Final Report Submission to Regulatory Authorities
This is an important step towards ensuring full compliance, data integrity, and readiness for audits or future reference. WEP expertly manages this to help Sponsors successfully avoid delays, regulatory rejection, legal liabilities, and loss of valuable data.
Post-Visit Activities & Final Close-Out Report
After the site close-out visit, the WEP CRA will:
- Complete a Site Close-Out Visit Report.
- Submit all finalized documents to the Trial Master File (TMF).
- Ensure the Investigator Site File (ISF) is archived correctly.
- Confirm that the site is ready for audits/inspections.
WEP will then finalize the following:
- Clinical Study Report (CSR) for regulatory submission
- Data Lock and Final Database Closure
- Regulatory submissions to FDA, EMA, PMDA, etc.
Final Regulatory Submissions & Study Archival
The Clinical Study Report (CSR) is submitted to regulatory agencies
It follows ICH E3 guidelines and includes:
- Trial design & methodology
- Final efficacy & safety data
- Statistical analyses
- Adverse event summaries
- Investigational product (IP) accountability
Submissions are made via the appropriate regulatory portals, e.g.:
- FDA: Electronic Submissions Gateway (ESG)
- EMA: eSubmission Gateway
- PMDA (Japan): Gateway system
- Health Canada & MHRA: Respective portals for submission
All trial data, documents, and records are then archived
Once the study is formally closed, we ensure that all trial data, documents, and regulatory records are appropriately archived for long-term compliance and inspection readiness. We follow structured processes and ensure compliance with the specified retention periods, which can range from anywhere from 2 years up to 25 years.
Following all the above steps, the site is formally released from study obligations.