All research activity at Royal Papworth Hospital is conducted in accordance with Trust approved Standard Operating Procedures (SOPs) which are available to view by clicking on the individual titles of the SOPs in the list below.

Please find attached here a routemap which shows a timelime of SOPs used for clinical trials.


The SOP Committee meets regularly to design and review the SOPs. For more information please email Vikki Hughes
 
Please note that forms, guidelines, templates and information sheets are available on the guidance documents, templates and forms page.

New SOP's for Review:

SOP 037 Amendments to Research Studies

SOP 038 Change of Investigator

SOP 073 Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies

 

PTUC SOP's

The standard operating procedures relating to PTUC can be found below by searching for PTUC.  They will have PTUC in the 'Tags' column.

The following SOPs apply to both PTUC and R&D:

SOP 001 Production Approval and Review of SOPs

SOP 002 Training Records for Research Active Staff

 

 

 

 

Title Tags Description
Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability (SOP 072).pdf PTUC SOP072
Urgent Safety Measures (SOP 071).pdf PTUC SOP071
Expedited Trust Approval of Urgent Public Health Research Studies (SOP 070).pdf PTUC SOP070
Code Breaking Unblinding of Clinical Trials Training and Procedure Testing (SOP 069).pdf PTUC SOP069
Tissue Bank (Deposits and Withdrawals) (SOP 067).pdf R&D SOP067
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066
Risk Adapted Approach to Management of Investigational Clinical Trials (SOP 065).pdf PTUC SOP065
Email Correspondence Study Related (SOP 064).pdf PTUC SOP064
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf PTUC SOP063
Preparation of Regulatory Progress Reports including Periodic Safety Reporting and Annual Reports (SOP 062).pdf PTUC SOP062
Version Control of Study Documentation (SOP 060).pdf PTUC SOP060
Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (SOP 055).pdf PTUC SOP055
Dealing with Misconduct and Fraud Good Research Practice (SOP052).pdf R&D SOP052
Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices (SOP 051).pdf PTUC SOP051
Protocol Non Compliance (SOP 050).pdf SOP050 SOP050
Protocol Non Compliance (SOP 050).pdf PTUC SOP050
GCP Training for Research Staff (SOP 049).pdf PTUC SOP049
Royal Papworth Sponsorship of Research Studies (SOP048).pdf PTUC SOP048
File Notes (SOP 041).pdf PTUC SOP041
Management of External Research Staff - Research Passport Scheme (SOP 040).pdf R&D SOP040