R09.05.01.01 · 任务小类

EDC研究搭建

EDC study build

Build forms, branching logic and validation in EDC tools.

20 条本项目编写的提案 · 分类 v1.1 · 新增基准运行 0 次。下方验证方式与部分得分规则是设计，不是执行结果。

典型应用: REDCap · Medidata Rave · OpenClinica
小类 GUI 需求标签: G2 · GUI 必要

任务提案 · 20

展开查看完整原文与建议检查方式；两种界面均保留提案英文原文。

R09.05.01.01-T01 Build a demographics instrument with validation and branching in REDCap

原始指令

In the sandbox REDCap project 'HTN-Pilot' (development mode, test login in input/creds.txt), use the Online Designer to build instrument 'Demographics' with the 15 fields in input/crf_demographics.pdf: field types, choice codes, validation (date_ymd, integer ranges), required flags, and branching (e.g. pregnancy questions only if sex = 2). Do not use the Data Dictionary upload.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单 drag · 拖放
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

Checker exports the data dictionary via admin API: 15 fields with names, types, choices, validation, ranges, required and branching logic matching gold (logic normalized). The test user's API rights are disabled, so no REDCap API token exists; REDCap Logging must show Online Designer events, and a Data Dictionary upload event fails the task.

建议部分得分

25% fields and types; 20% choices; 25% validation and required; 30% branching logic

R09.05.01.01-T02 Define longitudinal events and map instruments in REDCap

原始指令

Enable longitudinal mode in REDCap project 'HTN-Pilot' and define arm 1 events Screening (day 0), Baseline (day 7), Week 4 (day 35, window -3/+7) and Week 12 (day 91, window -7/+7). Designate instruments per the schedule of assessments in input/soa.pdf.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

Exported event list (names, day offsets, windows) exact; instrument-event mapping equals the 9 ticks in the schedule of assessments; logging shows GUI changes. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

15% longitudinal enabled; 40% events with offsets/windows; 45% instrument designations

R09.05.01.01-T03 Create a self-scoring GAD-7 survey with a severity category in REDCap

原始指令

In REDCap project 'Anxiety-Screen', build survey instrument 'GAD-7' with the 7 items (radio, 0-3 codes, exact item text from input/gad7.pdf), a calculated total, and a calculated severity field (0 minimal, 1 mild, 2 moderate, 3 severe by standard cut-offs). Enable it as a survey.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

Dictionary check of items and calc equations; checker submits 6 test survey responses and verifies total and severity values saved; survey enabled flag set. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

30% items and codes; 25% total calc; 30% severity calc on test records; 15% survey enabled

R09.05.01.01-T04 Add custom data quality rules and run them in REDCap

原始指令

In REDCap project 'HTN-Pilot' (with data), create Data Quality rules: 'SBP>250 or <70', 'DBP>=SBP', and 'Visit date before consent date', then run all rules and export the discrepancy list to output/dq.csv.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 2 / 5

建议验证方式

Rules exist with logic equivalent to gold (evaluated on a test matrix); exported discrepancy record/event list equals the 9 planted violations. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

45% three rules correct (equal share each); 45% discrepancy list; 10% export

R09.05.01.01-T05 Set up a repeating adverse-event form with CTCAE grading in REDCap

原始指令

In REDCap project 'Onc-Phase2', create instrument 'Adverse Events' with term, CTCAE grade (1-5 dropdown), onset and resolution dates, seriousness, relatedness, and action taken; make it a repeating instrument on the 'Treatment' event with custom label [ae_term] (grade [ae_grade]), and add a DQ rule that resolution date is not before onset.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

Dictionary fields and choices exact; repeating instrument setting and custom label exact; DQ rule logic correct on test data; logging confirms GUI edits. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

40% AE fields; 30% repeating setup and label; 30% DQ rule

R09.05.01.01-T06 Configure stratified randomization in REDCap

原始指令

In REDCap project 'HTN-Pilot' (development), enable the randomization module: stratify by site (3 DAGs) and sex, randomization field 'arm' (1 Drug, 2 Placebo). Generate an allocation table for development with block sizes 4 and 6 using the provided R template input/alloc_template.R (seed 2026), upload it, and test-randomize 3 dummy records.

平台: web · 任意系统（网页）
应用: REDCap · R
交互表面: brow · 浏览器 term · 终端
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 code · 代码与命令 multi · 跨应用
工作产物: WP08 · 应用 / 系统状态
条件: multiapp · 多应用
提案难度: 4 / 5

建议验证方式

Randomization setup: stratification fields and DAG grouping exact; uploaded development table matches seed-generated gold; 3 test records randomized consistent with the table; production table untouched. The test user's API rights are disabled, so no REDCap API token exists and randomization setup and the allocation upload must be done in the browser; REDCap's Logging page confirms this.

建议部分得分

30% module configuration; 35% allocation table; 25% test randomizations; 10% production untouched

R09.05.01.01-T07 Schedule automated follow-up survey invitations in REDCap

原始指令

In REDCap project 'Sleep-Study', set Automated Survey Invitations for instrument 'Week1 Diary': send 7 days after baseline survey completion at 09:00 if [consent_contact] = 1, with 2 reminders every 2 days, using the email text in input/asi_text.txt with piping of [first_name]. Emails go to the sandbox mail sink only.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

ASI settings exact (trigger, logic, delay, time, reminders, message with piping); checker creates a test record and advances the cron clock: invitation scheduled at the right datetime in the sink. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

35% trigger and logic; 25% timing and reminders; 20% message; 20% scheduled invitation verified

R09.05.01.01-T08 Build a vital-signs form with edit checks in Medidata Rave Architect

原始指令

In the Medidata Rave Architect sandbox draft 'HTN-201 v0.3', create form 'VS' with fields date, SBP, DBP, HR, temperature and position (data dictionary SUPINE/SITTING/STANDING), then add edit checks: query if SBP<=DBP, range checks per input/vs_spec.pdf, and a derivation for MAP. Publish to the UAT environment.

平台: web · 任意系统（网页）
应用: Medidata Rave
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: licensed · 授权专业软件
提案难度: 4 / 5

建议验证方式

Architect Loader export (ALS) parsed: form fields, data dictionary, 7 edit checks with correct logic and query text, MAP derivation; UAT test entry fires the expected queries. No Rave Web Services credentials are issued and Architect Loader upload is disabled for the sandbox role, so the draft must be built in Architect's UI; the draft audit trail confirms this.

建议部分得分

30% form fields; 40% edit checks; 15% derivation; 15% published to UAT

R09.05.01.01-T09 Define study events and attach CRFs with SDV requirements in OpenClinica

原始指令

In the OpenClinica sandbox study 'DIAB-Obs', create event definitions Screening (non-repeating), Visit (repeating) and Termination, attach the uploaded CRFs per input/event_crf_map.csv with required/optional and SDV code (100% for Screening CRFs, none otherwise), and set the study to 'available'.

平台: web · 任意系统（网页）
应用: OpenClinica
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

Study metadata export (ODM): 3 event definitions with repeating flags; CRF assignments, required flags and SDV codes exact; study status available. No OpenClinica web-services account is issued and the VM has no shell, so the study can only be built in the browser; the study audit log confirms web-session changes.

建议部分得分

30% events; 40% CRF assignments; 20% SDV codes; 10% status

R09.05.01.01-T10 Apply action tags and piping to a REDCap consent form

原始指令

In REDCap project 'HTN-Pilot' edit instrument 'Consent': add @NOW to consent_datetime, @HIDDEN-SURVEY to staff_id, @DEFAULT='[event-label]' to visit_label, @READONLY to age_calc, and pipe [first_name] into the signature field label. Keep all other attributes unchanged.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 2 / 5

建议验证方式

Dictionary field annotations contain exactly the specified action tags; label piping present; diff of other columns vs pre-task export is empty. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

60% four action tags (equal share each); 25% piping; 15% nothing else changed

R09.05.01.01-T11 Set up data access groups and role-based user rights in REDCap

原始指令

In REDCap project 'HTN-Pilot' create DAGs 'Site A', 'Site B', 'Site C'; create roles 'Coordinator' (view/edit all forms, no export), 'Monitor' (read-only, can open queries, de-identified export) and 'PI' (full rights except design); assign the 6 test users per input/users.csv to roles and DAGs.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

Admin export of DAGs, roles and user rights: role privileges match the spec (form-level rights, export level, data resolution rights); user role and DAG assignments exact. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

20% DAGs; 45% role privileges; 35% user assignments

R09.05.01.01-T12 Lay out a REDCap form to mirror a paper CRF with matrix fields and embedding

原始指令

Rebuild page 3 of paper CRF input/crf_page3.pdf (symptom grid of 10 symptoms x severity 0-3, plus a two-column medication table) in REDCap instrument 'Symptoms': a matrix field group for the grid and field embedding in a descriptive-text HTML table for the medication rows, so the rendered form visually matches the paper layout.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单 vis · 视觉判断
工作产物: WP03 · 视觉排版
条件: 未声明
提案难度: 4 / 5

建议验证方式

Dictionary: matrix group with 10 fields and shared choices; embedded field placeholders {field} in the HTML table for 12 fields; rendered data-entry page screenshot SSIM>=0.75 vs reference build; VLM rubric for alignment (10%). The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

35% matrix group; 35% field embedding; 20% rendered layout SSIM; 10% VLM alignment

R09.05.01.01-T13 Build dynamic visit forms and window edit checks in Medidata Rave

原始指令

In the Medidata Rave Architect sandbox draft 'ONC-305 v1.1', add a dynamic search list for concomitant medications, configure matrices so 'Unscheduled Visit' folders can be added on demand, add edit checks that query visit dates outside protocol windows relative to Cycle 1 Day 1, and publish to UAT. Verify by entering a test subject.

平台: web · 任意系统（网页）
应用: Medidata Rave
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单 nav · 平移 / 缩放 / 滚动
工作产物: WP08 · 应用 / 系统状态
条件: licensed · 授权专业软件 long · 长流程
提案难度: 5 / 5

建议验证方式

ALS export: matrix/folder configuration allowing unscheduled visits, dynamic search list, window checks per protocol table; UAT test subject shows queries on 3 planted out-of-window dates and none on in-window dates. No Rave Web Services credentials are issued and Architect Loader upload is disabled for the sandbox role, so the draft must be built in Architect's UI; the draft audit trail confirms this.

建议部分得分

25% dynamic search list; 25% unscheduled visit matrix; 35% window checks firing correctly; 15% published

R09.05.01.01-T14 Enable REDCap e-Consent with signature and PDF snapshot

原始指令

In REDCap project 'Sleep-Study' convert instrument 'Consent' to a survey, add a signature field and the name/date fields, enable the e-Consent Framework (version 'v2.1', type 'Adult') with PDF auto-archive and a PDF snapshot to the File Repository, then complete one test consent as a sandbox participant.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单 path · 连续路径
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

Survey settings show e-Consent enabled with version/type; signature field exists; test record completed with stored signature image; File Repository contains the consent PDF with the participant name. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

25% survey and fields; 35% e-Consent settings; 40% test consent archived

R09.05.01.01-T15 Execute a UAT test script and fix the build bugs it uncovers in REDCap

原始指令

REDCap project 'Cardio-Reg' is ready for UAT. Execute the 5 test cases in input/test_script.xlsx by entering test records, record pass/fail and observed behaviour in output/uat_results.xlsx, then fix the 3 planted build bugs (a wrong branching operator, a calc using the wrong field, a missing validation range) and re-run the failing cases.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: type · 文字与表单 click · 指向与点击 vis · 视觉判断
工作产物: WP08 · 应用 / 系统状态
条件: long · 长流程
提案难度: 5 / 5

建议验证方式

uat_results initial pass/fail column equals gold (3 fails); dictionary after fixes equals gold for the 3 fields and is otherwise unchanged; re-run outcomes all pass; test records present. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

30% initial UAT results; 45% three bugs fixed (equal share each); 25% no collateral changes and re-run documented (3:2)

R09.05.01.01-T16 Control pair of T01: build the demographics instrument by data dictionary upload

原始指令

Control pair of T01. Write the same 15-field 'Demographics' instrument as a REDCap data dictionary CSV and upload it with the REDCap API (token in input/api_token.txt) to project 'HTN-Pilot-API'.

平台: lin · Linux mac · macOS
应用: REDCap
交互表面: api · API / SDK term · 终端
GUI 需求 · 任务设定: AP · API 足够
GUI 需求 · 普通权限: AP · API 足够
交互原语: code · 代码与命令
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 2 / 5

建议验证方式

Same dictionary checks as T01 (fields, types, choices, validation, required, branching) enabling a GUI-vs-API comparison.

建议部分得分

25% fields and types; 20% choices; 25% validation and required; 30% branching

R09.05.01.01-T17 Write cross-form rules in OpenClinica and validate them on test data

原始指令

In the OpenClinica sandbox study 'DIAB-Obs', author a rules XML (or use the rule designer) with 3 rules: discrepancy note if HbA1c at Visit increases >2% vs Screening, email action suppressed, a hide/show action for the insulin dose item when on_insulin = 'No', and an InsertAction deriving BMI. Upload, test on 3 subjects, and keep the rules active.

平台: web · 任意系统（网页）
应用: OpenClinica
交互表面: brow · 浏览器 term · 终端
GUI 需求 · 任务设定: HY · 混合
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: code · 代码与命令 click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: tutorial · 阅读文档 / 教程
提案难度: 4 / 5

建议验证方式

Rules export: 3 rules with correct targets and expressions; on checker-entered test data the discrepancy note fires only for the planted subject, hide/show works in the rendered form, BMI inserted correctly.

建议部分得分

30% discrepancy rule; 30% show/hide action; 30% BMI insert; 10% active

R09.05.01.01-T18 Translate an instrument into Spanish with REDCap's Multi-Language Management

原始指令

In REDCap project 'Anxiety-Screen', enable Multi-Language Management, add Spanish (es), and translate the 'GAD-7' instrument field labels, choices and survey settings from input/translations.xlsx; set Spanish as an option on the survey language selector.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: 未声明
提案难度: 3 / 5

建议验证方式

MLM export JSON: language es active; all 7 labels, choice labels and survey title/instructions translated exactly per the spreadsheet; survey language switcher enabled. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

15% MLM enabled; 40% labels; 30% choices; 15% survey settings

R09.05.01.01-T19 Submit a production draft-mode change without data loss in REDCap

原始指令

REDCap project 'HTN-Live' is in production with data. In Draft Mode add field 'smoking_pack_years' (integer 0-200) to 'History', add a new choice '4, Former e-cigarette user' to smoking_status without recoding existing choices, and submit the changes for review. Do not delete or rename any existing fields or choices.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单
工作产物: WP08 · 应用 / 系统状态
条件: risk · 高风险 / 不可逆
提案难度: 4 / 5

建议验证方式

Draft changes submitted (pending approval) with exactly the 2 changes; REDCap's critical-change report shows no data-loss warnings; existing field and choice codes unchanged; data values untouched. The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

30% new field; 30% new choice with unchanged codes; 25% submitted for review; 15% no critical changes

R09.05.01.01-T20 Build a complete REDCap study database from a protocol synopsis

原始指令

From input/protocol_synopsis.pdf (12-week hypertension trial) build REDCap project 'HTN-201' in development: 6 instruments (eligibility, demographics, vitals, labs, AEs repeating, end of study), 5 events with windows, branching, BMI and eGFR calculations, 4 DQ rules, and a codebook export to output/codebook.pdf. Use the Online Designer.

平台: web · 任意系统（网页）
应用: REDCap
交互表面: brow · 浏览器
GUI 需求 · 任务设定: G2 · GUI 必要
GUI 需求 · 普通权限: G2 · GUI 必要
交互原语: click · 指向与点击 type · 文字与表单 drag · 拖放
工作产物: WP08 · 应用 / 系统状态
条件: long · 长流程
提案难度: 5 / 5

建议验证方式

Dictionary, event/instrument map, repeating setup and DQ rules compared with a gold build (field-level F1 on names/types/validation; calc correctness on 10 test records); logging shows Online Designer use (no dictionary upload). The test user's API rights are disabled, so no REDCap API token exists and changes must come from the browser session; REDCap's Logging page confirms how each change was made.

建议部分得分

35% instruments and fields; 20% events and mapping; 20% calcs and branching; 25% DQ rules and codebook (3:2)

已有研究映射

当前映射未给此小类指定基准参考。

EDC研究搭建

任务提案 · 20

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

原始指令

建议验证方式

建议部分得分

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