Resource Exchange
Search Category: Monitoring Plans (Data and Safety)
| Clinical Research Safety Monitoring Policy | |
| Type: Example Policy Author: Portsmouth Hospitals NHS Trust Keywords: SAEs, AEs, SUSARS, SARS, Adverse Events, Protocol, development, safety, safety monitoring, GCP, Additional Detail: This policy includes information for safety monitoring in protocol development. Section 7, p12 Link Reference: 388 Click here to access the resource |
| Statistical Analysis Plans | |
| Type: Guidance Author: European Network of Centres for Pharmacoepidemiology & Pharmacovigilence Keywords: Methodological Standards, Pharmacoepidemiology Link Reference: 387 Click here to access the resource |