Trial Management: Trial Master Files and Investigator Site Files
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1 Title: Outcome Statement: Written By: Trial Management: Trial Master Files and Investigator Site Files Staff working on research studies in NSFT will be informed about the requirements of setting up and maintaining study documentation and records to ensure systematic practice and compliance with research legislation. Kayte Russell, NIHR GCP Facilitator and Bonnie Teague, Research Manager Reviewed: Kayte Russell, Bonnie Teague 20 th April 2017 In Consultation With: Approved and Date: References and Bibliography: By Associated Trust Policies: Applicable To: For Use By: V1.0 Research Governance Committee 23 rd February 2012 V2.0 Research Committee 27 th April 2017 Research governance framework (2005) E6 Document; A pocket guide to clinical practice version 3 December 2014 Data Protection act. MHRA Good Clinical Practice Guide Q14: Development and Management of Trust Policy R&D009: Research Auditing and Monitoring R&D013: Research Study Close-Down and Archiving R&D005: Conducting Drug Trials in NSFT All Trust staff working on approved research studies in the NSFT. All Trust staff working on approved research studies in the NSFT All sponsoring organisations for which NSFT is a participating site R&D officers, monitors and auditing personnel. Reference R&D008 Number: Version: 2.0 Published V1.0 1 st March 2012 Date: V st April 2017 Review Date: 3 years Equality Completed 21 st April Assessment: Implementation and Monitoring The policy will be uploaded to the Trust policy library and research pages. It will be implemented through research induction, training and supported by associated guidance. The updated policy will apply to all studies receiving confirmation of capacity and capability from NSFT Research Office from 1 st May Page 1 of 11
2 Review and Amendment Log Version Reasons for Development/Review Date Description of Change(s) V1.0 To develop standardised research trial management practice across NSFT. 23 rd February 2012 N/A V2.0 To respond to recent updates in legislation and update terminology. 21 st April ) Removed guidance wording/suggestions and appendices 2) Updated legislation references and bibliography. 3) Simplified and standardised language and terminology. 4) Included electronic site file management statement. Page 2 of 11
3 1.0 Introduction 1.1 This standard operating policy stipulates administrative requirements for the management of information generated from approved research studies, where NSFT is acting as the sponsor organisation, or as a participating research site on external research. 1.2 The key to good research management and quality assurance is documenting all essential study information. The ICH Good Clinical Practice (ICH GCP section 8 and UK CT regulation 31A), which covers all types of research, states that the essential documents that are to be filed are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. 1.3 There is a requirement to ensure that All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification. (Guide on Good Practice for Data Management of Chief Investigators of research sponsored by UCL 2010) 1.4 The management of Clinical Trials of Investigational Medicinal Products (CTIMPs) is supported by the Medicines for Human use (Clinical trials) amendment regulations 2006, which legally requires a Trial Master File is set up for each clinical trial. The Research Governance framework (2005) which covers all clinical research with the exception of CTIMPs, requires transparency and accurate record-keeping in the conduct of research. 2.0 Purpose 2.1 The purpose of this Standard Operating Procedure (SOP) is to inform people involved in conducting clinical research in NSFT, the procedures for setting up and maintaining research study documentation in accordance with current legislation and frameworks. 2.2 The SOP will clarify the duties and responsibilities for quality research management, via the use of study trial files (Trial Master File and Investigator Site Files) and associated documentation. 3.0 Definitions and Abbreviations Case Report Forms (CRFs): A record of data collected for the specific purposes of clinical research, completed using source data. CRFs are used to collect data generated for a trial subject, in accordance with the protocol, during the course of their participation in a trial. They also ensure compliance with regulatory requirements. CRFs can be in paper, optical or electronic format, depending on the needs of the study protocol, but all should be dated and version controlled. Chief Investigator (CI): The lead researcher who has overall responsibility and oversight for the conduct of the research study across all sites, including maintaining study documentation. Clinical Trial of an Investigational Medicinal Product (CTIMP) A Clinical Trial of an Investigational Medicinal Product (CTIMP) is defined in the Medicines for Human Use (Clinical Trial) Regulations 2004 as any investigation in human subjects, other than a non interventional trial intended: To discover or verify the clinical, pharmacological or other pharmocodynamic effects of one or more medicinal products To identify one or more adverse effects of these medicinal products Page 3 of 11
4 To study absorption, excretion or distribution of medicinal products with a view of ascertaining the safety or efficacy of such products. Since May 2004 when the Trial Regulations came into force, CTIMPs have been regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA) who needs to give explicit authorisation for a CTIMP to be conducted in addition to the standard approvals required for clinical studies. This is termed Clinical Trial Authorisation or CTA. Essential Documents: Essential documents are those documents which individually or collectively permit the evaluation of the conduct of a trial and the quality of the data produced. (ICH GCP manual pg 21) and should be kept in a secure but accessible manner, they should be legible, accurate and with a clear description as to it s purpose. Examples of essential documents include: Case report forms Delegation of Duties Log signed by all research staff and agreed by the Principal Investigator. Serious adverse events/reactions (SAE s/sar s) Suspected Unexpected Serious Adverse Events (SUSAR s) Protocols Investigational Brochures Patient information leaflets Amendments to documents and protocols Communication Pharmocological documentation This list is not an exhaustible list of what could be regarded as essential. Further information can be found in Appendix A. GCP: Good Clinical Practice. Good clinical practice is a set of internationally-recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. [Definition from EU Directive 2001/20/EC, article 1, clause 2] Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate. MHRA: Medicines and Healthcare Products Regulatory Authority. The MHRA's Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Standards and Enforcement Division of the MHRA. The function of the GCP Inspectorate is to assess the compliance of organisations with UK and EU legislation relating to the conduct of clinical trials in investigational medicinal products. This is achieved through carrying out inspections of sponsor organisations that hold clinical trial authorisations (CTA) or organisations that provide services to clinical trial sponsors (host organisations). Principal Investigator (PI): The named researcher who has delegated responsibility for the conduct and oversight of the research study at each individual participating research site. Research Team Member: A research practitioner employed by the research team, Trust or research body to carry out specific allocated duties pertaining to the particular study. Page 4 of 11
5 Investigator Site File (ISF): This file is held with the PI on each specific participating trial site. An Investigator Site File should offer a comprehensive, accurate and auditable story of the trial at the participating site. (ICH GCP manual pg 21) In some studies in the NSFT where localities and teams work on studies independently there may be a number of files that would be regarded as Site Specific Files. In such cases an individual should be nominated to be responsible for the maintenance of the file and all the relevant documentation available. Source Data: Source data are all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the clinical trial. Source data are contained in source documents (original records or certified copies). Source documents are original documents and records where study data are first recorded e.g. hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists and pharmacy dispensing records. Source documents are considered "Essential Documents" that allow evaluation of the clinical trial and ensure the quality of the data and serve to certify Sponsor and CI compliance with GCP and regulatory requirements. The process referred to as Source Data Verification (SDV) is an evaluation of the data recorded in the data collection tool against the source documents. Trial Master File (TMF): A master file kept by the study sponsor or CI. It contains all the essential documents and correspondence for the study. Whilst TMF guidelines are directed towards CTIMP trials, Non-CTIMP studies should also follow the standard outlined and is specified by the ICH GCP when it refers to a Trial Master File as being for all studies, not only clinical trials. (ICH GCP manual pg 21) 4.0 Duties and Responsibilities 4.1 Sponsor: The organisation with overall responsibility and oversight for the conduct of the clinical trial. The sponsor will arrange for indemnity, regulatory and Study approvals to be in place by the start of the study, will set-up and provide full trial documentation and study training to local research teams, will ensure that appropriate emergency reporting procedures are in place, will provide study medication to be sent to local Pharmacy sites where required, will perform comprehensive monitoring and audit functions throughout the study by arrangement with local teams. Some of these functions may be delegated to members of the research team. 4.2 Chief Investigator (CI): The lead researcher with responsibility for the conduct of the clinical trial across all research sites, including but not limited to the following areas. Qualifications and agreements (Good Clinical Practice (GCP) Training, delegation of trial-related duties) Adequate Resources to conduct the overall study time, funding, demonstrate ability to recruit (via pilot etc) Medical care of trial subjects: A qualified clinician, who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical decisions On-going communication with Ethics/MHRA/R&D throughout trial (amendments, annual reports etc) Ensure full compliance with protocol and document deviations and submit amendments to Ethics and R&D. Investigational Product (if applicable) - responsible for IMP accountability at site/s (can be assigned to appropriate pharmacist) Randomization Procedures and Unblinding responsible for following trial s randomization and blinding/unblinding procedures (if applicable) Informed consent responsible for following GCP guidelines on informed consent Records and Reports follow GCP guidelines on Case Report Forms and source documentation, maintenance of trial documentation, financial agreements and archiving Page 5 of 11
6 Progress Reports provide written summaries to Ethics (annually or more frequently if requested) and sponsor and Ethics and R&D regarding substantial changes to trial Serious Adverse Events (SAEs)- responsible for ensuring all SAEs reported to sponsor Premature Termination or Suspension of Trial Responsible for ensuring trial subjects, institution sponsor, Ethics and R&D are promptly informed if trial ends prematurely or is suspended Final Report ensure that final report provided to institution, Ethics and R&D, regulatory authorities and sponsor 4.3 Principal Investigator (PI): The lead researcher with delegated responsibility for the conduct of the clinical trial aligned with the responsibilities of the chief investigator (listed above) across the local site only. The PI will report any adverse events or serious adverse events to the sponsor/ci, will be responsible for the set-up and conduct of the study at the local site and ensure that all trial documentation and appropriate training has been received and passed onto the study team. Duties will include set-up and maintenance of trial documentation, patient identification and recruitment, patient follow-up, arrangement and collection of prescribed study medication from Pharmacy and ensuring that the study is being conducted to study protocol, trust policy and GCP standards. 4.4 Local Research Team: The local research team, as named on approval documentation, have delegated duties from the CI and PI to conduct the clinical trial at the local site. Duties will include set-up and maintenance of trial documentation, patient identification and recruitment, patient follow-up, arrangement and collection of prescribed study medication from Pharmacy and ensuring that the study is being conducted to study protocol, trust policy and GCP standards 4.5 Research and Development (R&D): Ensure that the trial is being conducted to be compliant to approved protocol, GCP and Trust policies, and undertake local research audits of clinical trials where appropriate. The host NHS organisation is required to have procedures in place for conducting the trial in accordance with Good Clinical Practice and the Clinical Trials Regulations, including: Adequate training for all site staff and adequate training records; Ensuring clarity of roles and responsibilities (e.g. contracts and agreement, delegation log) Appropriate knowledge of the trial and quality systems in all peripheral departments (e.g. laboratories, radiology, medical records); Ensure systems and facilities are fit for purpose (e.g. computer systems, equipment) Conducting the trial in accordance with the protocol, including: informed consent; reporting of adverse events / reactions as per protocol (and urgent safety measures); unblinding procedures; and IMP accountability at the trial site; and Adequate trial documentation and archiving of trial documentation. Page 6 of 11
7 5.0 Research Trial File Management 5.1 Research Site Staff All members of the research study team involved in trial management should be trained and competent to perform the duties delegated and agreed, as evidenced by the delegation of duties, research CV and training log. 5.2 Site Files Prior to study start, a nominated member of the research team is required set up a Study research file containing all essential documentation and templates. Study research files should be maintained in accordance with the Research Site File Index (Appendix 1). Further guidance for the contents of the file can be found in the E6 ICH-GCP booklet and in NSFT Research Training and guidance. 5.3 Electronic Site File Management Study documentation which is required to be regularly updated may be kept electronically on secure trust servers. All procedures need to ensure that processes are in place for the protection of the study data, including encryption, password protection and limited access to delegated members of the research team. A study may use electronic methods of data capture (i.e. ecrfs) providing that the device used is secure and in accordance with Trust ICT Data protection policies. 5.4 Confidentiality and data protection. All research study documentation should be regarded as sensitive information therefore should be kept securely and in line with data protection act principles. Identifiable information related to study participants should be stored separately to non-identifiable information with the exception of protected electronic participant logs (see Section 5.3). Access to the files should be restricted to members of the research team with delegated authority in line with the study approved protocol and delegation of duties log. 5.5 Maintaining Trial Master Files and Investigator Site Files During the Trial Period. The process of updating the TMF and Investigator Site File should be an ongoing response to the progress of the trial. This should include any amendments to documents such as protocol and ethical approval, and management of adverse events. This documentation should serve as an auditable record of the management of the trial, and to evidence and ensure legislation and protocols are adhered to in a timely and accurate manner in all aspects of the study. Accurate and comprehensive maintenance involves documentation that details every aspect of the study, including Case Report forms and source data verification. Page 7 of 11
8 5.5.1 Amendments and Version control Amended documents should be approved through the appropriate channels such as ethics, R&D and regulatory authorities before implementation and disseminated as soon as possible to all participating research sites and teams Accuracy All data should be comprehensive and accurate. It should be auditable against the source data and to be of equal quality. Source data is regarded as the origin of information and should be of a standard that enables the date to be transferred to Research documentation accurately and legibly Transparency No data related to the research study is to be deleted or hidden. Any changes or mistakes are required to be recorded and explained. Any deliberate attempt to falsify or hide information, including prior mistakes, will be investigated under the Research Integrity policy. 5.6 Research Auditing Research site files and all associated documentation are required to be made available to research auditors and monitors upon request. 5.7 Archiving Trial Master and Investigator Site Files. Following study close-down, all study files need to be archived in accordance with Sponsor requirements. Archiving cannot proceed until permitted by the sponsor. Monitoring Statement Aspects of the policy to be monitored Compliance of research teams to the Policy Monitoring method Self-Audit toolkit, research audits. Individual/Tea m responsible for monitoring Research and Development- Audit Team and Quality Lead Frequency 10% of all research studies plus 1 month survey post set-up for all studies. Findings: Group/Commi ttee that will receive the findings/moni toring report NSFT Research Committee. Action: Group/Commi ttee responsible for ensuring actions are completed NSFT Research Committee. Page 8 of 11
9 Appendix 1: Trial Master File/Investigator Site-File Index Template R&D008 Appendix 1 This index gives a suggested guide to the order of site file documentation. Mandatory documents required for all studies are marked with a * before the document name. All documentation listed below is mandatory for CTIMPs. Core Study Documentation *Approved Protocol Financial aspects of the trial (if applicable) Insurance/indemnity (if non-nhs sponsor) Signed agreements between involved parties (if applicable) Study initiation visit report (if applicable) *Approval documents *Study contact sheet *Delegation of duties and signatures log *Research Team CVs *Training certificates *Sample case report forms/outcome measures *Amendments *Information given to potential participants (Approved Templates) Participant Specific Information *Participant logs (can be saved electronically and location referenced with site file) *Informed consent Forms *Mental Capacity status *Screening assessments *Completed CRFs (CRFs may not be available to the local site if ecrfs are in use) *Source data *File notes *Participant communication Page 9 of 11 All studies HRA Ethics R&D Confirmation of Capability and Capacity Must include 24/7 safety reporting details if relevant to study. Should be signed by all research team members. Amendment notification and approvals. PIS Consent forms Any other written information Advertisement for participant recruitment Recruitment Screening Completed copies in separate file To be kept with completed Informed Consent forms or location referenced via file note. Include blood tests, questionnaires In a separate file This may be test results/outcome measures Document any errors, omissions, corrections, protocol deviations GP letters Appointment letters Communication sheets documenting adverse events, willingness to continue Telephone logs
10 Additional Study Reporting and Procedures *Randomisation process (if randomised trial only) *Un-blinding process (if randomised trial only) *Safety reporting *Monitoring/audit reports Interim analysis reports *Annual reports *All other communication Records of retained body fluids/tissue samples Final close out report *All superseded documents s SAE report forms Evidence of being sent to REC if required ( SAR s) AE s (communication sheet) Initial/Notification Feedback Follow up s Minutes Records of retained body fluids/tissue samples and labels Final close out report All former versions of approved documentation should be kept securely. CTIMP specific Investigator s brochure or Summary of Product Characteristics (SmPC). Medical/Laboratory/technical procedure/test Normal value ranges for Medical/Laboratory/technical procedure/test Sample of labels Instructions for storing and handling or Investigational medicinal product and trial related materials Copy of card given to participants re: safety reporting Shipping/postage records Samples of labels and packaging Certificates of analysis of investigational products shipped Records of retained body fluids/tissue samples Final close out report All superseded documents All additional documentation is mandatory for CTIMPs. Certification Calibration certificates/arrangements Contracts Quality control Includes the proper storage, packaging, dispensing and disposition Page 10 of 11
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