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Developing the Clarity and Openness in Reporting: E3-based (CORE) reference user manual for creation of clinical study reports in the era of clinical trial transparency
| Reporting guideline provided for? (i.e. exactly what the authors state in the paper) |
Reporting clinical study reports (CSRs). |
| Full bibliographic reference | Hamilton S, Bernstein AB, Blakey G, Fagan V, Farrow T, Jordan D, Seiler W, Shannon A, Gertel A and for the Budapest Working Group. Developing the Clarity and Openness in Reporting: E3-based (CORE) reference user manual for creation of clinical study reports in the era of clinical trial transparency. Res Integr Peer Rev. 2016;1(4). |
| Language | English |
| PubMed ID | 29451540 |
| Relevant URLs (full-text if available) |
The CORE Reference Manual and Mapping Tool can be downloaded from: |
| Reporting guideline website URL | https://emwa.org/resources/the-core-reference-project/ |
| Reporting guideline acronym | CORE Reference |
| Study design | Clinical trials, Experimental studies |
| Applies to the whole report or to individual sections of the report? | Whole report |
| Additional information | Additional documents prepared during the development of this guideline: Hamilton, S, Seiler W, Gertel A. The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guidance with current practice and developing clinical study protocol guidance. Medical Writing 2014;23(4):281-288. Link to paper A detailed process map and a list of members of the 2014–2016 Budapest Working Group (BWG) can found at https://emwa.org/resources/the-core-reference-project/unmet-need/ |
| Record last updated on | September 30, 2026 |