Escolar Documentos
Profissional Documentos
Cultura Documentos
2. Ensure that the following materials have been checked and are ready for audit:
□ Copies of signed informed consent forms for all subjects entered in the study
□ Copies of all case report forms for all subjects
□ Copies of any corrections made, queries, etc.
□ Source documents for all subjects (office charts, test results, etc.)
□ Study document file
□ All study initiation records
□ List of involved study personnel and dates of involvement
□ All IRB communications
□ Sponsor communications
□ Study notes, etc.
□ Grant information should not be present
□ Drug dispensing records for all subjects
□ Overall drug accountability forms
□ Other materials, as requested or as appropriate