RESPONSIBILITIES OF AN INVESTIGATOR TOWARDS IEC

MODULE 8

As per the Indian GCP, an investigator is defined as a person responsible for the rights, safety and welfare of the study subjects. An investigator works in close coordination with the Ethics Committee thus his/her responsibilities towards ethics committee are clearly defined.

The Ethics Committee, whose prime responsibility is to safeguard the rights, safety, and well being of all trial subjects, reviews documents such as Informed Consent, Insurance Policy by the sponsor, IB, Protocol, Current CV of the investigator, advertisement for the subject enrollments, CTA, and Investigators undertaking submitted by the investigator. The investigator acts as the only communication link between the sponsor and the ethics committee thus it is the responsibility of the investigator to present the Protocol to the ethics committee and answer their queries. Only after obtaining a favorable opinion/approval from the ethics committee, can an investigator initiate subject enrollments for the study.

A. Investigator Responsibility towards IEC before Trial Initiate:

The Following Documents are to be submitted and the protocol is to be presented, to the ethics committee to obtain the approval for the Trial:

  • Approved Protocol
  • Investigator’s Brochure
  • Informed Consent Documents in English
  • Translation of Informed Consent Documents in vernacular language(s) if applicable
  • Translation Certificate for all vernacular language(s)
  • Investigator(s) CV
  • Any other project-specific documents
  • Recruitment procedure (e.g. advertisement, if applicable)
  • PI Undertaking
  • Clinical Trial Liability Insurance
  • DCGI Approval Letter for the Trial however it is the responsibility of Investigator(s) to ensure that the document is obtained prior to first subject entry in the trial (Optional Documents)
  • Case Report Forms/Clinical Report Forms (Optional Documents)
  • Agreement between Investigator and sponsor (Optional Documents)

B. Investigator Responsibility towards IEC during the Trial:

During the conduct of the trial it is responsibility of the investigator to update the ethics committee about any major finding which could lead to a change in the IB, protocol and ICF, and seek their approval before bringing it into effect. It is also his responsibility to report, all serious adverse drug reactions and adverse events that may occur during the trial within 7 working days from its start date. For Serious adverse event such as death of the study subject, the investigator must provide additional supporting information such as autopsy reports and medical reports to the ethics committee. Any subject withdrawals and dropouts should be notified along with the explanation of the same. Also the Investigator must allow monitoring and auditing of the records, procedures and facilities, by the ethics committee.

The Following Documents are to be notified to Ethics committee:

  • Investigator’s brochure updates ( if any revision)
  • Protocol amendments (if any)
  • Informed Consent Documents ( if any revision)
  • Curriculum Vitae of new investigators and sub-investigators
  • Initial Report of “Serious and Unexpected Adverse Events” within 7 working days
  • Notification of “Suspected Unexpected Serious Adverse Reactions” (SUSAR) and of other safety information

C. Investigator Responsibility towards IEC after the Trial Completion:

  • After the completion of the trial, investigator notifies EC about the outcome of the trial in a comprehensive study report.