S:\CLINICAL_TRIALS\SOPs\EFFECTIVE_SOPs_Guides\SPONSOR SOPs\SPON_S19_ SOP for monitoring UCL sponsored
CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
UK Regulation Compliance form (PART 2)
Protocol number
Trial Title
Name of CI / PI
Site Name
Date compliance assessment
completed:
DD/MMM/YYYY
UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
Table of Contents
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Site Contact Details: ........................................................................................................................................ 3
Risk level – For the purpose of UK Regulation Compliance Oversight (see Part 1): ...................................... 3
Recruitment Status .......................................................................................................................................... 3
Guidance on completing this TMF/ISF template: ............................................................................................ 4
Safety Recording and Reporting (Pharmacovigilance): .................................................................................. 5
MHRA, REC, R&D and Amendments: ............................................................................................................. 5
IMP Management: ........................................................................................................................................... 6
Labs & equipment: ........................................................................................................................................... 7
Research Team and Trial Conduct: ................................................................................................................. 8
Trial Oversight: ................................................................................................................................................ 9
End of trial: ....................................................................................................................................................... 9
PI/CI Proposed Corrective and Preventative Actions: ................................................................................... 10
Site to Complete: ........................................................................................................................................... 10
CI Oversight ................................................................................................................................................... 10
Signatures: ..................................................................................................................................................... 11
Source Data Verification (SDV) ..................................................................................................................... 11
Acronyms





CI: Chief Investigator
PI: Principal Investigator
TMF: Trial Master File (for CI site)
ISF: Investigator site file (for PI site)
JRO: Joint Research Office (formerly JBRU)
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
1. Site Contact Details:
Job description
Contact details
Person completing the form at site
Name:
Email Address:
Phone number:
CI / PI
Name:
Email Address:
Phone number:
Pharmacy lead:
Name:
Address:
Email Address:
Phone number:
Laboratories used for the study (central):
Name:
Address:
Email Address:
Phone number:
2. Risk level – For the purpose of UK Regulation Compliance Oversight (see Part 1):
Risk category:
A, B or C (please delete as appropriate)
The site team is to complete this document every 2 months to demonstrate to the MHRA inspector that the
PI has oversight of his Trial’s UK Regulation compliance status.
3. Recruitment Status on DD/MMM/YYYY:
Screened:
Enrolled:
Withdrawn:
Follow Up:
Completed:
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
4. Guidance on completing this TMF/ISF template:

This UK Regulation Compliance form (Part 2) is a tool designed by JRO to help the PI's teams to
assess some important aspects of the trial's compliance with the UK Regulations underlying clinical
trials in the UK.

Please complete this report electronically during the progress of the trial dependent on the risk
category defined on Page 3 of this document.

Return this form to the JRO Compliance Oversight Advisor via email along with the following
documents:
o Screening & Enrolment log,
o Delegation log,
o IMP accountability logs (single blind/ open labelled trials only)
o Log of Deviations/Violations/Potential serious breaches/Serious breaches
o SAE log

Please ensure all sections are complete prior to sending the form to the JRO for review

Kindly check that all documents have the following:
o Date
o Version Number
o Page Number

To complete the form:
o Insert Y - If a document is present in the CI / PI TMF
o Insert N – If a document is not present
o Insert Version and date for each document
o Insert NA – if Not Applicable to the trial
Please note JRO should not be sent any named patient data on any emails, reports, completed logs or
SAE reports as this is a breach of patient confidentiality.
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
5. Safety Recording and Reporting (Pharmacovigilance): Section 12 of the TMF / ISF
Site to complete
No. of SAEs recorded
Site No.
Patient No.
Date reported to JRO
No. of SUSARs recorded
Site No.
Patient No.
Date reported to JRO
No. of Urgent safety measures
recorded
Site No.
Patient No.
Date reported to JRO
JRO Review comments
(please complete for all sites if you are
the lead site CI).
Is your SAE Recording and Reporting
log up to date?
Version:
No. of entries in log:
Please send an updated copy to JRO
Blinding/Un-blinding issues:
Have any of your patients been code?
No. of code breaks:
Patients No.:
Person who has broken the code:
For blinded trials, is the unblinding SOP
filed in the TMF / ISF
Current version & date filed in the TMF /
ISF:
Have there been any changes to the
unblinding procedure or personnel?
Y/N
Development Safety Update Reports
(DSUR) : Date sent to:
MHRA:
REC:
Please note that the next DSUR is
due within a year of the initial CTA
approval date
6. MHRA, REC, R&D and Amendments: Refer to Section 3 and 4 of the TMF / ISF
Ensure all superseded versions are filed in the TMF/ISF
Current APPROVED VERSIONS:
Protocol
PIS
ICF
GP letter
Posters / Advertisements
Patient ID cards
Patient Questionnaires (e.g. QOL)
JRO REVIEW
Version/date:
Version/date:
Version/date:
Version/date:
Version/date:
Version/date:
Version/date:
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
Date on the cover letter to the REC,MHRA
and local R&D
(substantial or non substantial amendments)
List all documents and version amended and
/ or approved
If amendments were not sent to the REC/
MHRA please state why.
Have you informed your pharmacy, labs and
research team/oversight committees etc. of
amendments and is this documented to
demonstrate this?
Initial CTA Approval letter dated
Initial REC approval letter dated:
R&D approval letter dated:
Cover letter Date:
REC:
MHRA:
R&D
Annex 2 date if substantial amendment:
Amended documents:
Approval letter(s) date: :
REC:
MHRA:
R&D
Please repeat the previous rows if more
amendments were submitted since the last
report
Y/N
Method of dissemination and dates.
Annual Progress Reports:
DATE sent to the REC
DATE sent to the sponsor
Log of substantial and non-substantial
amendments present in the TMF/ISF and up
to date?
Date of the cover letter to the MHRA/REC
when the trial was declared on hold (if
applicable)
DD/MMM/YYYY
DD/MMM/YYYY
Y/N
Date:
OR
N/A
7. IMP Management: Refer to Section 7 of the TMF / ISF
Please confirm if there have been any
changes to the SmPC/IB/IMPD filed in your
TMF
List the versions of the IMP related
documents in the TMF/ISF
Please check the following website for
SmPC updates:
http://emc.medicines.org.uk/
Y/N
JRO Review
IMP Name:
IB or SmPC or IMPD?
Version date:
IMP Name:
IB or SmPC or IMPD?
Version date:
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
Have there been any deviations to the
storage temperature of the IMP(s) since trial
commencement?
(Please check with pharmacy and/or
request temperature monitoring logs and
enter dates and temperature deviations)
Have Accountability logs been requested
and reviewed from the pharmacy and are
there any discrepancies?
Y/N
If yes;
Date of temperature excursion:
IMP stock authorised for use:
ONLY FOR SINGLE BLIND / OPEN
LABELLED
Please send these forms to JRO
Cumulative accountability logs
Y/N
Patient specific
Has pharmacy got sufficient IMP for patient
treatment?
Y/N
Y/N
Has there been any subsequent QP release
of IMP?
Y/N
If yes, are documents filed?
Have there been any changes to
randomisation / prescription procedure?
Y/N
Prescription template
version and date:
8. Labs & equipment: Refer to Section 16 of the TMF / ISF
Lab reference ranges filed
Y/N
JRO Review
Kindly list all reference ranges
applicable for the study
Reference Range
Date of the reference range:
Haematology / Biochem / any others
DD/MMM/YYYY
Reference Range
Date of the reference range:
Haematology / Biochem / any others
DD/MMM/YYYY
Lab accreditation certificate(s)
Name of the Lab
Date of Accreditation:
DD/MMM/YYYY
Name of the Lab
Date of Accreditation:
DD/MMM/YYYY
Are logs being maintained for sample
storage / shipping?
Y/N
If there is a SOP for sample storage /
dispatch
Y/N
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
Have there been any changes to the
SOP?
Y/N
Have there been any changes to labs
used for sample analysis?
If Y, then update contact details section
Have the lab team been provided the
contact details in the event of any
emergency
Y/N
Y/N
9. Research Team and Trial Conduct: Refer to Section 19 of the TMF / ISF
JRO Review
As listed on delegation log
Are each team member’s CV certificate
present in the TMF/ISF
Y/N
Are each team member’s GCP
certificate present in the TMF/ISF
Y/N
Are the GCP training and CV been
updated within the past 2 years for all
team members?
Y/N
Kindly report here if any missing
Is the Delegation log updated for any
new staff?
Y/N
Has the log been initialled by all staff
Y/N
Is the Log signed & dated by CI and
team?
Y/N
(Please send copy to JRO)
Is the person completing the CRF
entered on the delegation of
responsibilities log?
Is the entire team (old and new) trained
on the study protocol and procedures?
Y/N
Are the following logs being maintained
and kept up to date?
(Please send copy of the DEVIATION
LOG to JRO)
Protocol deviation
Y/N
Master ID log
Screening log
Enrolment log
Y/N
Y/N
Y/N
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
10. Trial Oversight: Refer to Section 4 & 10of the TMF / ISF
If your trial is multi-site, have you reviewed
the PI QC templates?
Site 1 name:
Date of review
Please list dates each template was sent by
the PI and the date of sign off for each site.
Site 2 name:
Date of review
Are you recording and filing in the
TMF/ISF minutes of any relevant trial
meetings e.g. internal meetings, safety
meetings or MDT
Date of the last DMC/TMG or IDMC meeting
as per protocol or charter?
Y/N
Please check if this should also be sent
to the sponsor and that it is anonymised
before doing so.
Have there been any serious breaches of
GCP identified
Has the TMF/ISF been reviewed and
updated with all essential documents
Date of last review and update
JRO Review
DD/MMM/YYYY
Y/N
Y/N
DD/MMM/YYYY
Kindly review the TMF/ISF when
completing the compliance tool
11. End of trial:
Is trial declared ended,
Y/N
JRO review
If Yes – complete the sections below
If No – rest of the columns in Section 11
are NA
End of trial form sent to MHRA and REC?
Please ensure final clinical trial report
submitted 1 year after end of trial
notification
Has IMP accountability been performed and
provisions made for destruction / return?
Premature end of trial
notification date:
MHRA:
REC:
End of trial notification
date:
MHRA:
REC:
Y/N
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
Date accountability performed:
DD/MMM/YYYY
Is the IMP going to be destroyed at site or
returned to the sponsor?
Destruction at site /
Return to sponsor
Date returned or destroyed:
DD/MMM/YYYY
Archival arrangements for TMF/ISF
Location:
Person responsible:
TMF/ISF checklist review performed prior to
archive?
Date performed:
Y/N
DD/MMM/YYYY
12. PI/CI Proposed Corrective and Preventative Actions
Summary of findings from
Corrective and preventative
this review dated:
Action
Person
Responsible
Time line set by JRO
13. Site to Complete:
Does the CI/PI have any concerns about the trial?
E.g. recruitment rate, resources/funding, pending data, equipment, IMP
sourcing/storage/dispensing/accountability, safety recording and reporting, training, medical recording and
other trial aspect?
14. CI Oversight
If your trial is multi-site, have you reviewed
the PI QC templates?
Site 1 name:
Date of review
Please list dates each template was sent by
the PI and the date of sign off for each site.
Site 2 name:
Date of review
UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
JRO Review
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
Are you recording and filing in the
TMF/ISF minutes of any relevant trial
meetings e.g. internal meetings, safety
meetings or MDT
Y/N
Does the CI have any concerns about this
site
15. Signatures:
Please email this document to the JRO Compliance Oversight Advisor for review prior to obtaining
signatures
Job description
Print NAME
Signature & Date
Person completing the form at site
Signature
Date
CI / PI
Signature
Date
JRO trial monitor / sponsor regulatory
advisor
Signature
Date
QA manager (JRO)
Signature
Date
16. Source Data Verification (SDV)
This last section is about checking that the Medical Records (source data) contain that data
which has been recorded per patient from the point of consent to end of trial.
A. Definitions
What are Source Documents?
Original documents, data and records
e.g. hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or
evaluation checklists, pharmacy dispensing records, recorded data from automated instruments,
copies or transcriptions certified after verification as being accurate copies microfiches,
photographic negatives, microfilm or magnetic media, X-rays, subject files and records kept at
the pharmacy, at the laboratories and at medical technical apartments involved in a clinical trial.
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CTIMPs\UK Regulation Compliance Form Part 2 version 1 dated 11 Aug 2011
CONFIDENTIAL
What is Source data?
Source data: all information in original records and certified copies of original records of clinical
findings, observations or other activities in a clinical trial necessary for the reconstruction and
evaluation of the trial. Source data are contained in the source documents (original records and
certified copies)
What is Source data Verification?
Checking that data entered in the CRF is correct against information entered in the patient’s
Medical Record (MR)/ source data documents.
Data must first be entered in the source notes and then the CRF
Guidance for completing this section:
 Kindly perform SDV as stated in section B below
 This part can be handwritten
 Your data entered in the CRFs should accurately reflect this
 The Medical Records should be requested in advance of this exercise so that documents
can be checked against the CRF.
 Add as many SDV Tables as required. You should carry out data verification according to
the algorithm given by the JRO.
B. SDV algorithm (Strata Guidelines):


X % of patients to be SDVed
Patient numbers to be SDVed
Patient No: _______________________________ Date SDV performed_______________
How many visits has the patient completed as per the protocol? _________________________________
Source data Verification (SDV)
Date of consent
Date of first screening procedure
Are all medical records filed in the source file
including the latest visit:
Y/N
Comments
DD/MMM/YYYY
DD/MMM/YYYY
Report here if any missing
JRO Review
Are all records reviewed, signed and dated
by the Investigator(s) / delegate?
Lab reports
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CONFIDENTIAL
Imaging reports
Medical notes
Prescriptions
Past medical notes
Are all medical records available to
determine subject meets eligibility criteria
If for any criteria compliance cannot
be verified by a document in the file
please list here:
No. SAEs for this patient
IMP dispensed as per protocol?
(check IMP accountability log ONLY if
open labelled or single blind trial)
If no, please reason full dose not
dispensed
IMP compliance checked?
For double blinded trials – trial
pharmacist should check IMP compliance
and report discrepancies
Have any protocol deviations been
identified?
Have these been recorded in the protocol
deviation log?
Please send a copy to JRO
Have all corrections on the CRF been made
appropriately?
i.e. dated, initialled, no tippex and original
entry not obscured
Has the patient completed trial treatment and
follow up period?
If Yes,
Has the completed CRF been signed off by
the CI/PI?
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