Protocol Amendment

Protocol amendment is a formal and documented changes made to the study protocol. These changes can encompass modifications in study design, study procedures, eligibility criteria, data collection, informed consent, or other critical aspects of the trial. Protocol amendments require regulatory approvals and ethics committee review to ensure participant safety and data integrity. Updates to informed consent documents and re-consenting procedures are also necessary to ensure participant safety.

Definitions

ICH E6(R2)

1.45 Protocol Amendment:

A written description of a change(s) to or formal clarification of a protocol .

Reasons for a protocol amendment

There are several reasons why a sponsor might issue a protocol amendment to a clinical trial, including changes in study design, procedures, or endpoints aimed at enhancing the scientific validity or clinical relevance of the trial:

• scientific or medical reasons
• data integrity
• administrative changes
• safety concerns
• ethical considerations
• regulatory requirements

Thus, protocol amendments are typically made in response to new information, safety concerns, or logistical issues that arise during the course of the study.

Implementation

In most cases, amendments to the study protocol are issued after the initial approval by competent authorities and review of ethics committees, thus requiring subsequent regulatory and ethics committee review and approval before implementation at sites.

See also

Another relevant pages

• Protocol

Links to this page

• Amendment ‎ (← links)
• Glossary:Protocol Amendment (redirect page) ‎ (← links)