NINDS COMMON DATA ELEMENT (CDE) CHECKLIST FOR …



This checklist presents an outline of the case report form (CRF) modules. It can be used to help you and your staff members identify CDEs which appear to be relevant to your clinical trial. Headings followed by a group of modules are denoted with an alphabetic character. If an item or group of items are not relevant to your hypothesis or study design, then you do not need to include them in your study.NINDS STROKE CDE CHECKLISTCRF ModuleLocation(Disease Standards Page Name → Data Standards Domain → Sub-Domain)Needed?CommentsScreening LogGeneral → Protocol Experience → Participant/Subject Identification, Eligibility, and Enrollment FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteInclusion and Exclusion CriteriaGeneral → Protocol Experience → Participant/Subject Identification, Eligibility, and Enrollment FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteInformed Consent and Enrollment NOTEREF _Ref395511948 \f \h \* MERGEFORMAT 2General → Protocol Experience → Participant/Subject Identification, Eligibility, and Enrollment FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteVisit Schedule NOTEREF _Ref395514818 \f \h \* MERGEFORMAT 1General → Protocol Experience → Study Management FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteParticipant/Subject CharacteristicsN/AN/AN/ADemographicsStroke → Participant/Subject Characteristics → Demographics FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteSocial StatusStroke → Participant/Subject Characteristics → Social Status FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteMedical HistoryStroke → Participant /Subject History and Family History → General Health History FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteFamily HistoryStroke → Participant /Subject History and Family History → General Health History FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteMedication HistoryStroke → Participant /Subject History and Family History → General Health History FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteBehavioral HistoryStroke → Participant /Subject History and Family History → General Health History FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by sitePregnancy and Prenatal HistoryStroke → Participant /Subject History and Family History → General Health History FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by sitePrior Functional StatusStroke → Participant /Subject History and Family History → Prior Health Status FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteEvent OnsetN/A FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by sitePre-Hospital/ EMS CourseStroke → Disease/Injury Related Events → History of Disease/Injury Event FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteHospital Arrival/ AdmissionStroke → Disease/Injury Related Events → History of Disease/Injury Event FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteStroke Symptoms/ Comorbid EventsStroke → Disease/Injury Related Events → History of Disease/Injury Event FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteStroke Type/SubtypeStroke → Disease/Injury Related Events → Classification FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteBaseline AssessmentsN/AN/AN/APhysical/ Neurological ExamStroke → Assessments and Examinations → Physical/Neurological Examination FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteNIH Stroke ScaleStroke → Outcomes and End Points → Neurological Impairment FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteVital SignsStroke → Assessments and Examinations → Vital Signs and Other Body Measures FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteECGStroke → Assessments and Examinations → Non-Imaging Diagnostics FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteC.1 Laboratory Tests and Biospecimens/BiomarkersN/AN/AN/ALaboratory TestsStroke → Assessments and Examinations → Laboratory Test and Biospecimens/Biomarkers FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteBiospecimen Collection and ProcessingStroke → Assessments and Examinations → Laboratory Test and Biospecimens/Biomarkers FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteCoriell’s Cerebrovascular Data ElementsStroke→ Assessments and Examinations → Laboratory Tests and Biospecimens/Biomarkers FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteC.2 Imaging/Non-Imaging DiagnosticsN/AN/AN/AParenchymal ImagingStroke → Assessments and Examinations → Imaging Diagnostics FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by sitePerfusion and Penumbral ImagingStroke → Assessments and Examinations → Imaging Diagnostics FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteVessel Imaging AngiographyStroke → Assessments and Examinations → Imaging Diagnostics FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteVessel Carotid UltrasoundStroke → Assessments and Examinations → Imaging Diagnostics FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteVessel Imaging TCCSStroke → Assessments and Examinations → Imaging Diagnostics FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteVessel Imaging TCDStroke → Assessments and Examinations → Imaging Diagnostics FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by site[Randomization/ Treatment assignment]Data to be entered by siteData to be entered by siteData to be entered by siteTreatment InterventionsN/AN/AN/AStudy Drug Dosing NOTEREF _Ref395511948 \f \h \* MERGEFORMAT 2General → Treatment/Intervention Data → Drugs FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteStudy Drug Compliance NOTEREF _Ref395511948 \f \h \* MERGEFORMAT 2General → Treatment/Intervention Data → Drugs FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteConcomitant Medications NOTEREF _Ref395511948 \f \h \* MERGEFORMAT 2General → Treatment/Intervention Data → Drugs FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteRehabilitation TherapiesStroke → Treatment/Intervention Data → Therapies FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteFollow-upN/AN/AN/AHospital DischargeStroke → Disease/Injury Related Events → Discharge Information FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteE.1 Adverse EventsN/AN/AN/AAdverse Events NOTEREF _Ref395511948 \f \h \* MERGEFORMAT 2General → Safety Data → Adverse Events FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteSerious Adverse Events NOTEREF _Ref395511948 \f \h \* MERGEFORMAT 2General → Safety Data → Adverse Events FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteE.2 Outcomes and End PointsN/AN/AN/ANIH Stroke ScaleStroke → Outcomes and End Points → Neurological Impairment FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteBarthel IndexStroke → Outcomes and End Points → Activities of Daily Living/Functional Status FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteModified Rankin ScaleStroke → Outcomes and End Points → Activities of Daily Living/Functional Status FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by site[Choose additional appropriate outcomes/ endpoints](See Stroke → Outcomes and End Points → Summary of all Outcome Recommendations) FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteStudy Discontinuation/ Completion NOTEREF _Ref395511948 \f \h \* MERGEFORMAT 2General → Protocol Experience → Off Treatment /Off Study FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteE.3 OtherData to be entered by siteData to be entered to siteData to be entered by site[Repeat appropriate assessments under C.]Data to be entered by siteData to be entered to siteData to be entered by siteProtocol Deviations NOTEREF _Ref395514818 \f \h \* MERGEFORMAT 1General → Protocol Experience → Protocol Deviations FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by site ................
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