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Study Site Document Archiving

Protection of study participants and data integrity are two pillars of clinical research. Proper protection of study participants and good data quality must to be demonstrated by traceable records that are accessible to monitors, auditors and inspectors for verification whenever required. To ensure full compliance with various laws, regulations and guidelines, nowadays the industry commonly requires retention of study site documents for up to 15 years after completion of each clinical study.

ArchiveEasy is HKU-CTC’s study site document central archiving service specifically offered for meeting the compliance needs of sponsors and investigators. Under investigators’ formal written authorization, HKU-CTC will arrange for collection and delivery of study site documents for storage in ISO-certified professional document storage facilities for up to 15 years (or a longer period on request). In case of audits or inspections, rapid retrieval of documents can be arranged through HKU-CTC anytime during an archiving period. ArchiveEasy service is available to investigators of HKU/QMH as well as other study sites in Hong Kong.

Highlights
Central management of study site document archiving
Formal written authorization by investigators
Storage in ISO-certified professional document storage facilities with fire/flood protection and pest control
Rapid retrieval of archived documents for audits and inspections
Long-term archiving for up to 15 years
Permanent destruction (or extended archiving on request) after expiry of an archiving period
Service available to study sites anywhere in Hong Kong