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Standard Operating Procedure for Monitoring of
UCL Sponsored CTIMPs
SOP Number: JBRU/SPON/S19/02
Effective Date: 01/02/10
Version Number & Date of Authorisation: V02, 28/01/10
Review Date: 01/02/12
SOP eDocument kept: S:\CLINICAL_TRIALS\SOPs\EFFECTIVE_SOPs_Guides\SPONSOR SOPs\SPON_S19_SOP
for monitoring UCL sponsored CTIMPs_V02.doc
SOP for Monitoring of UCL Sponsored CTIMPs
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Revision Chronology:
SOP ID Number:
Effective
Date:
Reason for Change:
Author:
JBRU/08/S09/00
21/05/2008
N/A
Joanna
GaleaLauri
JBRU/SPON/S19/01
JBRU/SPON/S19/02
15/10/2008
14/02/10
To implement a new numbering system
and formatting changes by Ira Jakupovic
to comply with the SOP on SOPs
(JBRU/SPON/S01/02). The content of this
SOP was not affected.
SOP ID numbers that refer to Central
Monitoring SOP and TMF SOP have also
been changed to reflect a new numbering
system that has been applied to all SOPs.
To implement the self-monitoring template
for all active trials and outline the
procedure for the extent and frequency of
use.
To outline the review process of the forms
by the JBRU and requirements for sign off
with an agreed CAPA plan.
Format amended in line with revised SOP
on SOPs to incorporate a UCL logo only,
as UCLH no longer provides sponsorship
for CTIMPs, an Acronyms table,
eDocument file path, associated
templates/log table, SOP dissemination
and training and a signature page.
Joanna
GaleaLauri
Ann
Cochrane
and
Gurjinder
Kahlon
ACRONYMS:
JBRU
CAPA
GCP
SOP
CI
PI
TMF
ISF
MHRA
MREC
Joint UCLH/UCL Biomedical Research Unit http://www.ucl.ac.uk/joint-rd-unit
Corrective and Preventative Action
Good Clinical Practice
Standard Operating Procedure
Chief Investigator
Principal Investigator
Trial Master File (Sponsor’s)
Investigator Site File
Medicines and Healthcare Products Regulatory Agency
Main Research Ethics Committee
SOP for Monitoring of UCL Sponsored CTIMPs
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Standard Operating Procedure for Monitoring of
UCL Sponsored CTIMPs
1. PURPOSE
This Standard Operating Procedure (SOP) describes the procedure for the review of
the self-monitoring reports completed by the site for CTIMPs sponsored by UCL and
the procedures for any site monitoring visit performed by the sponsor representative.
2. JOINT UCLH/UCL BIOMEDICINE R&D UNIT POLICY
All SOPs are produced, reviewed and approved in accordance with the JBRU SOP on
SOPs.
3. BACKGROUND
The European Clinical Trials Directive (EUCTD) 2001/20/EC, the GCP Directive
2005/28/EC and The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI
2004/1031) and as amended, set out the requirements for implementation of Good
Clinical Practice (GCP) in the conduct of clinical trials that use a medicinal product in
humans within Europe and the UK. For convenience, this SOP will use the term
‘Regulations’ to cover the requirements of the UK SI legislation.
Monitoring is defined in ICH GCP 1.38 as: the act of overseeing the progress of a
clinical trial and of ensuring that it is conducted, recorded and reported in accordance
with the protocol, SOPs, GCP and the applicable regulatory requirements.
It is essential that trials be monitored to the highest standards possible and that the
Sponsor and CI/PI follow a well written procedure.
UCL has implemented a Self-Monitoring process for all CTIMPs sponsored by UCL.
This process is driven by a risk based monitoring strategy (Appendix 1) and is applied
to each active trial until the end of that trial.
Completion of the Self-monitoring template by a delegated site monitor is necessary to
ensure the regulatory requirements for the conduct of a CTIMP are adhered to and the
PI/CI/Sponsor has oversight of the trial in order to implement any corrective and
preventative actions (CAPA).
In addition, the sponsor may also perform a site visit in order to;



audit the completion of the self-monitoring template,
investigate a potential serious breach report or violation
other reason as recommended by site or the JBRU.
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3.1
Setting the Standard
The Sponsor monitors its sponsored CTIMPs according to the UK Regulations under
the SI 2004/1031 and as amended. The self-monitoring template is designed to
incorporate Regulations pertaining to the CI/PI responsibilities.
The protocol of a clinical trial needs to have provisions for monitoring (Schedule 1,
Part 2, Principle 7). The sponsor’s current protocol template defines the Monitoring
Plan required for the trial based on the agreed risk level with the CI which will
determine the minimum frequency for return of the self-monitoring template to the
Sponsor for review. This frequency also applies to multi-site trials.
The monitoring risk level may differ overall from the overall trial risk assessment which
is performed separately by the sponsor and not covered in this SOP (see
JBRU/SPON/07, “SOP to be used by Sponsor when assessing risk factors in CTIMPs
sponsorship decision”).
3.2 Extent and scope of monitoring (Monitoring Plan)
The Sponsor should ensure that trials are “adequately” monitored. The Sponsor should
determine the appropriate extent and nature of monitoring. The determination of the
extent and nature of monitoring should be based on considerations such as the
objective, purpose, design, complexity, blinding, size, and endpoints of the trial (5.18.3
ICH-GCP).
It is the responsibility of the CI to ensure that the sponsor’s self-monitoring template is
completed throughout the trial every two months and submitted to the JBRU at the
regularity determined by the risk based monitoring strategy (See Appendix 1)
It is the responsibility of the CI (prior to trial initiation) to determine the
monitoring risk assessment and explain the rationale. The sponsor must also
agree with this assessment.
As per the current UCL protocol template and the CI Self-Monitoring Template:
3.2.1
3.2.2
Where a trial is single site and non-Phase I or
non-Phase I/II:
All CTIMPs sponsored by UCL will be
monitored according to the self-monitoring
template and monitoring plan as defined in the
protocol and agreed by the CI/sponsor, using
the risk based monitoring strategy.
CI/JBRU Trial Monitor
(copies of self-monitoring
reports to be sent to the
JBRU as per the risk based
monitoring strategy)
CI must delegate a “Site
Monitor”
Phase I Project Manager
Where a trial is Phase I or Phase I/II trial
and a Trial specific Site
(single or multi-site):
It is mandatory that an experienced trial Monitor
specific Phase I Project Manager and a site
monitor will be hired to run this trial. The site
monitor will be expected to be on site to carry
out 100% SDV on patient one while the patient
is being treated (as a minimum) to ensure that
all procedures are documented appropriately
and carried out as per MHRA and REC
approved protocol.
The details of each trial will differ but the level
of monitoring by the site monitor must be
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3.2.3
clearly specified in the protocol. The hired site
monitor must provide the JBRU monitoring
reports of any monitoring performed at site.
Where a trial is a multi-site trial and non-Phase
I or non-Phase I/II
Depending on the number of sites, a trial
specific monitor should be hired to send the PI
self-monitoring template to each site, review
the completed templates from sites and ensure
that appropriate corrective and preventive
actions are implemented. That monitor will be
expected to go on site to check that the CI &
PI self-monitoring reports were completed
accurately (AUDIT).
Trial specific Monitor/PI/CI
(copies of self-monitoring
reports must also be sent
to the JBRU Trial Monitor)
The primary responsibility for operational trial oversight continues to rest with the CI/PI.
3.3
Rationale for Self-Monitoring
The sponsor has developed the self-monitoring template to assist CI/PIs to actively
maintain and demonstrate oversight of the trial during its conduct phase.
It is the CI and PI’s responsibility to allocate a “site monitor” within their team. The
team member acting as a “site monitor” for a particular monitoring exercise should
enter his/her name in the delegation log for this task and ensure this site monitoring
responsibility is signed off by the CI or PI at that site.
3.4
Definitions
Audit: A Quality Assurance (QA) activity to ensure that systems are achieving the
standards set, including highlighting any failures that have not been identified through
quality control (QC). Monitoring is a Quality Control procedure.
Corrective action: action to eliminate the cause of a detected fault or deviation.
Corrective action is taken to prevent recurrence of the detected fault or deviation.
CAPA: The Corrective and Preventative Action necessary to address any short
comings highlighted through completion or review of the self-monitoring template.
Findings: results of the evaluation of the collected evidence against set criteria, in this
instance the review of the self-monitoring template against the protocol, GCP, UK
Regulations and sponsor/investigator SOPs.
Monitoring: A quality control (QC) activity which involves a system of ongoing checks
to detect faults and failures in order to correct them, and prevent the failure recurring ,
so that the specified output is produced consistently, in this context compliance with
the UK Regulations, Sponsor SOPs, approved protocol and GCP.
Monitoring Plan: The agreed system for monitoring a CTIMP as specified in the
protocol and Master CI self-monitoring template i.e. completion of the CI/PI selfmonitoring form at the frequency as per the risk based monitoring strategy.
Preventive Action: An action to eliminate the cause of a potential non-conformity or
other undesirable potential situation. Preventive action is taken to prevent reoccurrence.
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4. SCOPE OF THIS SOP
This SOP outlines the procedures to be used for the review of the self-monitoring
template once it has been completed and returned to the JBRU. The procedures to
followed for a site visit by a sponsor representative are also outlined.
Monitoring of studies outside the UK will not be addressed in this SOP. This will be
defined in trial specific contracts.
5. RESPONSIBLE PERSONNEL
Chief Investigator (CI): to ensure the self-monitoring form is maintained every two
months on site by the delegated Site Monitor and ensure the form is returned to the
sponsor for review at the frequency agreed at the start of the trial, as set in the Risk
Based Monitoring Strategy.
For a single site trial the CI must follow the sign off procedure in the self-monitoring
template following review by the sponsor.
For a multi-site trial the CI must demonstrate oversight of the trial by reviewing all PI
self-monitoring reports from site and commenting on each return before they sign it off.
Principal Investigator (PI): responsible for the completion (or delegation of completion
at site) and return of the PI self-monitoring template to the CI for review and Sponsor
for oversight in parallel. Each PI must also sign off the report from their site. The PI is
responsible for ensuring that their site maintains the self monitoring form every two
months and returns forms to the CI and sponsor at the frequency stated in the Risk
Based Monitoring Strategy.
Site Monitor: delegated individual(s) on site to complete the self-monitoring report at
the recommended 2 monthly frequency and responsible for the return of the form to the
sponsor (and CI for multi-site trials) at the frequency determined by the risk based
monitoring strategy.
JBRU Trial Monitor (TM): on behalf of the sponsor, will review the self-monitoring
report form returned from the CI site. The JBRU monitor may also go to site to audit the
self-monitoring reports or perform a site visit in response to the outcome of a review
and the nature of any findings arisen.
The need to perform a site visit must first be discussed and agreed with the QA
Manager/and or Divisional Manager at JBRU.
JBRU Trial Co-ordinator (TC): The Lead TC will sign off the self-monitoring report
following review by the TM to demonstrate oversight of the trial findings and any
agreed CAPA requirements for the site CI/PI to implement on behalf of the sponsor
QA Manager: reviews the findings from a site visit by the JBRU Trial Monitor and
provides guidance for the required outcome. Upon request by the JBRU TM/TC
provides guidance on the creation of CAPA(s) from a review of a self-monitoring finding
where guidance is needed. The QA manager is also required to sign off the selfmonitoring report once a signed version is received from site.
SOP for Monitoring of UCL Sponsored CTIMPs
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6. PROCEDURE
6.1 Receipt of a CI Self-monitoring template
6.1.1
6.1.2
6.1.3
6.1.4
6.1.5
6.1.6
The initial completion of the CI self-monitoring template (Master JBRU
copy) as part of site initiation, must be kept up to date every two TM
months on site as recommended by the sponsor in the selfmonitoring template guidance section.
Thereafter, upon return of the 1st completed template to the sponsor
(e.g. six months after the first consent or the date of finalised
Master template) this should be sent electronically in word format to
the allocated JBRU Trial Monitor.
Upon receipt of the electronic report, the sponsor should save this
email
in
the
trial
specific
eTMF
under
section
13./Monitoring/Reports folder and create a ‘Self-Monitoring reports’
sub-folder.
The site monitor must also be acknowledged of the receipt of the
report; this may be done by email to the sender and c.c CI. Save
and print this documentation.
Check the word file naming convention is correct as per the selfmonitoring guidance.
The email containing the report from the site monitor and report
contained within must be printed and date stamped to confirm the
date of receipt by the JBRU monitor.
Receipt of the report and the date must also be logged on the excel
spreadsheet entitled ‘ UCL CTIMP Self-Monitoring templates_list.xls
held in file path S:\CLINICAL_TRIALS\Monitoring\Self-Monitoring
Template folder.
Check that the following have also been received with the
completed report:
 IMP accountability logs for any SDV patients have been
received,
 the current delegation log
 the current S/AE log
(check with site if they have been faxed or if these documents are
to follow as hard copies in the mail). These should also be date
stamped to confirm the date they were received by the JBRU.
Place the report and email from the site monitor and all date
stamped documents/logs received with the report in the applicable
section of the Monitor’s “self monitoring reports 2009-2010” folder in
Suite A of JBRU at Maple House.
6.2 Receipt of a PI self-monitoring form
6.2.1
6.2.2
JBRU
Follow the procedures as outlined in 6.1.1-6.1.6 above.
Ensure the CI’s site monitor and the CI have also been sent the TM/CI
Site
associated logs/documents in order to review them with the report.
Monitor
6.3 Review of the CI Self-monitoring Template by the sponsor
6.3.1
6.3.2
The JBRU Trial Monitor should aim to review each returned CI JBRU
TM
report in a timely manner.
The electronic return of the template (in word format) from a site
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should be saved in the corresponding trial eTMF folder. A second
electronic copy should then be created from this original file and
saved in the same eTMF folder but re-named as a ‘Review copy’.
This review copy file should then be saved in landscape format
and a column inserted to the right of the Date/Comments column
in sections 5.1 and 5.2. Name this new column as ‘JBRU Review’
and insert the date in the header of the column.
6.3.3
Make the document in ‘tracked change mode’ to show an edit
trail. Comments may then be added per row in the JBRU column
against the answers by the site monitor.
6.3.4
The sponsor TMF should also be reviewed at the time of the CI
self-monitoring review in order for the JBRU monitor to familiarise
themself with the trial core documents, regulatory documentation,
approved patient documents, and any amendments since the last
review period.
6.3.5
Before reviewing the report, perform a sponsor’s TMF review
using the template checklist from the S:Drive (TMF Index Review
Template) and save this in the S:Drive for the trial under Section
13.0/TMF review Check folder.
6.3.6
Check each question is answered on the report and cross
reference each response with the essential document set held in
the sponsor’s TMF. If a document is not present within the
sponsor TMF make a note to the site in the comments column to
request a copy is sent to the sponsor (where applicable to the
JBRU holding a copy).
6.3.7
If a document or version/date listed by the site does not match the
sponsor’s held copy in the TMF, make a note in the Review
column for the site to re-check their response.
If the site does not appear to hold a particular document send a
copy with the return of the reviewed report where this is feasible
or applicable.
6.3.8
If any questions are incomplete or not answered request that site
complete these ASAP and return the response following the
review. Specify a timeline in order to receive the response in a
timely manner.
6.3.9
If any potential Serious Breaches or violations are identified
during the review, the JBRU monitor must follow the JBRU SOP
on Deviations, Violations, Potential Serious Breaches, Urgent
Safety Measures and Serious Breaches. It is CI/PI’s responsibility
at each site to report an Urgent Safety Measure to the MHRA
(and REC/Sponsor) as a Substantial Amendment (Annex 2) within
3 days. Discuss any concerns with QA in the first instance for
further guidance.
6.3.10 Collate all findings from the JBRU review in section 6.0 to be
reviewed and any CAPAs implemented by site.
For minor deviations or findings provide recommendations in
section 6.0 and the JBRU Review section accordingly. (See the
‘Centralised
CAPA
summary
sheet’.doc
S:\CLINICAL_TRIALS\Monitoring\Self-Monitoring Template for
examples of previous recommendations made).
For findings or issues highlighted that may require further
investigation or action raise these with the QA Manager in the first
instance for further guidance.
6.3.11 In addition to the review of each response in the report as per
sections 5.1 and 5.2, check the delegation log, accountability logs
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and the S/AE log against the SAEs received in-house. If there are
any discrepancies with any of these documents, make a note on
the self-monitoring report review and request a response as part
of the CAPA in section 6.0.
6.3.12 When each review is completed, email the self-monitoring report
review back to the site monitor and CI, and c.c the JBRU TC &
QA Manager. Ensure a copy is also saved in the eTMF with the
email sent to site and a hard copy printed and kept in the
Monitor’s Self-Monitoring reports 2009-2010 file. If the review
highlighted any missing documents at site, attach the documents
(where applicable) with the review report email.
Use Appendix 2 email template response for the return of a
reviewed self-monitoring report to the CI site.
Request that the site acknowledge receipt of the reviewed report
by email.
6.3.13 The site should then review the comments from the JBRU and
proposed CAPA.
6.4 Review of PI Self –monitoring Reports.
6.4.1
6.4.2
Liaise with the Site monitor at the CI site. Establish if any immediate
action is required by the sponsor in relation to a potential serious
breach or a violation. The CI site monitor must follow their own SOP
for the review of the PI templates where feasible.
Ensure any review by the CI’s site monitor is copied to the JBRU
monitor and TC for sponsor oversight. Keep all correspondence
filed in the Monitor’s Self-Monitoring reports 2009-2010 folder.
JBRU
TM/CI
site
monitor
6.5 Finalisation of a CI Self-monitoring Report
6.5.1
6.5.2
6.5.3
6.5.4
6.5.5
Once site have reviewed, answered any comments and JBRU
implemented the CAPA plans it may then be signed off by the TM/CI/PI
site personnel as required on the signature template in section
7.0 of the self-monitoring report. Ensure the CI has also
completed the section for CI Concerns in section 6.0. If this is not
completed contact the CI by email to verify if any concerns are
present. File and save any response.
If an amendment or serious breach is required following the
review, then the report must be discussed with the lead TC and
QA to agree on when the report should be finalised by site.
Once the hard copy of the reviewed report has been signed off
by the Site monitor/CI, the sponsor must also sign the hard copy.
Date stamp the signature page upon it’s receipt at JBRU and
obtain signatures from the JBRU TM, TC and QA. Scan this
report and ensure a copy is filed in the eTMF.
File the wet ink hard copy in the sponsor’s TMF and transfer all
reports, logs and correspondence from that self-monitoring
exercise to the sponsor’s TMF/section 13.0.
Leave a file note in the Monitor’s Self-monitoring folder 20092010 that it has been transferred to the Sponsor’s TMF.
Return a paper copy or scanned PDF of the final signed off
report to the CI site for their records and ask them to file it in their
CI TMF.
Notify site when the next report is due, as per the risk based
monitoring strategy and a reminder to site to continue to maintain
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6.5.6
review of the document every 2 months.
Aim to update the centrally held file on the S:Drive
/Monitoring/Self-Monitoring
Template/
Centralised
CAPA
Summary document for findings of previous reviewed reports.
This should be updated regularly in order to identify trends and
common findings across the portfolio.
6.6 Procedures for performing a Site Visit
6.6.1
6.6.2
6.6.3
6.6.4
6.6.5
6.6.6
6.6.7
Upon the review of a CI self-monitoring report by the JBRU, a need JBRU TM
to visit the site may be identified,,however it must first be agreed
with the QA Manager in the first instance.
The requirements of a site visit will vary therefore the rationale for
the visit should be clearly documented before a visit request is
made and the team notified as soon as possible so that they have
time to prepare in relation to the nature of the visit and documents
required.
Use the letter in the Process Mapping 4 on the S:Drive to book a
site visit with the team. Notify the CI and site monitor. If a
pharmacy monitoring visit is also required liaise with the QA
Pharmacist at site to book this via email.
Explain in the letter the rationale for the visit and the documents
required for review e.g. medical records , CRFs for patients X, Y
and Z, site files, and any trial team training files. Propose some
potential dates that you are available and how long you will need
on site.
Before going to site, ensure you are familiar with the following
documents (as a minimum):
The current protocol, the enrolment procedure, current approved
patient documents, amendment history and all SAEs received by
the sponsor to date.
See Appendix 3 for potential documents to take to site (depending
on the nature of the site visit).
Depending on the nature of the monitoring visit, the following
documents may be necessary for review. Clarify with the QA
manager before the visit booking what should be reviewed:
All CI TMFs
All current SAEs are filed and complete and S/AE log up to date
All consent forms are present and correct
Screening, Enrolment and Master ID logs are up to date
Trial Team training logs, CVs and GCP training are up to date
Delegation of Tasks log is up to date and reconciled with trial team
CVs/GCP training records
Ensure those taking consent are delegated to do so
All CRFs are present and being maintained (e.g. AE sections)
Self-Monitoring reports are being maintained 2 monthly and
CAPAs are being implemented
CI/PI’s Log of Deviations/Violations/Potential Serious
Breaches/Urgent safety measures is being maintained
Sponsor SOPs are filed in the CI TMF and being signed off by the
team
At the site visit aim to discuss the main findings with the site
contact to clarify any discrepancies (this may help clarify some
findings). Ensure the Trial Meeting Log is signed and dated at site
to verify the visit by the JBRU monitor.
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The JBRU monitor must not deface any CRFs / source documents, use tippex,
highlighters or write on any CRFs or source documents .
6.7 Reporting of a Site Visit by JBRU
6.7.1
6.7.2
6.7.3
6.7.4
6.7.5
Ensure that all findings from the site visit are clearly documented.
Upon return to JBRU, collate all findings ready for review by the
QA Manager in the first instance.
If any potential serious breaches are confirmed at site or brought to
your attention when at site make a note of the details and gather
as much evidence as possible.
Discuss the findings with QA and and formulate an action plan
and/or prepare a Serious Breach Notification template (See
JBRU/SPON/S15/03).
Agree with QA on the format of the site visit report to be sent to the
site and resulting CAPA(s) to be implemented and any proposed
timelines.
JBRU
TM/QA
Manager
6.8 Follow up of a Site Visit
6.8.1
6.8.2
6.8.3
6.8.4
6.8.5
Liaising with the QA Manager and if necessary the Divisional
Manager, set timelines for each CAPA.
Work with the CI and team to support the achievement of the
CAPA where feasible, such as providing copies of any missing
documents.
If a further site visit is required in order to complete the review
repeat procedures in section 6.6 where applicable.
When the sponsor is satisfied the CAPA has been fully
implemented the findings may be closed.
Ensure the site continue to maintain the self-monitoring template
every two months and return the form at the next due date.
JBRU
TM/CI
6.9 Monitoring of Site close down procedures
6.9.1
6.9.2
Upon notification of the end of trial from the CI, request that the
site complete and return their final Self-monitoring template and
request evidence that all CAPAs have been addressed. If a
template was received within the last 6 months, then request
confirmation that all CAPAs are addressed.
 Confirm with the CI that:
 All trial data is complete and ready for analysis by trial
named statistician
 All essential documents are complete and filed
 All CRFs are present and complete
 IMP accountability documentation present and complete
 All consent forms are present and correct
 MHRA, REC and sponsor notified as per Declaration of
End of Trial Notification
 Final safety report is issued
 Final progress report is issued
 Report and publication copied to MHRA, REC and sponsor
within 12 months of end of trial declaration.
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JBRU
TM/TC
/CI
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
Ensure archiving arrangements are in place for site and
pharmacy
7. REFERENCES
The Medicines for Human Use (Clinical Trials) Regulations SI 2004/1031 and as
amended
EUCTD 2001/20/EC and GCP Directive 2005/28/EC
NHS R&D Forum. Distinguishing different types of Monitoring and Audit, November
2008
ICH GCP: Note for Guidance CPMP/ICH/135/95.
JBRU CI & PI Self-monitoring Templates, version 1.0
8. APPENDICES
Appendix 1:
Appendix 2:
Appendix 3:
Trial Risk-based Monitoring Strategy
Template email following the review of a self-monitoring report
Possible Documents to take to site when performing a site visit
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Appendix 1: Trial Risk-Based Monitoring Strategy
Risk-based monitoring strategy level
MINIMUM monitoring requirements
The CI together with the JBRU will determine
the risk level of the project, A, B, C or D as
defined below:
This monitoring report needs to be
maintained every second month on site by
the trial team but only sent to JBRU at the
frequency determined below:
Once a year : a year after the date on the
first signed consent form or the finalised
baseline template
A Low Risk
(e.g. a non-CTIMP non-invasive
pathophysiology/imaging )
B Medium (Similar to usual care)
(e.g. Therapeutic confirmatory use trial
(Phase III) or using a food supplement (eg.
vitamins).
Is the subject receiving the same treatment
on trial as he would be off trial? If yes, this is
level risk B
C High
(e.g. Therapeutic exploratory trial (Phase II)
D Very High (Phase I)
(e.g. gene therapy/cell therapy/first in man)
Once a year: a year after the date on the first
consent form or the finalised baseline
template
Twice a year: (six months after the date on
the first consent form and a year after the
date on the first signed consent form) or the
finalised baseline template
To be defined by the phase I/II site monitor
(and/or) project manager. The sponsor must
be sent site monitoring reports when
available. This form may also be used in
addition, and returned at the same frequency
as monitoring reports to the Sponsor.
Please complete this section:

This trial falls into category : X and this monitoring template will be sent to the
Joint UCL/UCLH R&D Office Y times a year

CI to justify why this trial falls into that category risk:

Overall recruitment total expected (as approved by the REC and MHRA): X

Overall Number recruited to date: X

Number of patients at each site: X/Y (if applicable)

Name of the person from the trial team completing this monitoring report and
acting as a site monitor (This should not be the Investigator unless the
Investigator leads the project on his/her own):
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Appendix 2
TEMPLATE EMAIL TO BE USED FOR THE REVIEW OF
a SELF MONITORING REPORT
Subject: Review of the Self-Monitoring Report
Sponsor Protocol number: XX/XXXX
PLEASE ACKNOWLEDGE RECEIPT OF THIS EMAIL.
Many thanks for returning the completed CI/PI self monitoring template to the
JBRU which was completed to a high standard. Having had the opportunity to
review the template, please find attached the monitoring template completed at
your site with the comments inserted by the JBRU monitor.
Could I please request that any points highlighted are resolved by (insert timeline)
where feasible please. We have designed the form in line with the current UK
Regulations.
Could I please draw your attention to the Corrective and Preventative Actions
(CAPA) actions section 6.0. The actions should also be addressed, with the
corrective and any preventative action undertaken at site and timelines logged in
the table accordingly.
Once the actions have been undertaken please ensure the template has been
signed off by the required personnel and please forward me a copy. It should
then be sent to the JBRU in wet ink to sign. JBRU will hold the original signed
version and a copy returned to site.
Finally may I remind you to please ensure the site monitor updates this template
every two months, saving a copy electronically at each review period. The
reviewed template only needs to be sent to the JBRU at the agreed intervals
highlighted in the risk assessment section of the template.
Attachments as listed:
Kind Regards
JBRU Trial Monitor
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Appendix 3
POSSIBLE DOCUMENTS TO PREPARE BEFORE A SITE VISIT
Sponsor’s File Review






Prepare and send the Request for Monitoring Visit Letter to CI/PI notifying
them of the intent to visit site
Perform a JBRU Trial file review to familiarise with protocol and essential
trial document set
Check all reported SAE reports and SAE logs received to date and make
a note to reconcile this with what is in the files at site
Use the JBRU file Checklist and perform a review, saving a copy on the
eTMF and printing a copy to take to site for reference
If a recent TMF review has been done use this and verify with the lead TC
if any documents have changed since the date of the latest TMF review
performed in-house, if documents have changed and site do not have a
copy please ensure it is taken with you to a site visit.
Take a copy of the current approved protocol for reference
SDV Sheets

If you are performing SDV of medical records and CRFs completed on
site, take blank copies of SDV query sheets
Monitoring History



Take a copy of the latest completed self-monitoring template from site and
review the CAPA implementation status, ensure that all CAPA(s)
recommended in the past are being implemented where applicable.
Review all self-monitoring forms completed to see the history of findings
at site
Copy(ies) of the hired site monitor monitoring report(s) (review all) which
may help with the nature of the the monitoring visit being performed.
CI Trial Master File or ISF review
 Take either a TMF or ISF checklist with you to reconcile the site file(s)
with the JBRU files and the latest self-monitoring report
Miscellaneous


Note paper, pens, highlighters, post-it notes to flag any documents for
further discussion.
Directions/map/venue/contact telephone numbers of the site personnel
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9. TEMPLATES/LOGS/SOPs ASSOCIATED TO THIS SOP:
1 CI & PI Self-Monitoring Templates
2
Appendix 1: Trial Risk-based Monitoring Strategy
3 Appendix 2: Template email following the review of a self-monitoring
report
4 Appendix 3: Possible documents to take to site when performing a site
visit
10. SOP DISSEMINATION & TRAINING
SOPs relevant to the JBRU only, will be distributed to the concerned JBRU staff,
by the named author under section 11.0 of the SOP. Staff involved by the SOP
will sign the SOP training log (Section 12. SOP TRAINING LOG) which is part of
each SOP. In addition each staff has an “Individual staff SOP training log” and will
need to update it once trained on the SOP.
In some instances, the SOP will be basic and the training will constitute of the
person reading the SOP and asking specific questions to the author of the SOP.
In some instances the staff member given training will carry out the procedure
under supervision of the author of the SOP or under supervision of a staff
member who has been trained. Both trainee and trainer will need to sign and date
the “SOP training log” in section 12 of each SOP held by the QA Manager and
the “Individual staff SOP training log”.
SOPs relevant to “JBRU staff and investigators” or investigators only will be
provided to the investigators during trial set-up where applicable and at the time
of the trial initiation.
New SOPs relevant to “JBRU staff and investigators” or investigators only will be
emailed to the investigators and their research team by the lead Trial Coordinator. The investigators will be requested to read the new SOP and email
back to acknowledge receipt and understanding of the new SOP. The email sent
to the investigators and their email acknowledging receipt and understanding of
the SOP should be printed out and filed in the JBRU SOP folder.
11. SIGNATURE PAGE
Author and Job
Title:
Ann Cochrane and Gurjinder Kahlon, JBRU Trial
Monitors
Signature:
Date:
Authorised by:
Name and Job Title
Helen Cadiou, QA Manager
Signature:
Date:
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12. SOP TRAINING LOG
SOP TRAINING LOG
Job Title:
Name of Staff (Capital letters)
Department:
Training
Date
I confirm that I
understand & agree
to work to this SOP
SIGNATURE of trainee
1
2
3
4
5
6
7
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Name of Trainer (if
applicable)
Signature
Date