Safety Monitoring and Data Management
Cross-source consensus on Safety Monitoring and Data Management from 1 sources and 5 claims.
1 sources · 5 claims
Preparation
Risks & contraindications
Other
Other
Highlighted claims
- T-CReDO serves as the primary coordinating centre and provides oversight, compliance auditing, and monitoring. — Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol
- Clinical trial data are managed through ACReSS with patient identifiers replaced by subject codes. — Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol
- No data monitoring committee performs interim analyses; instead, T-CReDO conducts continuous central surveillance. — Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol
- Adverse event management includes treatment, possible protocol modification, and possible discontinuation if safety concerns arise. — Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol
- Peripheral blood specimens from University of Tsukuba participants are stored at −80°C for planned RNA sequencing and biomarker analyses. — Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol