University Hospitals Birmingham
UCONTROLLED DOCUMENT
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NHS Foundation Trust
RDS009 Record Keeping,
Document and Data
Control in Research
CATEGORY:
Procedure
CLASSIFICATION:
Governance
PURPOSE
To outline general considerations
for the creation and management of
paper and electronic records
Controlled Document
Number:
RDS009
Version Number:
2
Controlled Document
Sponsor:
Head of R&D Governance
Controlled Document
Lead:
Research Governance Facilitator
Approved By:
R&D Committee
On:
May 2015
Review Date:
May 2016 (due to the nature of
content this SOP is for annual
review)
Distribution:
All research staff including R&D,
Cis, PIs and Research Nurses

Essential
Reading for:

Information for:
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Version Control Log:
The table below provides an overview of the summary of changes from
previous version of an SOP. Where no previous version exists there will be no
summary of changes on record.
Version
Summary of changes
Review date
number
1
N/A
dd-mmm-yyyy
2
Revised format and updated text.
May 2016
Included distinction between
requirements for electronic and
paper data
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Table of Contents
Table of Contents ........................................................................................................... 3 Abbreviations & Definitions .......................................................................................... 3 1. Purpose ................................................................................................................... 5 2. Scope ...................................................................................................................... 5 3. Procedure for the Creation and Control of Paper documentation .......................... 5 3.1. Document Creation ......................................................................................... 5 3.2. What is required for the Trial Master File and Site File?................................ 6 C
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3.3. Review and approval ....................................................................................... 6 3.4. Corrections and Annotations ........................................................................... 8 3.5. Amendments and addendums.......................................................................... 9 3.6. Superseding Previous Versions ....................................................................... 9 3.7. Document Control ............................................................................................. 10 3.8. Study Personnel Documentation- CVs and Training Certificates ................. 11 3.9. Physical Access to Documentation ............................................................... 11 3.10. Removal of Study Documentation off site ................................................ 11 d
4. Procedure for Paper and Electronic Data Creation, Control, Copying and
Storage ..................................................................................................................... 13 lle
4.1. Data Creation................................................................................................. 13 4.2. Data Control .................................................................................................. 13 tro
4.3. Data Copying – scanning and photocopying................................................. 14 4.4. Storage of Document and Data ..................................................................... 15 4.4.3. Storage and transfer of Electronic Data and media ................................... 15 nc
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4.5. Clinical Portal Electronic Health Records and Paper Health Records ............. 15 5. Quality Records .................................................................................................... 16 6. Templates.............................................................................................................. 16 7. References ............................................................................................................ 16 Abbreviations & Definitions
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Term/
Abbreviation
Audit Trail
CI
Essential
Documents
GMC
Definition/ Description
A process that captures details such as addition,
deletion or changes made to a document or electronic
record without removing the original record.
Chief Investigator
ICH GCP (E6 Section 8.1) essential documents are
those which individually and collectively permit
evaluation of the conduct of a trial and the quality of data
produced.
General Medical Council
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General Practitioner
Original approved/signed document.
Informed Consent Form
International Conference on Harmonisation Good
Clinical Practice
IT
Information Technology
Master Copy
Original copy
MHRA
Medicines and Healthcare Products Regulatory Agency
PI
Principle Investigator
PIS
Patient Information Sheet
REC
Research Ethics Committee
SOP
Standard Operating Procedure
Source Data
All information in original records and certified copies of
original records of clinical findings, observations or other
activities necessary for the reconstruction and evaluation
of the study.
Source Documents Original documents, data and records (e.g. hospital
records, clinical and office charts, laboratory notes,
memoranda, x-rays etc)
UHB/ UHBFT
University Hospitals Birmingham Foundation Trust
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GP
Hard Copy
ICF
ICH GCP
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1. Purpose
1.1. The purpose of this procedure is to:
1.1.1. Outline considerations for the creation of documentation in
research
1.1.2. Describe the process for record keeping and control of essential
documentation and data in accordance with Good Clinical Practice
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(GCP) and applicable regulatory requirements.
2. Scope
2.1. This procedure applies to essential documentation and data (paper
and electronic) created for research conducted at UHBFT.
2.2. All research staff involved in studies sponsored or hosted by UHB are
required to follow this SOP.
2.3. Where external Sponsors have provided their own record keeping
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procedures those must also be followed.
3. Procedure for the Creation and Control of Paper documentation
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3.1. Document Creation
3.1.1. All essential study related documentation created by personnel
for clinical studies shall in general conform to a basic format in
order to ensure that the documentation is valid, complete and up
on
to date.
3.1.2. This includes clearly stating:
the version number
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a)
b)
the creator of the document
c)
the effective date of the document
d)
the creator and date of each amendment (issue or version
numbers should be clearly documented)
e)
the review by dates (where applicable)
3.1.3. Page numbers must be included using the format `Page 1 of x’
on each page.
3.1.4. Members of the study team should be given opportunity to
provide feedback on draft documents. Once all comments have
been considered and incorporated into the document it shall be
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raised to Version 1 or if Version 1 has undergone revision the
document should be up-issued to Version 2.
3.1.5. Where signature is required the paper hard copy of a document
shall be signed or initialled by the author (as applicable). This
paper hard-copy shall be considered the `original copy’.
3.1.6. Some documents may be signed electronically where the facility
to do so is in place. For example electronically completed IRAS
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forms may be signed and dated electronically by the author and
reviewer.
3.2. What is required for the Trial Master File and Site File?
3.2.1. R&D Governance provides a template list of folder contents
based on the ICH GCP essential documents with the Trust
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Authorisation Letter. In addition R&D has developed guidance
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document RDG001 Content of a Study File, checklist templates
RDT010 UHB TMF Checklist and RDT010.1 Investigator Site File
Index that should be used as a reference point for completing the
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study files.
3.2.2. The CI/PI may delegate the responsibility for maintaining the
study files to a member of the research team, this must be
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documented within the delegation of duties log and authorised by
the CI/PI (see template RDT008 Delegation of Duties Log).
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3.3. Review and approval
3.3.1. For the review and approval of R&D SOPs, guidance and
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templates RDS001 Creation and Control of SOPs, Templates and
Guidance Documents should be followed.
3.3.2. For all documentation the reviewer shall take the following into
account:
a)
Are the changes minor or substantial (requiring substantial
amendment notification)
b)
The issue number, creator and date of each amendment must
be clearly stated on the document
c)
Page numbers are accurate
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d)
The content must be checked for accuracy
e)
Check document headers and footers
f)
Check study specific reference codes (for example R&D
reference
codes)
are
correct
and
follow
the
format
RRKXXXX, where XXXX represents a number sequence
generated by the R&D database once the study has been
registered with R&D.
The document must be complete
h)
Headings and titles must be accurate and relate to the
subsequent paragraphs.
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g)
i)
Document formatting
j)
Index Table or Table of Contents (where present) – match the
contents of the document.
Spelling grammar and legibility. Does the document follow
through logically?
If the document is based on a template does it match that
template?
SOPs have been followed to produce the document (where
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applicable)
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References are relevant, accurate and mentioned where
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appropriate.
o)
Where required – have relevant ICH-GCP and regulatory
guidelines been followed?
Where hand written annotations have been made, are these
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p)
according to GCP standards?
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3.3.3. If the document does not meet requirements the reviewer shall
notify the author of the document with details of changes in order
for the document to qualify for approval.
3.3.4. It is not necessary to obtain formal approval for documents while
they are still in draft format. Once the document is raised to
Version 1 the draft may be removed from file and deleted.
3.3.5. The level of authorisation required will depend on the nature of
the document. For example, documents such as protocols, PIS,
ICFs, GP information sheets/letters, Investigatory Brochures or
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user specification guides created for study specific research
purposes shall be submitted for review and approval to the REC,
MHRA (for CTIMPs) and R&D governance as applicable. Other
documents such as templates designed for specific research tasks
may be submitted to the relevant senior member of the team (e.g.
PI if research, R&D Manager if required) for approval.
3.3.6. The document may be implemented once approved.
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3.3.7. In addition to the above the R&D office shall a review of the
study files and documentation as part of the R&D audits and
monitoring process (see SOPs RDS005 R&D Study Audits and
RDS011 Study Monitoring).
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3.4. Corrections and Annotations
3.4.1. Minor corrections and annotations may be made to a document
provided it is clear who made the change, what the change is,
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when it was made and why.
3.4.2. The following should be taken into account when making
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corrections and annotations:
Correction fluid must not be used
b)
Pencil must not be used
c)
Annotations must be legible
d)
The word or section being amended must be struck through
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a)
but still legible so that it is clear to the reviewer what it
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previously said and what the correction now states.
e)
Annotations must be initialled and dated by the individual
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making the correction, where necessary explanations must be
provided for the changes
3.4.3. The example below shows how to and how not to make a
correction in accordance with GCP guidelines:
Incorrect method :
Original text is illegible
Only initials of individual making correction are included
Correction has not been dated.
Correct method:
Original text struck through and still visible
Initial of individual making the change and date change was made
are included
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31st December 2100
21st December 2010
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31st December 2100
21st December 2010
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3.4.4. Even where the annotation involves an amendment to a date as
shown above, the date the correction was made must also be
included.
3.5. Amendments and addendums
3.5.1. Where the change is significant enough that an annotation
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cannot be made, amendments or addendums may be put in place
(see SOP RDS013 R&D Office Procedure for reviewing
amendments).
3.5.2. The R&D office, REC and MHRA (for CTIMPs) shall be notified
of any amendments to the following:
Protocol amendments
b)
Change of PI or CI
c)
Substantial amendments to the study
d)
Change of sponsor
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3.5.3. Where a document is amended it shall be up-issued to the next
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version.
3.5.4. In some instances addendums may need to be put in place for
the original document. These can be created as a separate
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document but must reference the original document.
3.5.5. Minor amendments must be notified to R&D, REC and MHRA
(for CTIMPs).
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3.5.6. Substantial amendments must be submitted via email to R&D
and via IRAS to the REC and, in the case of CTIMP studies, the
MHRA for approval.
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3.5.7. See RDS013 R&D Office Procedure for Reviewing Amendments
for further details
3.6. Superseding Previous Versions
3.6.1. Superseded documents provide an audit trail for review should
this be required. The superseded document must be kept for the
duration of the study and archive period.
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3.6.2. The hard copy of any previous versions should be marked as
superseded, signed and dated (on the date superseded) by the
individual superseding the document.
3.6.3. On completion of a study the documentation shall be formally
archived as agreed with the Sponsor (see RDS014 Archiving in
3.7. Document Control
3.7.1. R&D SOPs and Templates
a)
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Research).
The Trusts Controlled Documents Policy and Procedure will
be adhered to when creating SOPs, guidance and templates.
b)
If the Procedure is specific to research related activities
RDS001 Creation and Control of SOPs, Templates and
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Guidance Documents will be followed.
3.7.2. Study Specific Documentation
a)
At present there is no requirement for controlled circulation of
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hard copy study specific documents as these should not be
released to anyone who is not involved in the study.
b)
The conditions for removing study documentation from site
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premises are described further in section 3.10. The conditions
for document storage and security are described in section
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3.9.
c)
Hard copy original documents may be made available for
inspections and audits and shown to auditors. Any hard copy
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documents requested for audit shall be tracked by a member
of the study team and returned immediately to the study files
once the audit is complete.
d)
Where copies of the original hard copy is requested the copy
(scanned or photocopied) shall be marked `Uncontrolled
Copy’.
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3.8. Study Personnel Documentation- CVs and Training Certificates
3.8.1. Personnel documentation includes Job descriptions, CVs,
training certificates and training records (where applicable).
3.8.2. Individual employees are responsible for their own personnel
documentation.
3.8.3. The following documents must be kept up to date:
CVs
b)
Job descriptions
c)
Professional registration (where applicable)
d)
For personnel involved in studies copies of their most recent
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a)
GCP training certificates must be on file.
e)
Training certificates or documented evidence for any other
training relating to the study.
f)
Where applicable training logs or record of training must be
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maintained and kept up to date.
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3.8.4. CI/ PI of a study is responsible for ensuring that copies of the
most current CVs and training certificates for employees listed on
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the delegation log are in the study files.
3.9. Physical Access to Documentation
3.9.1. All study documentation must be stored securely (via key or
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swipe access) PIs shall designate suitable areas for the storage of
study documentation and data. Access to the study documentation
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and data shall be restricted to the study team.
3.9.2. Where lockable filing cabinets are in place authorised key
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holders shall be identified.
3.10.
Removal of Study Documentation off site
3.10.1.
Hard copy originals of study specific documentation may
only be removed from site for the following reasons:
a)
If required for a sponsor meeting held off-site
b)
Study-specific documents may be removed temporarily by
employees working from home. Such documents should be
tracked and returned to the study file. Where applicable a
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document log sheet may be used to track removal and return
of the document.
c)
If deemed necessary a certified copy shall be made of the
document prior to being removed.
d)
The document shall be stored safely until it is returned to site.
e)
Study specific documents shall not be left on view when being
transported in cars.
If left unattended in a car the documents shall be locked in
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f)
the boot of the car.
g)
Once off-site the employee responsible shall ensure that the
document is stored in a dry room away from fire hazards until
its return.
h)
If faxing an original document to the sponsor the contact
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numbers should be checked prior to any faxes being sent.
3.10.2.
Original documents requested by a sponsor, or sent
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offsite for counter signing shall be scanned prior to being sent with
the scanned copy retained at site. Documents shall be sent via
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courier along with a request for confirmation of receipt. If the
document is going to remain off-site for some time a file note will
be kept in its place explaining the reason for the missing original
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document. The file note shall be destroyed upon the return of the
original document.
3.10.3.
Master SOPs shall not be removed from site by
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employees unless sending previous versions are sent for off-site
archiving.
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3.11.
Loss/Theft of Documentation
3.11.1.
In the event where documentation is lost or stolen the
PI/CI shall be informed. If the document contains highly
confidential information (i.e. is a study protocol, patient identifiable
information) the sponsor shall be notified of the loss together with
the circumstances surrounding the loss.
3.11.2.
If the study is sponsored by UHBFT the R&D office shall
be notified to take appropriate action (this may include conducting
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an investigation in the events surrounding the loss of the
document).
4. Procedure for Paper and Electronic Data Creation, Control, Copying
and Storage
a study. Data collected must be;
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4.1. Data Creation
4.1.1. The following apply to both electronic and paper data relating to
a)
Accurate
b)
Legible
c)
Recorded in a timely manner (i.e. at the subjects visit or as
close as possible to the visit taking place).
d)
Data generated must be original for example a blood
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pressure result required for a study must be traceable to the
subject and taken under controlled conditions in accordance
e)
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with the protocol
Traceable to the individual who made the entry i.e. who made
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the entry when and why
f)
Complete and consistent
g)
Where checks are required by the Investigator it must be
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possible to verify the review was performed by the
Investigator
h)
An audit trail should be maintained for the original creation
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and any modification of source data
i)
Study Specific Data entries on Case Report Forms (CRFs)
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must be made in accordance with the approved protocol
study.
j)
Duplicated records should be avoided where possible.
4.2. Data Control
4.2.1. The data must be held in a secure location with restricted
access (see 3.9 and 4.4).
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4.2.2. Source data and documents must be protected against
unauthorised access by the use of password protection and
lockable or swipe access facilities.
4.2.3. Unlike study specific documentation original source documents
and data must be;
a)
Maintained by the Investigator, the sponsor may hold
verifiable or certified copy of the data.
Original Source documents may not be sent off-site.
c)
Screenshots of electronic CRFs are not permissible as this
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b)
leads to the possibility of incorrect or unapproved versions
being used. The Investigator is responsible for ensuring data
reported to the sponsor in the approved CRFs is in
accordance with section 4.
In accordance with ICH GCP requirements the sponsor has
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d)
overall responsibility for data quality however, the sponsor
e)
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should not have exclusive control of source documents.
Direct access to source documents and data must be
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provided to authorised individuals including Monitors, Auditors
and Inspectors.
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4.3. Data Copying – scanning and photocopying
4.3.1. Where copies of source data are required the individual making
the copy must ensure that the following checks are performed for
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any scanned or photocopied documents;
a)
Is the copy an exact copy?
b)
Are the headers, footers and text clearly visible?
c)
Are there any smudges or missing sections?
d)
If the original document was double sided have all sides been
copied?
e)
Is the document complete?
4.3.2. The above also apply when creating PDF versions of source
documents and creating copies of electronic health records for the
purpose of monitoring, auditing and Inspecting.
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4.4. Storage of Document and Data
4.4.1. Essential Documents and Data must be stored in secure areas
(see 3.9) and protected against accidental or deliberate damage.
4.4.2. Documents must be stored in a dry place away from exposure to
the elements such as direct sunlight or dampness.
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4.4.3. Storage and transfer of Electronic Data and media
a)
Electronic data must be password protected with access
restricted to authorised members, held on validated systems
and backed up to secure servers.
b)
Where necessary any transfer of data must be done using
secure methods and encryption.
c)
Electronic media such as digital memory cards, CDs and USB
sticks must be stored in a cool dry location away from
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exposure to the elements such as direct sunlight, dampness
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and any electromagnetic waves that could wipe the data.
4.5. Clinical Portal Electronic Health Records and Paper Health
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Records
4.5.1. The Trust is in the process of moving towards electronic Health
Records, paper records may also be in use during this transition.
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4.5.2. It must be identified by the Investigator whether a subjects
health records will be held in paper, electronic or both forms. If it is
both in paper and electronic form then both records will need to be
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maintained. If one form is identified as the main health record then
the other must refer to the main record.
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4.5.3. Any study documents being scanned into portal must be
accurate, legible and complete (see 4.3).
4.5.4. Health records are controlled access and entries to a subjects
health records are audit trailed, this is monitored by IT.
4.5.5. All forms of Health Records whether paper or electronic must be
made available to inspectors, monitors and auditors for audits,
monitoring and inspections.
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4.5.6. The Trust wide policies and procedures relating to patients
health records must also be adhered to (see Health Records Filing
Protocol, Monitoring of health records standards, and Procedure
for the Development and Management of Patients Health
Records).
5. Quality Records
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5.1. Documentation produced by personnel involved in clinical studies
conducted at UHB.
5.2. Templates.
6. Templates
6.1. R&D templates
6.2. Study specific templates
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7. References
7.1. Record Management Policy and Information Lifecycle
7.2. Data Protection Act 1998
7.3. ICH GCP E6 Guideline for Good Clinical Practice
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7.4. UK SI 1031/2004 The Medicines for Human Use (Clinical Trials)
Regulations – As amended
7.5. Reflection paper on expectations for electronic source data and data
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transcribed to electronic data collection tools in clinical trials
(EMA/INS/GCP/454280/2010; GCP Inspectors Working Group)
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7.6. RDS001 Creation and Control of SOPs, Templates and Guidance
Documents
7.7. RDS005 R&D Study Audits
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7.8. RDS011 Study Monitoring
7.9. RDS014 Archiving in Research
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