Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol Current version plus all previous versions (or provide file note to detail location of previous versions) Previous versions should be clearly marked as such with Signed copy of the protocol signature page 2. Investigator Brochure Current version plus previous versions (or provide file note to detail location of previous versions) Previous versions should be clearly marked as such with 3. Study Documents 3.1 Participant information sheets 3.2 Informed consent form(s) 3.3 Participant invitation letters 3.4 GP letter 3.5 Diaries / Questionnaires 3.6 Adverts / posters 3.7 Participant contact cards 3.8 Decoding procedures for blinded investigations (if applicable) 4. Centre Agreements and Finance Master copies of current versions plus all previous versions Previous versions should be clearly marked as such with Current and previous procedure for decoding / unblinding participants if applicable to the investigation 4.1 Clinical Study Agreement / Signed legal agreement between sponsor and investigator / Financial agreement site(s) Financial agreements (if separate from legal agreement) 4.2 Sponsorship and indemnity letters Evidence of sponsorship and indemnity from the study centre 5. Regulatory approval Clinical Study Authorisation application to the MHRA and all correspondence through to approval, Amendment applications & related approvals 6. Research Ethics approval Ethics applications and all correspondence through to approval Effective Date 23/Mar/2017 Page 1 of 6
7. HRA and local confirmation of capacity 8. Informed Consent Forms (signed originals) 9. Study Logs Ethics committee review board attendance Amendment applications & related approvals (new versions of s from 1, 2, 3 should be filed in the appropriate section, copies do not need to be filed here) Safety /annual/ final reports HRA applications through to approval Include correspondence and approval for amendments (new versions of s from 1, 2, 3 should be filed in the appropriate section, copies do not need to be filed here) Original signed and dated informed consent form and participant information s must be kept here for all screened and enrolled participants Please file in alphabetical order 9.1 Participant Screening Log To all participants who entered pre-trial screening 9.2 Participant Enrolment Log A chronological list of all participants enrolled into the study, and their study status 9.3 Participant Identification Log and A complete list of the names of all study participants and Randomisation list (if applicable) their corresponding participant number allocated to them on enrolment in the study. The list verifies whether randomisation has been followed if applicable 10. Site Staff 10.1 Signature & Responsibility Log Signatures & delegated responsibilities of staff authorised to work on the study by the Principal Investigator To be updated with any changes to staff or responsibilities 10.2 CVs Original signed and dated version of key staff on the delegation log 10.3 Training Records Evidence that investigators and site staff have been trained in the use of the investigational device or the duties assigned to them in the delegation log Evidence of GCP training 11. Data Collection 11.1 Template Case Report Form (CRF) Master copy of CRF Current version plus previous versions Effective Date 23/Mar/2017 Page 2 of 6
11.2 CRF completion guidelines Current version plus previous versions 11.3 Completed CRF Signed, dated and completed CRF 11.4 Source s All s created and maintained at the site that substantiate integrity of the trial data and participant 12. SOPs Study specific SOPs and guidelines (other than 11.2, 16.2 & 17.3) 13. Study samples 13.1 Sample Log To all participant samples taken, and where they are stored / shipped 13.2 Temperature log (if applicable) To the monitored temperature of fridge / freezer where samples are stored (or provide file note to detail location of temperature log e.g. pharmacy) 13.3 Human tissue transfer agreement (if This is required if custodianship of samples changes applicable) 13.4 Processing of samples There should be study specific SOPs / guidelines in place relating to all sampling procedures. These should be filed in section 12 14. Laboratory 14.1 Laboratory reference ranges (local and/or central) 14.2 Accreditation certificates (local and/or central) 15. Pharmacy Current plus previous laboratory reference ranges Previous reference ranges should clearly be marked as such with reference to being superseded with date of the new Current plus previous accreditation certificates to perform the required test(s). Previous certificates should clearly be marked as such with reference to being superseded with date of the new 15.1 Study prescription Master copy of the study specific prescription 15.2 Investigational product labelling If different to manufacturer standard labelling 15.3 Instructions for handling of the investigational product Required if not part of the protocol. E.g.: storage, dispensing, dosing, blinding decoding and Effective Date 23/Mar/2017 Page 3 of 6
randomisation procedures 15.4 Pharmacy correspondence Any correspondence of particular importance to the research team. Most pharmacy correspondence will be filed in the pharmacy site file. This should include: Accountability logs and temperature records for the IMP storage area IMP shipment records and IMP destruction records Effective Date 23/Mar/2017 Page 4 of 6
16. Adverse Events 16.1 Serious Adverse Event reporting Master copies of current versions plus previous version. template 16.2 SAE completion guidelines Current version plus previous versions. 16.3 Completed SAE forms Original completed SAE forms (if filed separately provide file note to detail location) 16.4 Notification of SAE s Notification to the regulatory authorities & research ethics committees of SAE s and other safety issues 16.5 SAE updates Safety report updates (or provide file note to detail location) 16.6 SAE correspondence Any other SAE correspondence (or provide file note to detail location). This should include notifications from sponsor to all investigators of safety information 17. Deviations All protocol or SOP deviations Completed deviation log 18. Monitoring 18.1 Site initiation report All ation relating to the site initiation visit and final report 18.2 Training ation Documentation of study centre and / or in-house training 18.3 Monitoring plan Details of monitoring guidelines and source data verification plan 18.4 Monitoring Log Documentation of study centre and / or in-house monitoring 18.5 Monitoring Reports Final signed monitoring reports 18.6 Monitoring correspondence Any correspondence relating to monitoring 19. Investigator meetings 19.1 Agendas 19.2 Presentations 19.3 Minutes 19.4 Attendance log Documentation of study initiation training 19.5 Investigator meeting correspondence Any correspondence relating to investigator meetings Effective Date 23/Mar/2017 Page 5 of 6
20. Close-Out 20.1 Notification of investigation close out to the EC by PI or Sponsor 20.2 Notification of investigation close out to the regulatory authorities by PI or Sponsor, where required 20.3 Statistical analyses and End of Study Report 20.4 Site close out and End of Study correspondence 21. Miscellaneous Letter confirming close out of the site to the ethics committee Letter confirming close out of the site to the regulatory authorities To the results and interpretation of the trial Any correspondence relating to site close out and end of study 21.1 Notes to files Examples of miscellaneous items that could be included in this section. 21.2 Publications 21.3 Disclosures of conflicts of interest Document any conflicts of interest and any updates or amendments 21.4 Audit certificate (if applicable) Certificate of audit conduct where applicable 22. Correspondence All correspondence All correspondence not relating to s 4,5,6,7,15,16,17,18,19,20,21 Effective Date 23/Mar/2017 Page 6 of 6