NJRO SOPs

Below are our published SOPs for use by all research personnel. The SOP Training Matrix identifies which SOPs should be read by each staff group (or which SOPs each staff group should be aware of). Once read the SOPs should be recorded on the SOP Reading Log.

General

Protocol Deviations, Violations, Waivers and USMs in studies sponsored and hosted by NuTH FT – NJRO-GEN-SOP-002

Publications – NJRO-GEN-SOP-005

Preparation, Review and Approval of NJRO SOPs V4

Informed Consent for Research V4

Essential Documents – TMF V4

Obtaining Caldicott Approval for Research V3

Requests under the Research Passport Scheme V3

Archiving Clinical Research Documents V3

Obtaining Trust Sponsorship of a CTIMP V2

Monitoring of Research V2

Vendor Selection V3

Document Version Control V3

Data Management

Developing and Maintaining a Monitoring Plan

Ensuring Accuracy of Data Entry on eCRF and pCRFs V1

Processing and Storage of Clinical Research Samples V1

Vendor Assessment V1

Preparation, Review and Approval of Clinical Research SOPs & WIs V2

Document Control Systems V2

Preparing a Statistical Analysis Plan V1

Maintaining Training Records V1

Source Data Documentation V1

Application Assessment Meeting V1

Gaining Confirmation of Capacity and Capability V1

 

Regulatory Compliance

Randomisation and Code Breaking – NJRO-REG-SOP-001

Safety Reporting in NuTH Sponsored Device Trials – NJRO-REG-SOP-002

End of Study Procedures – NJRO-REG-SOP-003

Clinical Trial Risk Assessment for High Risk, NuTH FT Sponsored Trials – NJRO-REG-SOP-004

Notification of Serious Breaches of GCP or the Trial Protocol V3

Sponsor Process for reporting SUSARs V3

Research Misconduct and Fraud V3

Adverse Event Reporting for CTIMPs and ATMPs V4

Annual Updates to the IB V3

Regulatory Green Light Process for CTIMPs V2

Out of Hours Emergency Cover

Amendments to Sponsored CTIMP, ATMP or Device Trials V2

 

Governance

Adverse Event Recording for non-CTIMP V3

Obtaining Trust Sponsorship for non-CTIMP V3

Management Review for projects collecting tissue samples prospectively under Biobank REC Approval

Amendments to Hosted Research V2

 

Quality Assurance

GCP Auditing of Research Studies – NJRO-QA-SOP-001

 

 

 

New SOPs are being added all the time so please visit this page on a regular basis.

 

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