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Investigating possible fraudulent activity at a research site

Abstract:
• Two auditors: one to ask open questions, the other as witness and scribe. • Interview staff individually, establishing their knowledge of trial procedures and incident. Note conflicting information. • Establish key facts: 1. Were participants real and eligible? 2. Did they consent? 3. Are test/clinical measurements/data valid? 4. Was appropriate treatment/intervention given? 5. Was follow-up provided, were events reported? 6. Are participants safe and data reliable? • Obtain documentary evidence, maintaining confidentiality of trial participants • Document findings.
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1186/1745-6215-16-s2-p193

Authors

More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Nuffield Department of Population Health
Sub department:
Clinical Trial Service Unit
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Nuffield Department of Population Health
Sub department:
Clinical Trial Service Unit
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Nuffield Department of Population Health
Sub department:
Clinical Trial Service Unit
Role:
Author
ORCID:
0000-0003-1125-8616
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Nuffield Department of Population Health
Sub department:
Clinical Trial Service Unit
Role:
Author
ORCID:
0000-0001-6646-827X


Publisher:
BioMed Central
Journal:
Trials More from this journal
Volume:
16
Issue:
S2
Pages:
p193
Article number:
ARTN P193
Publication date:
2015-11-16
DOI:
EISSN:
1745-6215
ISSN:
1745-6215


Language:
English
Keywords:
Pubs id:
738319
Local pid:
pubs:738319
Source identifiers:
W2274158700
Deposit date:
2026-03-25
ARK identifier:
This ORA record was generated from metadata provided by an external service. It has not been edited by the ORA Team.

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