Standard Operating Procedures

SOP reference number

SOP title 

Initial documentation review process (PDF, 182KB)

Appendix 1a: UoL Sponsor application form (excluding data studies) (Word, 115KB)

Appendix 1b: UoL Sponsor application form for data studies (Word, 65KB)

Appendix 2: Sponsor review peer review form (Word, 61KB)

Sponsor risk assessment and management of research (PDF, 161KB)

Appendix 1: Risk assessment form (Word, 118KB)

Appendix 2: Sponsor review checklist (risk assessed) (Word, 67KB)

Appendix 3: Sponsor review checklist (non-risk assessed) (Word, 55KB)

Appendix 4: Risk assessment flowchart (PDF, 409KB)

Site management (monitoring) for University of Leicester when acting as Sponsor (PDF, 256KB)

Appendix 1: Monitoring plan (PDF, 659KB)

Appendix 2: Monitoring strategy table (PDF, 606KB)

Appendix 3: Monitoring visit log (PDF, 408KB)

Appendix 4: Source data agreement (PDF, 447KB)

Appendix 5: CTIMP monitoring visit report (PDF, 428KB)

Appendix 6 - Obsolete

Appendix 7: Non-CTIMP monitoring visit report (PDF, 406KB)

Appendix 8: Remote monitoring report (PDF, 1201KB)

Appendix 9: Remote pharmacy monitoring report (PDF, 890KB)

Appendix 10 - Monitoring plan for non-CE marked devices (Word, 61KB)

Appendix 11: Monitoring visit CAPA (PDF, 168KB)

Appendix 12: CE marked PoC device trial monitoring visit report (PDF, 1642KB)

Appendix 13: Remote pharmacy drug reconciliation (PDF, 89KB)

Processing and reporting of serious adverse events, serious adverse reactions and suspected unexpected serious adverse reactions (PDF, 199KB)

Appendix 1: Pregnancy reporting form (Word, 60KB)

Appendix 2: CTIMP multicentre line listing (PDF, 122KB)

Appendix 3: Non-CTIMP multicentre line listing (PDF, 143KB)

Appendix 4: eSUSAR guidance (PDF, 766KB)

Appendix 5: SAE listing table (PDF, 111KB)

Appendix 6: SAE review process flowchart (PDF, 120KB)

Appendix 7: Serious Adverse Events Cover Sheet (Word, 33KB)

S-1009 (1): SAE reporting form A CTIMP (Word, 59KB)

S-1009 (2): SAE guidelines form A (PDF, 182KB)

S-1009 (3): SAE reporting form B non-CTIMP (Word,546KB)

S-1009 (4): SAE guidelines form B (PDF, 170KB)

S-1009 (5): SAE Narrative continuation sheet (Word, 32KB)

S-1009 (6): SAE Additional drug sheet (Word, 39KB)

Chief investigator responsibilities (PDF, 128KB)

Appendix 1: Chief investigator roles and responsibilities (Word, 36KB)

Site initiation for research sponsored by University of Leicester (PDF, 158KB)

Appendix 1: CTIMP SIV report and actions (PDF, 849KB)

Appendix 2: Pharmacy SIV report and actions (PDF, 724KB)

Appendix 3: SOP read log (PDF, 441KB)

Appendix 4: SIV Visit log (PDF, 424KB)

Appendix 5: Screening Log (PDF, 434KB)

Appendix 6: Enrolment Log (PDF, 423KB)

Appendix 7: Non-CTIMP SIV report and actions (PDF, 583KB)

Appendix 8: Non-CTIMP SIV checklist guidance (PDF, 435KB)

Appendix 9: Participant screening and enrolment log (PDF, 447KB)

Management and production of corrective and preventative action plan (CAPA) (PDF, 113KB)

Appendix 1: CAPA template (PDF, 170KB)

Identifying and reporting deviations and serious breaches of GCP and/or the protocol for trials (PDF, 128KB)

Appendix 1: Serious breach notification form (Word, 35KB)

Appendix 2: Protocol deviation tracking log (Word, 37KB)

File note template (Word, 168KB)

Development safety update report for clinical trials of investigational medicinal product studies (PDF, 140KB)

Appendix 1: DSUR template (Word, 54KB)

Appendix 2: DSUR reporting timeframe illustration (PDF, 336KB)

Appendix 3: DSUR reporting timeframe working instructions (PDF, 477KB)

Management of essential documents and trial filing (PDF, 146KB)

Appendix 1: CTIMP Trial master file/investigator site file contents (PDF, 482KB)

Appendix 2: Non-CTIMP Trial master file/investigator site file contents (PDF, 473KB)

Appendix 3: Version control tracker (Word, 31KB)

Process for application for indemnity (PDF, 135KB)

Appendix 1: Indemnity flowchart (PDF, 312KB)

Training for Staff engaged in research (PDF, 167KB)

Appendix 1: Researcher training log (Word, 33KB)

Informed Consent for research (PDF, 204KB)

Appendix 1: Delegation of authority signature log (PDF, 125KB)

Appendix 2: Assent and authority signature log (Word, 31KB)

Appendix 3: Assent consent log (Word, 34KB)

Appendix 4: Pre-consent activity proforma (Word, 37KB)

Appendix 5:Obsolete

Appendix 6:Obsolete

Appendix 7: Consent and eligibility medical note annotation example (PDF, 149KB)

Investigator’s brochure preparation, review and approval (PDF, 134KB)

Appendix 1: Contents template (PDF, 106KB)

Appendix 2: Review template (Word, 57KB)

Study Close down and end of study reporting (PDF, 152KB)

Appendix 1: Site closedown checklist CTIMP studies (PDF, 657KB)

Appendix 2: Site closeout visit log (Word, 43KB)

Appendix 3: Site closeout checklist non-CTIMP studies (PDF, 152)

Sponsor green light process (PDF, 153KB)

Appendix 2: Sponsor green light checklist (PDF, 192KB)

Sponsor green light process for amendments to research (PDF, 141KB)

Appendix 1: Obsolete

Appendix 2: Obsolete

Appendix 3: Obsolete

Appendix 4: Obsolete

Appendix 5: Obsolete

Appendix 6: Amendment sponsor green light checklist (PDF, 251KB)

Appendix 7: How to submit (PDF, 664KB)

Convening a data safety monitoring committee (PDF, 138 KB)

Appendix 1: Data safety monitoring charter (PDF, 524KB)

Urgent safety measures for studies (PDF, 142KB)

Appendix 1: Urgent safety measure template (PDF, 666KB)

Archiving of essential documents for research studies (PDF, 164KB)

Appendix 1: Archiving facility checklist (PDF, 85KB)

Appendix 2: Archiving electronic aspects of the trial master file  (PDF, 293KB)

Appendix 3: Pre archiving checklist (Word, 24KB)

Appendix 4: Archiving process flowchart (PDF, 269KB)

Appendix 5: Retrieval process flowchart (PDF, 367KB)

Form A (PDF, 533KB)

Form B (PDF, 712KB)

Form C (PDF, 473KB)

Process for assessing site feasibility (PDF, 139KB)

Appendix 1: Site feasibility assessment (Word, 79KB)

Appendix 2: Site feasibility assessment pharmacy (Word, 33KB)

Inclusion of incapacitated adults in research studies (PDF, 135KB)

Appendix 1: Incapacitated adults (PDF, 133KB)

Appendix 2: Incapacitated adults nomination form (PDF, 516KB)

Case report form production for research studies (PDF, 194KB)

Appendix 1: Case report form template (PDF, 1516KB)

Appendix 2: A guide to designing a case report form (PDF, 638KB)

Finance process for research studies (PDF, 174KB)

Appendix 1: Sponsor finance NHS research costs form (PDF, 11KB)

Management of healthy volunteers in research studies of the bioequivalence, pharmacokinetics (PK) or pharmacodynamics (PD) of investigational medicinal products (PDF, 151KB)

Appendix 1: TOPs consent template (PDF, 107KB) 

Sample management in research (PDF, 144KB) 

Appendix 1a: Fridge temperature log (PDF, 442KB) 

Appendix 1b: Freezer temperature log (PDF, 439KB) 

Appendix 1c: Nitrogen log (PDF, 144KB)

Appendix 2: Sample tracking log (PDF, 129KB) 

Appendix 3: Sample end of study form (PDF, 711KB) 

Appendix 4: Shipping instructions for biological samples (PDF, 614KB) 

Medical device Studies safety reporting (requiring MHRA approval) (PDF, 189KB) 

Appendix 1: Event categorisation flowchart (PDF, 424KB) 

Appendix 2: Adverse event adverse effect record (PDF, 415KB) 

Appendix 3: Serious adverse event reporting form C (Device) (Word, 140KB)

Appendix 4: SAE guidelines form C (PDF, 512KB) 

Appendix 5: MHRA device reporting form (Excel, 29KB) 

Appendix 6: Medical device Sponsor process flowchart (PDF, 214KB) 

Appendix 7: Template SAE SADE email (PDF, 435KB) 

End of Sponsor Green Light Process (PDF, 122KB)

Appendix 1: End of Sponsor Green Light Checklist (Word, 56KB)