Ethics Committee AVP Research Foundation
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About Committee
Vision
Mission
Jurisdiction
Members
SOPs'
Forms
Contact
PBE Movement
About Committee
Vision
Mission
Jurisdiction
Members
SOPs'
Forms
Contact
PBE Movement
00 Cover Page -Introduction, Glossary, Approval
01 SOP Preparing Standard Operating Procedures
02 SOP Constitution of Institutional Ethics Committee
03 SOP Handling Confidentiality and Conflict of Interest among Ethics Committee Members
04 SOP Selection and Responsibilities of Independent Consultants
05 SOP Procedures for allowing Guest Observer to visit IEC office or attend IEC meeting
06 SOP Management of Submission of Research Study Protocol and Study Related Documents
07 SOP Categorisation of New Research Study Protocols Received for Initial Review
7A SOP Initial Full Board Review of New Research Study Protocols
7B SOP Expedited Review of Research Study Protocols
7C SOP Exemption from Ethics Review of Research Study Protocols
08 SOP Agenda Preparation, Meeting Procedures, and Recording of Minutes
09 SOP Review of Resubmitted Amended Protocols and Protocol-related Documents
10 SOP Continuing Review of Study Protocols
11 SOP Review of Protocol Deviations Violations Non-compliance
12 SOP Review of Serious Adverse Events (SAE) Reports
13 SOP Review of Study Completion
14 SOP Management of Premature Termination Suspension Discontinuation of the study
15 SOP Waiver of Written Verbal Informed Consent
16 SOP Monitoring and Post-Monitoring Activities
17 SOP Dealing with Participants` Requests andor Complaints
18 SOP Maintenance of Records and Archiving
19 SOP Reviewing Proposals Involving Vulnerable Populations
20 SOP Preparing for Ethics Committee Audit Inspection
21 SOP Training and Assessment of Ethics
22 Bibliography
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