EMA eSource paper (2010) and its 1 linked instrument
How to read this page
- First column: EMA eSource paper (2010). The others are every document linked to it.
- Scroll sideways if there are more columns than fit.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
| EMA eSource paper (2010) | EMA CS clinical trials | |
|---|---|---|
| Authority | EMA | EMA |
| Legal weight | Guidance & Q&A | Guidance & Q&A |
| Status | Superseded | Final |
| Last verified | Not yet | Not yet |
| Summary | Earlier EMA reflection paper on electronic source data in clinical trials. EMA has replaced it with the Guideline on computerised systems and electronic data in clinical trials. | EMA guideline for clinical trials on computerised systems and electronic data. It covers data integrity, responsibilities, validation, audit trails, user management, security, data migration and archiving, and it includes artificial intelligence. It replaced the 2010 reflection paper on electronic source data. |
| Lifecycle |
|
|
| Source | Official text Source: EMA. | Official text Source: EMA. |
These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.