Text Box: Preface

Sanjay Gandhi Postgraduate Institute of Medical Sciences

 

Standard Operating Procedures  of Institutional Ethics Committee (SOPs, IEC)

 

Useful link (Form/template)

 

 

Forms 1-Project submission

 

Form 2-Intimation of start of study

 

Forms 3-Annual status report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 4-Study Completion Report form

 

A. For Interventional study

 

B. For non Interventional study

 

Form 5-Amendment Reporting

 

Form 6-SAE reporting  

 

A. Onsite

                         

B. Offsite

 

Form 7-Deviation-Waiver-Violation-Reporting

 

Form 8-Premature Termination/Suspension/Discontinuation Report

 

Form 9-Review exemption application

 

Form 10-Request for Waiver of Written Informed Consent

 

Form 11-Formulation of New/Revision of SOP

 

Form 12-List of IEC Members

 

Appendices (Policy and Guideline)

Click here to download

Complete SOPs of IEC, SGPGI

 

Useful link (Form/Template)

 

Proposals for Ethical Review(Online)
 

Forms 1-Project Submission-Word / PDF

 

Form 2-Intimation of start of Study

 

Forms 3-Annual status Report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 4-Study Completion Report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 5-Amendment Reporting

 

Form 6-SAE Reporting          

 

A. Onsite

                      

B. Offsite

 

Form 7-Deviation-Waiver-Violation-Reporting

 

Form 8-Premature Termination/Suspension/Discontinuation Report

 

Form 9-Review exemption application

 

Form 10-Request for Waiver of Written Informed Consent

 

Form 11-Formulation of New/Revision of SOP

 

Form 12-List of IEC Members

 

Appendices (Policy and Guideline)

Click here to download

Complete SOPs of IEC, SGPGI