SOP Number and Version: 9, V1 Effective Date: 26/09/2014
Review Date : 26/09/2017
Please check this is the latest version of the SOP on the Joint Research Office website: www.ucl.ac.uk/jro .
Author:
Name: Patricia Galligan
Position: Quality Assurance Manager (Research Governance)
___________________________________
Signature Date
Approved by:
Name: Patricia Galligan
Position: Quality Assurance Manager (Research Governance)
____________________________________
Signature Date
Authorised by:
Name: Rajinder Sidhu
Position: Deputy Director of Research Support Centre
_______________________________________
Signature Date
Study Close Down, SOP 9, V1, 18/08/14
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Revision Chronology:
Version
Number:
Effective date:
Reason for change: Author :
Patricia 1 26/09/2014 Initial standardised SOP for use within UCLH.
Galligan
ACRONYMS
CI
CRF
CTIMP
HRA
IMP
ISF
JRO
MHRA
PI
REC
SOP
UCLH
Chief Investigator
Case Report Form
Clinical Trial of Investigational Medicinal Product
Health Research Authority
Investigational Medicinal Products
Investigator Site File
Joint Research Office
Medicines and Healthcare Products Regulatory Agency
Principal Investigator
Research Ethics Committee
Standard Operating Procedure
University College London NHS Foundation Trust
BACKGROUND
As soon as the Sponsor confirms that a study has ended, they need to notify the REC and
MHRA (as applicable) within 90 days of the end of the study or within 15 days if the study terminates early. The Sponsor will notify the PI of the end of the study and the research team will then need to proceed to close the study at the participating site.
PURPOSE
To describe how the study team need to proceed once written confirmation of the end of study, or early termination, is received from the Sponsor.
PROCEDURE
Actions (When? How?)
Responsible persons
(Who?)
1
2
3
When written confirmation of the end of study is received from the Sponsor by the
PI, the PI or their delegate should inform all members of the Study team of the end of the study.
A copy of the Declaration of the End of a Study form from the Sponsor should be forwarded to the JRO and Pharmacy (if applicable) as soon as possible.
For CTIMPs the form is available from the HRA website at: http://www.hra.nhs.uk/resources/during-and-after-your-study/end-of-studynotification-clinical-trials-of-investigational-medicinal-products-ctimps-eudractform/
Where UCLH is the Sponsor organisation (for non-CTIMPs), the Declaration of the
End of a Study Form should be completed and submitted to the REC and JRO for
PI or delegate
Delegated individual
CI or delegate
Study Close Down, SOP 9, V1, 18/08/14
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4
5
6
7 information.
For all other research (Non-CTIMPs) the form is available from the HRA website at: http://www.hra.nhs.uk/resources/during-and-after-your-study/end-of-studynotification-studies-other-than-clinical-trials-of-investigational-medicinal-products/
The study team should meet to confirm that all study-related activities have stopped . A record of the meeting should be included in the investigator site file
(ISF).
The sponsor site file index should be used to carry out an ISF review . Files notes should be inserted into the ISF to explain any missing essential documents. It should be documented that an ISF review has been carried out.
All site data should be collected, entered, validated and all data queries resolved.
Case Report Forms (CRFs) should be complete and accurate and the Database confirmed as closed.
If applicable: the study monitor will close out all data queries and perform a Study
Close Out Visit and produce a Study Close Out Visit Report which is to be filed in the ISF.
All financial matters are resolved and all site payments completed as agreed in the study agreements and approvals.
All unused trial supplies are returned or destroyed according to the study protocol and/or study agreement and/or requirements of the Sponsor.
Study Team
Delegated individual
Delegated individual
Monitor
8
9
Delegated individual
Delegated individual
10
11
12
Unused IMPs are returned to the Sponsor or destroyed locally on-site (as prearranged in the study Agreement and/or other arrangements made with Pharmacy onsite). If IMP is destroyed on-site, the destruction should be documented in the
ISF.
Investigators should comply with the study publication policy, as outlined in either the study protocol and/or study agreements. The results of the study should be outlined in the Final Study Report submitted to the REC within 12 months after the end of the study.
The Sponsor should be notified that the ISF is ready for archiving and request an email to confirm that the study team can proceed with archiving as per UCLH SOP
10 Archiving Investigator Site File and Pharmacy Site File (if applicable).
REFERENCES
Pharmacy
CI & PI
Delegated individual
SOP 8 Essential Documents
SOP 10 Archiving Investigator Site File and Pharmacy Site File (if applicable)
Joint Research Office http://www.ucl.ac.uk/jro/standingoperatingprocedures
Health Research Authority website: http://www.hra.nhs.uk/research-community/end-of-study-and-beyond/notifying-the-end-ofstudy/
Study Close Down, SOP 9, V1, 18/08/14
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