The trial protocol is finalized either by the sponsor operations team or by the CRO team, who has been given the contract of the trial by the sponsor. After the protocol and all the other study documents are ready, the sponsor / CRO file them to the Regulatory body and Ethics committee to acquire the approval for initiation of the proposed trial. Both the files can be submitted simultaneously or one after another. But most of the companies, as most of the trials are nowadays multicentric, file their project to the regulatory and then to the ethics committee after deciding upon the sites. In India, as per Indian GCP, ethics committee dossier should be submitted by the Investigator to the committee, at least three weeks in advance (or as per respective EC SOPs) of the scheduled meeting.

After the submission, there is an initial review of the proposal and discussion during the meeting. The researcher should present the proposal and clarify the queries of EC members during the meeting.

The proposal submitted to ethics committee should have essential following documents:

  • Study Protocol
  • Investigator’s Brochure
  • Informed Consent Documents in English
  • Investigator(s) CV
  • Recruitment procedure (e.g. advertisement, if applicable)
  • PI Undertaking
  • Clinical Trial Liability Insurance
  • Agreement between Investigator and sponsor
  • 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 document)
  • Case Report Forms/Clinical Report Forms (if required by EC)
  • Translation of Informed Consent Documents in vernacular language(s) if applicable (if required by EC)
  • Translation Certificate for all vernacular language(s) (if required by EC)

The IEC member will examine for the presence of the following points while reviewing the patient information sheet/Informed Consent Form as per guidelines to review Informed Consent Document/Patient Information Sheet as follows:

  • Voluntary, non-coercive recruitment/participation / withdrawal
  • Procedures for obtaining informed consent
  • Contents of the patient information sheet – title, objective, study design and procedures
  • Contents and language of the informed consent document
  • Translation of the informed consent document in the local languages
  • Language used – plain and easy to understand by general public
  • Contact persons with address and phone numbers for questions about subject’s rights and study or injury
  • Privacy and confidentiality
  • Risks and discomforts – physical / mental / social
  • Alternative treatments
  • Benefits – to participants and to others
  • Compensation for participation / for injury– reasonable /unreasonable
  • Involvement of vulnerable participants
  • Provisions for medical/psychosocial support
  • Treatment for study related injuries
  • Use of biological materials
  • Check for provision for signatures with dates of participant, person conducting informed
  • Consent discussion, investigator and witness
  • Study Protocols and related documents (such as case report forms, informed consents, diary forms, scientific documents, reports, records, expert opinions or reviews)
  • IEC documents (SOPs, meeting minutes, advice and decisions)
  • Investigator’s brochures or similar documents
  • Agreements signed by appropriate authorities, such as: Clinical trial agreement, Insurance document.
  • Photocopies of statutory permissions as applicable
  • Approved documents (protocols, amendment, informed consent form, advertising materials, etc.)
  • Approval letters for protocol & protocol related documents
  • Adverse experience reports or IND safety reports received/SAE reports
  • Continuing review reports
  • Copy of all original letters received from the Principal Investigator.
  • Copy of all correspondence letters sent to the investigator.