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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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.

 

About the Author
Proxima CRO Team
Aryan Abedi
Quality Assurance Intern

Aryan received his B.S. in Biomedical Engineering from Texas A&M University. He has experience in Design and Development, Quality Control, and Quality Assurance and is particularly interested in the use of biomaterials and production of cost-effective medical devices to improve quality of life for patients from various socioeconomics background.  

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