Research Standard Operating Procedures (SOPs)

Quality Assurance

Standard Operating Procedures for Quality Assurance

QA1_Preparing approval and review of SOPs & WIs.pdf [pdf] 122KB

QA2_Monitoring.pdf [pdf] 137KB

QA3_Audit.pdf [pdf] 110KB

QA4_Suspension and or discontinuation of Trust sponsored studies for unsafe or unacceptable practices.pdf [pdf] 176KB

QA5_Extnerally-led audit and inspection.pdf [pdf] 187KB

QA6 Suspected research fraud.pdf [pdf] 173KB

QA7_Reporting SUSARs 2018.pdf [pdf] 382KB

Templates

Template for Standard Operating Procedure (SOP) [docx] 87KB

 Template for Work Instruction (WI) [docx] 88KB

Pre-Study

Standard Operating Procedures for Pre-Study

P1_Feasibility and site selection.pdf [pdf] 165KB

P2_Trust Sponsorship of studies.pdf [pdf] 229KB

P3_Gaining and maintaining the authorisations for conducting research.pdf [pdf] 306KB

P4_Trial Registries.pdf [pdf] 179KB

P5_ Investigator Brochure.pdf [pdf] 193KB

P6_Risk Assessment.pdf [pdf] 281KB

P7_The use of human tissue in research.pdf [pdf] 371KB

P8_Document & Version Control.pdf [pdf] 207KB

P9_Trial Master File & Investigator Site File.pdf [pdf] 326KB

P10_Delgation of duties.pdf [pdf] 161KB

P11_Research Passports.pdf [pdf] 127KB

P12_Gaining permission for research involving medical exposures (using Ionising Radiations).pdf [pdf] 402KB

P13_Database management, security, design and validation.pdf [pdf] 252KB

P14_Computerised Systems for Supporting Clinical Trials.pdf [pdf] 157KB

P15_Case Report Form Design.pdf [pdf] 453KB

P16_Data Management & Independent Data Monitoring Committee.pdf [pdf] 161KB

P17_Statistical Analysis Plan.pdf [pdf] 140KB

P18_Randomisation & Blinding.pdf [pdf] 183KB

P19_Access and use of REDCap Community.pdf [pdf] 191KB

P20_Preparation and maintenance of an ISF.pdf [pdf] 197KB

Template

ISF Contents List Template 2022.docx [docx] 100KB

Trial Operation

Standard Operating Procedures for Trial Operation

T1_Study start up.pdf [pdf] 234KB

T2_Approach and Identification of Participants for Research.pdf [pdf] 188KB

T3_Consent procedures for entry into a Research study.pdf [pdf] 303KB

T4_Case Report Form (CRF) completion.pdf [pdf] 157KB

T5_Safety reporting.pdf [pdf] 336KB

T6_ Non-compliance reporting.pdf [pdf] 239KB

T7_Urgent Safety Measures.pdf [pdf] 256KB

T8_Research Study Amendments.pdf [pdf] 449KB

T9_ Periodic Reports to REC & MHRA.pdf [pdf] 210KB

T10_Recording of study data.pdf [pdf] 408KB

T11_Provision of virology test information.pdf [pdf] 165KB

T12_Researcher Audit Guidance.pdf [pdf] 287KB

T13_Consistency of images for clinical research.pdf [pdf] 132KB

Was this page helpful?

Was this page helpful?
Rating

Please answer the question below, this helps us to reduce the number of spam emails that we receive so that we can spend more time responding to genuine enquiries and feedback. Thank you.

Page footer image

Footer image
Recruitment - Page Footer Image