All submissions must meet the following requirements.
Documents required for a new submission of a sponsored trial:
SOP4 Initial Study Submission Template
Initial study submission checklist
Letter to IRB Chairperson
Letter to Head of Institute
Study Protocol
Patient Information Sheet and Informed Consent forms (English, Bengali and Hindi)
Assent forms (for studies on children aged 13-18)
Translation certificates for Bengali and Hindi Translations
Investigator Brochure
Case record form (CRF)
Investigator Undertaking
Insurance and Indemnity Documents
Draft of Clinical Trial Agreement (CTA) and /or Memorandum of Understanding (MoU)
Budget Details
Study Recruitment Plan
CDSCO/DCGI approval for drug trials
Research Support Directorate (RSD) approval (or proof of application)
Institutional Biosafety Committee (IBSC) approval
CVs and valid GCP certificates of all investigators
Powerpoint for IRB presentation
Documents required for a new submission of an investigator initiated study:
SOP4 Initial Study Submission Template
Initial study submission checklist
Letter to IRB Chairperson
Letter to Head of Institute
Study Protocol
Patient Information Sheet and Informed Consent forms (English, Bengali and Hindi) or consent waiver form
Assent forms (for studies on children aged 13-18) or consent waiver form
Translation certificates for Bengali and Hindi Translations when applicable
Case record form (CRF)
Investigator Undertaking
Insurance and Indemnity Documents
Draft of Clinical Trial Agreement (CTA) and /or Memorandum of Understanding (MoU) for multi-institutional studies
Budget Details
Study Recruitment Plan
CDSCO/DCGI approval for drug trials
Research Support Directorate (RSD) approval (or proof of application)
Institutional Biosafety Committee (IBSC) approval if indicated
CVs and valid GCP certificates of all investigators
Powerpoint for IRB presentation
How to format the Title of Submission:
To link this submission to the main study, please enter the Title in this format: (IRB Study Number- Study acronym - Initial/Final SAE - Patient ID - Month-Year -Initial/Final SAE ) e.g. IRB/TMC/2024/SS/001 KORTUC Initial SAE K-3-001 - May 2025
Documents required for a new submission of a Serious Adverse Event:
SOP13 SAE form
Letter to IRB Chairperson
Letter to Head of Institute
De-identified source documents (initial or updated)
Informed consent form for the patient
Current version of protocol
How to format the Title of Submission:
To link this submission to the main study, please enter the Title in this format: (IRB Study Number- Study acronym - Deviation/Violation - Patient ID(s) - Month-Year) e.g. IRB/TMC/2024/SS/001 KORTUC Deviation K-3-001May 2025
Documents to be submitted for Protocol Deviations or Violations
SOP11 Protocol Deviation/ Protocol Violation form
Letter to Chairperson and Head of Institute
Any other supporting document
How to format the Title of Submission:
To link this submission to the main study, please enter the Title in this format: (IRB Study Number- Study acronym - Amendment - Version - Month-Year) e.g. IRB/TMC/2024/SS/001 KORTUC Amendment Version 3.2 - May 2025
Documents to be submitted for study amendments:
SOP8 Amendment form
Letter to Head of Institute and IRB Chairperson
Protocol Amendment, including amendment to Patient Information Sheet and Informed Consent form where applicable.
Summary of Changes
For IRB waivers the following documents are mandatory:
Filled SOP for IRB waiver.
MoU/DTA (if the study involves collaborating centers).
IRB notifications are flexible and can include any new document that requires submission that does not belong to any other listed category.
In the Summary please provide a description of what is being submitted and the reason for the submission.
The names and email addresses entered in this IRB portal will be used exclusively for the stated purposes of this IRB and will not be made available for any other purpose or to any other party.