Step F6：AE & 风险/问题管理（PV）

backend/app/api/v1/aes.py

@@ -14,7 +14,7 @@ from app.schemas.ae import AECreate, AERead, AEUpdate
 router = APIRouter()
 
 ALLOWED_CREATE_ROLES = {"PM", "CRA", "PV"}
-ALLOWED_UPDATE_ROLES = {"PM", "PV"}
+ALLOWED_UPDATE_ROLES = {"PM", "PV", "CRA"}
 
 
 async def _ensure_study_exists(db: AsyncSession, study_id: uuid.UUID):

frontend/src/api/aes.ts

@@ -0,0 +1,11 @@
+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);

frontend/src/api/attachments.ts

@@ -0,0 +1,12 @@
+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" },
+  });
+};

frontend/src/api/comments.ts

@@ -0,0 +1,11 @@
+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);

frontend/src/api/issues.ts

@@ -0,0 +1,11 @@
+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);

frontend/src/components/AttachmentList.vue

@@ -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>

frontend/src/components/CommentList.vue

@@ -0,0 +1,101 @@
+<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>

frontend/src/components/IssueForm.vue

@@ -0,0 +1,128 @@
+<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>

frontend/src/components/Layout.vue

@@ -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>

frontend/src/router/index.ts

@@ -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",

frontend/src/views/Aes.vue

@@ -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>

frontend/src/views/IssueDetail.vue

@@ -0,0 +1,99 @@
+<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>

frontend/src/views/Issues.vue

@@ -0,0 +1,150 @@
+<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>