Level 2 Sponsored Study Monitoring Report form

Study Title: / PI Name:
Sponsor: / Visit Date:
Previous Visit Date:
Site Address / QueenAlexandraHospital, 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?
  1. 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.
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.
  1. 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 completiondata quality
3.8- Have all data queries been resolved?
  1. 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 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?
  1. 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 code-breaks 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?
  1. Follow-Up Action ItemsNone

Action Item # / Patient Involved / NA / Date Issue Identified / Status / Action Item / Corrective Action Plan
  1. Follow-Up Action Items Resolved from previous visitNone

Action Item # / Patient Involved / NA / Date Issue Identified / Date Issue Resolved / Action Item / Corrective Action Plan
  1. General Comments

Signature of Monitor/Date / Printed Name and Title
Monitor:
Signature of Reviewer/Date / Printed Name and Title
R&D Manager:

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Level 2 Sponsored Monitoring Report Form V1.1, 1st March 2012