Study Closedown And

STUDY CLOSEDOWN AND

ARCHIVING PROCEDURES

STANDARD OPERATING PROCEDURE NO / SOP 10
DATE RATIFIED / Sep 2014
NEXT REVIEW DATE / Sep 2016

POLICY STATEMENT/KEY OBJECTIVES:

This Standard Operating Procedure (SOP) guideline describes the process to ensure study closedown is managed.

POLICY AUTHOR: Katie Glickman; Research Facilitator

BACKGROUND

This Standard Operating Procedure guideline describes the process to ensure study closedown is managed. The diagram below designed by the Research Support Service shows its position in the SOP Dependency Framework for the Research life cycle.

This guideline describes the expected activities undertaken by Lancashire Care NHS Foundation Trust (LCFT) staff that manage research activity within the framework of the National Institute for Health Research (NIHR) Research Support Services.

PURPOSE

The purpose of this Standard Operating Procedure is to describe the standard procedure(s) which are undertaken by the Responsible Person(s) within LCFT when ensuring study closedown is managed.

These procedures cover:

a) Notification of study conclusion to relevant parties

b) Final report completion and maintenance

c) Archiving of essential documents

The end point of this process is when the study is concluded.

PROCEDURE

The tables below provide guidance on the expected activities to be included within this procedure. There may be additional activities depending on local circumstances at sites.

Study Closure – according to the study protocol

Responsibility / Delivered by / Activity
1 / CI / Site specific / Determine whether the study:
a)is due for conclusion as described in the study protocol; OR
b)requires extension to conclusion date; OR
c)is to terminate early, and why
(Additional tasks are required in the event that study is terminated early).
2 / CI / Site specific / Notify the person responsible for these activities as delegated by the Sponsor that study is concluded or extension is required.
3 / Responsible Person within LCFT / Senior R&D Officer / Receive study conclusion notification from CI.
Update end date on appropriate system and change study status to completed/closed.
OR
Receive request for study extension. Update end date on appropriate systems and change study status to active with comments related to extension conclusion date.
4 / Responsible Person within LCFT / Senior R&D Officer / Notify study finance staff that study has concluded.
5 / Responsible Person within LCFT / Study coordinator / PI / Inform the main Research Ethics Committee (REC) that the study has concluded using the relevant end of study form.
Submit the end of study form to the main REC within 90 days of the end of the study or within 15 days if the study terminated early. Where a study is terminated early or halted temporarily, reasons should be given.
For CTIMPs:
Complete documentation to notify the MHRA within 90 days of the trial ending.
6 / Responsible Person within LCFT / Study coordinator / PI / Organise study files ensuring all necessary documents are present. These must be gathered from all participating sites.

Study closure:

Conclusion for monitored trials can only be done when the Monitor has confirmed all necessary documents are in appropriate files.
Study conclusion must occur according to the definition outlined in the study protocol.
Some studies terminate prior to the conclusion date or event because of:

a)Unsafe events attributed to the study IMP (Investigational Medicinal Products)

b)Poor toleration of the IMP

c)Slow recruitment

d)Sponsor’s decision

e)Investigator’s decision

f)Regulatory decision (MHRA)

In regulated trials the Sponsor has a legal responsibility to notify the Licensing Authority and Research Ethics Committee within 15 days of the termination that the study has terminated early at that site.
Depending on the type of study, closure notification is required by regulatory bodies e.g. Medicines and Healthcare products Regulatory Agency (MHRA).
To enable accurate overview and reporting of research activity in the Trust, study closure tracking and study end dates on ReDA (or equivalent system) need to be kept up to date.

Managing the study final report (Quality account)

Responsibility / Delivered by / Activity
1 / Responsible Person within LCFT / Senior R&D Officer / Search all studies that have come to the end of their funding period or have been completed.
2 / Responsible Person within LCFT / Senior R&D Officer / Research Facilitator / Once all closing studies are identified, generate and issue conclusion date confirmation e-mails to Investigators.
Send one e-mail for each research study with a recently expired end date and an active status.
3 / Responsible Person within LCFT / Senior R&D Officer / Request the final report from identified CIs.
This must be submitted to the REC and MHRA simultaneously by the study coordinator / PI.
4 / CI / Study coordinator / PI / Send a copy of the final report to the Trust Research Department
5 / Responsible Person within LCFT / Senior R&D Officer / Acknowledge receipt and storage of the report to the appropriate Investigator.
6 / Responsible Person within LCFT / Senior R&D Officer / Retain all sent end date confirmation e-mails which have not been replied to by Investigators.
Resend the e-mail if no response has been received.
If a reply is not received notify the Responsible Person within the Research dept. who will manage study conclusion updates on a case by case basis and by phone call where necessary.

Final Report:

Managing the final report is the responsibility of the Sponsor at the conclusion of the study. The guidance will describe the process to be used by the person responsible for the activities as delegated by the Sponsor (typically the Trust Research Department) when collecting final reports from Principal Investigators (PIs) and Chief Investigators (CIs) at the conclusion of a study.

Archiving

Responsibility / Delivered by / Activity
1 / CI / Study coordinator / PI / Collate, organise and maintain essential documents in a legible condition.
2 / CI / Study coordinator / PI / For trials of medicinal products or research involving pharmacy, contact the relevant Clinical Pharmacist to ask for the Pharmacy file, so that all records can be transferred to the Sponsor Trust’s appropriate storage facility.
3 / CI / Study coordinator / PI / Inform the responsible person within the Research dept. that the study has concluded.
4 / Responsible Person within LCFT / Senior R&D Officer / Research Facilitator / Advise the PIs on requirements for transferring documents to the appropriate storage facility.
5 / Responsible Person within LCFT / Senior R&D Officer / Research Facilitator / Advise the CI on requirements for transferring documents to the appropriate storage facility.
6 / CI / Study coordinator / PI / Arrange a full set of accurate and auditable records to be collated and listed for transfer to the appropriate storage facility.
7 / CI / Study coordinator / PI / Check that all records for that study have been sent to the appropriate LCFT storage facility.
8 / Responsible Person within LCFT / Senior R&D Officer /
Research Facilitator / When contacted by storage facility on-site at the time of review, arrange to view the records (if required) and decide as to whether to destroy documents.
Consideration must be given to all affecting legal documents and the Data Protection Act, since personal data must not be kept for longer than necessary.
Once authorisation for destruction of records is given by all parties concerned, destroy the records as confidential waste and log the destruction on disposal register database.

Archiving:

Essential documents must be archived. Essential documents are documents which individually and collectively permit evaluation of the conduct of studies and the quality of the data.

In line with the Good Clinical Practice (GCP) (Schedule 1, Part 2 of Clinical Regulations), all essential documents should be stored in a way that allows accurate reporting, interpretation and verification, please refer to the LCFT Audit tool which can be located in SOP: Audit and Inspection of Clinical Research Trials. LCFT archives also require the following instructions to be followed when archiving:

Only purpose-structured archive boxes should be used. These are available as a stock item: WGB506 (Pack of 10) and can be ordered through the stationery process.
Packed boxes should weigh no more than 5kg, - if the box can’t be lifted comfortably – don’t send it
Files should be stacked with the spine facing the top of the box
Box contents should not be mixed but contain health records onlyie non-patient related information should not be submitted under this process, nor should staff diaries.
Box contents should be packed in strict alphabetical order.
A list of contents in a sealed envelope, marked confidential, should accompany any boxes sent to the store.
A contact name and details should accompany any boxes sent to the store. The correct address to be used is ‘Guild Park Health Records Archive Store, Guild Park, Whittingham Lane, Goosnargh, Preston.
All boxes will be transferred by internal transport.
Completion of the Trust archiving log is essential in order to document the storage locations, archiving reference and contents of boxes stored should they need to be retrieved. An example of this log can be seen in appendix one.
Ian Southward should be contacted on 01772 695376 prior to health records being despatched for archive to ensure that room at the store can be allocated to receive the delivery and suitable transport is available.

Send the research study records to the appropriate records centre (securing long term storage) at the end of each project. This is to comply with the Research Governance Framework 2005, the Data Protection Act 1998 and the NHS Organisation’s policy on the retention and disposal of records (based on Department of Health recommendations on records retention).
In the event that the Trust archiving log is misplaced, records of studies archived will be held with Ian Southward who should be contacted should copies of these be required.

OTHER RELATED PROCEDURES, POLICIES, LEGISLATION OR GUIDANCE

Barts and the London NHS Trust, SOP 19 v02, Project closure – R&D.

Barts and the London NHS Trust SOP 18 v02, Project closure – guidance for research staff.

Great Ormond Street Hospital for Children NHS Trust, Operating Procedure 49 Annual Reports (All Projects) and Final Reports (Own Account and Funded Non-commercial Projects, Version 02.

United Bristol Healthcare NHS Trust, Annual Reports and End of Study Reports V1.1.

Great Ormond Street Hospital for Children NHS Trust, Operating Procedure 35 Archiving R&D Paperwork.

The Joint Clinical Trials Dept., Archiving of Clinical Trial Data and Essential Documentation 2008.

Barts and the London NHS Trust, Standard Operating Procedure 20, Transferring research project records to Trust Records Centre (Known as archiving)

The Medicines for Human Use (Clinical Trials) Regulations 2004

LCFT Audit Tool; see SOP: Audit and Inspection of Clinical Research Trials

SOP Site file maintenance

SOP Pharmacovigilance

SOP Roles, responsibilities and delegation of duties

SOP Training and competence of research staff

SOP Audit and inspection by host organisation

GLOSSARY

Good Clinical Practice (GCP)

Standard Operating Procedure (SOP)

Lancashire Care NHS Foundation Trust (LCFT)

National Institute for Health Research (NIHR)

Medicines and Healthcare products Regulatory Agency (MHRA)

Research Ethics Committee (REC)

Appendix 1: Archiving Log

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