Professional Documents
Culture Documents
archiving\SPON_S21_SOP_for_archiving V02.doc
Page 1 of 13
Effective Date:
01/04/2012
Review Date:
01/04/2014
eDocument kept:
SOP on Archiving
JBRU/SPON/S21/02
Page 1 of 13
Page 2 of 13
Revision Chronology:
SOP ID Number:
Effective
Date:
JBRU/SPON/S21/01
15/02/10
JRO/SPON/S21/02
Routine
review
Change
01/04/2012 terminology,
change
department name
ACRONYMS:
JRO
Joint Research Office
GCP
SOP
CI
PI
TMF
ISF
MHRA
REC
QA
SOP on Archiving
JBRU/SPON/S21/02
Page 2 of 13
Author:
Dave Wilson
in
Daniel
of
Heather
www.ucl.ac.uk/jro/
Page 3 of 13
3. BACKGROUND
All SOPs are written in accordance with applicable GCP requirements as outlined in
Directives 2001/20/EC and 2005/20/EC (in the UK, these Directives were transposed
into UK law by SI 2004/1031, SI 2006/1928) and subsequent amendments and where
applicable incorporates elements of ICH GCP tripartite guidelines (E6).
The EU GCP Directive 2005/28/EC and subsequent enabling legislation set out the
standard for archiving clinical trials essential documentation. As public funded CTIMPs
need to meet UK regulatory standards set by the appropriate competent authority the
Medicines and Healthcare products Regulatory Agency (MHRA), it is necessary for
there to be a robust and secure archiving system to be in place for all essential
documentation managed by the JRO at the end of the life of a CTIMP.
5. RESPONSIBLE PERSONNEL
The JRO R&D Record Manager maintains oversight for the archiving of all documents
relating to CTIMPs within the JRO. The physical listing and transfer of records will be
delegated to the UCL CTIMP/Admin. team where appropriate. The responsible
archivist for UCL is the UCL Records Manager based within UCL Records Office. The
JRO is responsible for presenting the paper JRO sponsor file to the R&D Record
Manager for archiving. The named archivist for UCL is Mr Colin Penman (UCL Records
Officer).
SOP on Archiving
JBRU/SPON/S21/02
Page 3 of 13
Page 4 of 13
6. PROCEDURE
6.1 Storage and archiving
To ensure that results from CTIMPs can be examined and subject to internal and
regulatory audit, it is necessary that both Sponsor and Chief Investigator keep records
of the clinical trial throughout its life cycle at site that are capable of being archived.
Archiving of investigator site files as part of a multi-centre CTIMP will be determined by
local site guidance and policy and regulatory requirements.
A paper sponsor file is ready for archiving when the Chief Investigator of a CTIMP
informs the JRO that the End of Trial Study Report has been submitted to the
MHRA. This report is required within one year of formal notification of end of
Clinical Trial to Research Ethics Committee and MHRA.
All essential documents held within the JRO Sponsor file are appropriately archived
through the transfer of records to the UCL Records Office using the Records Office
Database in Citrix Program Neighbourhood. Records are stored securely at UCLs
external archiving repository based at Wickford in Essex. A log of documents archived
is kept within UCL Records Office.
6.2 Retention Policy
In accordance with UCL Records Management Policy, research findings will need to be
stored by UCL as sponsor for 20 years after the research has finished based on
recommendations made in the Medical Research Councils Ethics Series on Good
Clinical Practice. This is deemed a sufficient period of time to allow for audit and
inspections by regulatory authorities. The UCL Records Office provides a service to
UCL staff and maintains archived records in a safe and secure off site location. All
activities are conducted in accordance with the Data Protection Act and UCL Data
Protection Policy. Access to the data is strongly regulated and permissions to access
the data are treated case by case. The Records Office allows for records to be
catalogued onto an online database, and assists in recalling archives on demand.
In addition clinical trials of Advanced Therapy Investigational Medicinal Products
(ATIMP) are subject to the traceability requirements set-out in the Advanced Therapy
Medicinal Product Regulation (EC) No 1394/2007 transposed in UK law by SI
2010/1882. In line with this legislation, the Sponsor (or delegate) and investigator trial
site administering the ATIMP to patients must retain relevant records relating to
product traceability for at least 30 years after the expiry date of the product.
The European Commission guidance Detailed guidelines on good clinical practice
specific to advanced therapy medicinal products sets out the traceability records and
minimum data set the Sponsor, investigator and institutions responsible for human
application of ATIMP must retain for the minimum 30 year period.
SOP on Archiving
JBRU/SPON/S21/02
Page 4 of 13
Page 5 of 13
7. REFERENCES
Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031]
Section 8 of ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996)
Medical Research Council Ethics Series on Good Clinical Practice
EU GCP Directive 2005/28/EC
Data Protection Act 1998
Advanced Therapy Medicinal Product Regulation (EC) No 1394/2007
The Medicines for Human Use (Advanced Therapy Medicinal Product and
Miscellaneous Amendments) Regulations 2010 [SI 2010/1882]
Detailed guidelines on good clinical practice specific to advanced therapy medicinal
products [ENTR/F/2/SF/dn D(2009) 35810]
http://www.ucl.ac.uk/joint-rd-unit
COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and
detailed guidelines for good clinical practice as regards investigational medicinal
products for human use, as well as the requirements for authorisation of the
manufacturing or importation of such products.
8. APPENDICES
Appendix 1: UCL
Neighbourhood)
Records
Office
Archiving
System
(Citrix
Program
Page 6 of 13
SOP on Archiving
JBRU/SPON/S21/02
Page 6 of 13
Page 7 of 13
Page 8 of 13
Location WD is entered by UCL Records Office and contained in the Box List
prepared and sent to JBRU by UCL Records Office
+ green = new record
Appendix 2 UCL Records Management Service, How to transfer Records
The Records Office provides the Records Management Services for the whole of UCL.
The Records Management Policy, which was confirmed as a UCL Policy in 1999,
applies to all administrative records, whatever their format:
http://www.ucl.ac.uk/efd/recordsoffice/policy/
All Institutes, Departments and Schools within UCL are expected to consult the
Records Manager before disposing of non-current records.
Please follow these simple guidelines every time you want to transfer your
department's records to the Records Office. This will help us to help you to manage
your records correctly. There is no charge for use of this service.
Using
the
Database
We control management of records through the Records Office database. You can
describe your records on this database whenever you want to make a transfer.
When you contact us we will check that you have signed up to the database. If not, we
will arrange to provide you an account, give you access, and arrange training. The
training module provides technical detail on how to operate the system. It will also
provide instruction on what information should be held.
Method
of
Storage
Please use the boxes supplied by the Records Office for transferring your records. We
supply these as flat packs free. Please contact the Records Office to request the
number
of
boxes
you
need.
We use 2 box types:
(W)
Wall
&
260mm
Thickness
(H)
SOP on Archiving
JBRU/SPON/S21/02
Page 8 of 13
Secure
x
280mm
(W)
Weight
limit:
Packing the boxes
10
Page 9 of 13
kg.
Be careful not to overfill the box and keep the handles clear.
Weight limits: We have been advised by the Library Services Health and
Safety Officer that the weight limit for boxes should be as follows:
o
Please
note:
1. These limits are also necessary to meet the weight limits of the shelves in the library
store.
2. Over weight boxes will be returned to the user department for repacking.
Ring binders can be wasteful of space and, ideally, should not be put into
boxes. Please remove the contents and put them into a file wallet, carefully
writing the title and dates of the file on the outside.
Please print off a box list and put it into the box.
Please write the box no generated from the database system onto the box. We
will give them the full numbers in the Records Office.
Storage
of
items
other
than
paper:
Please advise the Records Office that you are intending to store items other than
paper, such as electronic material or photographic material in the boxes provided. We
can advise you of any issues that may need to be addressed.
We will also ensure that the boxes are stored in a suitable area to protect the media.
Collection
When you have completed listing and packing your records, please telephone the
Records Office and we will arrange for the College Porters to collect the boxes and
bring them to the Records Office for checking. At the checking stage, we may find
some boxes are badly packed or too heavy. In such cases we will contact you to find a
way
to
resolve
the
situation.
N.B. Please DO NOT contact the Estates & Facilities Help Desk for collection.
This must be arranged with the Records Office.
Records
Office
Administration
On arrival in the Records Office we check the contents of the boxes against the data
entered into the database and issue identifying department and shelf numbers, for the
store.
We then print off a box list with the full references and post it to the department. Please
check that you have received a box list for every box that you have deposited and that
the information is correct. It is your responsibility to contact the Records Office
immediately if there is a discrepancy.
Records
Retrieval
The database training module will instruct you how to retrieve records from storage.
The requested records will be returned to the Records Office by 2pm on the following
working day. You will be notified as soon as the records arrive. We would prefer that
you collect the records in person, but if you're unable to do this please call us and we
can
make
alternative
arrangements.
If you wish to retain items retrieved permanently, please advise the Records Office so
we can update the database.
SOP on Archiving
JBRU/SPON/S21/02
Page 9 of 13
Page 10 of 13
Destruction
Policy
All records should be retained or disposed of according to UCL retention schedules
and appraisal guidelines established by the Records Management Programme. These
are published separately and copies can be obtained from the Records Manager.
When a box is sent to the Records Store a retention period is assigned to the
box. The Records Office will contact you when the retention period has been
reached to obtain approval to destroy the records. No records will be destroyed
without your approval.
Other
Services:
Short
Term
Storage
In special circumstances and only after agreement with the Records Office, we can
accommodate items into the Records Management Service for short-term storage,
(e.g.: up to two years), while Departments are relocated. The standard guidelines for
transfer of records to the store must be adhered to.
Contacts
at
the
All
Record
Office
staff
can
provide
Our
collective
mailbox
is:
Records
Office
you
with
general
advice.
records.office@ucl.ac.uk.
Contacts:
1
2
3
Appendix 1
List of Essential Documents in the JBRU sponsor file, CI Trial
Master File
Appendix 2
Operation of the UCL Archiving System (Citrix Program
Neighbourhood)
Appendix 3
UCL Records Management Service How to transfer records
Date:
Authorised by:
Name and Job Title
Signature:
Date:
SOP on Archiving
JBRU/SPON/S21/02
Page 11 of 13
Page 11 of 13
Page 12 of 13
Department:
Training
Date
I confirm that
I
understand & agree
to work to this SOP
SIGNATURE
SOP on Archiving
JBRU/SPON/S21/02
Page 12 of 13
Signature
Date
Job Title:
Department:
Job Title:
Department:
Training
Date
Training
Date
I confirm that
I
understand & agree
to work to this SOP
SIGNATURE
I confirm that
I
understand & agree to
work to this SOP
SIGNATURE
SOP on Archiving
JBRU/SPON/S21/02
Page 13 of 13
Page 13 of 13
Signature
Signature
Date
Date