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
Close this folder5. RESPONSIBILITIES OF THE SPONSOR
View the document5.1 Selection of the investigator(s)
View the document5.2 Delegation of responsibilities
View the document5.3 Compliance with the protocol and procedures
View the document5.4 Product information
View the document5.5 Safety information
View the document5.6 Investigational product
View the document5.7 Trial management and handling of data
View the document5.8 Standard operating procedures
View the document5.9 Compensation for subjects and investigators
View the document5.10 Monitoring
View the document5.11 Quality assurance
View the document5.12 Study reports
View the document5.13 Handling of adverse events
View the document5.14 Termination of trial
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
 

5. RESPONSIBILITIES OF THE SPONSOR

The sponsor is often a pharmaceutical company, but may also be an individual, the investigator, or an independent institution or organization that initiates, funds, organizes and oversees the conduct of a clinical trial. When the sponsor is a foreign company or organization it should have a local representative to fulfil the appropriate local responsibilities as governed by national regulations.

The sponsor is responsible for providing the investigational and comparator (if any) products, as well as appropriate information to support the safe use of those products. In addition, the sponsor is responsible for ensuring that the trial is conducted in accordance with sound scientific principles and Good Clinical Practice standards by selecting qualified investigators, providing a protocol and ensuring protocol compliance, establishing the distribution of trial-related responsibilities, and providing facilities, equipment and staff for management of the trial, record-keeping, handling of data, monitoring, and quality assurance. The sponsor is also ultimately responsible for ensuring compliance with applicable legal, ethical, and regulatory requirements (although local regulations may designate certain required activities as responsibilities of the investigator), and for providing compensation and indemnity in the event of trial-related injury or death, according to local laws and regulations.

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