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New Information Reporting Guidance
Version date: January 1, 2013
NOTE: The information provided below does NOT alter or supersede the reporting requirements for unanticipated problems, noncompliance, or serious adverse events. See the Reporting Timeframes document for details on additional reporting requirements.
When Should a New Information Report Be Submitted?
New information reports should generally be used for two purposes:
1. Notifying the IRB of new risk information and a related forthcoming change of protocol: Study teams frequently
receive information from a sponsor or coordinating center involving new risk
information that should be reported to subjects. This information often involves notifying the
study team that a change to the protocol and/or consent documents is
forthcoming. This type of information is
often received in the form of an action letter, revised Comprehensive Adverse
Events and Potential Risks list (CAEPR), or sometimes an updated Investigator's
Drug Brochure (IDB). This new risk information
is frequently available well before the revised study documents are issued. In such cases, study teams still need to take prompt
action to inform subjects of the new risks.
If the revised study documents will not be available to the study team within 14 business days of receipt of the new risk information, a new information report must be submitted to the IRB to describe the new information and outline any action that will occur before the change of protocol is reviewed and approved by the IRB. This new information report allows the IRB to review new risk information in a timely manner in cases when a change of protocol may not be able to be submitted for weeks after the new information has been issued by the sponsor or coordinating center.
The following information should be included in the new information report:
- A description of any change to the enrollment status of the study based on this new risk information. If no change is being made to the enrollment status, justify why no change to enrollment status is needed.
- Confirmation that subjects will be orally informed of the new risk information and clarify if/how this will be documented.
- Confirmation that when the study team receives the revised documents, a change of protocol will be submitted to the IRB within 60 days of their receipt by the study team.
If the study team has been informed that they WILL receive revised study documents within 14 business days of receiving the new risk information, the study team does NOT need to submit a new information report. The study team should instead submit the change of protocol (with the action letter/revised CAEPR/updated IDB) within 60 days of receipt of the new risk information. In the submission comment box, the study team should include the information (points 1, 2 and 3 above) that would have been included in the new information report. NOTE: If the new risk information addressed in the change of protocol may constitute an unanticipated problem, this must be reported to the IRB within 14 business days.
NOTE: Although the study team has 60 days to submit the Change of Protocol, they are still required to orally inform study subjects of new risk information in a timely manner. If a study team wishes to send a letter to study subjects informing them of this new information, study teams should submit a New Information report including both the letter for subjects and the "new information" document (e.g., action letter, revised IDB). The revised study documents can then be submitted separately as a Change of Protocol.
If the study team is not sure whether the revised study documents will be received within 14 days of receipt of the new risk information, a new information report should be submitted as described above.
2. Notifying the IRB of other information that will not result in a change to protocol documents and may or may not impact the risk/benefit ratio of the study: Occasionally, study teams become aware of new information (e.g., through a literature review, correspondence from the sponsor or coordinating center) that is not expected to result in any changes to protocol documents and may not impact the risk/benefit ratio, but nonetheless has some relevance to the ongoing study. In these cases, the New Information report serves as the best means to alert the IRB of this information. Examples of such reports include the following:
- New risks discovered
on a different study using the same drug, but that does not appear to have
relevance to the current study (e.g., due to significant differences in subject
population or dose).
- A change in study status that was not previously specified in the protocol (e.g. halt to enrollment due to equipment malfunction or drug supply issues).