• IEC application form or Covering Letter.
• Protocol or protocol amendments.
• Investigator brochure or amendments.
• English language informed consent form, translations and its back translations.
• Translation and back translation certificates.
• Any recruitment or retention material or any other advertisement. Their translations and back translations along with certificates, if applicable.
• Insurance policy.
• Updated CVs of the Investigators along with medical registration certificates.
• GCP training certificates of the Investigators.
• Form FDA 1572.
• Undertaking from investigators.
• Draft Copy of Clinical Trial Agreement (CTA).
• DCGI clearance/approval, if applicable. If approval is awaited mention in application letter and submit the DCGI submission letter.
• CTRI registration number
• IEC approvals from other investigative site(s), if applicable.
• Other relevant regulatory approvals, if applicable.
• . Case Report Form (CRFs), subject diary, questionnaires, follow-up cards etc. If translations and back translations to be used, then those along with certificates also need to be submitted.
• Source templates provided by Sponsor. If it is site specific template printed on letter head it must only be notified to IEC for review. Site specific template does not require IEC approval.
• Any Other relevant documents required for the study.