Trial Master File Route Map

    Guidance from the MHRA on gaining authorisation in the UK    
  Essential documents required for Trial Master File Termplates Templates Relevant SOPs
1. Trial Summary Insert Executive summary and flow diagram from the protocol. Clinical Trials Toolkit - Routemap

Generic:SOP009;SOP013;

SOP011;SOP052;SOP055; SOP064

2. Version Control Log Version Control Template   SOP043
3. Contact Details Sheet Insert contact details from protocol    
4.   File Note Form   SOP041
5. Current approved protocol with signatures Protocol Template CTIMP   SOP019
6. Approved PIS, ICF, GP Letter Patient Information Sheet and Consent Form Template GP Letter Template SOP020; SOP003; SOP060
7. Previous Versions of protocol PIS, ICF, GP Letter      
8. Study specific Standard Operating Procedures      
9. Trust Approval Letter     SOP034
10. Letter of Acceptance of Sponsorship     SOP048
11. Peer Review      
12. Sponsorship Delegation Log Delegation of sponsor responsibilities form    
13. Project Management Delegation Log   MHRA Project Management Considerations Table SOP055
14. Risk Assessment and superseded versions CTIMP Risk Assessment form   SOP065
15. Up-to-date, signed and dated CVs and GCP training records     SOP049
16. Delegation Log Delegation Log Template   SOP030
17. Grant Application      
18. Clinical Trial Agreement/Funding agreement letters     SOP023; SOP024; SOP066
19. Finance correspondence: funder/contracts      
20. Indemnity certificates/policy      
21. Site Agreements Model clinical trial agreements    
22. Research Account Statements      
23. Invoices      
24. Finance correspondance with sites      
25. Other finance correspondence other than contracts      
26. EUDRACT number EudraCT website    
27. HRA correspondence  HRA Approval info page    
28. Adoption onto the NIHR portfolio      
29. Ethics application including correspondence REC approval information   SOP005
30. Favourable Ethical Approval Letter      
31. MHRA application including correspondence gaining MHRA approval information   SOP014
32. Clinical Trial Authorisation Letter      
33. Copy of the Annual Progress Report(s) to Ethics HRA website link giving up-to-date information    
34. Copy of the end of trial notification form and report sent to Ethics & MHRA      
35. Amendments to ethical approval
a separate bundle of documents filed in chronological order for each amendment comprising copies of:1) all the amended documentation2) approval – Ethics; MHRA; HRA; R&D (as required)
MHRA amendment process Which bodies need to approve an amendment SOP037
36. Correspondence regarding the amendment      
37. Investigators Brochure (IB) and/or Summary of Product Characteristics (SmPC) and updates SmPC / IB Checklist Check for updates to SmPC  
    Links to example IMPDs on MHRA website    
38. Pharmacovigilence SOP inc blank SAE forms Template AE reporting form Safety Reporting - Sponsor responsibilities SOP012
    Template SAE / SAR Reporting Form Safety Reporting - Investigator Responsibilities  
39. SAE Reports      
40. SUSAR Reports      
41. DSUR Reports DSUR Template Include covering letters to both MHRA and REC SOP063
42. Procedure for randomisation, unblinding and code break (if applicable)   Template code break request form SOP069
43. Details of Testing Test code break form    
44. Details of any codebreaks      
45. Details of any Protocol non-compliance or Serious Breach of protocol     SOP050; SOP051
46. Details of any Urgent Safety Measures     SOP071
47. Notification of sponsors to Investigators of safety information      
48. Copies of any adverse event reports made under the normal reporting procedures used by the Trust      
Pharmacy       SOP022; SOP073; SOP074; SOP075; SOP076
49. Quality Agreement      
50. Instructions for handling IMP (if not included in protocol)      
51. Sample of label/ superseded versions of label (if applicable)      
52. Shipping records, inc. ordering forms (if applicable)      
53. IMP accountability Template IMP accountability log   SOP072
54. Termination: Documentation of IMP destruction      
55. Data Management Plan      
56. Database management     SOP057; SOP058; SOP059; SOP068
57. Sample case report forms (CRFs) + Copy of other approved data collection instruments (eg questionnaires)     SOP047; SOP053; SOP054
58. Completed CRFs + data collection instruments      
59. Data queries      
60. Statistical Analysis Plan Template statistical analysis plan   SOP017; SOP018
61. Interim Reports      
62. Publications      
63. Monitoring Plan Template Monitoring Plan Template Monitoring Schedule SOP016
64. Audit Plan     SOP063
65. Trial Initiation Report Initiation report form   SOP015
66. Monitoring Reports      
67. Audit Reports      
68. Close Down Report     SOP021
69. Correspondence regarding monitoring and/or audit      
70. Project team meetings      
71. Project team correspondence      
72. Trial Steering Committee meeting Terms of Reference ToR for Trial Steering Committee TMG with independant Chair Charter (if no DMC)  
73. Trial Steering Committee meeting minutes      
74. Trial Steering Committee correspondence      
75. Data Monitoring Committee Charter / Terms of Reference DMC Charter template    
76. Data Monitoring Committee meeting      
77. Data Monitoring Committee correspondence      
78. Lab accreditation certificates      
79. Normal values/ranges      
80. Record of retained tissue/ body samples (if any)      
81. Material Transfer Agreements Material Transfer Agreement template    
82. Screening/enrolment log (including subject identification list)     SOP031
83. Signed Consent Forms      
84. Copies of all other correspondence relating to the trial (excluding REC, MHRA and R&D) records of all significant phone conversations relating to trial      

Click here to return to the top of the page