Tiêu đề 6. GOOD CLINICAL PRACTICE - CDSCO GUIDELINES.pdf ✅

PHARMD GURU Page 2 b) 2.3.2: SUPPLEMENTARIES & APPENDICES. 4) 2.4: ETHICAL & SAFETY CONSIDERATIONS. a) 2.4.1: ETHICAL PRINCIPLES.  Principles of essentiality.  Principles of voluntariness, informed consent, and community agreement.  Principles of non-exploitation.  Principles of privacy and confidentiality.  Principles of precaution and risk minimization.  Principles of professional competence.  Principles of accountability and transparency.  Principles of maximization of the public interest of distributive justice.  Principles of institutional agreements.  Principles of public domain.  Principles of totality of responsibility and principles of compliance. b) 2.4.2: ETHICS COMMITTEE. 2.3.1.4 Study design. 2.3.1.5 Inclusion, exclusion and withdrawal of subjects. 2.3.1.6 Handling of products. 2.3.1.7 Assessment of efficacy. 2.3.1.8 Assessment of safety. 2.3.1.9 Statistics. 2.3.1.10 Data handling and management. 2.3.1.11 Quality control and quality assurance. 2.3.1.12 Finance and insurance 2.3.1.13 Publication policy 2.3.1.14 Evaluation. 2.4.3.1 Basic responsibilities. 2.4.3.2 Composition.
PHARMD GURU Page 3 c) 2.4.3: INFORMED CONSENT PROCESS. d) 2.4.4: ESSENTIAL INFORMATION ON CONFIDENTIALITY FOR A PROSPECT TO RESEARCH SUBJECTS SAFEGUARDING CONFIDENTIALITY. e) 2.4.5: COMPENSATION FOR PUBLICATION. f) 2.4.6: SELECTION OF SPECIAL GROUPS AS RESEARCH SUBJECTS. g) 2.4.7: COMPENSATION FOR ACCIDENTAL INJURY. 2.4.3.3 Terms of reference. 2.4.3.4 Review procedures. 2.4.3.5 Submission of application. 2.4.3.6 Decision making process. 2.4.3.7 Interim review. 2.4.3.8 Record keeping. 2.4.3.9 Special considerations. 2.4.3.1 Informed consent of subject 2.4.3.2 Essential information for a prospect to research on subjects. 2.4.3.3 Informed Consent in non therapeutic study. 2.4.6.1 Pregnant, nursing woman. 2.4.6.2 Children. 2.4.6.3 Vulnerable groups. 2.4.7.1 Obligation for the sponsor to pay.