臨床數據管理（CDM Overview）

一、CDM在臨床試驗中的位置

CDM只是整個臨床試驗中的一環，而且算不得大環，但是是不可或缺的一環。

從不同部門的角度看：

從項目流程看：

二、CDM的定義和目標

1、定義

總的來說CDM就是整理、處理、分析臨床試驗數據的工作。

稍微正式一點的說法是：The set of processes, which includes the implementation of a system to capture data, that produce a high quality analyzable database with complete accountability for the integrity and completeness of clinical trial data.

2、目標

保證臨床數據的各種性：

Accurate

Accessible

Reproducible

Source-Verified

Timely

三、一些必須掌握的概念

1、Protocol 方案

A document that describes the objective(s), design, methodology,

statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

2、CRF 病例報告表

Case Report Form：A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

3、CSR 臨床研究報告

Clinical Study Report：A written description of a trial/study of any therapeutic, prophylactic, ordiagnostic agent conducted in human subjects, in which the clinical andstatistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content ofClinical Study Reports).

4、Source Data 原始數據

All information in original records and certified copies of original

records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

5、Source Documents 原始文件

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medicotechnical departments involved in the clinical trial).

6、TFL

Tables、Figures、Listings

四、主要工作內容

1、CRF Design 必須了解CDISC

2、Edit Check 邏輯核查

3、DMP 數據管理計劃

4、EDC Testing 驗證所建資料庫系統是否符合要求

5、CCG CRF填寫指南

6、Query 檢查數據，質疑數據，清理數據

7、Data Reconciliation 第三方數據和EDC數據的核對，包括IVRS，Lab，SAE等

8、Data Entry 雙人數據錄入

9、QA/QC

10、Coding 醫學編碼

……

EDC Flow:

CDM Work Flow:

五、總結

CDM的工作從CRF Design開始，到Database Lock結束。中間有很多細節需要學習，會跟其他各個部門的人溝通。

有點經驗的人會覺得CDM工作很無聊很枯燥。

集大成者則覺得CDM很重要，也很有意思。

從入門到集大成者，可能會經歷很多困難，需要持續學習，忍受煎熬，而且中間的任何一個地方都有可能使你放棄。我見過工作半年就走的，見過工作2年換行的，也見過4-5年放棄的。沒什麼不對，只是希望選擇了一行就堅持下去，包括我自己，肯定會有好的結果。

入門（新鮮）——> 有點經驗（開始枯燥）——> 不斷積累（學習完善核心知識）——> 有很多經驗（穩定）——> 尋求突破（繼續學習邊界知識）——> 集大成者（歸於平靜）

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