Resource Exchange
Search Category: Monitoring
| Code of Conduct For Clinical Research Monitors and Auditors – Remote Access | |
| Type: Example Tool Author: Royal Free London NHS Foundation Trust Keywords: Monitoring, audit, code, remote access, COVID-19, COVID Link Reference: 3629 Click here to access the resource |
| Data sharing in clinical trials – practical guidance on anonymising trial datasets | |
| Type: Article Author: Keywords: data sharing, anonymisation, data sets. clinical trials data, data management Additional Detail: Useful for Sponsors, CTUS and research teams when anonymising data sets for future use. Link Reference: 594 Click here to access the resource |
| Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review. | |
| Type: Paper Author: Cragg WJ, Hurley C, Yorke-Edwards V, Stenning SP. Clinical Trials. February 2021. Keywords: Monitoring, audit, code, remote access, COVID-19, COVID, Sponsorship, Sponsors Link Reference: 10657 Click here to access the resource |
| External Monitoring Research Visits: Code of Conduct | |
| Type: Example Author: Cambridge University Hospitals NHS Trust/ Cambridge BRC Keywords: Monitoring, COVID-19, external visitors, monitors, code of conduct Link Reference: 2887 Click here to access the resource |
| Guidance for site study teams and sponsors for remote monitoring and source data verification within Barts Health NHS Trust | |
| Type: Example Guidance Author: Joint Research Management Office, Queen Mary University of London and Barts Health NHS Trust Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring, monitoring, SDV, IG Link Reference: 2885 Click here to access the resource |
| Induction pack for PPI contributors on Trial Oversight Committees | |
| Type: Tool Author: MRC CTU at UCL Keywords: PPI, induction, induction pack Trial oversight committees, Patient and Public Involvement Link Reference: 692 Click here to access the resource |
| MHRA Blog: Sponsors Oversight Part 1 | |
| Type: Blog Author: MHRA Keywords: Sponsorship, oversight, audit, monitoring, quality, risk, sponsors, regulation, GCP, clinical trials Link Reference: 660 Click here to access the resource |
| Monitoring & Oversight of Research Activity | |
| Type: Example SOP Author: University Hospitals Bristol NHS Foundation Trust Keywords: Bristol, SOP, monitoring, oversight Link Reference: 503 Click here to access the resource |
| Monitoring during COVID 19 at GSTFT. | |
| Type: Example Guidance Author: Guy’s & St Thomas’ NHS Foundation Trust Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring, re-start, restart Link Reference: 2878 Click here to access the resource |
| Monitoring strategy table | |
| Type: Example Strategy Author: University Hospitals Leicester NHS Trust Keywords: Leicester, trial, monitoring, strategy, CTIMP Link Reference: 498 Click here to access the resource |
| Monitoring Systems | |
| Type: Paper Author: NHS R&D Forum Keywords: monitor, audit, quality Link Reference: 502 Click here to access the resource |
| Protocol Deviation Reporting: Cutting Through The Ambiguity | |
| Type: Article Author: Catherine Stewart, clinical sciences group lead, Pfizer, and Laura Galuchie, TransCelerate program lead, Merck Keywords: protocol deviations, monitoring, integrity, safety, data, oversight, Sponsorship, GCP, ICH Link Reference: 2830 Click here to access the resource |
| Protocol Deviations Toolkit | |
| Type: Website resources Author: Transcelerate Keywords: protocol deviations, monitoring, integrity, safety, data, oversight, Sponsorship, GCP, ICH Link Reference: 2819 Click here to access the resource |
| SOP: Remote Monitoring | |
| Type: Example SOP Author: Nottingham University Hospitals NHS Trust Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring Additional Detail: Please note this is a DRAFT SOP at the time of publication Link Reference: 2871 Click here to access the resource |
| Sponsor Monitoring guidelines: | |
| Type: Example Guidance Author: Royal Free London NHS Foundation Trust Keywords: Monitoring, audit, code, remote access, COVID-19, COVID, Sponsorship, Sponsors Link Reference: 3630 Click here to access the resource |
| Sponsor oversight, blog 2 | |
| Type: Blog Author: MHRA Keywords: Sponsorship, Sponsor, oversight, audit, monitoring, quality, risk, sponsors, regulation, GCP, clinical trials, CTIMPS Link Reference: 695 Click here to access the resource |