Trial Master File. SOP No. SOP 7

Transcription

1 Trial Master File SOP Title Trial Master File SOP No. SOP 7 Author Consultation Departments Date approved Julia Farmery Lincolnshire Clinical Research Facility, Research and Development, Trust consultants and Research staff. Lead Manager Dr. Tanweer Ahmed LCRF Director & R&D Manager Sign and Print Name Date published 17 th August 2010 Review date of SOP 17 th August 2012 Version 1

2 1. Purpose: This SOP has been produced in accordance with Good Clinical Practice requirements, adhering to the ICH Harmonised Guidelines for Good Clinical Practice. Section 8, sets out the guidance for Essential Documents for the conduct of a Clinical Trial. Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. (ICH Tripartite guideline, Version 4). The Trial Master File (TMF) content is to be maintained as per the set requirement in GCP. The purpose of this SOP is to enable individuals to ensure this practice is adhered too. A TMF will contain all the essential documents needed for the trial to be conducted. It will also hold the source documents, from which the trial can be audited and by which adherence to the principles of GCP can be demonstrated. This SOP sets out the requirements needed for correct management of the Trial Master File required for Clinical Trials of Investigational Medicinal Products (CTIMPs). However United Lincolnshire Hospitals Research Governance department stipulate that this SOP is to be adhered too for all research projects, in-order to meet the Research Governance requirements. This SOP outlines both the essential documents which should be included in the TMF and how the TMF should be managed, stored and archived. Applies to: All Essential Documents All trials conducted and approved within United Lincolnshire Hospital Relevant SOP documentation : SOP 5 y_and_data_protection.pdf

3 SOP 6 e_and_archiving.pdf Definitions : TMF Trial Master File ULHT United Lincolnshire Hospitals Trust Essential Documents All documents which pertain to the trial in question, including source data, results and correspondences. Policy: Information Governance Policy available at Data Quality Policy available at Storage and Transfer of Person Identification Data (PID) 2. Procedure: 2.1 The TMF, can consist of a series of files, or a single file, this should be set up in early development of the research project, before the project opens to recruitment. This file should be fully up to date and inclusive of all the documents and versions numbers approved by Ethics and ULHT Research and Development Department. 2.2 The TMF should be securely held, in a locked draw, within a locked room. All information collected in the Trial Master File must adhere to the Trust Information Governance and Data Protection standards. 2.3 The TMF must be easily assessable by the Chief Investigator of the trial. This is to ensure access of information on the conduct of the trial is always available, as well as enabling regular filing.

4 2.4 The TMF should be kept up to date at all times. All superseded documents, previously approved should be archived and retained in the TMF thus providing an audit trail. 2.5 If documents are not assessable/or held somewhere else, file notes should be made to where the documents are available. 2.6 The TMF should be clearly labelled with the name of the protocol, identifying numbers. 2.7 All approval letters should be filed, if missing these should be obtained for the sponsor and Research and Development. 2.8 TMF or content must not go off site, unless specified and approved by the centre, Ethics and Research and Development. 2.9 The essential documents should be filed in separate sections covering the following topics : Protocol and Patient Information Ethics and Regulatory Regulatory Agreements Correspondence Serious Adverse Events/Annual Safety Reports/Progress reports Staff and Training Patient Documents Data Collection Site Staff Pharmacy (Pharmacy keep individual files for each trial therefore a file note added to the TMF, stating the location of these essential documents is adequate). Additional Documentation Monitoring and Audit (Please see Appendix 1 for broken down list of ICH GCP regulatory requirements). 3. Responsibilities 3.1 The Chief Investigator has overall responsibility for the maintenance of the TMF. However a designated person may take the responsibility for the maintenance of this file.

5 3.2 Responsibility of the TMF will be dictated in the Delegation Log, pertaining to the Trial. 3.3 Individuals responsible are advised to follow the guidance given by the Chief Investigator/Sponsorship organisation; however whatever layout set, the essential documents, as listed in Appendix 1 should be present. 3.4 If no layout/instructions have been given for the layout of the TMF, ULHT requires this TMF SOP to apply. 3.5 Projects will be regularly audited by the Research and Development Department, as per the Research Governance Framework. References: Many thanks are given to Dr Maria Koufali, Assistant Director of Research & Innovation for the adoption of some parts of Nottingham University Hospitals, TMF SOP 2. ICH Harmonised Tripartite Guideline for Good Clinical Practice E6. Version 4. Available at This SOP will be reviewed every two years, a more updated revision of the SOP will be implemented if new local, national or international regulations change. This would therefore replace the existing document. All SOPs can be located on the Research and Development s shared file and a hard copy of all SOPs are kept in the SOP Trial Master File

6 Appendix 1 Trial title: TRIAL MASTER FILE & ESSENTIAL DOCUMENTS CONTENTS Investigator: 1. Study Documents Included 1.1 Study Summary (if applicable) 1.2 Protocol Current version plus previous versions (or provide file note to detail location of previous versions) 1.3 Investigator Brochure Current version plus previous versions (or provide file note to detail location of previous versions) 1.4 Patient Information PIS, Consent, GP letter, QoL, Questionnaires 1.5 Other Superseded Study Documents 1.6 Study guidelines/sops etc Master copies of current versions plus previous version. Any other study documents (e.g. patient diary cards or patient cards) plus previous versions. Previous versions should clearly be marked as such 2. Ethics Included 2.1 Ethics Approval(s) NREC 2.2 Ethics Correspondence Ethics Application & other correspondence 2.3 R&D Approvals 2.4 R&D Correspondence R&D application & costings 2.6 Sponsor and Indemnity Letters 3. Regulatory Included 3.1 Regulatory Authority (ies) Authorisation/Approval Clinical Trial Authorisation from the MHRA/ GTAC, current and previous approval letters 3.2 Insurance Statement /Indemnity. Copies of Certificates/Agreements 2.5 Clinical Trial Agreement / Financial agreement Legal agreement between sponsor and site / investigator 4. Correspondence (Except Ethics and/or Trust) Included All correspondence All correspondence not relating to any other section ( , minutes, notes of study meeting) 5. Serious Adverse Events Included 5.1 Sample SAE Form and copy of (if not included in the CRFs) reporting procedures 5.2 Completed SAE forms (if not included in the CRFs) 5.3 SAE Correspondence Copy of all correspondence from PI to Sponsor/ Regulatory Authority(ies) reporting SAEs/ULHT R&D 5.4 SAE Updates Safety Reports/Medical Alerts from Sponsor to PI Yearly Report Annual Safety Reports (CTIMPs only) and Yearly Progress Reports (Ethics)

7 6. Patient Documents Included 6.1 Original Signed Informed Consent (a copy should also be filed in medical notes and a Forms record made that the patient also has a copy) 6.2 Subject Screening Log To document all patients approached regarding the study with outcome 6.3 Subject Enrolment Log (to document chronological enrolment of subjects by trial number) 7. Data Collection Included 7.1 Sample CRF and guidance for Master copy CRF (or provide file note to detail completion. location of spare copies) 7.2 Data Queries & Correction Forms (may be filed in CRF) 7.3 Record of retained body (if appropriate) To document all patient samples fluids/tissue samples taken, and to where they are shipped 7.4 Laboratory Documentation Current plus previous accreditation & ranges (or provide file note to detail location of office central file) 7.5 Laboratory Ref. ranges + accreditation. 8. Site Staff Included 8.1 CVs + GCP Certificates Signed and dated by appropriate staff member signed onto the delegation log. 8.2 Study Delegation Log/Site Responsibility Log Signatures & delegated responsibilities of staff authorised to work on trial by Principle Investigator. To be updated with any changes to staff 9. Pharmacy Most pharmacy correspondence will be filed in the pharmacy site file 9.1 Instructions for handling (if not included in the protocol or Investigator s Investigational Product and Brochure) related materials 9.2 Investigational Products Accountability Record 9.3 Shipping Records For Investigational Product(s) and Trial-Related Materials. 9.4 Certificates of Analysis of (if appropriate but more likely to be held by Sponsor) Investigational Product 9.5 Decoding Procedure for Blinded Trials 9.6 Documentation of Investigational Product Destruction 9.7 Sample Label (as appropriate). (The location of the decoded envelopes should be noted in this section). Included 10. Monitoring & Audit Included 10.1 Study Initiation Report completed (as applicable) by Sponsor 10.2 Monitoring Log 10.3 Audit Reports 10.4 Clinical Study Report (if applicable) 10.5 Other