Q: What are the signature requirements for clinical trial summary report and sub-center clinical trial summary of food for special medical purpose?
A: The signature and seal requirements on the first page of the clinical trial summary report: the signature of the investigator, the seal of the clinical trial institution, the seal of the applicant, the signature of the statistical responsible person and the seal of the unit, etc.
For multi-center clinical trials, the sub-center clinical trial summary should be signed by the sub-center investigator and sealed with the official seal of the sub-center clinical trial institution.
The data management plan and report, and the statistical analysis plan and report should be signed by the data management responsible person and the statistical analysis responsible person respectively, and sealed with the official seal of the unit.
Source: SAMR
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