Ethics Committee

Member list

Office administrative staff

Guidelines for Investigators

ECRHS application form

Checklist for submission of documents

Contact us

Important links

    Guidelines for industry - good clinical practice

    Indian good clinical practices

    Schedule Y

    Ethical guidelines for biomedical research in humans - ICMR

Standard Operating Procedures (Hard Copy available with the ECRHS office on request)

Preparing Standard Operating Procedures (SOPs) for the Ethics Committee for Research on Human Subjects (ECRHS).

Organisational Chart

SOPs for Constituting the Ethics Committee for Research on Human Subjects

SOPs for Confidentiality / Conflict of Interest Agreements

SOPs for Selection and Responsibilities of Independent Consultants

SOPs for Management of Protocol Submissions

SOPs for Initial Review of Submitted Protocol

SOPS Projects Submitted to Expedited Review

SOPs for Review of Resubmitted Protocols

SOPs for Review of Amended Protocol/Protocol related documents

SOPs for Continuing Review of Study Protocols

SOPs for Review of Study Completion Reports

SOPs for Protocol Deviation/Non-Compliance/Violation

SOPs for Management of Premature Termination of the Study

SOPs for Review of Serious Adverse Event (SAE) Reports

SOPs for Site Monitoring Visit

SOPs for Agenda Preparation, Meeting Procedures and Recording of Minutes

SOPs  for Conduct of Emergency Meeting

SOPs for Maintenance of Active Project Files

SOPs to Archive and Retrieve Documents

SOPs for Maintaining Confidentiality of ECRHS Documents

SOPs for Responding to Research Participant’s Request

SOPs for Exemption from the Ethics Review for Research Projects

SOPs for Request for Waiver of Written Informed Consent