Investigator Site File Standard Operating Procedure (SOP) DOCUMENT CONTROL: Version: 1 Ratified by: Quality and Safety Sub Committee Date ratified: 30 January 2017 Name of originator/author: Research Nurse Name of responsible Research Panel committee/individual: Date issued: 8 March 2017 Review date: January 2020 Target Audience All Staff
1. Background 2. Aim 3. Scope All research carried out at Rotherham Doncaster & South Humber NHS Foundation Trust (RDaSH NHS FT) must have a Site File which contains essential documents. It is intended that the Principal Investigator (PI) initiates the Site File immediately upon confirmation of registration of the study with the Research Department and uses it for the duration of the study. A template sile file contents page (appendix A) can be accessed via the RDaSH NHS FT intranet, or on request to the Research Office groundedresearch@rdash.nhs.uk To ensure all Research Projects within the Trust maintain an appropriate Site File. This SOP has been produced in accordance with International Community of Harmonisation (ICH)/Good Clinical Practice (GCP) Guidelines, The Department of Health Research Governance Framework 2005, the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments. All staff internal or external to the Trust who are research study Principal Investigator 4. Link to overarching policy and/or procedure Research Governance Policy 5. Definition The Investigator Site File contains the essential documents necessary for the PI and the research team. Section 8 of ICH/GCP guidance details the essential documents necessary for the conduct of a trial. Essential documents are those which individually and collectively: Permit the evaluation of the conduct of a trial and the quality of the data produced Serve to demonstrate the compliance of the PI, research team and sponsor with the standards of GCP and with all regulatory requirements When filed in an appropriate and timely manner greatly assist in the successful management of a trial by the investigator Can be audited by the Trust and sponsors independent audit function and inspected by regulatory authorities as part of the process to confirm the validity of the trial conduct and data collection. Page 2 of 5
The Chief Investigator (CI) will keep a Trial Master File. The local PI/local collaborator (LC) will keep an Investigator Site File. In the case of a single centre study there will often be a single file for both CI and PI. In this case this file will be a Trial Master File 6. Procedure 6.1 The PI/LC is responsible for setting up, maintaining, storing and arranging archiving of the Investigator Site File. This duty may be delegated to another appropriately qualified member of the Research Team and recorded in the Delegation of Study Duties Log (see SOP Delegation of Study Duties) 6.2 The PI/LC sets up a site file at the time the research is registered with the Research Department. 6.3 The PI/LC should ensure all essential documents (see Appendix A) are filed in reverse date order unless specified otherwise. 6.4 The PI/LC should carry out regular checks to ensure the contents are up to date. The Research team will assist by submitting any new documents to the PI/LC. 6.5 The PI/LC should store the Investigator Site File securely but ensure all members of the research team have access to the file to complete any delegated duties. 6.6 The PI/LC should file documents promptly and file superseded documents in the appropriate section of the Site File. 6.7 The PI/LC should ensure that all working documents are made available to the support services, as appropriate, via RDaSH Research Team 6.8 The PI/LC is responsible for ensuring the final study report is filed in the site file at study closure. 6.9 The PI/LC should arrange for appropriate archiving of the Site File according to the requirements of the sponsor and regulatory authority and following RDaSH NHS FT policy. (Developed with guidance and support from STH NHS FT & CRN Yorkshire & Humber) Page 3 of 5
Appendix A Investigator Site File Contents SECTION TITLE CONTENT/COMMENTS 1 Protocol / amendments Current protocol Protocol amendments Historical protocols 2 Sample Case Report Form (CRF) / Quality of Life Questionnaire (QLQ) Diary Cards 3 Regulatory approval Documentation 4 Site signature /responsibility log If too bulky to put in file place file note in this section stating where it can be found 5 Curriculum Vitae CVs for all research personnel listed in the signature/responsibility log 6 Patient Identification form Patient recruitment /screening form 7 Sample of current and all historical Patient Information / Informed Consent form and GP Letter Completed patient Information and Informed Consent Forms 8 Correspondence File in chronological order all correspondence to/from the coordinating research body. File email communication Include a separate section here for newsletters 9 Minutes from Initiation meeting Monitoring logs Notes of telephone calls 10 Blank serious adverse event forms and guidelines for their completion 11 Notification of serious adverse events and/or safety reports If the study is not monitored state this in a file note in this section Document telephone call in relation to agreements or significant discussions regarding trial administration, trial conduct, adverse events or protocol violations By Investigator to co-ordinating research body By co-ordinating research body to Investigator By co-ordinating research body to regulatory authorities (if this will not be supplied place a file note stating this) 12 Randomisation details Instructions (if applicable) 13 Instructions for handling trial medication and trial related materials Shipping records This responsibility is normally that of the clinical trial pharmacist if this is the case place a file note in this section stating this Page 4 of 5
SECTION TITLE CONTENT/COMMENTS 14 Clinical Laboratory Laboratory normal reference ranges (including revisions) Laboratory certificate(s) 15 Contracts Investigator Commitment Statement/Study Acknowledgement Indemnity Confidentiality Clinical Trial Agreement including financial details. Completed and signed Food & Drug Administration (FDA) 1572 form (if applicable) Financial disclosure letter (if applicable) 16 Investigator s Brochure Safety alert letters/updates 17 Completed Data Queries 18 Study Training Materials 19 Miscellaneous (specify). AFTER THE COMPLETION OF THE TRIAL THE FOLLOWING MUST BE ALSO FILED IN THE SITE FILE SECTION TITLE CONTENT/COMMENTS 20 Investigational product(s) accountability at site 21 Documentation of Investigational product destruction This will be with the clinical trials pharmacist If destroyed at site this will be with the clinical trials pharmacist 22 Final report From Investigator to REC 23 Clinical study report To document results and interpretation of trial Page 5 of 5