Level 2 Sponsored Study Monitoring Report form
Study Title:
PI Name:
Sponsor:
Visit Date:
Previous Visit Date:
Site Address
Queen Alexandra Hospital, Southwick Hill Road, Cosham, PO6 3LY
Research team
present & role
R&D personnel
present & role
Specify which patients notes were reviewed: (Trial number and initials).
1. Informed Consent
Yes
No
NA
Comments
(if applicable include a comment and
describe any corrective actions that were
initiated)
1.1- Was consent obtained prior to any
study procedures being conducted?
1.2- Has consent been documented in
the patient notes?
1.3- Has the date the patient was
provided with the information sheet
been documented in the patient’s notes
in order to demonstrate that sufficient
time was provided for the patient to
consent?
1.4- Do patient notes have the Clinical
Trial Sticker inside the front cover?
1.5- If yes, has this been completed?
1.6- Is a copy of the consent form filed
in the patient notes?
2. Safety Reporting (SAEs)
Yes
No
NA
Comments
(if applicable include a comment and
describe any corrective actions that were
initiated)
2.1- Check selected patients’ notes for
any identified SAEs. Are there any
unreported SAEs? If yes please give
details.
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2.2- Have all SAEs been reported to
R&D within the correct time period?
2.3- Are all SAEs recorded in the patient
medical records?
2.4- Has follow-up information been
reported?
2.5- Have any SUSARS or serious
breaches been identified? If yes, please
give details.
3. Source Data Verification / Data Consistency Checking / CRF Completion
Yes No NA Comments
(if applicable include a comment and
describe any corrective actions that were
initiated)
3.1- Is the source documentation
adequate?
3.2- Are only eligible patients being
enrolled?
3.3- Are eligibility, consent, visit dates,
study drug treatment and safety
information etc clearly recorded in the
patient notes?
3.4- Is the source data legible, original
and accurate?
3.5- Were CRFs completed properly,
legibly and on-time?
3.6- Are CRF entries accurate and
verifiable against the source
documents?
3.7- Are there any repeated errors? If
yes, please highlight these to relevant
personnel to improve CRF completion &
data quality
3.8- Have all data queries been
resolved?
4. Study Conduct / Site Personnel, Facilities & Equipment / Study Supplies
Yes No NA Comments
(if applicable include a comment and
describe any corrective actions that were
initiated)
4.1- Are site personnel adhering to the
Protocol, patient visit and treatment
schedule?
4.2- Have any protocol compliance
issues been detected?
4.3- Have all protocol deviations been
properly document & reported
appropriately?
4.4- Has there been a repeated breach
of GCP or protocol?
4.5- If yes, has this been reported
appropriately?
4.6- Does the study have a Data
Monitoring Committee?
4.7- If yes, are site personnel adhering
to the schedule?
4.8- Have there been any changes in
facilities or equipment?
4.9- Do the facilities & equipment
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remain adequate for the conduct of the
study?
4.10- Are there adequate study supplies
(CRFs, lab kits etc) available on site?
4.11- Are there any study specific
conditions listed on the Contracts
Condition Tracker?
4.12- If yes, have these been adhered
to?
4.13- Are any samples being sent to the
labs?
4.14- If yes, are lab ranges documented
and justified?
5. Study Drug Management - delete section if non CTIMP
Yes No NA Comments
(if applicable include a comment and
describe any corrective actions that were
initiated)
5.1- Has any IMP been delivered since
the last visit?
5.2- Has site / pharmacy confirmed that
the delivery note(s) was/were consistent
with IMP received and that IMP was
received in good condition?
5.3- Is there sufficient IMP on site/held
in the pharmacy?
5.4- Is IMP being managed in
accordance with site/pharmacy SOPs?
5.5- Are the drug accountability records
correct and up-to-date?
5.6- Are IMP returns being destroyed
appropriately & destruction certificates
available?
5.7- Is IMP being stored in a secure
location & under the correct storage
conditions?
5.8- Is there an automated or min/max
temperature monitoring procedure in
place?
5.9- Has the temperature stayed within
the correct range throughout the
duration of the study?
5.10- If not, has this been reported and
resolved?
5.11- Are there randomisation codebreaks available for all supplies
delivered?
5.12- Are the code-breaks intact / has
the blind been maintained?
5.13- Has study drug been re-packed
locally?
5.14- If yes, is there documented
evidence of line clearance, label
reconciliation, sample labels / master
labels?
5.15- Has all associated paperwork
been completed adequately and been
appropriately authorised?
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6. Follow-Up Action Items
None
Action Patient
Date
Status
Action Item / Corrective Action Plan
Item # Involved Issue
/ NA
Identified
7. Follow-Up Action Items Resolved from previous visit
None
Action Patient
Date
Date
Action Item / Corrective Action Plan
Item # Involved Issue
Issue
/ NA
Identified Resolved
8. General Comments
Signature of Monitor/Date
Printed Name and Title
Signature of Reviewer/Date
Monitor:
Printed Name and Title
R&D Manager:
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