Standard Operating Procedures

The Sheffield Clinical Trials Research Unit runs studies/trials according to the Standard Operating Procedures below.

If you would like access to any of the Standard Operating Procedures please contact Richard Eyre, Quality Assurance Officer.

Data Management

Shef/CTRU/DM001 Data Protection

Shef/CTRU/DM003 Case Report Form Development

Shef/CTRU/DM004 Study Database Development

Shef/CTRU/DM005 Central Data Validation

Shef/CTRU/DM006 Data Entry and Import

Shef/CTRU/DM009 Data Management and Monitoring Plan

Shef/CTRU/DM012 Study Database Lock and Retention

Shef/CTRU/DM013 Case Report Form Sign-Off

Shef/CTRU/DM014 Data Protection for NHS Staff

General

Shef/CTRU/GEN001 SOP Requirements for Associated Staff

Shef/CTRU/GEN002 SOP Management

Shef/CTRU/GEN003 Training Records and Staff Training

Shef/CTRU/GEN004 Study Outputs

Project Management

Shef/CTRU/PM003 Writing a Protocol

Shef/CTRU/PM004 Adverse Events and Serious Adverse Events

Shef/CTRU/PM005 Investigational Medicinal Product Management

Shef/CTRU/PM007 Serious Breach of Trial Protocol or GCP

Shef/CTRU/PM008 Periodic Safety Reporting

Shef/CTRU/PM009 Urgent Safety Measures

Shef/CTRU/PM010 Delegation of Duties

Shef/CTRU/PM011 Protocol and GCP Non-Compliances

Shef/CTRU/PM012 Archiving

Shef/CTRU/PM013 Document Control

Shef/CTRU/PM014 End of Trial Reporting

Shef/CTRU/PM015 Study Files and Filing

Regulatory Authority Approval

Shef/CTRU/RA003 Regulatory and Ethical Approvals

Statistics

Shef/CTRU/ST001 The Statistical Analysis Plan

Shef/CTRU/ST003 Data Evaluability

Shef/CTRU/ST004 Interim Data Analysis

Shef/CTRU/ST005 Randomisation and Blinding

Shef/CTRU/ST006 Undertaking a Statistical Analysis

Shef/CTRU/ST007 Randomisation using the CTRU randomisation system

Shef/CTRU/ST008 Sample Size

Shef/CTRU/ST009 Blinding

Study Governance

Shef/CTRU/GOV001 Trial Management Group

Shef/CTRU/GOV002 Trial Steering Committee

Shef/CTRU/GOV003 Data Monitoring and Ethics Committee

Study Set-up

Shef/CTRU/SSU001 Informed Consent Procedures

Shef/CTRU/SSU003 Participant Discontinuation and Withdrawal of Consent

Shef/CTRU/SSU004 Assessment of Investigator Sites

Shef/CTRU/SSU005 Proposal Development

Shef/CTRU/SSU006 Contracting

Quality Assurance

Shef/CTRU/QA001 Site Monitoring

Shef/CTRU/QA002 Audits

Shef/CTRU/QA004 Risk Assessment

Information Services

Shef/CTRU/IS001 Computer System Validation

Shef/CTRU/IS002 Computer System Security

Shef/CTRU/IS003 Computer System Disaster Mitigation and Recovery