Study Subjects Data and Documents For Clinical Research

Study Subjects Data and Documents For Clinical Research

Ø            All signed and dated informed consent forms (for enrolled and screened subjects).

Ø            Study subject screening and/or enrolment log.

Ø            Study subject identification list.

Ø            Copy of all Case Report Forms (CRFs).

Ø            Copy of the Serious Adverse Event form.

Ø            Copy of documentation of CRF corrections.

Ø            All study subjects source documents including laboratory results.

Ø            Copy of all subjects CRFs retrieval certificate.