private void SetInstanceValuesForSpontaneousRelease2(DatasetInstance e2bInstance, DatasetInstance spontaneousReport, User currentUser) { // ************************************* ichicsrmessageheader e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Message Header").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Message Number").DatasetElement, e2bInstance.Id.ToString("D8")); e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Message Header").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Message Date").DatasetElement, DateTime.Today.ToString("yyyyMMddhhmmss")); // ************************************* safetyreport e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Safety Report").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Safety Report ID").DatasetElement, string.Format("PH-FDA-{0}", spontaneousReport.Id.ToString("D5"))); e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Safety Report").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Transmission Date").DatasetElement, DateTime.Today.ToString("yyyyMMdd")); e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Safety Report").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Report Type").DatasetElement, "1"); var seriousReason = spontaneousReport.GetInstanceValue("Reaction serious details"); if (!String.IsNullOrWhiteSpace(seriousReason)) { var sd = "2=No"; var slt = "2=No"; var sh = "2=No"; var sdi = "2=No"; var sca = "2=No"; var so = "2=No"; switch (seriousReason) { case "Resulted in death": sd = "1=Yes"; break; case "Is life-threatening": slt = "1=Yes"; break; case "Is a congenital anomaly/birth defect": sca = "1=Yes"; break; case "Requires hospitalization or longer stay in hospital": sh = "1=Yes"; break; case "Results in persistent or significant disability/incapacity (as per reporter's opinion)": sdi = "1=Yes"; break; case "Other medically important condition": so = "1=Yes"; break; default: break; } e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.DatasetElementGuid.ToString() == "B4EA6CBF-2D9C-482D-918A-36ABB0C96EFA"), sd); //Seriousness Death e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.DatasetElementGuid.ToString() == "26C6F08E-B80B-411E-BFDC-0506FE102253"), slt); //Seriousness Life Threatening e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.DatasetElementGuid.ToString() == "837154A9-D088-41C6-A9E2-8A0231128496"), sh); //Seriousness Hospitalization e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.DatasetElementGuid.ToString() == "DDEBDEC0-2A90-49C7-970E-B7855CFDF19D"), sdi); //Seriousness Disabling e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.DatasetElementGuid.ToString() == "DF89C98B-1D2A-4C8E-A753-02E265841F4F"), sca); //Seriousness Congenital Anomaly e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.DatasetElementGuid.ToString() == "33A75547-EF1B-42FB-8768-CD6EC52B24F8"), so); //Seriousness Other e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.DatasetElementGuid.ToString() == "510EB752-2D75-4DC3-8502-A4FCDC8A621A"), "1"); //Serious } else { e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.DatasetElementGuid.ToString() == "510EB752-2D75-4DC3-8502-A4FCDC8A621A"), "2"); //Serious } e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Safety Report").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Date report was first received").DatasetElement, spontaneousReport.Created.ToString("yyyyMMdd")); e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Safety Report").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Date of most recent info").DatasetElement, spontaneousReport.Created.ToString("yyyyMMdd")); // ************************************* primarysource var fullName = spontaneousReport.GetInstanceValue("Reporter Name"); if (!String.IsNullOrWhiteSpace(fullName)) { if (fullName.Contains(" ")) { e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Primary Source").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Reporter Given Name").DatasetElement, fullName.Substring(0, fullName.IndexOf(" "))); e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Primary Source").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Reporter Family Name").DatasetElement, fullName.Substring(fullName.IndexOf(" ") + 1, fullName.Length - (fullName.IndexOf(" ") + 1))); } else { e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Primary Source").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Reporter Given Name").DatasetElement, fullName); } } MapSenderAndReceivedRelatedFields(e2bInstance); // ************************************* patient var dob = spontaneousReport.GetInstanceValue("Date of Birth"); var onset = spontaneousReport.GetInstanceValue("Reaction known start date"); var recovery = spontaneousReport.GetInstanceValue("Reaction date of recovery"); if (!String.IsNullOrWhiteSpace(dob)) { e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Patient").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Patient Birthdate").DatasetElement, Convert.ToDateTime(dob).ToString("yyyyMMdd")); if (!String.IsNullOrWhiteSpace(onset)) { var age = (Convert.ToDateTime(onset) - Convert.ToDateTime(dob)).Days; e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Patient").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Patient Onset Age").DatasetElement, age.ToString()); e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Patient").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Patient Onset Age Unit").DatasetElement, "804=Day"); } } // ************************************* reaction var term = spontaneousReport.GetInstanceValue("TerminologyMedDra"); var termOut = "NOT SET"; if (!String.IsNullOrWhiteSpace(term)) { var termid = Convert.ToInt32(term); termOut = _unitOfWork.Repository <TerminologyMedDra>().Queryable().Single(u => u.Id == termid).DisplayName; } ; e2bInstance.SetInstanceValue(_unitOfWork.Repository <DatasetElement>().Queryable().Single(dse => dse.ElementName == "Reaction MedDRA LLT"), termOut); if (!String.IsNullOrWhiteSpace(onset)) { e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Reaction").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Reaction Start Date").DatasetElement, Convert.ToDateTime(onset).ToString("yyyyMMdd")); } ; if (!String.IsNullOrWhiteSpace(onset) && !String.IsNullOrWhiteSpace(recovery)) { var rduration = (Convert.ToDateTime(recovery) - Convert.ToDateTime(onset)).Days; e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Reaction").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Reaction Duration").DatasetElement, rduration.ToString()); e2bInstance.SetInstanceValue(e2bInstance.Dataset.DatasetCategories.Single(dc => dc.DatasetCategoryName == "Reaction").DatasetCategoryElements.Single(dce => dce.DatasetElement.ElementName == "Reaction Duration Unit").DatasetElement, "804=Day"); } // ************************************* drug var destinationProductElement = _unitOfWork.Repository <DatasetElement>().Queryable().SingleOrDefault(u => u.ElementName == "Medicinal Products"); var sourceContexts = spontaneousReport.GetInstanceSubValuesContext("Product Information"); foreach (Guid sourceContext in sourceContexts) { var drugItemValues = spontaneousReport.GetInstanceSubValues("Product Information", sourceContext); var drugName = drugItemValues.SingleOrDefault(div => div.DatasetElementSub.ElementName == "Product").InstanceValue; if (drugName != string.Empty) { Guid?newContext = e2bInstance.GetContextForInstanceSubValue(destinationProductElement, destinationProductElement.DatasetElementSubs.SingleOrDefault(des => des.ElementName == "Medicinal Product"), drugName); if (newContext != null) { var reportInstanceMedication = _unitOfWork.Repository <ReportInstanceMedication>().Queryable().Single(x => x.ReportInstanceMedicationGuid == sourceContext); // Causality if (reportInstanceMedication.WhoCausality != null) { e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Drug Reaction Assessment"), spontaneousReport.GetInstanceValue("Description of reaction"), (Guid)newContext); e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Method of Assessment"), "WHO Causality Scale", (Guid)newContext); e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Assessment Result"), reportInstanceMedication.WhoCausality.ToLowerInvariant() == "ignored" ? "" : reportInstanceMedication.WhoCausality, (Guid)newContext); } else { if (reportInstanceMedication.NaranjoCausality != null) { e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Drug Reaction Assessment"), spontaneousReport.GetInstanceValue("Description of reaction"), (Guid)newContext); e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Method of Assessment"), "Naranjo Causality Scale", (Guid)newContext); e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Assessment Result"), reportInstanceMedication.NaranjoCausality.ToLowerInvariant() == "ignored" ? "" : reportInstanceMedication.NaranjoCausality, (Guid)newContext); } } // Treatment Duration var startValue = drugItemValues.SingleOrDefault(div => div.DatasetElementSub.ElementName == "Drug Start Date"); var endValue = drugItemValues.SingleOrDefault(div => div.DatasetElementSub.ElementName == "Drug End Date"); if (startValue != null && endValue != null) { var rduration = (Convert.ToDateTime(endValue.InstanceValue) - Convert.ToDateTime(startValue.InstanceValue)).Days; e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Drug Treatment Duration"), rduration.ToString(), (Guid)newContext); e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Drug Treatment Duration Unit"), "804=Day", (Guid)newContext); } // Dosage if (drugItemValues.SingleOrDefault(div => div.DatasetElementSub.ElementName == "Drug Strength") != null && drugItemValues.SingleOrDefault(div => div.DatasetElementSub.ElementName == "Dose Number") != null) { decimal strength = ConvertValueToDecimal(drugItemValues.SingleOrDefault(div => div.DatasetElementSub.ElementName == "Drug Strength").InstanceValue); decimal dosage = ConvertValueToDecimal(drugItemValues.SingleOrDefault(div => div.DatasetElementSub.ElementName == "Dose Number").InstanceValue); decimal dosageCalc = strength * dosage; e2bInstance.SetInstanceSubValue(destinationProductElement.DatasetElementSubs.Single(des => des.ElementName == "Structured Dosage"), dosageCalc.ToString(), (Guid)newContext); } } } } }