Once an IND application is in effect, the sponsor of the application may amend the application as needed to ensure that the clinical investigations are conducted according to protocols included in the IND application. The sponsor-investigator may initiate the new protocol
once the following two conditions are met: The sponsor-investigator may comply with these two conditions in either order. If the IND application sponsor desires FDA to comment
on a submission, they should submit a request for such comment and the specific questions that FDA’s response should address. When several submissions with minor amendments are expected within a short period, sponsors are encouraged, to the extent feasible, to include all amendments in a single submission. Any specific technical information referenced in an IND application amendment as already submitted to FDA in the original IND application is expected to be identified by name, reference
number, volume, page number, and date of submission. Click one of the options in the list below to jump to the content you need or scroll down the page to see which amendment applies to your application.
New protocolsThis will be identified as “Protocol Amendment: New Protocol” When to submit a new protocol amendment: If a sponsor intends to conduct a study not covered by a protocol already contained in their IND application; the sponsor is expected to submit to FDA a protocol amendment containing a copy of the new protocol and a brief description of the most clinically significant differences between it and the previous protocols. Documents and required information for a new protocol amendment:
Changes to existing protocol(s)This will be identified as “Protocol Amendment: Change in Protocol” When to submit a change in protocol amendment: A sponsor of an IND application is expected to submit a protocol amendment in cases when there are changes in the existing protocol that significantly affect safety of subjects, scope of the investigation, or scientific quality of the study. Such amendment should contain a brief description of the change and reference (date and number) to the submission that contained the original protocol. For example, changes requiring an amendment to an IND application may include:
Note: a protocol change intended to eliminate an apparent immediate hazard to human subjects may be implemented immediately provided the FDA is subsequently notified by protocol amendment, and the reviewing IRB is also notified. Documents and required information for a change in protocol amendment:
Addition of a new investigatorThis will be identified as “Protocol Amendment: New Investigator” When to submit a new investigator amendment: A sponsor of an IND application is expected to submit a protocol amendment when a new investigator is added to carry out a previously submitted protocol. The amendment should include the investigator’s name, the qualifications to conduct the investigation, and any reference to the previously submitted protocol, if relevant. The FDA should be notified within 30 days of the investigator being added. Documents and required information for a new investigator amendment:
Questions?Use the form below or contact CTSI Regulatory Specialist Sheila Austin, (352) 273-8702, for assistance with the IND process and forms. We are happy to answer any questions you might have.What requires an IRB amendment?For exempt projects amendments are required only for sustantive changes that impact or alter the criteria used to make the initial exempt determination.
What is a protocol amendment?Any significant change in the design of a protocol (such as the addition or elimination of a control group).
Can an IRB approved protocol be changed?An amendment to an existing approved Institutional Review Board (IRB) protocol is viewed as any change to what was previously approved during the period for which approval was given. Amendments are categorized as either major or minor and are distinguished based on the type of changes proposed.
What is an amendment in research?Amendments are changes made to a research project after approval from a review body has been given. If you plan to make an amendment to your research project, you will need to determine whether you need to notify the review bodies from whom you have received approvals.
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