Human Ethics Committee

Protecting participant’s and guiding investigators

Standard operating procedures For institutional ethics committee  (human studies)

Download Document's

SOP No FileName Downloads
Ethics Committee Registration
01 CDSCO Download
Ethics Committee SOP Version 3
History of SOP Download
01 Preparation of Standard Operating Procedures for SMVMCH Ethics Committee Download
02 Constitution of SMVMCH Ethics Committee (EC), Selection, Roles and Responsibilities of Members of the EC Download
03 Handling Conflict of Interest among Ethics Committee Members Download
04 Selection and Responsibilities of Independent Consultants Download
05 Procedures for allowing Guest/ Observer to visit Sri Manakula Vinayagar Medical College and Hospital Ethics Committee (SMVMCH-EC) or attend EC meeting Download
06 Management of Submission of Research Study Protocol and Study Related Documents Download
07 Categorization of New Research Study Protocols Received for Initial Review Download
07 A Initial Full Board Review of New Research Study Protocols Download
07 B Expedited Review of Research Study Protocols Download
07 C Exemption from ethics review of research study protocols Download
08 Agenda Preparation, Meeting Procedures and Recording of Minutes Download
09 Review of Resubmitted and Amended Protocols and Protocol-related Documents Download
10 Continuing Review of Study Protocols Download
11 Review of Protocol Deviations / Violations Download
12 Review of Serious Adverse Event (SAE) Reports Download
13 Review of Study Completion reports Download
14 Management of Premature Termination / Suspension / Discontinuation of the study Download
15 Waiver of written / verbal informed consent Download
16 Site Monitoring and Post-Monitoring Activities Download
17 Dealing with participants requests and/or Complaints to Institutional Ethics Committee Download
18 Maintenance of active study files, Administrative records of the ethics committee, Archival of closed files and retrieval of documents Download
19 Reviewing Proposals Involving Vulnerable Populations Download
20 Preparing for Ethics Committee Audit/ Inspection Download
21 Training and Assessment of Ethics Committee Members Download
22 To Review Biomedical & Health Research during COVID-19 Pandemic Download
SNo. FileName Downloads
SOP Amended on 23.04.19
SOP 06 Management of Submission of Research Study Protocol and Study Related Documents Download
SOP 07 B Expedited Review of Research Study Protocols Download
SOP 07 C Exemption from ethics review of research study protocols Download
SOP 09 Review of Resubmitted and Amended Protocols and Protocol-related Documents Download
SOP 10 Continuing Review of Study Protocols Download
SOP 11 Review of Protocol Deviations / Violations Download
SOP 13 Review of Study Completion reports Download
SOP 14 Management of Premature Termination / Suspension / Discontinuation of the study Download
SOP Amended on 15.11.2019
SOP 6 Management of submission of Research Study Protocol and study related documents Download
SOP 7 A Initial full board review of new research study protocols Download
Common Forms
01 Covering letter Download
02 Checklist Download
03 Application form Download
04 Research protocol submission format Download
05 Reply Template Download
Additional Information Forms
05 Additional information for Clinical trials Download
06 Additional information for Human genetic testing reseach Download
07 Additional information for Socio-behavioural & public health research Download
08 Informed consent document template Download
09 Template for Assent Form Download
10 Continuing Review-Annual report format Download
11 Investigator CV for clinical trials Download
12 Notification form for Amendments Download
13 Premature Termination-Suspension- Discontinuation Report Format Download
14 Protocol Violation - Deviation Reporting Form (Reporting by case) Download
15 Requisition for Exemption review Download
16 Requisition for Expedited review Download
17 Data Elements for reporting serious adverse events occurring in a clinical trial Download
18 Checklist for Serious Adverse Event (SAE) submission and analysis report Download
19 Study Completion - Final report format Download