#DI系列#100-3#数据完整性原则ALCOA(+)（有视频）

待到凌霄花开

各个法规和指导原则对数据完整性的原则认识基本一致，主要都遵循ALCOA原则。

ALCOA原则早期由是美国DIA（Drug Information Association）于2007年在其指导原则《临床研究中使用的计算机化系统》中提出的。
1. Attributable 可追溯的 记录可追溯

Attributable, The identity of the person creating a record should be documented. For paper records this is normally done by the individual signing and dating the record with their signature.

As the record you may be signing may be a legal document, you should clearly understand the implication of your signature.

A signature should be individual to a specific individual and the practice of signing someone else’s name or initials is fraud, and is taken very seriously.

2. Legible 清晰的 可见的

A record that cannot be read or understood has no value and might as well not exist.
All records should be composed so they conform to grammatical convention which should be consistent throughout.

It is best to avoid buzzwords, cliques and slang as these are prone to change with time and are often not understood outside a particular locality.

It is always good practice to have any record reviewed by a second person as this can often highlight any ambiguities.

3. Contemporaneous 同步的

All records must be made at the time an activity takes place. Delaying writing up, for example until the end of the day, will inevitably affect the accuracy of that record as details can be forgotten or miss-remembered.

4. Original 原始的

All records must be original; information must be recorded directly onto the document. This avoids the potential of introducing errors in transcribing information between documents.

If information from an instrument is printed out, by the instrument, that printout is the original record and should be signed, dated and attached to the record.

5. Accurate 准确的

The record must reflect what actually happened.

Any changes should be made without obscuring or obliterating the original information, the use of whiteout or correction fluid is prohibited.

Any changes made to a record should be signed by the person making the change and dated to show when it was made and a written explanation should also be provided.

Remember, the record may be needed after you have left the company and cannot be contacted for clarification.

ALCOA+原则是欧盟GCP监察官工作组（EU GCPIWG）于2010年在其发布的《关于临床试验中对电子源数据和转录成电子数据收集工具的期望的反馈书》中阐释的。

即ALCOA+CCEA

Complete C 完整的 无遗漏
Consistent C 一致的 与实际生成逻辑顺序一致，显示的记录人同实际操作者一致
Enduring E 长久的，耐受的 原始数据长久保存，不易删除，丢弃
Available A 可获得的 数据在审计时可见，不被隐藏

ALCOA+原则是Complete（完整性）：所有的数据都存在，如所有检测结果都被保留，包括元数据；Consistent（一致性）：数据没有矛盾或差异，如使用标准化的数据；Enduring（持久性）：数据可被保留所要求的时间长度并可在需要时恢复，如硬盘、CD、磁带等；Available when needed（可取性）：一旦要求，可以及时获取并提供给管理当局。

附送一个老外的讲解动画：

https://v.qq.com/x/page/r0796ix1c36.html

懒虫9527

谢谢楼主分享

syhorchid

谢谢分享

c01zxcc

谢谢楼主分享

cxf1205

非常实用，谢谢分享。