Archiving Study Documents

Transcription

1 This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document for training and reference purposes but are responsible for regularly checking the JRCO website for more recent versions Archiving Study Documents SOP Reference: JRCO/SOP/019 Version Number: Final Version 6.0 Effective Date: 18/02/15 Review by: 18/02/17 Author: Susana Murphy, Clinical Trials Monitor Approved by: Gary Roper Date: 18/02/15 Version Date Reason for Change Final /05/2007 Final /06/2008 Annual Review Final /02/2010 Formation of Joint Research Office Final /07/11 Annual Review Final /11/12 Annual Review Final Feb 2015 Annual Review Final v6.018/02/15 Page 1 of 8

2 Table of Contents 1. Purpose Page 3 2. Introduction Page 3 3. Procedure 3.1 Determining the end of the study 3.2 Who is responsible? 3.3 When should documents be archived? 3.4 How should documents be archived? 3.5 What documents should be archived? 3.6 How long should documents be archived for? 3.7 Imperial College AHSC archiving facilities Page 3 Page 3 Page 3 Page 3 Page 4 Page 4 Page 4 Page 5 4. References Page 5 5. Appendices 5.1 Transferring Records to the Corporate Records Unit Page 6 Page 6 Final v6.018/02/15 Page 2 of 8

3 1. PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for archiving study documents in a clinical trial. 2. INTRODUCTION Study documentation must be kept so that the data is accessible after the trial is completed. This is because future studies may suggest further period of follow-up, allegations are made of fraudulent behaviour, or if concerns arise about side effects and participants need to be contacted. In current regulations, archiving is recognised as the responsibility of the Sponsor, which may be delegated to the Chief/Principal Investigator. The International Conference on Harmonisation of Good Clinical Practice (ICH GCP) guidelines are specific about which documents are essential for the conduct of a clinical trial (for further information, please see JRCO/SOP/005). 3. PROCEDURE 3.1 Determining the end of the study The end of study should be defined in the protocol (please see JRCO/SOP/012), for example, when the last patient entered onto the study has had their last study visit. 3.2 Who is responsible? Clinical trial documentation should be archived by the Chief Investigator (CI) or a person delegated by the CI. At Imperial College Academic Health Science Centre (AHSC), the logistics and necessary arrangements of archiving study data should be arranged by the CI. At a local site, the Principal Investigator (PI) should undertake these arrangements in conjunction with the CI. The Investigator has a responsibility to allow the Sponsor access to the archived data on request. The archived data can be audited by the Sponsor or competent authority on request. The management of trial documentation and Study File may be the responsibility of a designated member of the research team. The Principal Investigator at the site, however, retains overall responsibility. If the Principal Investigator leaves the institution during the archival period, arrangements must be made to ensure the safekeeping and security of the archive information. Changes in personnel must be defined in the Study File and handover of responsibility documented. The Sponsor must also be informed of the new arrangements. 3.3 When should documents be archived? Essential documents should be archived as soon as practicable after the completion of the study. Final v6.018/02/15 Page 3 of 8

4 3.4 What documents should be archived? All essential documentation as defined in ICH-GCP Guidelines (Sections 8.2, 8.3, 8.4), including minutes from all trial related meetings, must be retained until notification from the Sponsor. Further information on the documents to be retained in the Trial Master File (TMF) can be found in JRCO/SOP/005). 3.5 How should documents be archived? All archived material should be stored in archive boxes that are clearly labelled with the name and reference number of the study, Sponsor, Investigator and date to be archived until. The archive boxes should be stored in a secure, environmentally-controlled location, i.e. fire protection without water sprinkler systems, water protection for humid conditions. Archive material should be stored in a legible condition, with fax thermal paper copied to standard paper. Access to the material should be restricted to the CI, Sponsor and the regulatory authorities. Details of the archiving location should be recorded by the CI and notified to the Sponsor. Whenever an item is retrieved from archive, the date, item and person retrieving the item should be documented, together with the date returned to archive. All data should be made available if requested by relevant authorities. 3.6 How long should documents be archived for? ICH GCP section states that essential documents be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. ICH GCP 8.1 also states that Essential documents are defined as those documents which individually and collectively permit evaluation of the conduct of a clinical 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 the applicable regulatory requirements. In the UK, The Medicines for Human Use (Clinical Trials) Regulations (2004, amended 2006) Trial master file and archiving 31A. (7) States that The Sponsor and the chief investigator shall ensure that the documents contained, or which have been contained, in the trial master file are retained for at least 5 years after the conclusion of the trial and that during that period are a) readily available to the licensing authority on request; and b) complete and legible The Imperial College London Retention Schedule states that primary research data should be retained for a minimum period of 10 years following completion of the study. This refers to all forms of research and not just clinical trials. Final v6.018/02/15 Page 4 of 8

5 3.7 Imperial College archiving facilities The College maintains archiving facilities at the Charing Cross Campus, with smaller storage facilities located on other campuses. This is managed by the Corporate Records Unit (CRU). To transfer documents to the College archive, contact the CRU staff in the first instance to discuss requirements and agree the transfer The CRU will organise storage and retrieval of documents at their archiving facilities. Costs of removals between campuses are the responsibility of each Division and should be included in any initial project costings. Further information on the transfer, including the transfer form can be found in Appendix 1 as well as at: 4. REFERENCES JRCO/SOP/005: Essential documentation and the creation and maintenance of trial master files JRCO/SOP/012: Writing a Protocol to Good Clinical Practice (GCP) ICH GCP (1996), Section Imperial College policy on document retention and archiving Imperial College Retention Schedule Statutory Instrument 1928 (2006), 31A: Trial Master File and archiving Final v6.018/02/15 Page 5 of 8

6 5. APPENDICES 5.1 Transferring Records to the Corporate Records Unit Contact CRU to discuss your requirements Contact ACRU staff in the first instance to discuss requirements and agree transfer: They can supply boxes where the quantity required is small. The Office Depot code to use when ordering boxes through iproc is They come in packs of ten. Storage of items not required frequently may be offsite. ACRU will organise the retrieval of any required records sent to offsite storage. Any costs incurred in the transfer of boxes to storage is the responsibility of the sending Department. Disposal of boxes (by shredding) will be organised by ACRU once they have reached the end of their retention period. Payment for the disposal costs incurred is the responsibility of the sending Department. When a specific transfer has been agreed, you will receive a unique transfer number. Please also list the items you are sending using the form below If the material / boxes are transferred to storage by car / taxi please ensure that they are not left unattended at any time during transit. 1. Packing boxes They can supply boxes where the quantity required is small otherwise you will be required to purchase them. The Office Depot code to use when ordering boxes through iproc is They come in packs of ten. Remove any unnecessary papers, see Use confidential waste disposal to discard of any material of a sensitive nature or containing personal details. Avoid placing items with differing dates of destruction in the same box Do not overfill the boxes you have to be able to lift them, for guidance on safe lifting see Remove papers from binders and place in labelled folders Tie together in bundles items that are too large to fit comfortably inside a box Do not use tape to fix the box together Complete a transfer form in order to provide a full description of the contents of the box/es. On occasion you may be requested to complete a transfer form for each box. Please photocopy extra sheets as required. Place a copy of the transfer form in Box 1 and send a copy to the ACRU. Write on the narrow end of the box the following details - transfer number (issued to you by ACRU) Final v6.018/02/15 Page 6 of 8

7 - box number (a running sequence starting with 1) - date of destruction (see below for explanation) - name of Department/Division and Section/Office to which the box/item belongs - brief description of the contents of the box 2. Completing the Transfer Form The form can be found at The Department/Division and Section/Office sections refer to where the records belong and from where they are being transferred. This is not necessarily the same as where they were originally created. Please indicate the original Records Creator if different. The Contact Name and Ext should refer to the person to whom the records belong, not necessarily the person listing them. Include your name in Listed By if this is different. Include the Date the form was completed The Box Number is a running number sequence starting at 1. This matches the number written on the outside of the box or folder If there is no destruction date (see below) and the files are for Permanent Retention tick this option. The Transfer number is the code allocated to you when you contacted the ACRU prior to packing and listing the boxes. Transfer form table: The Box Number/ Inventory ID column is for the running box number allocated by you or for the inventory id taken from the ReMAS (Records Management and Archive Storage) database if applicable. The Other Reference refers to your department s file references, should any be in use. The Box Title or File Title or Description of Item should be detailed enough to enable someone else, perhaps in several years time, to identify from your list the records they require (expand abbreviations etc). Include both the Start date of record/s and End date of record/s. If only one year is covered, put the date in the End Date column. This will then provide us with the covering dates of the material in that box or file. The Destruction Date refers to the year the records/box can be destroyed. Refer to the College Retention Schedule found in Annex B of the Code of Practice for the Management of Records Under the Freedom of Information Act 2000, see ule%20version% pdf Using the Retention Schedule the destruction date is calculated by adding the number of years a file or box must be kept to the date of closure of the files inside. If you are unsure as to how long the records should be kept contact the ACRU. For example: Final v6.018/02/15 Page 7 of 8

8 Box Number/ Inventory ID Other Reference Box Title or File Title or Description of Item Start Date End Date Destruction Date Box 1 Expenses Aug 2004 Sep /04/2011 Box Number/ Inventory ID SCRT SCRT or Other Reference CONS1 Box Title or File Title or Description of Item Contract between Joe Bloggs and Imperial College File relating to the sale of land known as Blah Park by Josephine Bloggs to Imperial College Start Date End Date Destruction Date 21/01/2004 N/A 03/08/ /08/1999 Review Completed forms Photocopy the completed Transfer Form and place a copy into Box 1. If you have been asked to complete a Transfer Form for each box please put one copy into each relevant box, ensuring the box number matches that on the outside. Send a copy of any completed forms to the ACRU ACRU staff will check the box contents against your lists and add a location once the boxes are in storage. If you do have a copy of the ReMAS database please update this at inventory level. In the Details screen state that the files have been transferred to the ACRU and note the date of transfer and the transfer number. Final v6.018/02/15 Page 8 of 8