Standard Operating Procedures (SOPs)

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

The SOP Committee meets regularly to design and review the R&D SOPs. Further information is available from Sophie.Jackson3@nhs.net

Please note that Forms (FRM), Guidelines (GDS) and Template (TPL) documents and information sheets e.g. Adverse Event Form, Template Protocol etc are available in Template Documents

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SOPs in NUMERICAL order are HERE


New SOPs for Review:

SOP002 Training Records for Research Active Staff

SOP003 Informed Consent for Research Studies

SOP011 Archiving of Research Studies

SOP034 Trust Confirmation of Capacity and Capability to Conduct Research Studies

SOP048 Papworth Sponsorship of Research Studies

SOP080 Study Data - Collection and Entry

 


 

 

 

Please click on the links below to view our SOPs:

A  |  BCDE |  FG HI J KLM NO PQR STU V | W | X | Y | Z

 

A.
Adverse Event Reporting (SOP 012)
Amendments to Research Documents of Papworth Sponsored Studies (SOP 037)
Archiving of Research Studies (SOP 011)
Assessment and Registration of Trust Risk Rating for Research Studies (SOP 025)

 

B.

 

C.
Change of Investigator (SOP 038)
Code Breaking/Unblinding of Clinical Trials Training and Procedure Testing (SOP 069)
Compliance Handling of Non-Compliance (SOP 050) (Please see Handling of non compliance SOP 050)
Consent (Informed consent for resarch studies) SOP003
Contract Negotiation and Review (SOP 024)
 
D.

Data Management Overview (SOP 077)

Delegation Log: Please see Roles and Responsibilities Delegation Log(SOP 030)
Drug Alerts Handling of Drug Alerts and Recalls of IMPs and other Trial-Related Drugs (SOP 074)

 

E.
Email Correspondence: Study Related (SOP 064)
Emergency Trolley in CTBI (SOP 044)
End/Closure of Study Reporting (SOP 021)
Ethics Approval of Research Studies(SOP 005)
Expedited Trust Approval of Urgent Public Health Research Studies (SOP 070)

 

F.
File Notes (SOP 041)
Financial Procedures for Research Projects (SOP 023)
Freezer Management of R&D Freezers (SOP 029)

 

G.
GCP Training for Research Staff  (SOP 049)

 

H.

 
I.
IMP: Sourcing of Clinical Trial Investigational Medicinal Products for Papworth Sponsored Studies (SOP 073)
IMP: Supply of Clinical Trial Investigational Material: Dispensing, Returns and Accountability (SOP 072)
IMP:Transport Storage and Environmental Monitoring of Investigational Medicinal Products (SOP 076)
Informed Consent for Research Studies (SOP 003)
Intellectual Property Policy and SOP
J.

 

K.

 

L.

 

M.
 
Management of External Research Staff - Research Passport Scheme (SOP 040)
MHRA: Gaining Regulatory Approval from the MHRA Approval (SOP 014)
Misconduct and Fraud Good Research Practice (SOP 052)
Monitoring Papworth Sponsored Studies (SOP 016)

 

N.

 

O.

 

P.
 
Papworth Sponsorship of Research Studies (SOP048)
Patient Information Sheet & Consent Form Implementation and Development to the Research Team (SOP 020)
Patient Recruitment (SOP031)
Project Management of Papworth Sponsored Studies (SOP 009)
Protocol Design for Papworth Sponsored Research Studies (SOP 019) (see Research protocol [...]SOP019
Protocol Non Compliance (SOP 050)
Progress Reports including periodic safety reporting and annual reports (SOP 062)

 

Q.
Quarantine of CTIMPs (SOP 075)

 

R.
Randomisation of Papworth Sponsored Clinical Trials (SOP 018)
Research and Development: Internal Good Clinical Practice (GCP) Audit (SOP 063)
Research Database Application ReDa (SOP 035)
Research Protocol Design for Papworth Sponsored Clinical Trials (SOP 019)
Risk Adapted Approach to Management of Investigational Clinical Trials (SOP 065)
Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (SOP 055)
Roles-and-Responsibilities-Delegation Log-(SOP 030)
Reference Safety Information (RSI) (SOP 079)

 

S.
Serious Breach of Protocol (SOP 051)
Site Recruitment and Initiation for Papworth Sponsored Research (SOP 015)
Statistical Input in Clinical Trials (SOP 017)
Study Data (CRF nad Source Data) (SOP 047)
Standard Operating Procedures (SOPs): Production, approval and review (001)
Subcontracting of Research Activities (SOP 066)
Supply of Clinical Trials Investigational Material Dispensing Returns and Accountability (SOP 072)
Study Data - Collection and Entry

 

T.
Tissue Bank Review of Applications to the Tissue Bank to Obtain Human Biological Materials for Research (SOP 067)
Training Records for Research Active Staff (SOP 002)
Transport and Storage and enviromental monitoring of IMPS (SOP 076)
Trial Closure and End of Trial Reporting (SOP 021)

Trial Master File and Site File Creation and Maintenance (SOP013)

Trust Confirmation of Capacity and Capability to Conduct Research Studies (SOP034)
Trust Approval: Expedited Trust Approval of Urgent Public Health Research Studies (SOP 070)

 

U.
Unblinding: please see Codebreaking (SOP 069)
Urgent Safety Measures (SOP 071)

 

V.
Version Control of Study Documentation (SOP 060)
 
W. X. Y. Z
 
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