The protocol is an essential document that goes through multiple reviews and amendments before, and, during the approval process. The Central Drugs Standard Control Organization (CDSCO) and/or the Ethics Committee(s) reviewing the application for conducting a clinical trial may in some instances recommend modifications or amendments in the protocol before giving an approval to commence the trial. The version of the protocol that has been given an approval by CDSCO and EC(s), is called the Final Protocol. It is important that the final protocol is made available to all site investigators, before the trial commences.
During the course of a trial, protocol amendments might become necessary. All such amendments and/or deviations from the final protocol must be notified to CDSCO and the EC in writing. Protocol amendment(s) are any changes or formal clarifications made to the protocol. All amendments to the protocol must be agreed upon and signed by the persons who were signatories to the Final Protocol (example, sponsor, principal investigator, biostatistician, etc.).
Amendments or deviations from the protocol cannot be implemented without an approval from CDSCO and the EC. Exceptions to this rule are:
- Implementing the change or amendment in the protocol is necessary to eliminate immediate hazard(s) to the trial participant(s). All such exceptions must be notified to the CDSCO and EC immediately.
- Amendments only include administrative or logistical aspects of the trial. These changes must be notified within 30 days.
It is the responsibility of the investigator to notify CDSCO and EC about amendments and/or deviations from protocol.
In 2018, the Indian Council of Medical Research released Common Forms for EC Review. For protocol amendments/deviation, the following two resources are available:
- Application or Notification form for Amendments: the form can be accessed here.
- Protocol Violation / Deviation Reporting Form (Reporting by Case): the form can be accessed here.
- New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 01.04.2019).
- National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research, 2017, available online (last accessed on 26.02.2019).
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
- Further information regarding the Common Forms for EC Review by ICMR can be accessed here.