Is it an existing and ongoing IND?
To be concise:- 1571 to precise the purpose of the amendment
- 1572 should be supported with CV
- Submit IB if multi-site trial
- ICF not required but suggested
- if the IND is ongoing I would submit tracked protocol as well and a quick summary of why the change was implemented (not required but will smoothen the process
- the rest as listed in section 14 in FDA-1571.
Comments:
IB serves as a communication tool in between sites. So if you have other sites participating definitely revise it and provide it to other participating sites.
Docs tend to have million pages in their CV. I usually include first 5 pages of their CV and make sure it includes enough of relevant information.
I am not sure where do you conduct the clinical trials, but if it is within the USA you should also update your
Data and Safety Monitoring Board (DSMB) plan or whatever your organization calls this impartial group required by NCI.
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Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
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Original Message:
Sent: 13-Mar-2020 20:05
From: Anonymous Member
Subject: IND Amendments
This message was posted by a user wishing to remain anonymous
Our company is submitting a ne protocol to their IND . A few questions: Do we submit the new version of the IB? Should the PI 1572 also have the CV?. Should the informed consents be submitted?. This a oncology project and complex. Iknow the regs dont require these extra docs but will it make for a smoother review? My older company always submitted these routinely .