NCP/R&D_004 – Closing and Archiving a Study

STANDARD OPERATING PROCEDURE (SOP)

SOP Number: NCP/R&D_004

SOP Title: Study Closure

Role Name Signature Date

Kirsty Rogers –
SOP Author WET Signature 15 May 2015
Research Facilitator
Dr Peter Phiri – R&D
SOP Reviewer Peter Phiri 10 October 2015
Manager
Dr Shanaya Rathod –
SOP Authorizer Shanaya Rathod 05 August 2016
R&D Director

SOP Review Date Effective date stamp

Review History

Version Effective Review Undertaken/Significant Changes Date

Date Approved
1 01-Dec- Initial Version 28-Aug-
2012 2012
2 Template updated to include additional sections.
Included the timescales on archiving and the nomination
of an archivist. Referenced the archiving of SOPs.

SOP Number R&D_004 Version Number 2 Page 1 of 8

SOP Title Study Closure

Based on NIHR Guideline May 2011

NCP/R&D_004 – Closing and Archiving a Study

PURPOSE AND CONTEXT This standard operating procedure (SOP) describes the activities to
manage the conclusion of a study at a site. It should be used by the R&D office in a
participating organization.

SOP Number R&D_004 Version Number 2 Page 2 of 8

SOP Title Study Closure

Based on NIHR Guideline May 2011

NCP/R&D_004 – Closing and Archiving a Study

These procedures include:

 Notifying the sponsor and the organization that the study has ended

 Archiving essential documents which individually and collectively permit evaluation

of the conduct of studies and the quality of the data

1. DEFINITIONS

R&D – Research & Development Department

PI – Principal Investigator

TMF – Trial Master File

ISF – Investigator Site File

CTIMP – Clinical Trial Investigational Medicinal Product

2. PROCEDURE

3.1 The Sponsor is responsible for keeping the Trial Master File (TMF) and the site the
Investigator Site File (ISF) which should be readily available for inspection at any point.
In the case of Southern Health NHS Foundation Trust (SHFT), the R&D department has
both Sponsor responsibilities and Site responsibilities.

3.2 If SHFT is a Site for a study, the R&D Manager (or delegate) should discuss the
archiving arrangements with the Sponsor during the preparation stage of taking on a
clinical study within the Trust.

3.3. If SHFT is the Sponsor, the archiving arrangements should be explained to the
Principal Investigator (PI) at the start of the study to ensure all information is stored
correctly.

3.4 Retention of the documents within the TMF/ISF and the medical records of study
participants is a legal requirement. To ensure that information is archived for the
appropriate amount of time, SHFT R&D department archive all documents for 20 years
after the date of closure, with the end of the year as the destruction date i.e. if archived
15Jun15, the documents would then be destroyed 31Dec35.

3.5 SHFT centralized documents, i.e. SOPs, staff training, should also have arrangements
for archiving as these documents may be required to recreate a TMF/ISF for inspection.
In this instance documents should be retained for 15 years from the superseding date.

SOP Number R&D_004 Version Number 2 Page 3 of 8

SOP Title Study Closure

Based on NIHR Guideline May 2011

 NCP/R&D_004 – Closing and Archiving a Study

3.6 It is a legal requirement that the Sponsor appoints a named individual within the
organization to be responsible for archiving. Documentation of who is assigned as
archivist will be logged. If SHFT is site, there does not need to be a named archivist
however, as possible, the R&D department will try for this to happen.

3.7 Archived studies will be detailed on the Master R&D Register database.

3.8 If SHFT, is responsible as Sponsor, the R&D Co-ordinator will check if the Research
Ethics Committee (REC) and as applicable competent authority have been made aware
of the end of study and if this has not been done, provide a letter to document the end
of study.

3.9 Per SHFT CP R&D_011 – Archiving, at the end of a study pharmacy clinical trial
documents will be archived with the ISF documents. If pharmacy records exist, the
Principal Investigator will arrange for these documents to be returned to the nominated
archivist to be archived along with the other study documentation.

Responsibility Undertaken by Activity

Actions at start of study
1 R&D Office
R&D Manager/R&D  Sponsor – If SHFT is Sponsor, it should be
Director discussed who will be responsible for the
archiving of the study and an archivist
nominated.
 Site – Review the archiving requirements
of the study (i.e. SHFT to store or return
for archiving to Sponsor) and assign a
local archivist to co-ordinate.
 Document with a file note the confirmed
archivist.
N.B. Archivist may be the PI or a member
of the R&D department.

Actions during study

1 Nominated Principal Investigator  Keep track of whether the study:
Person
a. is approaching its conclusion as described in
the protocol, or
b. requires extension to the conclusion date, or
c. is to terminate early (and the reason)
 Search R&D database approximately on a
quarterly basis to identify studies that are
past end date. Send an email with End of
2 R&D office R&D Co-ordinator
Project Notification Form to PI and
request confirmation of the following:
a. is approaching its conclusion as
SOP Number R&D_004 Version Number 2 Page 4 of 8

SOP Title Study Closure

Based on NIHR Guideline May 2011

 NCP/R&D_004 – Closing and Archiving a Study

described in the protocol, or

b. requires extension to the conclusion
date, or
c. is to terminate early (and the
reason).
Actions at end of study
1 Nominated Principal Investigator  Returns to R&D department a completed
Person End of Project Notification Form and
confirms if REC and/or Competent
Authority have been information.
 Ensure all letters of access and honorary
research contracts belonging to
researchers at the closing site are
terminated or extended as appropriate.
 If REC/Competent Authority have not
been advised and SHFT is Sponsor,
2 R&D office R & D Co-ordinator
arrange for letter for End of Study
notification.
 Review End of Study Notification form
and check all relevant information has
been provided, if concerns highlight to
R&D Manager.
3 R&D Office R&D Manager/Research  Where appropriate arrange final site visit
Facilitator and confirm site file archive
arrangements, following NCP-R&D_003 –
Monitoring SOP.
4 R&D Research  Lead Research Facilitator, R&D Archivist
Office/Nominated Facilitator/PI/Nominated and PI work together to organize and
Person Archivist maintain legible site specific study
records according to the study file index.
 Review appropriateness of archiving
R&D Manager/R&D
5 R&D Office arrangements and confirm to PI and
Director
nominated archivist.
6 R&D Office R&D Coordinator  Obtain details of retrieval arrangements
and record in Master R&D Register
 Ensure Governance File is archived with
the site documents as appropriate.

SOP Number R&D_004 Version Number 2 Page 5 of 8

SOP Title Study Closure

Based on NIHR Guideline May 2011

NCP/R&D_004 – Closing and Archiving a Study

3. SUPPORTING MATERIAL

The following documents can be used in conjunction with this SOP: SOPs

NCP-R&D_003 – Monitoring

CP R&D_011 - Archiving

Forms

NCF-R&D_014 - End of Project Notification Form

Database

Master R&D Register

SOP Number R&D_004 Version Number 2 Page 6 of 8

SOP Title Study Closure

Based on NIHR Guideline May 2011

NCP/R&D_004 – Closing and Archiving a Study

4. TRAINING

5.1 All R&D staff are required to read and understand the content within this SOP. Staff
should sign to confirm that the SOP has been read and document this within the R&D
SOP file. When a SOP is updated or each 2 years (as appropriate), staff will be notified
and will need to re-read and sign against the SOPs within the R&D SOP file.

5. REFERENCES

Department of Health Research Governance Framework for Health and Social Care

https://www.gov.uk/government/publications/research-governance-framework-for-
health-and-social-care-second-edition

The Medicines for Human Use (Clinical Trials) Regulations 2004

http://www.legislation.gov.uk/uksi/2004/1031/contents/made

The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
http://www.legislation.gov.uk/uksi/2006/1928/contents/made

Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006,
Statutory Instrument 2006/2984
http://www.legislation.gov.uk/uksi/2006/2984/contents/made

Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment)
Regulations 2008, Statutory Instrument 2008/941
http://www.legislation.gov.uk/uksi/2008/941/pdfs/uksi_20080941_en.pdf

Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2008,
Statutory Instrument 2008/3097

http://www.legislation.gov.uk/uksi/2008/3097/made

Medicines for Human Use (Advanced Therapy and Miscellaneous Amendments)

Regulations 2010, Statutory Instrument 2010/1882
http://www.legislation.gov.uk/uksi/2010/1882/pdfs/uksi_20101882_en.pdf

NIHR Research Support Services Framework, May 2011

http://www.nihr.ac.uk/policy-and-standards/framework-for-research-support-
services.htm

Government GCP Guidance

https://www.gov.uk/good-clinical-practice-for-clinical-trials

SOP Number R&D_004 Version Number 2 Page 7 of 8

SOP Title Study Closure

Based on NIHR Guideline May 2011

NCP/R&D_004 – Closing and Archiving a Study

SOP Number R&D_004 Version Number 2 Page 8 of 8

SOP Title Study Closure

Based on NIHR Guideline May 2011