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When must a Form 1572 be updated or a new Form 1572 completed and signed by an investigator to reflect new or changed information?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

There are two instances where the investigator must complete and sign a new 1572:

  1. When a new protocol is added and the investigator must employ that protocol
  2. When a new investigator is added to the investigation(21 CFR 312.53(c))

If there are any changes to the information on the signed and dated 1572, the investigator must document the changes in the study records and update the sponsor. The sponsor must update the IND accordingly. However, the 1572 does not need to be edited and a new one is not required. The sponsor can collect certain information and implement them to the IND. Examples of such information are an amendment or protocol amendment.

 

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