I.S. EN ISO 14155:2011&LC:2011-11
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Hardcopy , PDF
17-09-2020
English
31-10-2011
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Ethical considerations
5 Clinical investigation planning
6 Clinical investigation conduct
7 Suspension, termination and close-out of the clinical investigation
8 Responsibilities of the sponsor
9 Responsibilities of the principal investigator
Annex A (normative) Clinical investigation plan (CIP)
Annex B (normative) Investigator's brochure (IB)
Annex C (informative) Case report forms (CRFs)
Annex D (informative) Clinical investigation report
Annex E (informative) Essential clinical investigation documents
Annex F (informative) Adverse event categorization
Bibliography
This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
| Committee |
TC 194
|
| DocumentType |
Standard
|
| Pages |
79
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 14155:2011/Cor 1:2011 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.