Resource Exchange
Search Category: Safety Reporting and Urgent Safety Measures
| Development Safety Update Report (DSUR) Form | |
| Type: Example Form Author: York Foundation Trust Keywords: Safety, reporting, transparency; adverse event, Link Reference: 304 Click here to access the resource |
| Example of Development Safety Update Report (DUSR) – completed | |
| Type: Example Report Author: ICH Keywords: Safety, reporting, adverse, event, Link Reference: 303 Click here to access the resource |
| Progress & Safety Reporting | |
| Type: Guidance Author: Health Research Authority Keywords: Safety, Reporting, CTIMPs, non-CTIMPs, HRA, REC, Progress reports Link Reference: 302 Click here to access the resource |
| Reference Safety Information | |
| Type: Blog Author: MHRA Keywords: MHRA, reference, safety, IB, SMPC, trial, RSI Link Reference: 308 Click here to access the resource |
| Research Safety Reporting | |
| Type: Example SOP Author: University Hospital Bristol NHS Foundation Trust Keywords: Safety, SAE, AE, SUSAR, Sponsorship, DSUR Link Reference: 307 Click here to access the resource |
| Safety Reporting in Clinical Investigations of Medical Devices (MHRA regulated) | |
| Type: Example SOP Author: Manchester University NHS Foundation Trust Keywords: Device, Clinical Investigation of a Medical Device, SADE, USADE, SAE, Device deficiency Link Reference: 15106 Click here to access the resource |
| Safety Training Slides | |
| Type: Slide set Author: Transcelerate Keywords: transcelerate, safety, training, resources, qualification Link Reference: 306 Click here to access the resource |
| Urgent Safety Measures Reporting Form | |
| Type: Example Form Author: Portsmouth Hospitals NHS Trust Keywords: SOP, Clinical Trial Reporting, Urgent Safety Measures Link Reference: 305 Click here to access the resource |