WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report
(1995; 36 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentINTRODUCTION
View the documentGLOSSARY
Open this folder and view contents1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
View the document2. THE PROTOCOL
Open this folder and view contents3. PROTECTION OF TRIAL SUBJECTS
Close this folder4. RESPONSIBILITIES OF THE INVESTIGATOR
View the document4.1 Medical care of trial subjects
View the document4.2 Qualifications
View the document4.3 Selection of trial subjects
View the document4.4 Compliance with the protocol
View the document4.5 Information for subjects and informed consent
View the document4.6 The investigational product
View the document4.7 Site of the trial, facilities and staff
View the document4.8 Notification of the trial or submission to the drug regulatory authority
View the document4.9 Review by an ethics committee
View the document4.10 Serious adverse events/reactions
View the document4.11 Financing
View the document4.12 Monitoring, auditing and inspection
View the document4.13 Record-keeping and handling of data
View the document4.14 Handling of and accountability for pharmaceutical products for trial
View the document4.15 Termination of trial
View the document4.16 Final report
View the document4.17 Trials in which the investigator is the sponsor
Open this folder and view contents5. RESPONSIBILITIES OF THE SPONSOR
Open this folder and view contents6. RESPONSIBILITIES OF THE MONITOR
Open this folder and view contents7. MONITORING OF SAFETY
Open this folder and view contents8. RECORD KEEPING AND HANDLING OF DATA
Open this folder and view contents9. STATISTICS AND CALCULATIONS
Open this folder and view contents10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Open this folder and view contents11. ROLE OF THE DRUG REGULATORY AUTHORITY
View the document12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
View the document13. CONSIDERATIONS FOR MULTICENTRE TRIALS
View the documentREFERENCES
View the documentAPPENDIX 1: World Medical Association’s Declaration of Helsinki1
View the documentAPPENDIX 2: Model list of items to be contained in a clinical trial protocol
 

4.10 Serious adverse events/reactions

The investigator must take appropriate measures to ensure the safety of clinical trial subjects (see also Section 7). The investigator is also responsible for notifying (with documentation) the relevant health authorities, the sponsor and, when applicable, the ethics committee immediately in the case of serious adverse events or reactions, as governed by national regulations.

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