SOP reference number
|
SOP title
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S-1000
|
Process for writing standard operating procedures (SOPs) for Research Governance Procedures for research (PDF, 66KB) |
S-1002 |
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)
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S-1003
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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)
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S-1005
|
Sponsor contracts management (PDF, 144KB) |
S-1006
|
Ensure NHS permission is received by CI for use when University of Leicester (UoL) are sponsor (PDF, 165KB) |
S-1007
|
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)
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S-1009
|
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)
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S-1010
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Chief investigator responsibilities (PDF, 128KB)
Appendix 1: Chief investigator roles and responsibilities (Word, 36KB)
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S-1011
|
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)
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S-1012
|
Management and production of corrective and preventative action plan (CAPA) (PDF, 113KB)
Appendix 1: CAPA template (PDF, 170KB)
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S-1013
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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)
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S-1014
|
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)
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S-1015
|
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)
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S-1016
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Procedure in the event of non-compliance in research (PDF, 210KB) |
S-1017
|
Process for application for indemnity (PDF, 135KB)
Appendix 1: Indemnity flowchart (PDF, 312KB)
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S-1018
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Process for sponsor approval of amendments or additions to documents (PDF, 129KB) |
S-1020
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Training for Staff engaged in research (PDF, 167KB)
Appendix 1: Researcher training log (Word, 33KB)
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S-1021
|
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)
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S-1022
|
Process for Submission of Annual Progress Reports (PDF, 68KB) |
S-1023
|
Investigator’s brochure preparation, review and approval (PDF, 134KB)
Appendix 1: Contents template (PDF, 106KB)
Appendix 2: Review template (Word, 57KB)
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S-1024
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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)
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S-1025
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Sponsor green light process (PDF, 153KB)
Appendix 2: Sponsor green light checklist (PDF, 192KB)
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S-1026
|
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)
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S-1027
|
Process for writing protocols (PDF, 142KB) |
S-1028
|
Convening a data safety monitoring committee (PDF, 138 KB)
Appendix 1: Data safety monitoring charter (PDF, 524KB)
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S-1029
|
Urgent safety measures for studies (PDF, 142KB)
Appendix 1: Urgent safety measure template (PDF, 666KB)
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S-1030
|
Creating a statistical analysis plan (SAP) (PDF, 117KB) |
S-1031 |
Managing amendments to contracts (PDF, 120KB) |
S-1032 |
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)
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S-1033
|
Process for assessing site feasibility (PDF, 139KB)
Appendix 1: Site feasibility assessment (Word, 79KB)
Appendix 2: Site feasibility assessment pharmacy (Word, 33KB)
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S-1034
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Inclusion of incapacitated adults in research studies (PDF, 135KB)
Appendix 1: Incapacitated adults (PDF, 133KB)
Appendix 2: Incapacitated adults nomination form (PDF, 516KB)
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S-1035
|
Randomisation and blinding for research studies (PDF, 157KB) |
S-1036
|
Data management process for research (PDF, 239KB) |
S-1037
|
Vendor selection and oversight for research studies (PDF, 119KB) |
S-1038
|
End of study reporting requirements for research studies (PDF, 234KB) |
S-1039
|
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)
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S-1040
|
Finance process for research studies (PDF, 174KB)
Appendix 1: Sponsor finance NHS research costs form (PDF, 11KB)
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S-1041
|
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)
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S-1042
|
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)
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S-1043
|
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)
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S-1044
|
Process for quality assurance (PDF, 168KB) |
S-1047 |
End of Sponsor Green Light Process (PDF, 122KB)
Appendix 1: End of Sponsor Green Light Checklist (Word, 56KB)
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S-1050
|
Pandemic Research (PDF, 576KB)
|