Working Instruction Template. Instructions for Archiving of Essential Trial Documents at Datatron Off Site Facility

Transcription

1 Working Instruction Template WI number: WI full title: WI-JRO-001 Instructions for Archiving of Essential Trial Documents at Datatron Off Site Facility WI effective: 28 th October 2013 Review date: 28 th October 2015 WI author signature: SIGNED COPY KEPT WITHIN THE NJRO Date: Hattie Murdoch, Clinical Trial Coordinator WI approval signature: SIGNED COPY KEPT WITHIN THE NJRO Date: Susan Ridge, Research Governance Manager WI HISTORY Version Date Reason for change 1. BACKGROUND/INTRODUCTION This Work Instruction (WI) details the procedure to be followed by the research team for the off-site archiving of essential documents generated during Clinical Trials performed at The Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH FT) at the dedicated off-site archiving facility, Datatron. This off-site facility was selected as it reflects the requirements of the UK Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 the EU Good Clinical Practice (GCP) Directive 2005/28/EC. This WI has been produced in accordance with these regulations and guidelines. 2. PURPOSE The purpose of this document is to provide detailed instructions for the archiving process of essential documents generated during Clinical Trials performed at NUTH FT at the designated off site archiving facility: Datatron Document Image Archiving Ltd. WI Template Version Page 1 of 8 WI-JRO

2 6 Orion Business Park, North Shields Tyne and Wear NE29 7SN This WI is mandatory for all research projects classified as Clinical Trials of Investigational Medicinal Products (CTIMPs) and Advanced Therapy Medicinal Products (ATMPs) where it is a regulatory requirement under the Medicines for Human Use (Clinical Trials) Amended Regulations 2006 and the offsite archiving responsibility falls to NUTH FT. SOP-JRO-12: Archiving Clinical Research Documents must be read before proceeding with the archiving process. 3. SCOPE This WI is applicable to all research staff responsible for archiving of Essential documents at the conclusion of Clinical Trials performed at NUTH FT Part A is applicable to the Research Team members preparing documents for archive Part B is for research team members / team leads who have been granted access to the Datatron system. As per some team structures, Part A and Part B may be done by the same person. 4. PROCEDURE 4.1 Part A - Research Team Members File Review, Document Preparation and Box Pick Up (Appendix A) Section 1 - File Review 1. Confirm with the Chief Investigator (CI), Principal Investigator (PI) and Sponsor that the study has concluded and the trial documentation no longer needs to be accessed regularly by the Investigator. Confirm that they authorise that the files can be archived off-site. 2. Notify R&D that the study is complete and provide a copy of the End of Trial Notification. 3. Perform and document a full file review and file a copy as part of the Trial Master File (TMF). Essential documentation is defined in ICH GCP guidelines (sections 8.2, 8.3, 8.4) and outlined in SOP-JRO-06. WI Template Version Page 2 of 8 WI-JRO

3 a. Any discrepancies should be resolved where at all possible but if not, must be explained by file note. b. Empty sections should contain file notes explaining or referencing where documents can be found. c. Investigator Site File (ISF) review to be done by the delegated team member (usually the study co-ordinator, research nurse or data manager) d. Review of pharmacy file to be done by delegated pharmacy staff e. ISFs for non-nuth FT sponsored studies will be checked by or on behalf of the sponsor at the close out visit. 4. Confirm length of archiving period in accordance to SOP-JRO-12. Confirm contact details for sponsor if the study is not sponsored by NUTH FT. This is for obtaining the destruction authorisation at the end of the archival length and to notify sponsor in the event of any changes to local site details. Section 2 - Document Preparation 1. Box all files. Where possible, remove staples, paperclips and plastic pockets. The box must not weigh more than 8kg. 2. Attach a clear identifier on all sides of the box, lid use permanent marker and not sellotape. 3. Contact team lead or R&D to obtain the required number of barcodes. Allocate one barcode and stick on the side of the box. These numbers are unique, do not photocopy or allocate more than one per box. 4. Complete spreadsheet Offsite Archiving Log (Appendix C) and fill in all details a. Trust R&D number b. Datatron box number (see section 3) c. Name of study or protocol number d. PI/CI e. Study Type f. Date of Archive g. Date of Destruction h. Sponsor Contact Details i. Team 5. Create a new section in your Post Archive Binder. In this binder, you will keep information relating to the projects that have been archived offsite. This would include documents such as a print out of the offsite archiving log, document control sheets, and collection receipts, any relevant correspondence, and destruction letters. 4.2 Part B Datatron Entry and Box Pick Up Datatron System, Pick Up and Retrieval (Appendix B) Section 1 Datatron System WI Template Version Page 3 of 8 WI-JRO

4 1. Once the boxes are complete and the above steps have been followed, log into using your username and password provided. 2. Click on Warehouse Document Management Service. 3. Make sure you are in your department on the drop down list e.g CRF Clinical Trial Records. You may only have one option. 4. At the bottom of the screen make sure that boxes not collected is chosen on the drop down list. 5. Click on New Box 6. Scan or type in the barcode number including the leading zeros. 7. Complete only the following two fields using the information on the Offsite Archiving log so that it matches exactly: a. REF NUMBER R&D reference number b. TITLE Protocol title or short title. c. DESTRUCTION DATE Section 2 Pick Up Request 1. When you are ready for your boxes to be collected, dpopay@datatron.co.uk to request collection and specify number of boxes (no more than 30 at a time) and the pick up location. 2. Select the boxes that are being collected and press Print for collection. 3. Print the receipt and the document control sheets. 4. The driver will not pick up the boxes if the receipts have not been signed by both parties. 5. Deliver boxes to driver to the most suitable designated pick up points: a. Freeman Hospital Sir Bobby Robson Cancer Unit Reception b. RVI Clinical Research Facility Reception c. CAV Clinical Aging Research Unit Reception d. JRO Level 6, Leazes Wing, RVI 6. Once these boxes have been collected, within the Datatron system they will be moved into the section Boxes Collected and a shelving location assigned. For further help with the Datatron system, there is a help section when you log in Box Retrieval 1. For box retrieval, highlight the box and select the Return Box tab at the bottom. 2. Complete all the information in the pop up box retrievals can come directly to your department so be sure to add all the delivery address. 3. To send back, select the drop down list Boxes Delivered. Highlight the box and select Return Box. Complete pop up box as before Destruction Process 1. When the review date has been reached, Datatron will contact the listed users of the department to notify. 2. As per GCP, you must have sponsor permission to destroy the information. WI Template Version Page 4 of 8 WI-JRO

5 3. If sponsor have not contacted the PI, it is the department s responsibility to contact the sponsor in writing to request this authorisation. 4. If the sponsor has not responded in 30 days, there must be a second documented attempt. If there has been no response within the next 30 days, the boxes will be destroyed. 5. This MUST be documented. A good place to keep this documentation is within your POST ARCHIVE FILE. FOR ALL USERNAME REQUESTS, NEW BARCODES, TRAINING MATERIAL, QUERIES AND QUESTIONS PLEASE THE R&D TEAM ON: Research.archiving@nuth.nhs.uk 5. REVIEW AND MONITORING OF THIS DOCUMENT This document will be reviewed every 2 years or if there is a change to the national guidance/regulations. The use of the WI will be monitored during the annual audit cycle of research projects performed by Trust Research & Development. 6. REFERENCES 6.1. SOP-JRO-12: Archiving Clinical Research Documents 6.2. SOP-JRO-06: Essential Documents 6.3. Medicines for Human use (Clinical Trials) Regulations 2004 [SI 2004/1031] 6.4. Medicines for Human use (Clinical Trials) Amended Regulations 2006 [SI 2006/1928] 6.5. Section 8 of ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996) 6.6. European Union Good Clinical Practice Directive 2005/28/EC 6.7. European Commission Detailed Guidance on Good Clinical Practice Specific to Advanced Therapy Medicinal Products (2009) 6.8. Data Protection Act APPENDICES 7.1. Part A Flow Chart 7.2. Part B Flow Chart 7.3. Master Archiving Log Example WI Template Version Page 5 of 8 WI-JRO

6 7.1. Part A Flow Chart Part A Research Team Members Start Authorisation that the study can be archived offsite No tify R& D of closu re a nd archiving File Review Com plete Box all files Add clear stud y identifiers to the box es and seal. Allocate unique Datatron barcode Complete offsite archiving log Enter box information on Datatron S yste m as per P art B and arrange pick up Deliver boxes to pick up point End WI Template Version Page 6 of 8 WI-JRO

7 7.2. Part B Flow Chart Part B Team Leads or Delegates Start Request from Research Team Member to authorise off site archiving Research Team Member has Reviewed and boxed up as per WI No Return to Research Team Member Yes Log in to and complete all details as per WI dpopay@datatron.co.uk To arrange pick up Print off document control Sheets and receipts. Sign receipts and place with boxes. Notify research team member to Deliver to pick up point End WI Template Version Page 7 of 8 WI-JRO

8 7.3. Master Archiving Log Example WI Template Version Page 8 of 8 WI-JRO