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Clinical Trials Resource Group

Clinical Trials Resource Group

Number6IND Process: Protocol Amendments

You need to submit an IND Protocol Admendment if you have either of the following changes during the course of your study:
  • New Protocol
  • Change in Protocol
  • New Investigator (new site)

For changes in the Protocol, the IND Protocol Amendment consists of:

  1. Cover Letter identifying the submission as Protocol Amendment:  Change in Protocol   or   Protocol Amendment: New Protocol (Example )
  2. Form 1571 - Check an appropriate box under Paragraph 11, "Protocol Amendments" (Example )
  3. A document outlining the differences between the new protocol and the original protocol (Template )

The study may begin after you obtain IRB approval based in the new or amended protocol and after the FDA received the amendment (effective immediately).

For changes in the Investigators, the IND Protocol Amendment consists of:

  1. Cover Letter indentifying the submission as Protocol Amendment: New Investigator
  2. Form 1571 - Check an appropriate box under Paragraph 11, "Protocol Amendments"
  3. Form 1572 for the new investigator

The study may begin after you obtain IRB approval based in the new or amended protocol and after the FDA received the amendment. FDA does not issue "permissions", your changes are effective immediately upon the receipt of your amendment by the FDA.

If the drug manufacturer has the following changes during the course of your study:

  • Changes in Chemistry, Manufacturing and Control,
  • Changes in Pharmacology/toxicology (new findings affecting safety and efficacy),
  • Decides to discontinue a clinical study,

the company will notify you. Your reponsibility is to notify the IRB and make a decision as to whether to proceed with your trial.