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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.

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

New SOP's for Review:

SOP016 Monitoring Research Studies - NOT requiring MHRA approval

SOP069 Code Breaking in Clinical Trials 

SOP070 Expedited Trust Approval of Urgent Public Health Research Studies

SOP095 Laboratory Biological Safety Cabinet

SOP096 Centrifugation

SOP098 Pipetting

SOP124 Biological Sample Handling

SOP129 R&D Use of Shared Care Record

Title Tags Description
SOP072 Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability PTUC SOP072
SOP071 Urgent Safety Measures PTUC SOP071
SOP070 Expedited Trust Approval of Urgent Public Health Research Studies PTUC SOP070
Tissue Bank (Deposits and Withdrawals) (SOP 067).pdf R&D SOP067
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066
SOP065 Risk Adapted Approach to Management of Investigational Clinical Trials 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
SOP055 Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs PTUC SOP055
SOP052 Dealing with Misconduct and Fraud Good Research Practice R&D SOP052
Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices (SOP 051).pdf PTUC SOP051
SOP 050 Protocol Non Compliance PTUC SOP050
SOP049 GCP Training for Research Staff PTUC SOP049
SOP048 Royal Papworth Sponsorship of Research Studies PTUC SOP048
SOP041 File Notes PTUC SOP041
SOP040 Management of External Research Staff - Research Passport Scheme R&D SOP040
Change of Investigator (SOP 038).pdf PTUC SOP038
SOP037 Amendments to Research Studies PTUC SOP037
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