Type","Study Type","Cardiology","Funding Source","Consents","Results Routing","Adverse Events","Consent Scanning"," Potential Study Disqualification"," Investigational Medication interaction","New Study/Amendment","Change Type","RSH / SOC"]
["Outpatient Lab","CHCO Main Lab","CHCO Main Lab","Yes","In-Clinic","Study Team","Study Team","Study Team","Use Adjusted Weight and BSA","Smartset (Menu Style)","Observational","Study Team","Industry","Inpatient","PI Only","CTCAE VERSION 4.03","PI",1,3,"New Study","IRB Approved Protocol Revision","R"]
["CTRC Nurses","CTRC Nurses","Back Office","No","OP Prescription","Radiology","Cardiology","Respiratory Therapy","Use Documented Weight and BSA","Smartset (Visit Style)","Interventional","Cardiology","Federal","Outpatient","PI and Coordinators","CTCAE VERSION 5.0","Co-I",2,4,"Amendment","Ancillary/Support Services Requested Change","S"]
["Study Team","Study Team","Central Lab","Unknown",null,null,null,null,"Use Ideal Weight and BSA","Protocol/Treatment Plan","Expanded Access",null,"Unfunded","Both","PI and Other Providers","CTCAE VERSION 4.03 & 5.0","Both",null,null,null,"Medication Only"]
["Inpatient Care Team","CTRC Ped Lab","CTRC Ped Lab",null,null,null,null,null,"Use Manually Entered Weight and BSA",null,null,null,null,"Unknown","PI, RC, and Other Providers","N/A","N/A",null,null,null,"Other"]
[null,"CTRC Adult Lab","CTRC Adult Lab",null,null,null,null,null,"Recalculate Dose each time a new weight or height is documented",null,null,null,null,null,"N/A"]
[]
[]
[]
[]
[]
[]
[]
[]
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[null,null,"Read Me Password: epic"]