From 4a65a810da89de38a2d8156bea6d6d86219c0740 Mon Sep 17 00:00:00 2001 From: Zach Robin Date: Tue, 31 May 2022 11:26:39 -0700 Subject: [PATCH 1/8] Created Questionnaire for enrollment and CES --- .../R4/files/DrugHasREMSRule-0.1.0.cql | 3 + .../Questionnaire-Prescriber-Enrollment.json | 336 ++++++++++++++++++ ...naire-Prescriber-Knowledge-Assessment.json | 282 +++++++++++++++ .../org.eclipse.buildship.core.prefs | 4 +- 4 files changed, 623 insertions(+), 2 deletions(-) create mode 100644 CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Enrollment.json create mode 100644 CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Knowledge-Assessment.json diff --git a/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql b/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql index 1d33ba5d..4347cbc4 100644 --- a/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql +++ b/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql @@ -29,6 +29,9 @@ define RESULT_QuestionnaireDispenseUri: define RESULT_QuestionnaireProgressNoteUri: 'Questionnaire/TuralioRemsPatientStatus' +define RESULT_QuestionairePrescriberEnrollmentUri: + 'Questionaire/TuralioPrescriberEnrollmentForm' + define RESULT_requestId: medication_request diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Enrollment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Enrollment.json new file mode 100644 index 00000000..629199f0 --- /dev/null +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Enrollment.json @@ -0,0 +1,336 @@ +{ + "resourceType": "Questionnaire", + "id": "TuralioPrescriberEnrollmentForm", + "title": "Turalio REMS Prescriber Enrollment Form", + "status": "draft", + "subjectType": [ + "Prescriber" + ], + "date": "2022-05-28", + "publisher": "FDA-REMS", + "item": [ + { + "linkId": "1", + "type": "group", + "text": "Prescriber Information", + "item": [ + { + "linkId": "1.1", + "text": "First Name", + "type": "string", + "required": true + }, + { + "linkId": "1.2", + "text": "Last Name", + "type": "string", + "required": true + }, + { + "linkId": "1.3", + "text": "Middle Initial", + "type": "string", + "required": false + }, + { + "linkId": "1.4", + "text": "Credentials", + "type": "open-choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "MD", + "display": "MD" + } + }, + { + "valueCoding": { + "code": "DO", + "display": "DO" + } + }, + { + "valueCoding": { + "code": "NP", + "display": "NP" + } + }, + { + "valueCoding": { + "code": "PA", + "display": "PA" + } + }, + { + "valueCoding": { + "code": "Other", + "display": "Other" + } + } + ] + }, + { + "linkId": "1.4", + "text": "Specialty", + "type": "open-choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "Oncolgy", + "display": "Oncology" + } + }, + { + "valueCoding": { + "code": "Orthopedics", + "display": "Orthopedics" + } + }, + { + "valueCoding": { + "code": "Other", + "display": "Other" + } + } + ] + }, + { + "linkId": "1.5", + "text": "National Provider Identifier (NPI) #", + "type": "string", + "required": true + }, + { + "linkId": "1.6", + "text": "State License #", + "type": "string", + "required": true + }, + { + "linkId": "1.7", + "text": "Practice/Facility Name", + "type": "string", + "required": false + }, + { + "linkId": "1.7", + "text": "Practice/Facility Name", + "type": "string", + "required": false + }, + { + "linkId": "1.8", + "text": "Street Address", + "type": "string", + "required": true + }, + { + "linkId": "1.9", + "text": "City", + "type": "string", + "required": true + }, + { + "linkId": "1.10", + "text": "State", + "type": "string", + "required": true + }, + { + "linkId": "1.11", + "text": "ZIP Code", + "type": "string", + "required": true + }, + { + "linkId": "1.12", + "text": "Office Phone Number", + "type": "string", + "required": true + }, + { + "linkId": "1.13", + "text": "Office Fax Number", + "type": "string", + "required": true + }, + { + "linkId": "1.14", + "text": "E-Mail", + "type": "string", + "required": true + }, + { + "linkId": "1.15", + "text": "Perfered Method of Communication", + "type": "open-choice", + "required": false, + "answerOption": [ + { + "valueCoding": { + "code": "Fax", + "display": "Fax" + } + }, + { + "valueCoding": { + "code": "Email", + "display": "Email" + } + }, + { + "valueCoding": { + "code": "Phone", + "display": "Phone" + } + } + ] + }, + { + "linkId": "1.4", + "text": "Perferred Time of Contact", + "type": "open-choice", + "required": false, + "answerOption": [ + { + "valueCoding": { + "code": "AM", + "display": "AM" + } + }, + { + "valueCoding": { + "code": "PM", + "display": "PM" + } + } + ] + } + + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Office Contact Information", + "item": [ + { + "linkId": "2.1", + "text": "Prescribers may grant administrative rights to two (2) Office Contacts which allow them to view, edit, and initiate paperwork related to the TURALIO REMS via the REMS Portal.", + "type": "display" + }, + { + "linkId": "2.2", + "text": "I, the prescriber, grant administrative rights to the office contact(s) listed below and understand that I must review all paperwork and sign prior to submitting to the REMS.", + "type": "display" + }, + { + "linkId": "2.3", + "type": "group", + "text": "Office Contact #1 (Optional)", + "item": [ + { + "linkId": "2.3.1", + "text": "First Name", + "type": "string", + "required": false + }, + { + "linkId": "2.3.2", + "text": "Last Name", + "type": "string", + "required": false + }, + { + "linkId": "2.3.3", + "text": "Office Phone Number", + "type": "string", + "required": false + }, + { + "linkId": "2.3.4", + "text": "Office Fax Number", + "type": "string", + "required": false + }, + { + "linkId": "2.3.5", + "text": "Email", + "type": "string", + "required": false + } + ] + }, + { + "linkId": "2.4", + "type": "group", + "text": "Office Contact #2 (Optional)", + "item": [ + { + "linkId": "2.4.1", + "text": "First Name", + "type": "string", + "required": false + }, + { + "linkId": "2.4.2", + "text": "Last Name", + "type": "string", + "required": false + }, + { + "linkId": "2.4.3", + "text": "Office Phone Number", + "type": "string", + "required": false + }, + { + "linkId": "2.4.4", + "text": "Office Fax Number", + "type": "string", + "required": false + }, + { + "linkId": "2.4.5", + "text": "Email", + "type": "string", + "required": false + } + ] + }, + { + "linkId": "2.5", + "text": "Office Contacts can be updated by visiting www.turaliorems.com or contacting the TURALIO REMS Coordinating Center at 1-833-TURALIO (833-887-2546).", + "type": "display" + } + ] + }, + { + "linkId": "3", + "type": "group", + "text": "Prescriber Attestations", + "item": [ + { + "linkId": "3.1", + "text": "NEED TEXT", + + "type": "display", + "readOnly": true + }, + { + "linkId": "3.2", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire", + "valueCanonical": "questionnaire/provider-signature" + } + ], + "type": "display" + } + + ] + } + ] +} \ No newline at end of file diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Knowledge-Assessment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Knowledge-Assessment.json new file mode 100644 index 00000000..82477a31 --- /dev/null +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Knowledge-Assessment.json @@ -0,0 +1,282 @@ +{ + "resourceType": "Questionnaire", + "id": "TuralioPrescriberKnowledgeAssessment", + "title": "Turalio REMS Prescriber Knowledge Assessment", + "status": "draft", + "subjectType": [ + "Prescriber" + ], + "date": "2022-05-28", + "publisher": "FDA-REMS", + "item": [ + { + "linkId": "1", + "type": "group", + "text": "Prescriber Information", + "item": [ + { + "linkId": "1.1", + "text": "First Name", + "type": "string", + "required": true + }, + { + "linkId": "1.2", + "text": "Last Name", + "type": "string", + "required": true + }, + { + "linkId": "1.3", + "text": "Middle Initial", + "type": "string", + "required": false + }, + { + "linkId": "1.4", + "text": "National Provider Identifier (NPI) #", + "type": "string", + "required": true + }, + { + "linkId": "1.5", + "text": "Phone Number", + "type": "string", + "required": true + }, + { + "linkId": "1.6", + "text": "Fax Number", + "type": "string", + "required": true + }, + { + "linkId": "1.7", + "text": "Email", + "type": "string", + "required": true + } + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Knowledge Assessment: Questions 1-9", + "item": [ + { + "linkId": "2.1", + "text": "1. TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "Tue" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.2", + "text": "2. TURALIO is contraindicated in patients with hepatic impairment.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "Tue" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.3", + "text": "3. To prescribe TURALIO, I must enroll each patient in the TURALIO REMS by completing a Patient Enrollment Form with the patient and submitting it to the TURALIO REMS.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "Tue" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.4", + "text": "4. Before treating each patient with TURALIO, I must", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "Become certified in the TURALIO REMS", + "display": "Become certified in the TURALIO REMS" + } + }, + { + "valueCoding": { + "code": "Counsel the patient regarding the risk of serious and potentially fatal liver injury associated with TURALIO", + "display": "Counsel the patient regarding the risk of serious and potentially fatal liver injury associated with TURALIO" + } + }, + { + "valueCoding": { + "code": "Obtain and review baseline liver tests", + "display": "Obtain and review baseline liver tests" + } + }, + { + "valueCoding": { + "code": "All of the above", + "display": "All of the above" + } + } + ] + }, + { + "linkId": "2.5", + "text": "5. One of the primary counseling messages I must tell my patients before prescribing TURALIO is", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "Do not take TURALIO if you have vision issues", + "display": "Do not take TURALIO if you have vision issues" + } + }, + { + "valueCoding": { + "code": "Patients with renal impairment should not start TURALIO at a reduced dose", + "display": "Patients with renal impairment should not start TURALIO at a reduced dose" + } + }, + { + "valueCoding": { + "code": "There is a risk of liver injury associated with TURALIO and liver monitoring is required prior to treatment initiation and periodically while taking TURALIO", + "display": "There is a risk of liver injury associated with TURALIO and liver monitoring is required prior to treatment initiation and periodically while taking TURALIO" + } + }, + { + "valueCoding": { + "code": "None of the above", + "display": "None of the above" + } + } + ] + }, + { + "linkId": "2.6", + "text": "6. I am required to educate my patients on the signs and symptoms of liver injury and the need to notify me should they experience them.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "Tue" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.7", + "text": "7. If any dose modifications are required, they must be done in increments of 200 mg.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "Tue" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.8", + "text": "8. After treatment initiation, I need to monitor liver tests weekly for the first 8 weeks of treatment, every 2 weeks for the next month, and every 3 months thereafter.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "Tue" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.9", + "text": "9. I must complete a Patient Status Form for each patient taking TURALIO and submit it to the TURALIO RE-MS:", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "Every month during treatment", + "display": "Every month during treatment" + } + }, + { + "valueCoding": { + "code": "Weekly for 8 weeks of treatment, every 2 weeks for the next month, and every 3 months thereafter", + "display": "Weekly for 8 weeks of treatment, every 2 weeks for the next month, and every 3 months thereafter" + } + }, + { + "valueCoding": { + "code": "Every month for the first 3 months of treatment, month 6, month 9, and month 12 of treatment, and every 6 months thereafter", + "display": "Every month for the first 3 months of treatment, month 6, month 9, and month 12 of treatment, and every 6 months thereafter" + } + }, + { + "valueCoding": { + "code": "Every month for the first 6 months of treatment and every 6 months thereafter", + "display": "Every month for the first 6 months of treatment and every 6 months thereafter" + } + }, + { + "valueCoding": { + "code": "None of the above", + "display": "None of the above" + } + } + ] + } + ] + } + ] +} \ No newline at end of file diff --git a/RuleUtils/.settings/org.eclipse.buildship.core.prefs b/RuleUtils/.settings/org.eclipse.buildship.core.prefs index 97a9583f..b27bccc4 100644 --- a/RuleUtils/.settings/org.eclipse.buildship.core.prefs +++ b/RuleUtils/.settings/org.eclipse.buildship.core.prefs @@ -1,11 +1,11 @@ arguments= auto.sync=false build.scans.enabled=false -connection.gradle.distribution=GRADLE_DISTRIBUTION(VERSION(6.3)) +connection.gradle.distribution=GRADLE_DISTRIBUTION(LOCAL_INSTALLATION(/Users/zrobin/.sdkman/candidates/gradle/current)) connection.project.dir= eclipse.preferences.version=1 gradle.user.home= -java.home=/Library/Java/JavaVirtualMachines/adoptopenjdk-11-openj9.jdk/Contents/Home +java.home=/Users/zrobin/.sdkman/candidates/java/11.0.2-open jvm.arguments= offline.mode=false override.workspace.settings=true From d8f8e8d8467b663ba7ec8d580d934c2d690aafaf Mon Sep 17 00:00:00 2001 From: Zach Robin Date: Tue, 31 May 2022 12:58:20 -0700 Subject: [PATCH 2/8] Added provider CES Quesitonnaire --- CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql | 7 +++++-- 1 file changed, 5 insertions(+), 2 deletions(-) diff --git a/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql b/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql index 4347cbc4..18808765 100644 --- a/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql +++ b/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql @@ -29,8 +29,11 @@ define RESULT_QuestionnaireDispenseUri: define RESULT_QuestionnaireProgressNoteUri: 'Questionnaire/TuralioRemsPatientStatus' -define RESULT_QuestionairePrescriberEnrollmentUri: - 'Questionaire/TuralioPrescriberEnrollmentForm' +define RESULT_QuestionnairePrescriberEnrollmentUri: + 'Questionnaire/TuralioPrescriberEnrollmentForm' + +define RESULT_QuestionnairePrescriberKnowledgeAssessmentUri: + 'Questionnaire/TuralioPrescriberKnowledgeAssessment' define RESULT_requestId: medication_request From 79de524e0329f9c32c789dee245747d31740c6d9 Mon Sep 17 00:00:00 2001 From: kghoreshi Date: Tue, 31 May 2022 17:00:29 -0400 Subject: [PATCH 3/8] rename files and various fixes --- ...estionnaire-R4-Prescriber-Enrollment.json} | 31 ++++++++++--------- ...e-R4-Prescriber-Knowledge-Assessment.json} | 1 + 2 files changed, 17 insertions(+), 15 deletions(-) rename CRD-DTR/DrugHasREMS/R4/resources/{Questionnaire-Prescriber-Enrollment.json => Questionnaire-R4-Prescriber-Enrollment.json} (98%) rename CRD-DTR/DrugHasREMS/R4/resources/{Questionnaire-Prescriber-Knowledge-Assessment.json => Questionnaire-R4-Prescriber-Knowledge-Assessment.json} (99%) diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Enrollment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json similarity index 98% rename from CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Enrollment.json rename to CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json index 629199f0..cf7a0863 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Enrollment.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json @@ -1,10 +1,11 @@ { "resourceType": "Questionnaire", "id": "TuralioPrescriberEnrollmentForm", + "name": "TuralioPrescriberEnrollmentForm", "title": "Turalio REMS Prescriber Enrollment Form", "status": "draft", "subjectType": [ - "Prescriber" + "Practitioner" ], "date": "2022-05-28", "publisher": "FDA-REMS", @@ -71,7 +72,7 @@ ] }, { - "linkId": "1.4", + "linkId": "1.5", "text": "Specialty", "type": "open-choice", "required": true, @@ -97,73 +98,73 @@ ] }, { - "linkId": "1.5", + "linkId": "1.6", "text": "National Provider Identifier (NPI) #", "type": "string", "required": true }, { - "linkId": "1.6", + "linkId": "1.7", "text": "State License #", "type": "string", "required": true }, { - "linkId": "1.7", + "linkId": "1.8", "text": "Practice/Facility Name", "type": "string", "required": false }, { - "linkId": "1.7", + "linkId": "1.9", "text": "Practice/Facility Name", "type": "string", "required": false }, { - "linkId": "1.8", + "linkId": "1.10", "text": "Street Address", "type": "string", "required": true }, { - "linkId": "1.9", + "linkId": "1.11", "text": "City", "type": "string", "required": true }, { - "linkId": "1.10", + "linkId": "1.12", "text": "State", "type": "string", "required": true }, { - "linkId": "1.11", + "linkId": "1.13", "text": "ZIP Code", "type": "string", "required": true }, { - "linkId": "1.12", + "linkId": "1.14", "text": "Office Phone Number", "type": "string", "required": true }, { - "linkId": "1.13", + "linkId": "1.15", "text": "Office Fax Number", "type": "string", "required": true }, { - "linkId": "1.14", + "linkId": "1.16", "text": "E-Mail", "type": "string", "required": true }, { - "linkId": "1.15", + "linkId": "1.17", "text": "Perfered Method of Communication", "type": "open-choice", "required": false, @@ -189,7 +190,7 @@ ] }, { - "linkId": "1.4", + "linkId": "1.18", "text": "Perferred Time of Contact", "type": "open-choice", "required": false, diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Knowledge-Assessment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json similarity index 99% rename from CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Knowledge-Assessment.json rename to CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json index 82477a31..7485fcbf 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-Prescriber-Knowledge-Assessment.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json @@ -1,6 +1,7 @@ { "resourceType": "Questionnaire", "id": "TuralioPrescriberKnowledgeAssessment", + "name": "TuralioPrescriberKnowledgeAssessment", "title": "Turalio REMS Prescriber Knowledge Assessment", "status": "draft", "subjectType": [ From 478d3ef7d545495f1859da6603ea42d79b6bbb25 Mon Sep 17 00:00:00 2001 From: kghoreshi Date: Wed, 1 Jun 2022 13:14:47 -0400 Subject: [PATCH 4/8] revert settings file and gitignore it --- .gitignore | 1 + RuleUtils/.settings/org.eclipse.buildship.core.prefs | 4 ++-- 2 files changed, 3 insertions(+), 2 deletions(-) diff --git a/.gitignore b/.gitignore index 0721a57e..39600b82 100644 --- a/.gitignore +++ b/.gitignore @@ -20,6 +20,7 @@ gradle/gradle-4.10.1/* request-generator/* server/src/main/resources/react/node_modules/* +RuleUtils/.settings/ node_modules package-lock.json diff --git a/RuleUtils/.settings/org.eclipse.buildship.core.prefs b/RuleUtils/.settings/org.eclipse.buildship.core.prefs index b27bccc4..97a9583f 100644 --- a/RuleUtils/.settings/org.eclipse.buildship.core.prefs +++ b/RuleUtils/.settings/org.eclipse.buildship.core.prefs @@ -1,11 +1,11 @@ arguments= auto.sync=false build.scans.enabled=false -connection.gradle.distribution=GRADLE_DISTRIBUTION(LOCAL_INSTALLATION(/Users/zrobin/.sdkman/candidates/gradle/current)) +connection.gradle.distribution=GRADLE_DISTRIBUTION(VERSION(6.3)) connection.project.dir= eclipse.preferences.version=1 gradle.user.home= -java.home=/Users/zrobin/.sdkman/candidates/java/11.0.2-open +java.home=/Library/Java/JavaVirtualMachines/adoptopenjdk-11-openj9.jdk/Contents/Home jvm.arguments= offline.mode=false override.workspace.settings=true From f027dfc841151c124c6d641fdad4cf3f64ed0d65 Mon Sep 17 00:00:00 2001 From: Sahil Malhotra Date: Wed, 1 Jun 2022 14:33:27 -0400 Subject: [PATCH 5/8] prescriber enrollment attestation --- .../R4/resources/Questionnaire-R4-Prescriber-Enrollment.json | 3 +-- 1 file changed, 1 insertion(+), 2 deletions(-) diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json index cf7a0863..99db9cba 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json @@ -315,8 +315,7 @@ "item": [ { "linkId": "3.1", - "text": "NEED TEXT", - + "text": "By signing this form, I agree TURALIO is only available through the TURALIO REMS and I agree to comply with the following TURALIO REMS requirements: \n\n I have: \n - Reviewed the Prescribing Information, Program Overview and Prescriber Training. \n - Successfully completed the Prescriber Knowledge Assessment and submitted it to the TURALIO REMS. \n\n Before treatment initiation and with the first dose of TURALIO: \n - I understand that I should counsel the patient on the risk of serious and potentially fatal liver injury, and liver test monitoring at baseline and periodically during treatment. \n - I must assess the patient by obtaining baseline liver tests. I must submit the results of the assessment on the Patient Enrollment Form. \n - I must enroll patients in the TURALIO REMS by completing and submitting the Patient Enrollment Form. \n\n During treatment with TURALIO: \n - I must assess the patient by obtaining liver tests weekly for the first 8 weeks, then every 2 weeks for 1 month, then every 3 months and modify the dose of TURALIO as needed in accordance with the Prescribing Information. \n - I must prescribe no more than a 30 days supply for each of the first 3 months of treatment. \n - I must complete the Patient Status Form every month for the first 3 months of treatment, at months 6, 9, and 12 and then every 6 months thereafter while the patient receives TURALIO. \n\n At all times: \n - I must report adverse events of serious and potentially fatal liver injury by submitting the Liver Adverse Event Reporting Form. \n - I understand that Daiichi Sankyo, Inc. and/or its agents may contact me by phone, mail or email to provide or obtain additional information related to the REMS program, including details regarding any reported liver adverse events. \n", "type": "display", "readOnly": true }, From 3174a6d7e8d8599373b9e0bc6f0b47e6b82f9cf6 Mon Sep 17 00:00:00 2001 From: kghoreshi Date: Wed, 1 Jun 2022 14:55:05 -0400 Subject: [PATCH 6/8] cql reference modifications --- ...re-R4-Prescriber-Knowledge-Assessment.json | 58 +++++++++++- ...Questionnaire-R4-Turalio-ProgressNote.json | 90 ++----------------- 2 files changed, 61 insertions(+), 87 deletions(-) diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json index 7485fcbf..e4b2235c 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json @@ -9,6 +9,12 @@ ], "date": "2022-05-28", "publisher": "FDA-REMS", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", + "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/BasicPractitionerInfo-prepopulation" + } + ], "item": [ { "linkId": "1", @@ -19,25 +25,69 @@ "linkId": "1.1", "text": "First Name", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicClinicalInfoPrepopulation\".EncounterProviderFirstName" + } + }, + { + "url" : "http://hl7.org/fhir/StructureDefinition/minLength", + "valueInteger": 2 + } + ] }, { "linkId": "1.2", "text": "Last Name", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicClinicalInfoPrepopulation\".EncounterProviderLastName" + } + }, + { + "url" : "http://hl7.org/fhir/StructureDefinition/minLength", + "valueInteger": 2 + } + ] }, { "linkId": "1.3", "text": "Middle Initial", "type": "string", - "required": false + "required": false, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicClinicalInfoPrepopulation\".EncounterProviderMiddleInitial" + } + } + ] }, { "linkId": "1.4", "text": "National Provider Identifier (NPI) #", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicClinicalInfoPrepopulation\".EncounterProviderNPI" + } + } + ] }, { "linkId": "1.5", diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Turalio-ProgressNote.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Turalio-ProgressNote.json index 491b7540..f0cbd0dc 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Turalio-ProgressNote.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Turalio-ProgressNote.json @@ -9,10 +9,6 @@ ] }, "extension": [ - { - "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", - "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/RemsDrugs-prepopulation" - }, { "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/BasicClinicalInfo-prepopulation" @@ -62,15 +58,6 @@ { "linkId": "4", "text": "Current Other Diagnoses", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".CurrentDiagnoses" - } - } - ], "type": "open-choice", "repeats": true, "required": true, @@ -87,31 +74,13 @@ "text": "Transplants for Order", "type": "open-choice", "repeats": true, - "answerOption": [], - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".QualifyingTransplantCodings" - } - } - ] + "answerOption": [] }, { "linkId": "5.2", "text": "Date of transplant", "type": "date", - "required": true, - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".TransplantDate" - } - } - ] + "required": true }, { "linkId": "5.3", @@ -254,72 +223,27 @@ { "linkId": "9.1", "type": "text", - "text": "RxNorm Code", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationCode" - } - } - ] + "text": "RxNorm Code" }, { "linkId": "9.2", "type": "text", - "text": "Drug", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationName" - } - } - ] + "text": "Drug" }, { "linkId": "9.3", "type": "text", - "text": "Route", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationRoute" - } - } - ] + "text": "Route" }, { "linkId": "9.4", "type": "text", - "text": "Dose", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationDoseWithUnit" - } - } - ] + "text": "Dose" }, { "linkId": "9.5", "type": "text", - "text": "Frequency", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationFrequency" - } - } - ] + "text": "Frequency" } ] }, From 17510dc82c1a47fd54cdff46166c7d87403aa0f5 Mon Sep 17 00:00:00 2001 From: kghoreshi Date: Wed, 1 Jun 2022 15:07:34 -0400 Subject: [PATCH 7/8] fix typos --- ...uestionnaire-R4-Prescriber-Enrollment.json | 30 ++++++------------- ...re-R4-Prescriber-Knowledge-Assessment.json | 14 ++++----- 2 files changed, 16 insertions(+), 28 deletions(-) diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json index 99db9cba..d8bd80e1 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json @@ -105,66 +105,54 @@ }, { "linkId": "1.7", - "text": "State License #", - "type": "string", - "required": true - }, - { - "linkId": "1.8", - "text": "Practice/Facility Name", - "type": "string", - "required": false - }, - { - "linkId": "1.9", "text": "Practice/Facility Name", "type": "string", "required": false }, { - "linkId": "1.10", + "linkId": "1.8", "text": "Street Address", "type": "string", "required": true }, { - "linkId": "1.11", + "linkId": "1.9", "text": "City", "type": "string", "required": true }, { - "linkId": "1.12", + "linkId": "1.10", "text": "State", "type": "string", "required": true }, { - "linkId": "1.13", + "linkId": "1.11", "text": "ZIP Code", "type": "string", "required": true }, { - "linkId": "1.14", + "linkId": "1.12", "text": "Office Phone Number", "type": "string", "required": true }, { - "linkId": "1.15", + "linkId": "1.13", "text": "Office Fax Number", "type": "string", "required": true }, { - "linkId": "1.16", + "linkId": "1.14", "text": "E-Mail", "type": "string", "required": true }, { - "linkId": "1.17", + "linkId": "1.15", "text": "Perfered Method of Communication", "type": "open-choice", "required": false, @@ -190,7 +178,7 @@ ] }, { - "linkId": "1.18", + "linkId": "1.16", "text": "Perferred Time of Contact", "type": "open-choice", "required": false, diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json index e4b2235c..b1071a2b 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json @@ -122,7 +122,7 @@ { "valueCoding": { "code": "true", - "display": "Tue" + "display": "True" } }, { @@ -141,7 +141,7 @@ { "valueCoding": { "code": "true", - "display": "Tue" + "display": "True" } }, { @@ -160,7 +160,7 @@ { "valueCoding": { "code": "true", - "display": "Tue" + "display": "True" } }, { @@ -241,7 +241,7 @@ { "valueCoding": { "code": "true", - "display": "Tue" + "display": "True" } }, { @@ -260,7 +260,7 @@ { "valueCoding": { "code": "true", - "display": "Tue" + "display": "True" } }, { @@ -279,7 +279,7 @@ { "valueCoding": { "code": "true", - "display": "Tue" + "display": "True" } }, { @@ -292,7 +292,7 @@ }, { "linkId": "2.9", - "text": "9. I must complete a Patient Status Form for each patient taking TURALIO and submit it to the TURALIO RE-MS:", + "text": "9. I must complete a Patient Status Form for each patient taking TURALIO and submit it to the TURALIO REMS:", "type": "open-choice", "answerOption": [ { From 18a98371e94d3099b20f04e8d110743fe662f017 Mon Sep 17 00:00:00 2001 From: kghoreshi Date: Wed, 1 Jun 2022 17:11:11 -0400 Subject: [PATCH 8/8] minor fix --- ...uestionnaire-R4-Prescriber-Enrollment.json | 26 ++++++++++++------- 1 file changed, 16 insertions(+), 10 deletions(-) diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json index d8bd80e1..786ea90f 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json @@ -104,55 +104,61 @@ "required": true }, { - "linkId": "1.7", + "linkId": "1.7", + "text": "State License #", + "type": "string", + "required": false + }, + { + "linkId": "1.8", "text": "Practice/Facility Name", "type": "string", "required": false }, { - "linkId": "1.8", + "linkId": "1.9", "text": "Street Address", "type": "string", "required": true }, { - "linkId": "1.9", + "linkId": "1.10", "text": "City", "type": "string", "required": true }, { - "linkId": "1.10", + "linkId": "1.11", "text": "State", "type": "string", "required": true }, { - "linkId": "1.11", + "linkId": "1.12", "text": "ZIP Code", "type": "string", "required": true }, { - "linkId": "1.12", + "linkId": "1.13", "text": "Office Phone Number", "type": "string", "required": true }, { - "linkId": "1.13", + "linkId": "1.14", "text": "Office Fax Number", "type": "string", "required": true }, { - "linkId": "1.14", + "linkId": "1.15", "text": "E-Mail", "type": "string", "required": true }, { - "linkId": "1.15", + "linkId": "1.16", "text": "Perfered Method of Communication", "type": "open-choice", "required": false, @@ -178,7 +184,7 @@ ] }, { - "linkId": "1.16", + "linkId": "1.17", "text": "Perferred Time of Contact", "type": "open-choice", "required": false,