Research Document Archiving
Research Document Archiving
| When to Apply | Within 6 months after the end of the clinical trial·completion of the IRB final report |
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| How to Apply | Online application - ctcm.snuh.org |
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Free Storage Period
(Article 30(1)12 of KGCP) |
- Documents for product approval: 3 years from the product approval date
- Early-termination documents: 3 years from the early-termination date
- IRB final-report documents: 3 years from the report date
- Other documents: 3 years from the trial completion date (IRB final-report date)
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| Paid Storage | For requests exceeding 3 years, KRW 300,000 per study per year (VAT 10% separate)
※ The deposit account is provided separately (different from the research-funding account). |
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| Binder Labeling | Mark the study number (not the IRB number) + the archiving application number on the binder's spine |
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| Provided Box | 41 × 33 × 31.5 cm (holds 5–6 binders) |
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※ Please verify carefully, as errors require re-approval and cause inconvenience.
※ It is convenient to submit the storage-fee payment application together after early termination·final report·product approval.
Related Manuals
- PI Manual - Clinical Trial Support System
- CRC Manual - Clinical Trial Support System
- CRA Manual - Clinical Trial Support System
- Pharmacist·IRB Manual - Clinical Trial Support System
※ The manual PDF files are being prepared.
