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
Open this folder and view contents4. RESPONSIBILITIES OF THE INVESTIGATOR
Open this folder and view contents5. RESPONSIBILITIES OF THE SPONSOR
Close this folder6. RESPONSIBILITIES OF THE MONITOR
View the document6.1 Qualifications
View the document6.2 Assessment of the trial site
View the document6.3 Staff education and compliance
View the document6.4 Data management
View the document6.5 Case-report forms
View the document6.6 Investigational product
View the document6.7 Communication
View the document6.8 Notification of the trial or submission to the drug regulatory authority
View the document6.9 Reports
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
 

6.8 Notification of the trial or submission to the drug regulatory authority

The monitor should assist the investigator in notifying the drug regulatory authority of the clinical trial and submitting any necessary documentation.

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