Operating and Financial Review by HBZr139B

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									 Cambridge Clinical Trials Unit Box 111                                                CCTU/FRM024



                                     Investigator Site File Index
Trial Information
Protocol Number:
EudraCT Number:
Study Title:
Site no. / Name:
Principal Investigator:
Local R&D Number:


  Section                                                        Documents
     0.0           Index
                   Copy of Index (including superseded indices) used for the study must be filed in this section
                    File Note Log

     1.0           Study Team
                   Section is for documents pertinent to local study team education, experience and training for the
                   duration of the trial.
                   Contact Lists
                   Delegation of Responsibility and Signature Log
                   Signed and dated CVs (including Honorary Contracts/status) and GCP training
                   certificates
                   Study Specific Training
                   Site selection documentation

     2.0           Protocol / Protocol Amendments
                   Protocols (current and superseded) with signature page signed by Principal
                   Investigator
                   Local Protocol non-compliance document
                   Protocol Amendment tracking list

     3.0           Participant Documentation (Local Versions)
                   Section for documents pertinent to participants’ consent and participation in trial. All documents must
                   be on appropriate institution letterhead.
                   Participant Information Sheet and Informed Consent Templates
                   GP Letter Templates
                   Patient ID Card Templates
                   Advertisement and other documents for participants
                   Participants signed Informed Consent with Patient Information Sheet

     4.0           Competent Authority (UK – MHRA)
                   This section is for all documents pertinent to competent authority.
                   Clinical Trial Authorisation (CTA) application and Notice of Acceptance;
                   Amendment(s) Notification and Notice of Acceptance
                   Development Safety Update Reports (DSUR)
                   Notification of End of Study to Competent Authority
                   MHRA Correspondence (including local issues)

     5.0           Research Ethics Committee
                   For all documents pertaining to the application for opinion from an approved Ethics Committee (REC)
                   and its ongoing maintenance.
                   Application to REC and Opinion; Amendment(s) notification to REC and REC
                   Opinion
                   Annual Progress Report
                   Notification of End of Study to REC
                   REC Correspondence (including local issues)


     Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager
        This document is reviewed and updated in line with emerging evidence or local requirements at least every two years
 CCTU/FRM024                       Associated with CCTU/SOP015            Version No.1        Approved: 10/02/2012       Page 1 of 4
Cambridge Clinical Trials Unit Box 111                                                CCTU/FRM024


 Section                                                        Documents

    6.0           R&D
                  For all documents pertaining to the application and approval from R&D
                  Application to local R&D and approval; Amendment(s) notification and approval
                  Annual Reports (DSUR and Progress) related correspondence to local R&D
                  Notification of End of Trial to local R&D
                  R&D Correspondence

    7.0           Other Approvals
                  For all documents pertaining to the application and approval necessary for the trial (internal and
                  external)
                  Application and approval; Notification and Approval of amendment(s)
                  Other approval related Correspondence

    8.0           Financial / Legal
                  For documents pertaining to legal, funding and agreements for the trial
                  Insurance and/or Indemnity Statement
                  Participating Site Agreement
                  Material Transfer Agreement
                  Account Details
                  Invoices
                  Financial Correspondence

    9.0           Subject Information
                  Section is for documents pertaining to subject information. All documents filed in this section with the
                  exception of the subject ID log must not disclose the subjects’ identities.
                  Subject ID Log
                  Subject Screening & Enrolment Log

    10.0          Study Related Supplies
                  For templates of all clinical trial materials provided for data recording
                  Blank CRF template and CRF Completion Guidelines
                  Completed supplies re-order form
                  Other Templates

    11.0          Data Management
                  For all documents pertaining to the management for trial data
                   Data Management Documentation
                   Data Management Correspondence

    12.0          Pharmacovigilance / Pregnancy Reporting
                  For all documents pertaining to the reporting of all SAEs/SARs/SUSARs and Pregnancies.
                  Study Pharmacovigilance Reporting Guidelines
                  Emergency code-break Procedures
                  SAE / SAR Reporting Form Template / Pregnancy Reporting Form
                  Completed SAE Forms / Listings (clinical evaluation forms), Pregnancy reports
                  and associated correspondence
                  Tracking of reportable events

    13.0          Clinical Laboratory
                  For all documents pertaining to Clinical Laboratory for duration of study
                  Local Certificate(s) of accreditation (not relevant for main NHS labs)
                  Local Normal Reference Ranges
                  Laboratory Manual
                  Sample Labels
                  Sample shipment/receipt tracking
                  Storage condition monitoring


    Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager
       This document is reviewed and updated in line with emerging evidence or local requirements at least every two years
CCTU/FRM024                       Associated with CCTU/SOP015            Version No.1        Approved: 10/02/2012       Page 2 of 4
Cambridge Clinical Trials Unit Box 111                                                CCTU/FRM024


 Section                                                        Documents
                  Study-specific equipments maintenance records

    14.0          Investigational Medicinal Product(s)
                  For all documents pertinent to the management of Investigational Medicinal Product(s) (IMPs),
                  including comparator, placebo if applicable. Documents can be filed away from the ISF during the
                  trial; this must be confirmed in a file note.
                  Investigator’s Brochure (IB) and Dossier for IMP and/or placebo / Summary of
                  Product Characteristics (SmPC)
                  Safety alert updates
                  IMP packaging (label specification, copies of labels) and manufacturing
                  Instruction for handling trial medication and trial related materials
                  Site Pharmacy staff signature and delegation log
                  Documentation of IMP shipment
                  Documentation of IMP dispensing and accountability
                  Documentation of IMP storage monitoring (including temperature deviation
                  reports)
                  Documentation of IMP quarantine / return / destruction
                  Correspondence pertinent to IMP

    15.0          Study Management and Monitoring
                  Monitoring Log
                  Site Initiation Meeting documentation
                  Monitoring Feedback

    16.0          Quality Assurance & Audit
                  For all documents pertinent to audit activities at local site
                  Local SOPs/Procedures
                  Audit certificates
                  Audit correspondence

    17.0          Study Reports / Publications
                  For documents pertaining to submission made locally
                  End of study report
                  Publications

    18.0          General Correspondence
                  Status Report / Newsletter
                  All other correspondence




    Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager
       This document is reviewed and updated in line with emerging evidence or local requirements at least every two years
CCTU/FRM024                       Associated with CCTU/SOP015            Version No.1        Approved: 10/02/2012       Page 3 of 4
Cambridge Clinical Trials Unit Box 111                                                CCTU/FRM024

General Guidance
    -    Refer to CCTU/SOP015 and CCTU/GD006;
    -    Sections can be added as appropriate, but ensure the numbering remains in sequential order;
    -    Certain sections in the ISF may be filed separately from the ISF - a file note will be
         required in the ISF to confirm where the documents are filed for example the IMP
         Accountability documentation may be filed in a pharmacy file, held by the dispensing
         trials pharmacy;
    -    Superseded versions can be marked by a single line through the front page, noting
         “Superseded”, initialled and dated;
    -    Some sections can be sub-divided to ease filing;
    -    Correspondence and version-controlled documents must be filed in chronological
         order with the most recent on top;
    -    Completed participants’ CRFs are considered part of the ISF but must be filed
         separately;
    -    There must be no participant identifiable information present in the ISF with the
         exception of signed informed consent form and subject ID log.




    Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager
       This document is reviewed and updated in line with emerging evidence or local requirements at least every two years
CCTU/FRM024                       Associated with CCTU/SOP015            Version No.1        Approved: 10/02/2012       Page 4 of 4

								
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