Table 1.
Principles of E6(R3)
| Sr.no. | Principle | Practice |
|---|---|---|
| 1 | Rights, safety, and well-being of participant | Prevail over interests of science and society |
| Require periodic review of new safety information | ||
| Need to balance risks and benefits to participants and society | ||
| Selection of participants representative of the anticipated population | ||
| Qualified physician responsible for medical decisions and care | ||
| Protection of confidentiality of participant’s identity | ||
| 2 | IC | Freely given IC before clinical trial participation |
| Information adequate to make informed decision about participation | ||
| Focus on critical aspects of trial protocol | ||
| 3 | IRB/IEC approval | Conduct of trial in compliance with IRB/IEC approved protocol |
| Periodic review of the trial by the IRB/IEC | ||
| 4 | Scientific knowledge | Adequate preclinical and clinical information on IP |
| Scientifically sound clinical trial design based on state of art and current knowledge | ||
| Periodic review of current scientific knowledge and approaches | ||
| 5 | Qualified individuals | Designed and conducted by individuals qualified by education, training, and experience |
| 6 | Quality in design and conduct | Quality and information generated supportive of good decision |
| Quality by design with focus on factors fundamental to the protection of participants, the reliability and interpretability of the trial results | ||
| Strategies implemented to avoid, detect, and address serious noncompliance with GCP, the trial protocol, and applicable regulatory requirements | ||
| 7 | Participant risk and importance of data | Trial processes proportionate to the risks to human protection and data reliability |
| Emphasis on the risks to participants beyond those associated with standard medical care | ||
| Prospective management of risks critical to quality factors | ||
| 8 | Protocol | Well-designed for human protection and data reliability |
| Scientific objectives explicit | ||
| Clear, concise, feasible protocol, plans, or documents | ||
| 9 | Results | Quality and information generated supportive of good decision |
| Data capture, management and analyses, and quality of the information fit for purpose and proportionate to the risks | ||
| Operationally feasible processes to support key trial objectives | ||
| Computerized systems focus on factors critical to quality | ||
| Efficient and well-controlled documentation for accurate reporting, interpretation, and verification | ||
| Secure retention of records for the required period | ||
| Transparency-registration of trials and posting of results | ||
| 10 | Roles and responsibilities of the sponsor and the investigator | Responsible for respective activities–tasks, duties, or functions |
| Responsible for conduct, quality, and data integrity for activities transferred to service providers | ||
| Responsible for appropriate oversight of the activities | ||
| 11 | IP | Manufacture in accordance with GMP |
| Measures to retain quality of IP | ||
| Use of IP in accordance with the protocol and trial documents | ||
| Manufacturing, handling, and labeling of IP to ensure blinding | ||
| Labeling of IP in compliance with regulatory requirements | ||
| Adequate measures to ensure handling and shipping |
IC=Informed consent, IRB/IEC=Institutional review board/independent ethics committee, IP=Investigational product, GMP=Good manufacturing practice, GCP=Good Clinical Practice