Step F6:AE & 风险/问题管理(PV)

This commit is contained in:
Cheng Zhou
2025-12-16 22:17:26 +08:00
parent e047756b9c
commit abb5b0a107
42 changed files with 779 additions and 3 deletions
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import { apiGet, apiPost, apiPatch } from "./axios";
import type { ApiListResponse } from "../types/api";
export const fetchAes = (studyId: string, params?: Record<string, any>) =>
apiGet<ApiListResponse<any>>(`/api/v1/studies/${studyId}/aes/`, { params });
export const createAe = (studyId: string, payload: Record<string, any>) =>
apiPost(`/api/v1/studies/${studyId}/aes/`, payload);
export const updateAe = (studyId: string, aeId: string, payload: Record<string, any>) =>
apiPatch(`/api/v1/studies/${studyId}/aes/${aeId}`, payload);
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import { apiGet, apiPost } from "./axios";
export const fetchAttachments = (studyId: string, entityType: string, entityId: string) =>
apiGet(`/api/v1/studies/${studyId}/${entityType}/${entityId}/attachments`);
export const uploadAttachment = (studyId: string, entityType: string, entityId: string, file: File) => {
const formData = new FormData();
formData.append("file", file);
return apiPost(`/api/v1/studies/${studyId}/${entityType}/${entityId}/attachments`, formData, {
headers: { "Content-Type": "multipart/form-data" },
});
};
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import { apiGet, apiPost } from "./axios";
export const fetchComments = (studyId: string, entityType: string, entityId: string) =>
apiGet(`/api/v1/studies/${studyId}/${entityType}/${entityId}/comments`);
export const createComment = (
studyId: string,
entityType: string,
entityId: string,
payload: Record<string, any>
) => apiPost(`/api/v1/studies/${studyId}/${entityType}/${entityId}/comments`, payload);
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import { apiGet, apiPost, apiPatch } from "./axios";
import type { ApiListResponse } from "../types/api";
export const fetchIssues = (studyId: string, params?: Record<string, any>) =>
apiGet<ApiListResponse<any>>(`/api/v1/studies/${studyId}/issues/`, { params });
export const createIssue = (studyId: string, payload: Record<string, any>) =>
apiPost(`/api/v1/studies/${studyId}/issues/`, payload);
export const updateIssue = (studyId: string, issueId: string, payload: Record<string, any>) =>
apiPatch(`/api/v1/studies/${studyId}/issues/${issueId}`, payload);
@@ -0,0 +1,84 @@
<template>
<el-card class="attachment-card">
<template #header>
<div class="header">
<span>附件</span>
<el-upload
v-if="canUpload"
:http-request="onUpload"
:show-file-list="false"
:auto-upload="false"
:limit="1"
>
<el-button size="small" type="primary">上传</el-button>
</el-upload>
</div>
</template>
<el-table :data="attachments" v-loading="loading" style="width: 100%">
<el-table-column prop="filename" label="文件名" />
<el-table-column prop="uploaded_by" label="上传人" width="160" />
<el-table-column prop="uploaded_at" label="上传时间" width="180" />
<el-table-column label="操作" width="120">
<template #default="scope">
<el-link type="primary" :href="scope.row.file_path" target="_blank">下载</el-link>
</template>
</el-table-column>
</el-table>
</el-card>
</template>
<script setup lang="ts">
import { onMounted, ref } from "vue";
import { ElMessage } from "element-plus";
import { fetchAttachments, uploadAttachment } from "../api/attachments";
import { useStudyStore } from "../store/study";
interface Props {
studyId: string;
entityType: string;
entityId: string;
canUpload?: boolean;
}
const props = defineProps<Props>();
const study = useStudyStore();
const attachments = ref<any[]>([]);
const loading = ref(false);
const load = async () => {
if (!props.studyId) return;
loading.value = true;
try {
const { data } = await fetchAttachments(props.studyId, props.entityType, props.entityId);
attachments.value = data.items || data || [];
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "附件加载失败");
} finally {
loading.value = false;
}
};
const onUpload = async (options: any) => {
if (!study.currentStudy) return;
loading.value = true;
try {
await uploadAttachment(study.currentStudy.id, props.entityType, props.entityId, options.file as File);
ElMessage.success("上传成功");
load();
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "上传失败");
} finally {
loading.value = false;
}
};
onMounted(() => load());
</script>
<style scoped>
.header {
display: flex;
justify-content: space-between;
align-items: center;
}
</style>
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<template>
<el-card class="comment-card">
<template #header>
<div class="header">
<span>评论</span>
<el-button v-if="canComment" type="primary" size="small" @click="showInput = !showInput">新增</el-button>
</div>
</template>
<div v-if="showInput" class="input-area">
<el-input v-model="newComment" type="textarea" rows="3" placeholder="输入评论" />
<div class="actions">
<el-button size="small" @click="showInput = false">取消</el-button>
<el-button size="small" type="primary" :loading="loading" @click="submit">提交</el-button>
</div>
</div>
<el-timeline>
<el-timeline-item v-for="c in comments" :key="c.id" :timestamp="c.created_at">
<div class="comment-item">
<strong>{{ c.created_by }}</strong>
<p>{{ c.content }}</p>
</div>
</el-timeline-item>
</el-timeline>
</el-card>
</template>
<script setup lang="ts">
import { onMounted, ref } from "vue";
import { ElMessage } from "element-plus";
import { fetchComments, createComment } from "../api/comments";
import { useStudyStore } from "../store/study";
interface Props {
studyId: string;
entityType: string;
entityId: string;
canComment?: boolean;
}
const props = defineProps<Props>();
const comments = ref<any[]>([]);
const loading = ref(false);
const newComment = ref("");
const showInput = ref(false);
const study = useStudyStore();
const load = async () => {
if (!props.studyId) return;
loading.value = true;
try {
const { data } = await fetchComments(props.studyId, props.entityType, props.entityId);
comments.value = data.items || data || [];
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "评论加载失败");
} finally {
loading.value = false;
}
};
const submit = async () => {
if (!newComment.value.trim()) {
ElMessage.warning("请输入评论");
return;
}
if (!study.currentStudy) return;
loading.value = true;
try {
await createComment(study.currentStudy.id, props.entityType, props.entityId, { content: newComment.value });
ElMessage.success("提交成功");
newComment.value = "";
showInput.value = false;
load();
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "提交失败");
} finally {
loading.value = false;
}
};
onMounted(() => load());
</script>
<style scoped>
.header {
display: flex;
justify-content: space-between;
align-items: center;
}
.input-area {
margin-bottom: 12px;
}
.actions {
margin-top: 8px;
display: flex;
justify-content: flex-end;
gap: 8px;
}
.comment-item p {
margin: 4px 0 0;
}
</style>
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<template>
<el-dialog :title="isEdit ? '编辑问题' : '新增问题'" v-model="visible" width="600px" @close="onClose">
<el-form ref="formRef" :model="form" :rules="rules" label-width="120px">
<el-form-item label="标题" prop="title">
<el-input v-model="form.title" />
</el-form-item>
<el-form-item label="类别" prop="category">
<el-select v-model="form.category" placeholder="请选择">
<el-option v-for="c in categories" :key="c" :label="c" :value="c" />
</el-select>
</el-form-item>
<el-form-item label="等级" prop="level">
<el-select v-model="form.level" placeholder="请选择">
<el-option v-for="l in levels" :key="l" :label="l" :value="l" />
</el-select>
</el-form-item>
<el-form-item label="截止日期" prop="due_date">
<el-date-picker v-model="form.due_date" type="date" value-format="YYYY-MM-DD" />
</el-form-item>
<el-form-item label="描述" prop="description">
<el-input v-model="form.description" type="textarea" />
</el-form-item>
</el-form>
<template #footer>
<el-button @click="onClose">取消</el-button>
<el-button type="primary" :loading="submitting" @click="onSubmit">提交</el-button>
</template>
</el-dialog>
</template>
<script setup lang="ts">
import { computed, reactive, ref, watch } from "vue";
import type { FormInstance, FormRules } from "element-plus";
import { ElMessage } from "element-plus";
import { createIssue, updateIssue } from "../api/issues";
import { useStudyStore } from "../store/study";
interface Props {
modelValue: boolean;
issue?: Record<string, any>;
}
const props = defineProps<Props>();
const emit = defineEmits(["update:modelValue", "success"]);
const visible = computed({
get: () => props.modelValue,
set: (v: boolean) => emit("update:modelValue", v),
});
const formRef = ref<FormInstance>();
const submitting = ref(false);
const study = useStudyStore();
const categories = ["RISK", "ISSUE", "PROTOCOL_DEVIATION"];
const levels = ["LOW", "MEDIUM", "HIGH", "CRITICAL"];
const form = reactive({
title: "",
category: "ISSUE",
level: "MEDIUM",
due_date: "",
description: "",
});
const rules: FormRules = {
title: [{ required: true, message: "请输入标题", trigger: "blur" }],
category: [{ required: true, message: "请选择类别", trigger: "change" }],
level: [{ required: true, message: "请选择等级", trigger: "change" }],
};
const isEdit = computed(() => !!props.issue);
watch(
() => props.issue,
(val) => {
if (val) {
Object.assign(form, {
title: val.title || "",
category: val.category || "ISSUE",
level: val.level || "MEDIUM",
due_date: val.due_date || "",
description: val.description || "",
});
} else {
Object.assign(form, {
title: "",
category: "ISSUE",
level: "MEDIUM",
due_date: "",
description: "",
});
}
},
{ immediate: true }
);
const onClose = () => {
visible.value = false;
};
const onSubmit = async () => {
if (!formRef.value) return;
await formRef.value.validate(async (valid) => {
if (!valid) return;
if (!study.currentStudy) {
ElMessage.error("未选择项目");
return;
}
submitting.value = true;
try {
const payload = { ...form };
if (isEdit.value && props.issue) {
await updateIssue(study.currentStudy.id, props.issue.id, payload);
} else {
await createIssue(study.currentStudy.id, payload);
}
ElMessage.success("提交成功");
emit("success");
onClose();
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "提交失败");
} finally {
submitting.value = false;
}
});
};
</script>
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@@ -20,6 +20,8 @@
<el-menu-item index="/study/milestones">里程碑</el-menu-item>
<el-menu-item index="/study/tasks">任务</el-menu-item>
<el-menu-item index="/study/subjects">受试者</el-menu-item>
<el-menu-item index="/study/aes">AE</el-menu-item>
<el-menu-item index="/study/issues">风险/问题</el-menu-item>
</el-menu>
</el-aside>
<el-main>
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@@ -11,10 +11,13 @@ import Milestones from "../views/Milestones.vue";
import Subjects from "../views/Subjects.vue";
import SubjectDetail from "../views/SubjectDetail.vue";
import Aes from "../views/Aes.vue";
import AeDetail from "../views/AeDetail.vue";
import DataQueries from "../views/DataQueries.vue";
import Imp from "../views/Imp.vue";
import Finance from "../views/Finance.vue";
import Faq from "../views/Faq.vue";
import Issues from "../views/Issues.vue";
import IssueDetail from "../views/IssueDetail.vue";
const routes: RouteRecordRaw[] = [
{
@@ -70,12 +73,30 @@ const routes: RouteRecordRaw[] = [
component: Aes,
meta: { title: "AE", requiresStudy: true },
},
{
path: "study/aes/:aeId",
name: "StudyAeDetail",
component: AeDetail,
meta: { title: "AE详情", requiresStudy: true },
},
{
path: "study/data-queries",
name: "StudyDataQueries",
component: DataQueries,
meta: { title: "数据问题", requiresStudy: true },
},
{
path: "study/issues",
name: "StudyIssues",
component: Issues,
meta: { title: "风险/问题", requiresStudy: true },
},
{
path: "study/issues/:issueId",
name: "StudyIssueDetail",
component: IssueDetail,
meta: { title: "风险详情", requiresStudy: true },
},
{
path: "study/imp",
name: "StudyImp",
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@@ -1,13 +1,159 @@
<template>
<div class="page">
<el-card><h2>不良事件</h2></el-card>
<el-card class="mb-12">
<div class="filters">
<el-select v-model="filters.status" placeholder="状态" clearable @change="loadAes">
<el-option v-for="s in statuses" :key="s" :label="s" :value="s" />
</el-select>
<el-select v-model="filters.seriousness" placeholder="严重性" clearable @change="loadAes">
<el-option label="SERIOUS" value="SERIOUS" />
<el-option label="NON_SERIOUS" value="NON_SERIOUS" />
</el-select>
<el-switch v-model="filters.overdue" active-text="仅逾期" @change="loadAes" />
<div class="spacer" />
<el-button type="primary" v-if="canCreate" @click="showForm = true">新建 AE</el-button>
</div>
</el-card>
<el-card>
<el-table :data="aes" v-loading="loading" style="width: 100%" @row-click="goDetail">
<el-table-column prop="term" label="事件" />
<el-table-column prop="subject_id" label="受试者ID" width="200" />
<el-table-column prop="seriousness" label="严重性" width="140" />
<el-table-column prop="onset_date" label="发生日期" width="140" />
<el-table-column prop="report_due_date" label="报告截止" width="140" />
<el-table-column prop="status" label="状态" width="120">
<template #default="scope">
<el-tag :type="scope.row.is_overdue ? 'danger' : 'info'">{{ scope.row.status }}</el-tag>
</template>
</el-table-column>
</el-table>
<el-pagination
class="pagination"
layout="prev, pager, next"
:page-size="pageSize"
:current-page="page"
:total="total"
@current-change="onPageChange"
/>
</el-card>
<AeForm v-model="showForm" :subjects="subjects" @success="loadAes" />
</div>
</template>
<script setup lang="ts"></script>
<script setup lang="ts">
import { computed, onMounted, ref } from "vue";
import { useRouter } from "vue-router";
import { ElMessage } from "element-plus";
import { fetchAes } from "../api/aes";
import { fetchSubjects } from "../api/subjects";
import { useStudyStore } from "../store/study";
import { useAuthStore } from "../store/auth";
import AeForm from "../components/AeForm.vue";
const study = useStudyStore();
const auth = useAuthStore();
const router = useRouter();
const aes = ref<any[]>([]);
const loading = ref(false);
const total = ref(0);
const page = ref(1);
const pageSize = 10;
const subjects = ref<any[]>([]);
const statuses = ["NEW", "FOLLOW_UP", "CLOSED"];
const filters = ref({
status: "",
seriousness: "",
overdue: false,
});
const showForm = ref(false);
const canCreate = computed(() => {
const role = auth.user?.role;
return role === "ADMIN" || role === "PM" || role === "CRA" || role === "PV";
});
const loadAes = async () => {
if (!study.currentStudy) return;
loading.value = true;
try {
const params: Record<string, any> = { skip: (page.value - 1) * pageSize, limit: pageSize };
if (filters.value.status) params.status = filters.value.status;
if (filters.value.seriousness) params.seriousness = filters.value.seriousness;
if (filters.value.overdue) params.overdue = true;
const { data } = await fetchAes(study.currentStudy.id, params);
const mapOverdue = (list: any[]) =>
list.map((item) => ({
...item,
is_overdue:
item.is_overdue ??
(item.report_due_date && item.status !== "CLOSED" && new Date() > new Date(item.report_due_date)),
}));
if (Array.isArray(data)) {
aes.value = mapOverdue(data);
total.value = data.length;
} else {
const items = data.items || [];
aes.value = mapOverdue(items);
total.value = data.total || aes.value.length;
}
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "AE 加载失败");
} finally {
loading.value = false;
}
};
const onPageChange = (p: number) => {
page.value = p;
loadAes();
};
const loadSubjects = async () => {
if (!study.currentStudy) return;
try {
const { data } = await fetchSubjects(study.currentStudy.id, { skip: 0, limit: 500 });
subjects.value = data.items || data || [];
} catch {
// ignore
}
};
const goDetail = (row: any) => {
router.push(`/study/aes/${row.id}`);
};
onMounted(async () => {
if (!auth.user && auth.token) {
await auth.fetchMe().catch(() => {});
}
await loadSubjects();
loadAes();
});
</script>
<style scoped>
.page {
padding: 16px;
}
.filters {
display: flex;
gap: 8px;
align-items: center;
}
.spacer {
flex: 1;
}
.pagination {
margin-top: 12px;
text-align: right;
}
.mb-12 {
margin-bottom: 12px;
}
</style>
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<template>
<div class="page" v-if="issue">
<el-card class="mb-12">
<div class="header">
<div>
<h3>Issue 详情</h3>
<p>{{ issue.title }}</p>
</div>
<el-button v-if="canEdit" type="danger" size="small" @click="closeIssue">关闭</el-button>
</div>
<el-descriptions :column="2" border>
<el-descriptions-item label="类别">{{ issue.category }}</el-descriptions-item>
<el-descriptions-item label="等级">{{ issue.level }}</el-descriptions-item>
<el-descriptions-item label="截止日期">{{ issue.due_date }}</el-descriptions-item>
<el-descriptions-item label="状态">{{ issue.status }}</el-descriptions-item>
<el-descriptions-item label="描述">{{ issue.description }}</el-descriptions-item>
</el-descriptions>
</el-card>
<el-tabs>
<el-tab-pane label="评论">
<CommentList :study-id="studyId" entity-type="issues" :entity-id="issue.id" :can-comment="true" />
</el-tab-pane>
<el-tab-pane label="附件">
<AttachmentList :study-id="studyId" entity-type="issues" :entity-id="issue.id" :can-upload="canEdit" />
</el-tab-pane>
</el-tabs>
</div>
<div v-else class="page">
<el-skeleton rows="4" animated />
</div>
</template>
<script setup lang="ts">
import { computed, onMounted, ref } from "vue";
import { useRoute } from "vue-router";
import { ElMessage, ElMessageBox } from "element-plus";
import { fetchIssues, updateIssue } from "../api/issues";
import { useStudyStore } from "../store/study";
import { useAuthStore } from "../store/auth";
import CommentList from "../components/CommentList.vue";
import AttachmentList from "../components/AttachmentList.vue";
const route = useRoute();
const study = useStudyStore();
const auth = useAuthStore();
const issue = ref<any | null>(null);
const studyId = computed(() => study.currentStudy?.id || "");
const canEdit = computed(() => {
const role = auth.user?.role;
return role === "ADMIN" || role === "PM" || role === "PV";
});
const load = async () => {
if (!study.currentStudy) return;
try {
const { data } = await fetchIssues(study.currentStudy.id, { skip: 0, limit: 500 });
const list = data.items || data || [];
issue.value = list.find((item: any) => item.id === route.params.issueId);
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "Issue 加载失败");
}
};
const closeIssue = async () => {
await ElMessageBox.confirm("确认将 Issue 关闭?", "提示");
if (!study.currentStudy || !issue.value) return;
try {
await updateIssue(study.currentStudy.id, issue.value.id, { status: "CLOSED" });
ElMessage.success("已关闭");
load();
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "更新失败");
}
};
onMounted(async () => {
if (!auth.user && auth.token) {
await auth.fetchMe().catch(() => {});
}
load();
});
</script>
<style scoped>
.page {
padding: 16px;
}
.header {
display: flex;
align-items: center;
justify-content: space-between;
}
.mb-12 {
margin-bottom: 12px;
}
</style>
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<template>
<div class="page">
<el-card class="mb-12">
<div class="filters">
<el-select v-model="filters.status" placeholder="状态" clearable @change="loadIssues">
<el-option v-for="s in statuses" :key="s" :label="s" :value="s" />
</el-select>
<el-select v-model="filters.level" placeholder="等级" clearable @change="loadIssues">
<el-option v-for="l in levels" :key="l" :label="l" :value="l" />
</el-select>
<el-select v-model="filters.category" placeholder="类别" clearable @change="loadIssues">
<el-option v-for="c in categories" :key="c" :label="c" :value="c" />
</el-select>
<el-switch v-model="filters.overdue" active-text="仅逾期" @change="loadIssues" />
<div class="spacer" />
<el-button type="primary" v-if="canCreate" @click="showForm = true">新建 Issue</el-button>
</div>
</el-card>
<el-card>
<el-table :data="issues" v-loading="loading" style="width: 100%" @row-click="goDetail">
<el-table-column prop="title" label="标题" />
<el-table-column prop="level" label="等级" width="120" />
<el-table-column prop="category" label="类别" width="140" />
<el-table-column prop="due_date" label="截止日期" width="140" />
<el-table-column prop="status" label="状态" width="120">
<template #default="scope">
<el-tag :type="scope.row.is_overdue ? 'danger' : 'info'">{{ scope.row.status }}</el-tag>
</template>
</el-table-column>
</el-table>
<el-pagination
class="pagination"
layout="prev, pager, next"
:page-size="pageSize"
:current-page="page"
:total="total"
@current-change="onPageChange"
/>
</el-card>
<IssueForm v-model="showForm" @success="loadIssues" />
</div>
</template>
<script setup lang="ts">
import { computed, onMounted, ref } from "vue";
import { useRouter } from "vue-router";
import { ElMessage } from "element-plus";
import { fetchIssues } from "../api/issues";
import { useStudyStore } from "../store/study";
import { useAuthStore } from "../store/auth";
import IssueForm from "../components/IssueForm.vue";
const study = useStudyStore();
const auth = useAuthStore();
const router = useRouter();
const issues = ref<any[]>([]);
const loading = ref(false);
const total = ref(0);
const page = ref(1);
const pageSize = 10;
const statuses = ["OPEN", "MITIGATING", "CLOSED"];
const levels = ["LOW", "MEDIUM", "HIGH", "CRITICAL"];
const categories = ["RISK", "ISSUE", "PROTOCOL_DEVIATION"];
const filters = ref({
status: "",
level: "",
category: "",
overdue: false,
});
const showForm = ref(false);
const canCreate = computed(() => {
const role = auth.user?.role;
return role === "ADMIN" || role === "PM" || role === "PV";
});
const loadIssues = async () => {
if (!study.currentStudy) return;
loading.value = true;
try {
const params: Record<string, any> = { skip: (page.value - 1) * pageSize, limit: pageSize };
if (filters.value.status) params.status = filters.value.status;
if (filters.value.level) params.level = filters.value.level;
if (filters.value.category) params.category = filters.value.category;
if (filters.value.overdue) params.overdue = true;
const { data } = await fetchIssues(study.currentStudy.id, params);
const mapOverdue = (list: any[]) =>
list.map((item) => ({
...item,
is_overdue:
item.is_overdue ?? (item.due_date && item.status !== "CLOSED" && new Date() > new Date(item.due_date)),
}));
if (Array.isArray(data)) {
issues.value = mapOverdue(data);
total.value = data.length;
} else {
const list = data.items || [];
issues.value = mapOverdue(list);
total.value = data.total || issues.value.length;
}
} catch (e: any) {
ElMessage.error(e?.response?.data?.message || "Issue 加载失败");
} finally {
loading.value = false;
}
};
const onPageChange = (p: number) => {
page.value = p;
loadIssues();
};
const goDetail = (row: any) => {
router.push(`/study/issues/${row.id}`);
};
onMounted(async () => {
if (!auth.user && auth.token) {
await auth.fetchMe().catch(() => {});
}
loadIssues();
});
</script>
<style scoped>
.page {
padding: 16px;
}
.filters {
display: flex;
gap: 8px;
align-items: center;
}
.spacer {
flex: 1;
}
.pagination {
margin-top: 12px;
text-align: right;
}
.mb-12 {
margin-bottom: 12px;
}
</style>