Archiving of Research Documentation

Transcription

1 Suspension, Termination & Completion Standard Operating Procedure VERSION / REVISION: 2.0 EFFECTIVE DATE: REVIEW DATE: AUTHOR(S): CONTROLLER: APPROVED BY: Clinical Trials Manager; Recruitment Data Administrator Contracts & Quality Management Officer Deputy Director, Research & Innovation VERSION / REVISION DATE REASON FOR CHANGE Review DO NOT USE THIS SOP IN PRINTED FORM WITHOUT FIRST CHECKING IT IS THE LATEST VERSION Current versions of all Research & Innovation ISOPs are available online. If you are reading this document in printed form, please check that the version number and date match the most recent version on the Table of ISOPs page on the R&I website: Version 2.0/ /Page 1 of 13

2 CONTENTS 1. Purpose and Scope 3 2. Who should use this SOP 3 3. When should this SOP be used 3 4. Definitions 4 5. Standards of Retention 4 6. Responsibilities 4 7. Archiving Clinical Trials of Investigational Medicinal Products (ctimps) 5 8. Archiving Projects other than Clinical Trials of Investigational Medicinal Products (non ctimps) 5 9. Archiving Procedure Retrieving Archived Documents Destruction of Archived Documents Related SOPs and Documents 7 APPENDICES A: NBT Archiving Record Form 9 Version 2.0/ /Page 2 of 13

3 1. PURPOSE AND SCOPE This Standard Operating Procedure (SOP) describes the procedure for the archiving of all study documents on ALL research studies that are sponsored by or hosted by North Bristol NHS Trust The purpose of this SOP is to ensure confidential information is: Stored correctly Not passed on without the appropriate consent Accessed in line with Trust policies and procedures Only used for the defined purpose And to ensure: Patient safety in using and recording information Up to date information is stored Protection of sensitive data Staff awareness of responsibilities and accountability Information is accessible when required 1.2. Storage of personal data is subject to the Data Protection Act 1998 and, in clinical trials, the applicable elements of The UK Clinical Trial Regulations Study documentation must be kept so that the data is accessible after a study is completed. This is because future studies may suggest a further period of follow up, allegations may be made of fraudulent behaviour, or concerns may arise about side effects and participants may need to be contacted The archiving process is the responsibility of the study Sponsor, which may be delegated to the Chief or Principal Investigator. It is the Sponsor s responsibility to ensure that any such delegation is clearly documented. 2. WHO SHOULD USE THIS SOP 2.1. This SOP is aimed at all research staff working within North Bristol NHS Trust (NBT). The responsibility of the archiving process applies to Chief Investigators of research studies sponsored by NBT as well as Principal Investigators of research studies carried out at NBT and sponsored by an external organisation ( hosted studies ). 3. WHEN SHOULD THIS SOP BE USED 3.1. For studies sponsored by NBT, this SOP should be referred to during study design and again, as soon as practicable, within 12 months of the end of a research project For hosted studies, this SOP should be referred to during study set up to ensure that any costs of archiving have been identified and again, as soon as practicable, within 12 months of the end of a research project. Version 2.0/ /Page 3 of 13

4 4. DEFINITONS 4.1. Guidance on defining when a study has completed can be found in ISOP I01 Close out & Completion of Research Projects Depending on the stage at which a study is terminated, some documentation may still need to be archived (see ISOP I02 Suspension & Termination of Research Projects) The International Conference on Harmonisation of Good Clinical Practice (ICH GCP) Guidelines define and list all of the documents that are essential for the conduct of a clinical trial (see ICH GCP 8.2, 8.3, 8.4 and ISOP H01 Research Documentation & File Management (ctimps)). Essential documentation refers to those documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. 5. STANDARDS OF RETENTION 5.1. The end of study should be defined in the study protocol but may be for example, when the last patient entered onto the study has had their last study visit. For hosted studies the study is deemed complete following study close down by the study Sponsor All essential documentation must be complete and legible with all data queries resolved All essential documentation must be collated and indexed in a manner that allows all documents to be traceable at all times and readily accessible to the authorities upon request A copy of the archiving indices, file location identification (third party barcode/ unique identifier) and archive provider must be provided to the Research & Innovation office (R&I) when the essential documentation is archived R&I will store an electronic copy of the archiving indices and location identification against the corresponding study file It is important that research data are stored in facilities that are fit for purpose. For studies sponsored by NBT or where the arrangements for archiving have been transferred to NBT by the Sponsor, archiving is managed by a reputable third party provider Currently, there are no guidelines relating to the storage of documents in electronic format. It is good practice to print and retain hard copies of this information. Electronic copies should be passwordprotected or stored in a password protected folder or drive for backup purposes. 6. RESPONSIBILITIES 6.1. Responsibility for making archiving arrangements generally lies with the Sponsor. However this may be delegated to the Chief Investigator (CI) or Principal Investigator (PI). See ISOP E01 Sponsorship, Roles & Responsibilities Where NBT is Sponsor, the R&I office will make arrangements for archiving however the archiving of the essential documentation itself is delegated to the CI/PI as appropriate. In the case of a multi centre Version 2.0/ /Page 4 of 13

5 study, essential documentation will be archived at each study site and the lead investigator at each site has a responsibility to allow NBT access to archived data upon request If the PI at an institution leaves during the archival period, arrangements should be made to ensure the safekeeping and security of information. There should be a handover of responsibility for this which is clearly documented (see ISOP E01 Sponsorship, Roles & Responsibilities) Costs of archiving essential documentation MUST be included in the research grant. 7. ARCHIVING CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS (ctimps) 7.1. The Medicines for Human Use (Clinical Trials) Regulations (2004, amended 2006) make the archiving of essential documentation in clinical trials of Investigational Medicinal Products (ctimps), a legal requirement The Sponsor of a ctimp is responsible for determining the archiving duration of the essential documentation, taking into account: The type of ctimp performed (e.g. for regulatory submission) The regulatory requirements at the time that the ctimp is ready for archiving Any statements made in the protocol or other submissions. At the end of a ctimp a minimum period of six months should be allowed to ensure that all queries are answered and study related paperwork collected. Archiving should take place following this period but within twelve months of the end of a ctimp Documents must be retained for at least 5 years after the conclusion of a trial and during that period must be: Readily available to the licensing authority on request Complete and legible 7.4. Retention for 5 years may be considered appropriate under circumstances when trials are not to be used in regulatory submissions. However, longer retention may be required if requested by the Sponsor, funder, or regulatory bodies If trials are to be included in regulatory submissions then study specific documents should be retained until at least 2 years after the last approval of a marketing application to the EU (where appropriate). It is the responsibility of the Chief Investigator to determine and to inform the Sponsor via R&I as to when essential documents are to be retained for longer Where NBT is the Sponsor, essential documentation will be retained for a period of 10 years. 8. ARCHIVING PROJECTS OTHER THAN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS (nonctimps) 8.1. There is no legal requirement to archive essential documentation for non ctimps. The Medical Devices Regulations 2002 do not include any express legal requirement to archive trial data gathered from clinical investigations of Medical Devices (cimds). Version 2.0/ /Page 5 of 13

6 8.2. However the principles established in the ICH GCP Guidelines may also be applied to other clinical investigations that may have an impact on the safety and well being of human subjects. The Guidelines state that the Sponsor or owners of the data should retain all of the sponsor specific essential documents pertaining to the trial In light of the above principles and the possibility of inspection by the Department of Health, it is therefore good practice to archive essential research documentation Where NBT is the Sponsor of any non ctimp project, essential documentation must be retained for a period of 5 years. 9. ARCHIVING PROCEDURE 9.1. The following procedure should be followed in order to archive research documentation: STEP 1) Upon completion (or termination) of a study follow the procedure in ISOP I01 in relation to notifying the appropriate authorities and completing other obligations. STEP 2) Ensure that the study file is complete, tidy and documents are stored in a logical order. STEP 3) Collate and order Case Report Forms (CRFs) and other patient related medical documentation, and ensure all data queries are resolved. STEP 4) Documents held in lever arch files should be removed in preparation for archiving to reduce the space required for archiving. STEP 5) Documents may be held together by plastic archiving clips but all paper clips, elastic bands, staples or metallic means of combining sheets should be removed to prevent rusting or other chemical deterioration. STEP 6) Complete the NBT Archiving Record Form (Appendix A), filling out the list of documents archived or attaching a separate list. STEP 7) Contact the R&I Office by ing [email protected] or calling to request guidance on Completing the transmittal/using the barcode label document if appropriate and arrange for collection of the archive box(es) for transfer to the off site storage facility. 10. RETRIEVING ARCHIVED DOCUMENTS Retrievals from archive are restricted to a limited number of circumstances and should be kept to an absolute minimum. Retrieval may be permitted where audit of the results is required to comply with a Department of Health, regulatory authority, NBT Trust Board or other quality assurance request The retrieval of any documents held under an account with NBT will require the approval of the Deputy Director of Research & Innovation with the costs for doing so being recovered from the Sponsor (if not NBT). The transfer of records should be documented. Version 2.0/ /Page 6 of 13

7 10.3. The R&I Office will maintain a log of archived projects including their box numbers and locations for retrieval. 11. DESTRUCTION OF ARCHIVED ESSENTIAL DOCUMENTATION Destruction of archived essential documentation is only permitted with the written approval of the Sponsor All essential documentation must be destroyed in accordance with confidentiality guidelines Where third party organisations destroy the essential documentation on behalf of NBT, evidence of this must be provided to R&I R&I will record the destruction documentation in the corresponding R&I study folder. 12. RELATED SOPS AND DOCUMENTS Department of Health (DoH) Research Governance Framework for Health & Social Care, 2 nd Edition, April Department of Health (DoH) Research involving the NHS: Retention of Records Department of Health (DoH) & Medical Research Council (MRC) Clinical Trials Toolkit: Joint Project Notes on the Archiving, Storage & Destruction of Documents toolkit.ac.uk/_db/_documents/archiving.pdf ICH Secretariat Guidelines for Good Clinical Practice (GCP) (E6 R1 Step 4, 1996) Institute of Clinical Research (ICR Publishing) Archiving Clinical Trial Documents (2 nd Ed.) UK Government Medicines for Human Use (Clinical Trials) Regulations 2004 SI 2004/ ethical review/endof/ UK Government Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2006 SI 2006/ ethical review/endof/ Version 2.0/ /Page 7 of 13

8 RELATED SOPS ISOP E01 ISOP H01 ISOP I01 ISOP I02 Sponsorship, Roles & Responsibilities Research Documentation & File Management (ctimps) Close Out & Completion of Research Projects Suspension & Termination of Research Projects Version 2.0/ /Page 8 of 13

9 Appendix A NBT Archiving Record Form 1 Archive Index R&D number. NAME OF TRIAL: CONTACT DETAILS Chief Investigator Name: Telephone Number: Principal Investigator Name: Telephone Number: Sponsor / R&I contact / Name: Telephone Number: Archive Provider: Contact Details: Archive Box Identifiers : : : : Study Close out Visit Date: Documents to be retained until: Version 2.0/ /Page 9 of 13

10 Study Archive Index Study No: Documents Version / Date Archive Number / Identifier Protocol 1.1 Current Protocol 1.2 PI Protocol Acknowledgements 1.3 Previous Protocol Investigator Brochure / Summary of Product Characteristics 2.1 Current Version 2.2 PI acknowledgement 2.3 Previous Investigator Brochure etc Ethics Approval 3.1 IRAS application form 3.2 MREC approval 3.3 R&I SSI application form 3.4 Subsequent amendment form Trust Approval 4.1 Original Trust approval 4.2 Subsequent Trust approvals MHRA 5.1 Original MHRA approval 5.2 Subsequent MHRA approvals Other Regulatory Approvals 6.1 Originals 6.2 Subsequent approvals Recruitment 7.1 SOP Consent 7.2 Current Consent 7.3 Previous Consents Patient Information 8.1 Current patient information 8.2 Previous patient information Copy of GP Letter Screening 10.1 Screening log pro forma 10.2 Completed screening log Signature: Initials: Name: Job Title: PI / Research Nurse signature: PI / Research Nurse name: Version 2.0/ /Page 10 of 13

11 Documents Version / Date Archive Number / Identifier Enrolment/Subject ID 11.1 Enrolment log pro forma 11.2 Completed enrolment log Recruitment Advertisement 12.1 Approved advert material Randomisation/Unblinding 13.1 IVRS information or study specific randomisation and unblinding procedure CRF Template 14.1 Current data capture forms 14.2 End of study SOP 14.3 End of study report pro forma Personnel 15.1 CV 15.2 GCP certificates 15.3 Delegation log 15.4 Training log 15.5 Letter of access/honorary contract Safety Reporting SOP safety reporting 22.1 Procedures for on call staff 22.2 Adverse events pro forma 22.3 Serious adverse events/susar pro forma 22.4 Follow up/closure report for SAE.SUSAR 22.5 R&I response to SAE/SUSAR 22.6 Regulatory authority response to SAE/SUSAR 22.7 Procedures for noti ficati on of safety information dissemination 22.8 Notification of serious breach of GCP form 22.9 Notification of protocol violation form Legal Documentation 23.1 Signed copy of CTA/contract 23.2 Signed material transfer agreement (if applicable) 23.3 Documentation of insurance 23.4 Grant application 23.5 Grant approval letter 23.6 Sponsorship confirmation 23.7 Finance schedule Signature: Initials: Name: Job Title: PI / Research Nurse signature: PI / Research Nurse name: Version 2.0/ /Page 11 of 13

12 Documents Version / Date Archive Number / Identifier Reports 24.1 SOP monitoring 24.2 Monitoring plan and risk assessment 24.3 Monitoring reports including initiation visit 24.4 Annual safety report to regulatory bodies 24.5 Annual reports pro forma 24.6 Completed annual reports 24.7 End of study report Correspondence 25.1 Newsletters 25.2 Sponsor correspondence Archiving 26.1 Archiving SOP 26.2 Archiving agreements and procedure File notes Investigational product/procedures section 16.1 Instruction for handling investigational product 16.2 Sample of label 16.3 Sample of product/procedures instruction 16.4 Sample of prescription 16.5 Completed prescriptions Investigational Product Accountability 17.1 Sample return form 17.2 Completed return forms IMP destruction 18.1 SOP on IMP destruction 18.2 Documentation of return to supplier/destruction Temperature and Transportation of IMP 19.1 SOP on temperature and transportation of IMP 19.2 Temperature log 19.3 Transportation log 19.4 Correspondence with IMP manufacturer Signature: Initials: Name: Job Title: PI / Research Nurse signature: PI / Research Nurse name: Version 2.0/ /Page 12 of 13

13 Documents Version / Date Archive Number / Identifier Laboratory 20a Central Labs 20a.1 Accreditation certificates 20a.2 Normal ranges 20a.3 Transport arrangements 20a.4 Reporting arrangements 20a.5 Supplies/re supplies arrangements 20a.6 Sample collection/preparation protocol 20a.7 Calibration records 20b Local labs 20b.1 Accreditation certificates 20b.2 Normal Ranges 20b.3 Sample collection/preparation protocol 20b.4 Calibration records 20b.5 Relevant NBT protocol/policy 20b.6 Service level agreement and funding arrangements 20b.7 calibration and maintenance arrangements Other Support Departments 21.1 Accreditation certificates 21.2 Normal ranges 21.3 Sample collection/preparation protocol 21.4 Calibration records 21.5 Relevant NBT protocol/policy 21.6 Service level agreement and funding arrangements 21.7 Calibration and maintenance arrangements Completed CRFs by Pt Unique identifier: Source Documentation not located in Medical Notes Signature: Initials: Name: Job Title: PI / Research Nurse signature: PI / Research Nurse name: Version 2.0/ /Page 13 of 13