Joint Research Office

Joint Research Office

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  • SOPs for UCL trials
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SOPs for UCL trials

Standard Operating Procedures for UCL sponsored CTIMPs

The Joint Research Unit has produced Standard Operating Procedures (SOPs) for investigators and sponsors, governing the management and operational aspects of  UCL Clinical Trials of Investigational Medicinal Products (CTIMPs).

SOPs and guides for investigators

S01

• JBRU/INV/S01/02 - SOP for using the UCL First Contact Questionnaire and CTIMP Protocol Template
• UCL First Contact Questionnaire
• UCL Protocol Template

S02

• JBRU/INV/S02/04 - SOP for Preparation and Maintenance of TMF-ISF

S05

• JRO/INV/S05/04 - SOP for Recording, Management and Reporting of Adverse Events by Investigators

• SAE Recording and Reporting Log 
• SAE Reporting Form
• Pregnancy Form
• CIOMS Form

S06

• JBRU/INV/S06/02 - SOP for the Preparation of a Study Specific Randomisation, Blinding and Code Break

S07

• JBRU/INV/S07/02 SOP for Investigators for End of Trial Notification, Close Out and Trial Reporting Procedures

Additional Documents

• UCL Patient Information Sheet (PIS) Template
• UCL Informed Consent Form (ICF) Template
• Guide for the design, use and completion of paper Case Report Forms (CRFs)
• UCL Case Report Form (CRF) Template
• Guidance for the Identification and Management of intellectual Property
• Guidance on Contracting for UCL Sponsored IMP Trials
• UCL Site Feasibility Questionnaire
• Good Clinical Practice (GCP) Lab Feasibility Questionnaire
• UCL Managing Organisation Suitability Questionnaire
• Guide on Good Practice for Data Management for Chief Investigators

 Sponsor SOPs

S01

• JBRU/SPON/S01/04 - SOP for the Preparation, Review and Approval of Standard Operating Procedures for UCL Sponsored Clinical Trials
• UCL SOP Template
• Individual Staff SOP and courses log

S02

• JBRU/SPON/S02/02 - SOP for Calculation of Sample Size

S12

• JBRU/SPON/S12/01 - SOP on Training Requirements for staff participating in CTIMPS
• CI TMF File Index
• File Note Template

S13

• JBRU/SPON/S13/03 - SOP for the Classification, Review and Submission of Clinical Trial Amendments
• Substantial and non-Substantial Amendment log

S14

• JBRU/SPON/S14/05 SOP for the Recording, Management and Reporting of Adverse Events by the Sponsor

S15

• JBRU/SPON/S15/04 - SOP for the Recording and Reporting of (Protocol and/or GCP) Deviations, Violations, Serious Breaches and Urgent Safety Measures
• CI/PI Log of Protocol and/or GCP Deviations, Violations, Serious Breaches and Urgent Safety measures

S19

• JRO/SPON/S19/03 - SOP for Oversight and Monitoring of UCL Sponsored CTIMPs
• Initiation Pack Forms
• Independent Data Monitoring Committee (IMDC) Charter Template
• UK Regulations Compliance Form part 1 version 1
• UK Regulations Compliance Form part 2 version 1

S20

• JBRU/SPON/S20/03 - SOP for Initiation of a CTIMP

S21

• JBRU/SPON/S21/01 - SOP for Archiving Essential Documents relating to CTIMPs

S29

• JBRU/SPON/S29/01 SOP for obtaining REC and CTA approvals for CTIMPs

S31

• JBRU/SPON/S31/01 - SOP for the Preparation and Submission of Development Safety Update Reports