MCTC069 Guidance | eTMF Filing Guideline

Document ID
MCTC069
Version #
1.1
Author
CRDO (CRDO)
Publication Date
01/06/2021
Document Type
Guidance
Applicability
Intervention: drug/device Intervention: no drug/device Observational Other
Study Team Role
Melbourne Children’s Sponsored / Lead
Team Role
Principal Investigator Sub-Investigator Study Assistant Research Nurse Study Coordinator Statistician Data Manager Pharmacist Other
Topics
Monitoring / QA Other Software Records Data