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
SOP031 Patient Recruitment version 5.0.pdf Patient Recruitment Patient Recruitment
SOP037 Amendments to Research Studies PTUC SOP037
SOP069_Code_breaking_in_Clinical_Trials_vs_4.0_Final_Signed.pdf
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
SOP084 Direct to Patient Delivery of IMP version 1.0 FINAL.pdf R&D SOP084
SOP085 Monitoring Research Studies - External Monitors and Remote Monitoring.pdf R&D SOP085
SOP086 Electronic Signature.pdf R&D SOP086
SOP088 Clinical Trial Participants and Pregnancy.pdf R&D SOP088
SOP095 Biological Hood Laboratory v1.docx.pdf SOP095 SOP095 Biological Hood Laboratory
SOP096_Centrifugation_v2.0 Signed.pdf Centrifugation SOP096 CRF SOP096 Centrifugation
SOP097 Sample Transport v1.0.pdf SOP097 Sample Transport Sample Transport SOP
SOP098_Pipetting__v1.0.pdf SOP098 Pipetting SOP098 Pipetting
SOP099 HLRI CRF Medical cover v2 .pdf SOP099 HLRI CFR Medical Cover for Research Studies SOP099 HLRI CRF Medical Cover for Research Studies
SOP125 HLRI CRF Quality Management Plan__v1.docx.pdf SOP125 CRF Quality Management Plan SOP125 CRF Quality Management Plan v1
Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling (SOP073).pdf PTUC SOP073
Standard Operating Procedures (SOPs) Production, approval and review (001).pdf R&D SOP001
Statistical Input into Clinical Trials (SOP 017).pdf PTUC SOP017
Study Data - Collection and Entry (SOP080).pdf PTUC SOP080
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066